CA2373983C - Systems comprising organosiloxane resins for delivering oral care substances and for prolonging such delivery - Google Patents
Systems comprising organosiloxane resins for delivering oral care substances and for prolonging such delivery Download PDFInfo
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- CA2373983C CA2373983C CA002373983A CA2373983A CA2373983C CA 2373983 C CA2373983 C CA 2373983C CA 002373983 A CA002373983 A CA 002373983A CA 2373983 A CA2373983 A CA 2373983A CA 2373983 C CA2373983 C CA 2373983C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
- A61K8/89—Polysiloxanes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C19/00—Dental auxiliary appliances
- A61C19/06—Implements for therapeutic treatment
- A61C19/063—Medicament applicators for teeth or gums, e.g. treatment with fluorides
-
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- A61K6/60—Preparations for dentistry comprising organic or organo-metallic additives
- A61K6/69—Medicaments
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- A61K6/78—Pigments
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- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/41—Amines
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- A61K8/89—Polysiloxanes
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- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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Abstract
Disclosed is a system for delivering an oral care substance to the oral cavity comprising: (a) a delivery composition comprised of: (i) an organosiloxane resin; (ii) a volatile carrier capable of solubilizing the organosiloxane resin; (iii) a rheology modifier; and (iv) at least one oral care substance; and (b) a protective composition comprised of: (i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin. Further disclosed is a system for delivering an oral care substance to the oral cavity comprising: (a) a delivery composition comprised of: (i) an organosiloxane resin; (ii) a fluid diorganopolysiloxane-based polymer; (iii) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer; (iv) a rheology modifier; and (v) at least one oral care substance;
and (b) a protective composition comprised of: (i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin. The protective composition may further comprise a fluid diorganopolysiloxane-based polymer and/or a rheology modifier. Still further disclosed is a method of using these systems.
and (b) a protective composition comprised of: (i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin. The protective composition may further comprise a fluid diorganopolysiloxane-based polymer and/or a rheology modifier. Still further disclosed is a method of using these systems.
Description
2 PCT/USOO/18189 SYSTEMS COMPRISING ORGANOSILOXANE
RESINS FOR DELIVERING ORAL CARE SUBSTANCES
AND FOR PROLONGING SUCH DELIVERY
FIELD
The present invention relates to systems for delivering oral care substances to the surfaces of the teeth and for prolonging such delivery. More specifically, the present invention relates to a system comprising a delivery composition comprising organosiloxane resins and at least one oral care substance for delivering the oral care substance, and a protective composition comprised of organosiloxane resins for prolonging the presence of the delivery composition in the oral cavity. The delivery composition forms a film on the surface to which it has been applied and provides sustained release of the oral care substance from the film for prolonged therapeutic, prophylactic, and/or cosmetic benefits. In addition, it is believed that the systems herein may further provide sustained release benefits to other oral surfaces, such as the gingival and mucosal tissues, as well as to the surfaces of the teeth.
BACKGROUND
Oral care products by which various oral care substances or actives can be delivered to the soft and hard tissues of the oral cavity have previously been known. Examples of such oral care products include, for example, brushing aids such as dentifrice products for delivery of anti-caries actives such as fluoride or other actives for the reduction of the bacteria that lead to the formation of plaque, and mouthwashes containing breath freshening actives and/or anti-bacterial actives. In addition, bleaching agents such as peroxide that can be applied directly to the surfaces of the teeth, i.e., to the tooth enamel, have been developed.
However, it has been found that such conventional product forms typically do not provide substantivity sufficient to maintain actives on the hard and soft oral tissues for a period of time sufficient to enhance or prolong the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. Neither have such conventional product forms been able to provide sustained delivery of oral care actives, without periodic reapplication at relatively short time intervals, or without a special delivery device or containment means such as a mouthpiece.
Attempts have previously been made to enhance the substantivity of whitening bleaches, bactericides, and other active components of oral care lo products. See, e.g., US patent no. 5,425,953 to Sintov et al. on June 20, 1995, in which a film forming, water-soluble cellulosic polymer is used to deliver a bleaching agent to the teeth; US patent no. 5,438,076 to Friedman et al., in which liquid methacrylate acid copolymer compositions are used to deliver a bacteriocidal pharmacological agent; and intemational Patent Appin. No.
to Huang, published as WO 97/25968 on July 24, 1997, disclosing a film-coating composition comprising cellulose and polyvinyl acetal, coumarone-indene resin, or shellac as a film former to deliver bleaches to the tooth enamel.
However, the above systems are water-soluble, i.e., they are readily dissolved by saliva, generally within about 1-3 hours after application.
Therefore, their degree of durability is low, and they cannot provide long-term delivery of the active ingredient that is present in the composition. In addition, their water-soluble nature precludes them from being used with oral care actives that would be unstable in water-based films. Sodium percarbonate is one example of such an active; it would be unstable in the high pH environment of an aqueous-based fiim.
In order to provide an applied composition with a relatively higher degree of durability, the use of protective coatings that are applied to the teeth has been described. See, US patent no. 5,401,528, to Schmidt on March 18, 1995, in which organically modified silicic acid polycondensates are deposited on the teeth, then polymerized in-situ by curing, to coat the teeth in order to protect them from plaque deposits. This system is not a true delivery system by which an active ingredient is released over time; instead, it provides a barrier by which the deieterious effect of plaque-causing bacteria may be diminished.
Although such a barrier coating may offer a benefit in terms of enhanced durability, it requires the use of special equipment and complex application;
thus, it cannot be performed at home and cannot be used for self-treatment.
Therefore, it can be seen that none of these previous developments can offer the combination of both long-term delivery of an oral care substance or active ingredient and the convenience of discrete self-treatment and home use.
Based on the foregoing, there Is a need for a convenient delivery system for various oral care substances in which th8 substantivfty of the active Ingredients is enhanced, and in which the presence of the oral care substance in the oral cavity is pmlonged to further enhance the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. None of the existing art provides all of the advantages and benefft of the pmsent invention.
SUMMARY
The present invention is directed to systems for detivering an oral care substance to the oral cavity comprising: (a) a deiivery composition comprised of:
(i) an organositoxane msin; (il) a volatile ca-rier capable of solubllizing the is organosiloxane resin; (iii) a rheology modif;er, and (lv) at least- one oral care substance; and (b) a protective cnmpositlon comprised of: (i) an organosiloxane resin; and (li) a volatile carrier capable of solubilizing the orgariositoxane resin.
The protective composiNon may furtriw aompdse a fluid diorganopotysiloxane-based polymer andlor a rheology modifier.
The present invsrttion is further directed to systems for delivering an oral oare substance to the oral cavIiy comprising: (a) a delivery composition comprised of: (i) an orqanoeiloxane resin; (G) a fluid diorganopolysiinxane-based polymer, (iii) a volatila canier capable of 8olubillzing the organosiloxane resin and the fluid dlorganopolysildxene-based polymer; (iv) a rheology modi#'ier, and 26 (v) at least one oral care substance; and (b) a proteotive oQmposition cbrnprised of. (1) an organosioxane resin; and (ii) a volattle carrier capable of solubilizing the organosAoxane resin. The pmtective compositian may further,comprise a fluid diorganopolysilox.ane-sased polymer and/or a rheoiogy moKiifier.
The present invention further is, directed to a method of using these systems.
RESINS FOR DELIVERING ORAL CARE SUBSTANCES
AND FOR PROLONGING SUCH DELIVERY
FIELD
The present invention relates to systems for delivering oral care substances to the surfaces of the teeth and for prolonging such delivery. More specifically, the present invention relates to a system comprising a delivery composition comprising organosiloxane resins and at least one oral care substance for delivering the oral care substance, and a protective composition comprised of organosiloxane resins for prolonging the presence of the delivery composition in the oral cavity. The delivery composition forms a film on the surface to which it has been applied and provides sustained release of the oral care substance from the film for prolonged therapeutic, prophylactic, and/or cosmetic benefits. In addition, it is believed that the systems herein may further provide sustained release benefits to other oral surfaces, such as the gingival and mucosal tissues, as well as to the surfaces of the teeth.
BACKGROUND
Oral care products by which various oral care substances or actives can be delivered to the soft and hard tissues of the oral cavity have previously been known. Examples of such oral care products include, for example, brushing aids such as dentifrice products for delivery of anti-caries actives such as fluoride or other actives for the reduction of the bacteria that lead to the formation of plaque, and mouthwashes containing breath freshening actives and/or anti-bacterial actives. In addition, bleaching agents such as peroxide that can be applied directly to the surfaces of the teeth, i.e., to the tooth enamel, have been developed.
However, it has been found that such conventional product forms typically do not provide substantivity sufficient to maintain actives on the hard and soft oral tissues for a period of time sufficient to enhance or prolong the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. Neither have such conventional product forms been able to provide sustained delivery of oral care actives, without periodic reapplication at relatively short time intervals, or without a special delivery device or containment means such as a mouthpiece.
Attempts have previously been made to enhance the substantivity of whitening bleaches, bactericides, and other active components of oral care lo products. See, e.g., US patent no. 5,425,953 to Sintov et al. on June 20, 1995, in which a film forming, water-soluble cellulosic polymer is used to deliver a bleaching agent to the teeth; US patent no. 5,438,076 to Friedman et al., in which liquid methacrylate acid copolymer compositions are used to deliver a bacteriocidal pharmacological agent; and intemational Patent Appin. No.
to Huang, published as WO 97/25968 on July 24, 1997, disclosing a film-coating composition comprising cellulose and polyvinyl acetal, coumarone-indene resin, or shellac as a film former to deliver bleaches to the tooth enamel.
However, the above systems are water-soluble, i.e., they are readily dissolved by saliva, generally within about 1-3 hours after application.
Therefore, their degree of durability is low, and they cannot provide long-term delivery of the active ingredient that is present in the composition. In addition, their water-soluble nature precludes them from being used with oral care actives that would be unstable in water-based films. Sodium percarbonate is one example of such an active; it would be unstable in the high pH environment of an aqueous-based fiim.
In order to provide an applied composition with a relatively higher degree of durability, the use of protective coatings that are applied to the teeth has been described. See, US patent no. 5,401,528, to Schmidt on March 18, 1995, in which organically modified silicic acid polycondensates are deposited on the teeth, then polymerized in-situ by curing, to coat the teeth in order to protect them from plaque deposits. This system is not a true delivery system by which an active ingredient is released over time; instead, it provides a barrier by which the deieterious effect of plaque-causing bacteria may be diminished.
Although such a barrier coating may offer a benefit in terms of enhanced durability, it requires the use of special equipment and complex application;
thus, it cannot be performed at home and cannot be used for self-treatment.
Therefore, it can be seen that none of these previous developments can offer the combination of both long-term delivery of an oral care substance or active ingredient and the convenience of discrete self-treatment and home use.
Based on the foregoing, there Is a need for a convenient delivery system for various oral care substances in which th8 substantivfty of the active Ingredients is enhanced, and in which the presence of the oral care substance in the oral cavity is pmlonged to further enhance the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. None of the existing art provides all of the advantages and benefft of the pmsent invention.
SUMMARY
The present invention is directed to systems for detivering an oral care substance to the oral cavity comprising: (a) a deiivery composition comprised of:
(i) an organositoxane msin; (il) a volatile ca-rier capable of solubllizing the is organosiloxane resin; (iii) a rheology modif;er, and (lv) at least- one oral care substance; and (b) a protective cnmpositlon comprised of: (i) an organosiloxane resin; and (li) a volatile carrier capable of solubilizing the orgariositoxane resin.
The protective composiNon may furtriw aompdse a fluid diorganopotysiloxane-based polymer andlor a rheology modifier.
The present invsrttion is further directed to systems for delivering an oral oare substance to the oral cavIiy comprising: (a) a delivery composition comprised of: (i) an orqanoeiloxane resin; (G) a fluid diorganopolysiinxane-based polymer, (iii) a volatila canier capable of 8olubillzing the organosiloxane resin and the fluid dlorganopolysildxene-based polymer; (iv) a rheology modi#'ier, and 26 (v) at least one oral care substance; and (b) a proteotive oQmposition cbrnprised of. (1) an organosioxane resin; and (ii) a volattle carrier capable of solubilizing the organosAoxane resin. The pmtective compositian may further,comprise a fluid diorganopolysilox.ane-sased polymer and/or a rheoiogy moKiifier.
The present invention further is, directed to a method of using these systems.
3 The present invention is further directed to the uae of an organoslloxane resin in the manufacture of a system for the delivery of an oral care substance to at least one surface of the oral Cavity_ 7he present invent3ion Is further directed 'to the use of an organosiloxane resin in the manufacture of a system for the delivery of an oral care substance to at least one surface of the oral cavity wherein the delivery oomposition comprises a teeth whitening active and wherein the oral cavity surface is enamel of the teeth.
The present invention is further dinected to the use of a sys#ern of the present invention whenein a delivery composition comprises a tooth whitening aotive.
The present invention is further direCted to the use wherein a delivery oomposition is used in. the establishment of a film on the enamel of at least one tooth.
These and other feature% aspects, and advantages of the invention will become evident to those stdlled in the art from a reading of !he present disctosure.
DETAILED DESCRlPTIOM
3a While the specification concludes with daims particularly pointing out and distinctly claiming the Invention, it is believed that the present invention w-li be better understood from the.failowing description.
All percentages and ratios used hereinafter are by weight of total comFlosition, unless otherwise indicated.
AU measurements referred to herein. are made at 25 C unless othervvise specified.
All percentages, ratios, and levels of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, ffllens, io or other materials with which the ingredierit may be combined as a aommercfally available pnxiuct, unless otherwise indicated.
f5 Herein, "comprising" means that other steps and other components which do not affect the end resuit can be added. This term encompasses the terms "consisting of" and "oonsisting essentially of."
The delivery systems herein are comprised of a delivery composition and 20 a protective composition. The delivery and proteotive compositions herein comprise.essentiai cornponents, as wett as optional components. The essentiai and optional components of these oompvsitions of the present invention are described in the fiallowing paragraphs.
The delivery cornposition herein is a cornpositjon for delivering an oral care substance to the oral cavity. The delivery camposition Wmpriws an oral care substance for provicfing a therapeutic, prophylactic, and/or cosmetic benefit to the oral cavity. One preferred embodiment of the delivery con-iposition is 30 comprised of an orr;anosltaxane resin; a votadte carrier capable of solubiEizing the organosiioxene resin; a rheotogy niodifier, and at least one oral care substance.
Another preferred embodimant of the delivery composition is comprised of an organostioxane resin; a fluid dEonganopolysiloxane-based pcafymer; a ss volatile carrier capable of solubiiizing the organosiloacane resin and the = fluid
The present invention is further dinected to the use of a sys#ern of the present invention whenein a delivery composition comprises a tooth whitening aotive.
The present invention is further direCted to the use wherein a delivery oomposition is used in. the establishment of a film on the enamel of at least one tooth.
These and other feature% aspects, and advantages of the invention will become evident to those stdlled in the art from a reading of !he present disctosure.
DETAILED DESCRlPTIOM
3a While the specification concludes with daims particularly pointing out and distinctly claiming the Invention, it is believed that the present invention w-li be better understood from the.failowing description.
All percentages and ratios used hereinafter are by weight of total comFlosition, unless otherwise indicated.
AU measurements referred to herein. are made at 25 C unless othervvise specified.
All percentages, ratios, and levels of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, ffllens, io or other materials with which the ingredierit may be combined as a aommercfally available pnxiuct, unless otherwise indicated.
f5 Herein, "comprising" means that other steps and other components which do not affect the end resuit can be added. This term encompasses the terms "consisting of" and "oonsisting essentially of."
The delivery systems herein are comprised of a delivery composition and 20 a protective composition. The delivery and proteotive compositions herein comprise.essentiai cornponents, as wett as optional components. The essentiai and optional components of these oompvsitions of the present invention are described in the fiallowing paragraphs.
The delivery cornposition herein is a cornpositjon for delivering an oral care substance to the oral cavity. The delivery camposition Wmpriws an oral care substance for provicfing a therapeutic, prophylactic, and/or cosmetic benefit to the oral cavity. One preferred embodiment of the delivery con-iposition is 30 comprised of an orr;anosltaxane resin; a votadte carrier capable of solubiEizing the organosiioxene resin; a rheotogy niodifier, and at least one oral care substance.
Another preferred embodimant of the delivery composition is comprised of an organostioxane resin; a fluid dEonganopolysiloxane-based pcafymer; a ss volatile carrier capable of solubiiizing the organosiloacane resin and the = fluid
4 diorganopolysiloxane-based polymer; a rheology modifier; and at least one oral care substance.
PROTECTIVE COMPOSITION
The protective composition acts as a protective coating to prolong the presence of the oral care substance or substances contained in the delivery composition in the oral cavity. The protective composition need not comprise an oral care substance.
One preferred embodiment of the protective composition is comprised of 1o an organosiloxane resin and a volatile carrier capable of solubilizing the organosiloxane resin. A rheology modifier may also be present.
Another preferred embodiment of the protective composition is comprised of an organosiloxane resin, a fluid diorganopolysiloxane-based polymer, a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer. A rheology modifier may also be present.
The protective composition need not comprise an oral care substance in order to act as a protective coating for the delivery composition. However, it should be noted that any of the oral care substances described herein could additionally be added to the protective composition.
It should also be noted that more than one application of the protective composition, following the application of the delivery composition, can be made.
Multiple applications of the protective composition can be made and are within the scope of the present invention.
Organosiloxane Resins Silicone resins are highly crosslinked polymeric siloxane systems. The crosslinking is introduced through the incorporation of tri-functional and tetra-functional silanes with mono-functional or di-functional, or both, silanes during manufacture of the silicone resin. As is well understood in the art, the degree of crosslinking that is required in order to result in a silicone resin will vary according to the specific silane units incorporated into the silicone resin.
In general, silicone materials which have a sufficient level of trifunctional and tetrafunctional siloxane monomer units, and hence, a sufficient level of crosslinking, such that they dry down to a rigid, or hard, film are considered to be silicone resins. The ratio of oxygen atoms to silicon atoms is indicative of the level of crosslinking in a particular silicone material. Silicone materials which
PROTECTIVE COMPOSITION
The protective composition acts as a protective coating to prolong the presence of the oral care substance or substances contained in the delivery composition in the oral cavity. The protective composition need not comprise an oral care substance.
One preferred embodiment of the protective composition is comprised of 1o an organosiloxane resin and a volatile carrier capable of solubilizing the organosiloxane resin. A rheology modifier may also be present.
Another preferred embodiment of the protective composition is comprised of an organosiloxane resin, a fluid diorganopolysiloxane-based polymer, a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer. A rheology modifier may also be present.
The protective composition need not comprise an oral care substance in order to act as a protective coating for the delivery composition. However, it should be noted that any of the oral care substances described herein could additionally be added to the protective composition.
It should also be noted that more than one application of the protective composition, following the application of the delivery composition, can be made.
Multiple applications of the protective composition can be made and are within the scope of the present invention.
Organosiloxane Resins Silicone resins are highly crosslinked polymeric siloxane systems. The crosslinking is introduced through the incorporation of tri-functional and tetra-functional silanes with mono-functional or di-functional, or both, silanes during manufacture of the silicone resin. As is well understood in the art, the degree of crosslinking that is required in order to result in a silicone resin will vary according to the specific silane units incorporated into the silicone resin.
In general, silicone materials which have a sufficient level of trifunctional and tetrafunctional siloxane monomer units, and hence, a sufficient level of crosslinking, such that they dry down to a rigid, or hard, film are considered to be silicone resins. The ratio of oxygen atoms to silicon atoms is indicative of the level of crosslinking in a particular silicone material. Silicone materials which
5 have at least about 1.1 oxygen atoms per silicon atom wtli generally be silicone resins herein. Preferably, the r=atio of oxygen:siiicon atoms is at least about 1.2:1Ø
Silicone materials and silicone resins in particuiar can convaniently be identified according to a sharthand nomeneiature system wsll known to those skilled in the art as the'MDTQ" nomenciature. Urider this system, the sificone is describsd according to the presence of various siioxane monomer units which make up the silicone. Briefly, the symbd M denotes the nnon8-fi,nctional unit (CH3)3S;OQS; D danot$s the diFunctlonai untt (CH3)2SiO: T denotes the to frifunctional unit (CH3)SiO1,5: and Q denofes the quadra- or tetra-funcnanal unit SiQ2. Note that a small amvunt, up to about 5% of siianoi or alkoxy functionality may also be presant in the resin structure as a nssult of processing.
Primes, of the unit symbols, e.g., M', D', V. and 0', denote substituents other than m+athyi, and must be specifically defined for aadl occurrence.
Typical altrmate substituents indude groupa such es vinyl, phenyi, aminb, hydroxyl, etc.
The molar ratios of the various units. ekher in term of subscripts to the symbols indicating the total number of each type of unit in the silicone, or an average thereof, or as specifically indicated ratios in combinatian with molecular weight, complete the description of the silicone mafisriai under the MDTO system.
Higher relative rnolar arnounts of T. Q. 'i' andlor 0' to O, D', M and/or M' in a siiicone resin is indicative of higher leveis of crossiinking. As discussed before, however, the overati level of crossiinking can also be indicated by the oxygen to siiican ratio.
The organosiloxane resins are solid at about= 25 C and the average molecular weight of ihs resins Is from about 1,OO0 to about 10,00U. The resins are soluble in organio solvents such as toluene, xylene, .isoparaffins, and cyclosiloxanes or the voiatiie carrier deacriiaeci Wkriy, irttticating that the reSin is not sufFiciently crmstinked such that the nssln Is insoluble in the voiatiie canfer.
The, sNieona resins preferred for use herein am MQ, MT, MTQ, and MDTQ
80 resins; such MQ resins are d'isciosed in U.S. Patant 5,330,747, Krzysik, issued July 19, 1994. Thus, the preferred silicone substituent is rnethyi, rmspeaially preferred are MO resins wherein the M:Q ratio is from sbout 0.5:1.0 to about 1.5:1Ø Organosiioxane resins such as these are convner+cfally availabie, for example, Wadcer 843"artd 8Wavaiiable trorn Wacker Siiioones Corporafion of Adrian, Mich;gan, US, and G.E. 1170-U42 -fram the General Eiecdrio Companyr
Silicone materials and silicone resins in particuiar can convaniently be identified according to a sharthand nomeneiature system wsll known to those skilled in the art as the'MDTQ" nomenciature. Urider this system, the sificone is describsd according to the presence of various siioxane monomer units which make up the silicone. Briefly, the symbd M denotes the nnon8-fi,nctional unit (CH3)3S;OQS; D danot$s the diFunctlonai untt (CH3)2SiO: T denotes the to frifunctional unit (CH3)SiO1,5: and Q denofes the quadra- or tetra-funcnanal unit SiQ2. Note that a small amvunt, up to about 5% of siianoi or alkoxy functionality may also be presant in the resin structure as a nssult of processing.
Primes, of the unit symbols, e.g., M', D', V. and 0', denote substituents other than m+athyi, and must be specifically defined for aadl occurrence.
Typical altrmate substituents indude groupa such es vinyl, phenyi, aminb, hydroxyl, etc.
The molar ratios of the various units. ekher in term of subscripts to the symbols indicating the total number of each type of unit in the silicone, or an average thereof, or as specifically indicated ratios in combinatian with molecular weight, complete the description of the silicone mafisriai under the MDTO system.
Higher relative rnolar arnounts of T. Q. 'i' andlor 0' to O, D', M and/or M' in a siiicone resin is indicative of higher leveis of crossiinking. As discussed before, however, the overati level of crossiinking can also be indicated by the oxygen to siiican ratio.
The organosiloxane resins are solid at about= 25 C and the average molecular weight of ihs resins Is from about 1,OO0 to about 10,00U. The resins are soluble in organio solvents such as toluene, xylene, .isoparaffins, and cyclosiloxanes or the voiatiie carrier deacriiaeci Wkriy, irttticating that the reSin is not sufFiciently crmstinked such that the nssln Is insoluble in the voiatiie canfer.
The, sNieona resins preferred for use herein am MQ, MT, MTQ, and MDTQ
80 resins; such MQ resins are d'isciosed in U.S. Patant 5,330,747, Krzysik, issued July 19, 1994. Thus, the preferred silicone substituent is rnethyi, rmspeaially preferred are MO resins wherein the M:Q ratio is from sbout 0.5:1.0 to about 1.5:1Ø Organosiioxane resins such as these are convner+cfally availabie, for example, Wadcer 843"artd 8Wavaiiable trorn Wacker Siiioones Corporafion of Adrian, Mich;gan, US, and G.E. 1170-U42 -fram the General Eiecdrio Companyr
6 " Trade-mark The level of the resin that is used in the rompo9itions is dependent on its degree of sotubiltty in the formulation, particularly in the solvents used.
Genetaily. the range of resin used In the present invention Is from about 5%
to about 70%, preferably from about 15% to about 45%,. and even more preferably from about 20% to about 40%.
FluisiDjaraanQp t~if pty~--based Pnlymers In addition to the organosifoxane resins disclosed above, the compositlons of the present inverttion may further comprise a ffuid so diorganopolyskxane-based polymer to ~be combined with the organosiloxane resins_ Said fluid diorganopolysUoxane-based polymers useful In the present Invention span a targe range of viscoai#iaa; from about 10 to about 10,000,000 centistokes (r.St) at 25 C. Some diorganopolysfloxf3ne poiymei's useful' in this invention exhibit viscosities greater than 10,000,000 centisiokes (cSt) at 25 'C
and therafore are charaatesized by manufactiurer,specific penetration testing.
Examples of this character9zation are GE siticons"materzals SE Wand SE 83*
with penetration specifications of 500-1500 srtd 250-600 (tenths of a millimeter) respectively.
Among the fluid diorganopolysdbxana-based polymeis of the present inventiort are diorgdnopotysifoxane polymers conq3rising repeating units, where said units corrlespond to the formufa (R2Sic0),,, where R is a monovalent, hydrocarbon radical containing from 1 to 6 carbon atoms, preferably selected from the graup consisting of inethy1, sthyl, propyl, isopropyt, butyl, Iso.butyl, t.
butyl, amyl, 'hexyi, . vinyl, allyi, cydohexyl, amino alkyl, phenyl, iiuonoalkyl and 26 -sWres thereof. The polymet is comprised of repeating units of the fnrrnuta RaSiO
and the subscript 'n' In the above formula (RsSip)õ is the number of such repeat,ing units in the polymer.
~
* 'frade-mark 25 The fluid diorganopolysiioxane polymers employed in the preserit invention. may contain one or mors of these hydrocarbon radicals as substituents on the siloxane polymer backbone. The fluid diorgenopoiysitoxane polymers may bo terminated by tHorganosiiyi groups of the formula (R'3Si) where R' is a radical selected from the group consisting of monovalent hydrocarbons ao containing from 1-6 carbon atoms, hydroxyl groups, atkoxyi groups and mixtures thereof. The fluid d9organopolysiloxane poiyrner must be oampatibie in solution with the organosiioxane resin and the volatile carrier. The term "compatibie refers to the fomk-it9on of a single phase solution when the fluid diorganopolysitoxane polymer, the organosiloxane resin arnd the votatiie carrier ss are mnced together in ratios required for a specific formulation. For exampie, the lower visoosity fluid diorganopoiysiioxane polymers (viscosity of about 10 to 7a lOOcSt.) are particularly useful when using ethanol as the principal volatile carrier. For higher viscosity polymers, e.g., poly(dimethylsiloxane), herein referred to as PDMS or silicone gum, having a viscosity of at least 100,000 cSt, volatile carriers other than ethanol are preferred.
Silicone gum corresponds to the formula:
-- -S i-O-- -R
where R is a methyl group.
Fluid diorganopolysiloxane polymers such as these are commercially available, for example, SE 30 silicone gum and SF96 silicone fluid available from the General Electric Company. Similar materials can also be obtained from Dow Corning and from Wacker Silicones.
Another fluid diorganosiloxane-based polymer preferred for use in the present invention is a dimethicone copolyol to modify film forming characteristics as desired. The dimethicone copolyol can be further characterized as polyalkylene oxide modified polydimethysiloxanes, such as manufactured by the Witco Corporation under the trade name Silwet. Similar materials can be obtained from Dow Corning, Wacker Silicones and Goldschmidt Chemical Corporation as well as other silicone manufacturers.
In preferred embodiments of the present invention, the ratio of organosiloxane resin to fluid diorganopolysiloxane-based polymer is preferably from about 15:1 to about 1:15, more preferably from about 2:1 to about 8:1, and still more preferably from about 4:1 to about 6:1.
Volatile Carriers In the present invention, the organosiloxane resin and the fluid diorganosiloxane-based polymer above must be easily transferred to the oral cavity surfaces, such as to the tooth enamel. To achieve delivery, it is necessary that the resin or the resin/polymer combination above be incorporated into a carrier, specifically a volatile carrier which must quickly volatilize from the oral cavity surfaces, leaving a film on the application surfaces. The volatile carrier must solubilize the organosiloxane resin and if present in the composition, the fluid diorganosiloxane-based polymer.
The volatile camier comprises fram about 10% to about 9096, preferably from about 15% to about 80%, and more preferably from about 20% to about 70% of the composition. The.votatile carrier of the present invention is selected from the group consisting of hydrocarbon oils, voiati>e siiicones, non-hydrocarbon solvents, and mixtures thereof.
Hydrocarbon ols useful in the present invention include those having boling points In the range of 60-260'C. rnore preferably hydrexcarbon oils having from about C8 to about C20 chain lengths, most pre+ferabiy C5 to C20 isoparatfins. Of these isoparaf5ns most praferred are seiected from the group io oonsisting of isadodecane, isohexadewne, isoeocosane, 2,2.44rimethylpentane, 2,3-dimethythexane and mixtures thereof. Most preferred is isocieodecane, avaRabie as, for example, Pennsethyl B9AF from Pemnethyl Corporation corresponding to the formula:
CH3(CH2)1 p CH3 Preferred voiatfle siiioone fluids include cyck-methicones having 3, 4 and 5 rnembered ring structures corresponding to the fnrmula-, qH3 (qi_ 4)x where X ls from about 3 to about 6. Such votatlle silioones include 244 Fiuid%
344 Fluid and 245 Fluid,' and 345 Flvid all from Dow Coming Corporation.
The general dasses of non-hydrqcarbon soivents useful herein Include esten3, ketones. alcohols, fluorrmcarfions and ifuorocarbon ethers having boiling 2!i points in the range of 50 to 240 C. NQn-hydrocarbon solvents or mixtures thereof parfic.ularly useful inciude tho3c that are capsbfe of solubitizing'the resin andfor the diorganopoiyslioxsne-based polymer. Such soivents include but are not limited to ethanol, acetone, butanone, ethyi acetate, propyl acetate, amyi acetate, ethyl butyrate, methyl ncxnaffuoroisobutyl ether, methyi nonafluorotwiyl aa - ether, and mixtures thereof. These non-hydrocaarbon sohrents are readily avapabie sualt aS sthyl amtate and methyl ethyl ketone, both supplied by J. T.
* Trade-maric g Baker of Phillispburg, NJ, and HFE (a niacture of methyl nonafluonoisobutyl ether and methyl nonafluorobutyl ether), supplied by the 3M Company.
Rh~io.gv Modif~
fi The compositions further comprise a rheology modifier which inhibits seftiing and separation of components or controls settling in a manner which #aca"fitstes re-dispersion and may control rheotogical flow properties.
Suitable rheology modifiers herein include organo modified clays, sdicas, polyethylene, and m;xtures thereof. The preferted organophiliC clays comprise quaternium-18 9o hectorite or Stearalkonium hectorits, such as t3entone 27 and 38' ftm Rheox, organoday dispersion such as Bentone ISD gel "m; or bentonite organo modified clays such as Bentone 347"' from Rheox or the Claytctne SeriesI from Souftrn.
Clay Products; and mixtures thereof. The prefetred eAicas may be fumed silica such as the Aerosil T"" series from Degussa or the Cab-Q-sil T'A series from Cabot is Corporation, sllica geis 9uch as the Sylodent *1" or Syiax TM' series from W. R.
Grace & Co. or precipitated silica such as Zeothix 265*frorn J- M. Huber Corporation.
The rheology rnadifier is preferably present in the compo$ition at a level of from about 0.1 "/o to about 34%, preferably frarn about 0.5%. to about 10%, and 2o even more preferably about 1% to about 3% of the composition_ (?ral Care Su nces The oral care substance preferably contains=an active at a level where upon directed use, the benefit sought by the wearer fs promoted without 26 detrirmnt to the oral surface to which it is appGed. Examples of the orai conditions these actives address indude, but, are not limited to, appe>aranoe and Structural changes to teoth, whitening, stain bleaching, stain remavai; plaque rernoval, tartar rernpvat; cevity prevention and treatment, inflarned and/or bleeding gums, mucosal wounds, lesions, uicom, aphthaus ulcers, cold sores, 30 tooth abscesses, and the elirnination of mouth malodor resul6r,g from the conditions above and other causes such as rnicrobial proliferation.
Suitable oral care substances inclyde Dny material that is generaiiy considered safe far use in the oral .cavity and that provides changes to the overall appearance andJor health of the orai cavity. The level of oral care a5 substance in the eompasitions of the pesesent invention is genera[ly, unless specificaity noted, from about 0.01% to about 5096, pn:ferably fnxn aboeat 0,1%
" Trade-rnark to about 20%, more preferably from about 0.5% to about 10%, and even more preferably from about 1 % to about 7%, by weight of the composition.
Oral care compositions or substances of the present invention may include many of the actives previously disclosed in the art. The following is a non-limiting list of oral care actives that may be used in the present invention.
1. Teeth WhitenincActives Teeth whitening actives may be included in the oral care substance of the present invention. The actives suitable for whitening are selected from the group consisting of the peroxides, metal chlorites, perborates, percarbonates, 1o peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Most preferred is carbamide peroxide. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite.
Additional whitening actives may be hypochlorite and chlorine dioxide. The preferred chlorite is sodium chlorite. A preferred percarbonate is sodium percarbonate. Preferred persulfates are xones.
2. Anti-tartar Aqents Anti-tartar agents known for use in dental care products include phosphates. Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. Pyrophosphates are among the best known for use in dental care products. Pyrophosphate and polyphosphate ions are delivered to the teeth derive from pyrophosphate polyphosphate salts. The pyrophosphate salts useful in the present compositions include the dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof. Disodium dihydrogen pyrophosphate (Na2H2P2O7), tetrasodium pyrophosphate (Na4P2O7), and tetrapotassium pyrophosphate (K4P207) in their unhydrated as well as hydrated forms are the preferred species. While any of the above mentioned pyrophosphate salts may be used, tetrasodium pyrophosphate salt is preferred. Sodium polyphosphate and triethanolamine polyphosphates, for example, are preferred.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 17, Wiley-lnterscience Publishers (1982). Additional anticalculus agents include pyrophosphates or polyphosphates disclosed in U.S. Patent No. 4,590,066 issued to Parran & Sakkab on May 20, 1986; polyacrylates and other polycarboxyEates such as those disclosed in U.S. Patent No. 3,429,963 Issued to Shedlovsky on February 25, 1969 artd U.S. Patent No. 4,304,766 issued to Chang on December 8, 1981; and U.S. Patent No. 4,661,341 issued to Benedict & Sunberg on Apri! 28, 1987; polyepoxysuccinates such as thase disclosed in s U.S. Patent No. 4,846,650 issued to Benedict, Bush & Sunberg on July 11, 1989; ethylenediaminetetraacetic acid as disclosed in British Patent No.
490,384 dated February 15, 1937; nrtrilotriaceac acid and related compounds as disclosed In U.S. Pgtent No. 3,678,154 issued to Widder & Briner on July 18, 1972; potyphosphonates as disclosed in U.S. Patent No. 3,737,533 issued to ao Francis on June 5, 1973, U.S. Patent No. 3,988,443 issued to Ptoger.
Schmidt-Dunker & Gioxhuber on October 26. 1976 and U.S. Patent No. 4,877,603 issued to Degenhardt & Kozikowski on October 31, 1989. Anticalculus phosphates Include potassium and sodium pyrophosphates; sadium tripolyphosphate;
diphosphonates. such as ethane-l-hydnoxy1,1-diphosphonate, 1-is azacycloheptarle-l,l-diphosphonate, and linear alkyl diphosphonates; linear carboxylic acids: and sodiurr121nc citrate.
Agents that may be used In place of or in combination with the pyrophosphate saft include such known materials as synthetic anionic polymers induding polyacrylates and copolymers of maleic anhydride or acid and methyl 2o vinyl ether (e.g., +Gantrezj, as described, for example, in U.S. Patent 4,627,977, to Gatfiar at al.; as weit as, e.g., poly$mino propoane sulfonic acic! (AMPS), zinc citrate trihydrate, polyphosphates (e.g., tripoiyphosphate; -hexametaphosphate), diphosphonates (e.g.. EHDP; AHP). polypeptides (such as polyaapartic and polyglutamic acids), and mixtures thereof.
26 3. F'luo ' ion Squ=, Fluoride ion sources are well known for use in oral care compositions as antiaaries agents. Fluoride ions 'are oontained In a number of oral care compositions for this purpose, particularly toothpasteg. Patents disclosing such toothpastes include U.S. Pat No. 3,538,230, Nov. 3. 1970 to Pader et at; U.S.
so F'at. No. 3,689.637, 3ept. 5, 1972 to Pader; U.S. Pat. Na. 3,711,604. Jan 16, 1973 to Colodney et al; U.S. Pat. No. 3.911,104, Oct. 7, 1975 to Harrison;
U.S.
Pat. No. 3,935,306, Jan. 27, 1976 to Roberts et al; and U.S. Pat. No_ 4,040,858, Aug. 9, 1977 to Wason.
Applioatlon of liuoride ians to dental ename! serves to protect teeth 35 . againet decay. A wide variety of ffiuoride ion yielding materiai9 can be employed as soun;as of soluble fluoride in the instant compovsitions: Examples of suitable " Trade-mark fltsoride ion-yieiding materials are found In Briner at al; U.S. Pat. No.
3,535,421;
issued Oct. 20, 1970 and Widder et al; U.S. Pat. No. 3,678.154; issued July 18, 1972. Preferred fluoride ion sources for use herein inciude svdiurn fluoride, potassium fluoride and ammonium fluoride. Sodium fluoride Is particuiarty S preferred. Pref"biy the Instant cofnpositions provide from about 50 ppm to 90,000 ppm, more preferably from about 100 to 3000 ppm, of fluoride Ions in the compositions that contact dental suifaces when used with the defivery system of the present invention.
4. Anti-microbial Aaents ta Anti-mictobiai agents can also be present in the oral care composifians or substances of the present invention. Such agents may include, but are not iimi#ed to, 5-chlero-2-(2,4-dichiorophenoxy)-phenol, commonly referred to as triciosan, and described in "[lie MeTA Index 11th ed. (1989). pp. 1529 (entry no:
9573) in U.S. Patent No. 3,506,720, and in European Patent Appiicafion No.
is 0,251,591 of Beecham Group, PLC, published January 7, 1988; phthalic acid and its salts inciuding, but not iirnited to those disclosed in U.S. F'at.
4,994,262, Feb. 19, 1991, prefsrabfy magnesium monopotassium phthaiate, chiwhexidine (Merch Index, no. 2090), alexidine (Merok Index. no. 222; hexetidine (M-qmk Index, no. 4524); sanguinarine (Merck.index. no. 8320); benzalkonium chloride 20 (MoM index. no. 1488); saiicytaniiide (Merck lradm, no. 8299); domiphen bromide (Merck Index, no. 3411); cetyipyridinium chioricie (CPC) (Merek lrdõP.x.
no. 2024; tetr8decyipyridinium chioride (TPC); N-tetradecyl-4-ethyipyridinium chloride (TDi=PC);. cx tenidine; de4 mopinoi, oetapinoi, and othet piperidinp derivatives; nicin preparations; zinclstannmis ion agents; antibiotics such as 25 augmentin, amoxiciliin, tetracydine, doxycyciine, minocycline, and metrQrudazote; and analogs and. salts of the above; essential oiis including thymol, geranioi, carvacroi, citral, hinoFatioi, eucalyptoi, catechol (particufarly 4 allyt catechof) and mixtures thereof; methyl saiicyiate; hydroVen peroxide;
metgi salts of cHorite and mixtures of all of the above.
30 S. (jnti4n8ammgYQry Agents Anti-inflammatory agents can also be present in the oral care eompositions or substanaes of=the present invention. Such agents may include, but are not Iimited to, non-steroidai anti-inflammatory agents or NSAIDs such as ketoroiac, flurbiprofen. ibuprofen, naproxen: indQnYethacin, aspirin;
ketoprofen.
s5 p4roxicam and meclofenamlc acid. klse of NSAIDs such as Ketorolac are ciairned in U.S. Patent 5,626,838, issued May 6, 1997. Disciosed= therein are " Trade-mark methods of preventing and, or treating primary and reoccurring squamous cell carcinoma of the oral cavity or oropharynx by topical administration to the oral cavity or oropharynx an effective amount of an NSAID.
6. Nutrients Nutrients may improve the condition of the oral cavity and can be included in the oral care compositions or substances of the present invention.
Nutrients include minerals, vitamins, oral nutritional supplements, enteral nutritional supplements, and mixtures thereof.
Minerals that can be included with the compositions of the present 1o invention include calcium, phosphorus, fluoride, zinc, manganese, potassium and mixtures thereof. These minerals are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St.
Louis, Mo., 1997, pp10-17.
Vitamins can be included with minerals or used separately. Vitamins include Vitamins C and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid, nicotinamide, pyridoxine, cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures thereof. Such vitamins are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 3-10.
Oral nutritional supplements include amino acids, lipotropics, fish oil, and mixtures thereof, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 54-54e.
Amino acids include, but, are not limited to L-Tryptophan, L-Lysine, Methionine, Threonine, Levocarnitine or L- carnitine and mixtures thereof. Lipotropics include, but, are not limited to choline, inositol, betaine, linoleic acid, linolenic acid, and mixtures thereof. Fish oil contains large amounts of Omega-3 (N-3) Polyunsaturated fatty acids, eicosapentaenoic acid and docosahexaenoic acid.
Entenal nutritional supplements include, but, are not limited to protein products, glucose polymers, corn oil, safflower oil, medium chain triglycerides as 3o disclosed in Druca Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 55-57.
Genetaily. the range of resin used In the present invention Is from about 5%
to about 70%, preferably from about 15% to about 45%,. and even more preferably from about 20% to about 40%.
FluisiDjaraanQp t~if pty~--based Pnlymers In addition to the organosifoxane resins disclosed above, the compositlons of the present inverttion may further comprise a ffuid so diorganopolyskxane-based polymer to ~be combined with the organosiloxane resins_ Said fluid diorganopolysUoxane-based polymers useful In the present Invention span a targe range of viscoai#iaa; from about 10 to about 10,000,000 centistokes (r.St) at 25 C. Some diorganopolysfloxf3ne poiymei's useful' in this invention exhibit viscosities greater than 10,000,000 centisiokes (cSt) at 25 'C
and therafore are charaatesized by manufactiurer,specific penetration testing.
Examples of this character9zation are GE siticons"materzals SE Wand SE 83*
with penetration specifications of 500-1500 srtd 250-600 (tenths of a millimeter) respectively.
Among the fluid diorganopolysdbxana-based polymeis of the present inventiort are diorgdnopotysifoxane polymers conq3rising repeating units, where said units corrlespond to the formufa (R2Sic0),,, where R is a monovalent, hydrocarbon radical containing from 1 to 6 carbon atoms, preferably selected from the graup consisting of inethy1, sthyl, propyl, isopropyt, butyl, Iso.butyl, t.
butyl, amyl, 'hexyi, . vinyl, allyi, cydohexyl, amino alkyl, phenyl, iiuonoalkyl and 26 -sWres thereof. The polymet is comprised of repeating units of the fnrrnuta RaSiO
and the subscript 'n' In the above formula (RsSip)õ is the number of such repeat,ing units in the polymer.
~
* 'frade-mark 25 The fluid diorganopolysiioxane polymers employed in the preserit invention. may contain one or mors of these hydrocarbon radicals as substituents on the siloxane polymer backbone. The fluid diorgenopoiysitoxane polymers may bo terminated by tHorganosiiyi groups of the formula (R'3Si) where R' is a radical selected from the group consisting of monovalent hydrocarbons ao containing from 1-6 carbon atoms, hydroxyl groups, atkoxyi groups and mixtures thereof. The fluid d9organopolysiloxane poiyrner must be oampatibie in solution with the organosiioxane resin and the volatile carrier. The term "compatibie refers to the fomk-it9on of a single phase solution when the fluid diorganopolysitoxane polymer, the organosiloxane resin arnd the votatiie carrier ss are mnced together in ratios required for a specific formulation. For exampie, the lower visoosity fluid diorganopoiysiioxane polymers (viscosity of about 10 to 7a lOOcSt.) are particularly useful when using ethanol as the principal volatile carrier. For higher viscosity polymers, e.g., poly(dimethylsiloxane), herein referred to as PDMS or silicone gum, having a viscosity of at least 100,000 cSt, volatile carriers other than ethanol are preferred.
Silicone gum corresponds to the formula:
-- -S i-O-- -R
where R is a methyl group.
Fluid diorganopolysiloxane polymers such as these are commercially available, for example, SE 30 silicone gum and SF96 silicone fluid available from the General Electric Company. Similar materials can also be obtained from Dow Corning and from Wacker Silicones.
Another fluid diorganosiloxane-based polymer preferred for use in the present invention is a dimethicone copolyol to modify film forming characteristics as desired. The dimethicone copolyol can be further characterized as polyalkylene oxide modified polydimethysiloxanes, such as manufactured by the Witco Corporation under the trade name Silwet. Similar materials can be obtained from Dow Corning, Wacker Silicones and Goldschmidt Chemical Corporation as well as other silicone manufacturers.
In preferred embodiments of the present invention, the ratio of organosiloxane resin to fluid diorganopolysiloxane-based polymer is preferably from about 15:1 to about 1:15, more preferably from about 2:1 to about 8:1, and still more preferably from about 4:1 to about 6:1.
Volatile Carriers In the present invention, the organosiloxane resin and the fluid diorganosiloxane-based polymer above must be easily transferred to the oral cavity surfaces, such as to the tooth enamel. To achieve delivery, it is necessary that the resin or the resin/polymer combination above be incorporated into a carrier, specifically a volatile carrier which must quickly volatilize from the oral cavity surfaces, leaving a film on the application surfaces. The volatile carrier must solubilize the organosiloxane resin and if present in the composition, the fluid diorganosiloxane-based polymer.
The volatile camier comprises fram about 10% to about 9096, preferably from about 15% to about 80%, and more preferably from about 20% to about 70% of the composition. The.votatile carrier of the present invention is selected from the group consisting of hydrocarbon oils, voiati>e siiicones, non-hydrocarbon solvents, and mixtures thereof.
Hydrocarbon ols useful in the present invention include those having boling points In the range of 60-260'C. rnore preferably hydrexcarbon oils having from about C8 to about C20 chain lengths, most pre+ferabiy C5 to C20 isoparatfins. Of these isoparaf5ns most praferred are seiected from the group io oonsisting of isadodecane, isohexadewne, isoeocosane, 2,2.44rimethylpentane, 2,3-dimethythexane and mixtures thereof. Most preferred is isocieodecane, avaRabie as, for example, Pennsethyl B9AF from Pemnethyl Corporation corresponding to the formula:
CH3(CH2)1 p CH3 Preferred voiatfle siiioone fluids include cyck-methicones having 3, 4 and 5 rnembered ring structures corresponding to the fnrmula-, qH3 (qi_ 4)x where X ls from about 3 to about 6. Such votatlle silioones include 244 Fiuid%
344 Fluid and 245 Fluid,' and 345 Flvid all from Dow Coming Corporation.
The general dasses of non-hydrqcarbon soivents useful herein Include esten3, ketones. alcohols, fluorrmcarfions and ifuorocarbon ethers having boiling 2!i points in the range of 50 to 240 C. NQn-hydrocarbon solvents or mixtures thereof parfic.ularly useful inciude tho3c that are capsbfe of solubitizing'the resin andfor the diorganopoiyslioxsne-based polymer. Such soivents include but are not limited to ethanol, acetone, butanone, ethyi acetate, propyl acetate, amyi acetate, ethyl butyrate, methyl ncxnaffuoroisobutyl ether, methyi nonafluorotwiyl aa - ether, and mixtures thereof. These non-hydrocaarbon sohrents are readily avapabie sualt aS sthyl amtate and methyl ethyl ketone, both supplied by J. T.
* Trade-maric g Baker of Phillispburg, NJ, and HFE (a niacture of methyl nonafluonoisobutyl ether and methyl nonafluorobutyl ether), supplied by the 3M Company.
Rh~io.gv Modif~
fi The compositions further comprise a rheology modifier which inhibits seftiing and separation of components or controls settling in a manner which #aca"fitstes re-dispersion and may control rheotogical flow properties.
Suitable rheology modifiers herein include organo modified clays, sdicas, polyethylene, and m;xtures thereof. The preferted organophiliC clays comprise quaternium-18 9o hectorite or Stearalkonium hectorits, such as t3entone 27 and 38' ftm Rheox, organoday dispersion such as Bentone ISD gel "m; or bentonite organo modified clays such as Bentone 347"' from Rheox or the Claytctne SeriesI from Souftrn.
Clay Products; and mixtures thereof. The prefetred eAicas may be fumed silica such as the Aerosil T"" series from Degussa or the Cab-Q-sil T'A series from Cabot is Corporation, sllica geis 9uch as the Sylodent *1" or Syiax TM' series from W. R.
Grace & Co. or precipitated silica such as Zeothix 265*frorn J- M. Huber Corporation.
The rheology rnadifier is preferably present in the compo$ition at a level of from about 0.1 "/o to about 34%, preferably frarn about 0.5%. to about 10%, and 2o even more preferably about 1% to about 3% of the composition_ (?ral Care Su nces The oral care substance preferably contains=an active at a level where upon directed use, the benefit sought by the wearer fs promoted without 26 detrirmnt to the oral surface to which it is appGed. Examples of the orai conditions these actives address indude, but, are not limited to, appe>aranoe and Structural changes to teoth, whitening, stain bleaching, stain remavai; plaque rernoval, tartar rernpvat; cevity prevention and treatment, inflarned and/or bleeding gums, mucosal wounds, lesions, uicom, aphthaus ulcers, cold sores, 30 tooth abscesses, and the elirnination of mouth malodor resul6r,g from the conditions above and other causes such as rnicrobial proliferation.
Suitable oral care substances inclyde Dny material that is generaiiy considered safe far use in the oral .cavity and that provides changes to the overall appearance andJor health of the orai cavity. The level of oral care a5 substance in the eompasitions of the pesesent invention is genera[ly, unless specificaity noted, from about 0.01% to about 5096, pn:ferably fnxn aboeat 0,1%
" Trade-rnark to about 20%, more preferably from about 0.5% to about 10%, and even more preferably from about 1 % to about 7%, by weight of the composition.
Oral care compositions or substances of the present invention may include many of the actives previously disclosed in the art. The following is a non-limiting list of oral care actives that may be used in the present invention.
1. Teeth WhitenincActives Teeth whitening actives may be included in the oral care substance of the present invention. The actives suitable for whitening are selected from the group consisting of the peroxides, metal chlorites, perborates, percarbonates, 1o peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Most preferred is carbamide peroxide. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite.
Additional whitening actives may be hypochlorite and chlorine dioxide. The preferred chlorite is sodium chlorite. A preferred percarbonate is sodium percarbonate. Preferred persulfates are xones.
2. Anti-tartar Aqents Anti-tartar agents known for use in dental care products include phosphates. Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. Pyrophosphates are among the best known for use in dental care products. Pyrophosphate and polyphosphate ions are delivered to the teeth derive from pyrophosphate polyphosphate salts. The pyrophosphate salts useful in the present compositions include the dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof. Disodium dihydrogen pyrophosphate (Na2H2P2O7), tetrasodium pyrophosphate (Na4P2O7), and tetrapotassium pyrophosphate (K4P207) in their unhydrated as well as hydrated forms are the preferred species. While any of the above mentioned pyrophosphate salts may be used, tetrasodium pyrophosphate salt is preferred. Sodium polyphosphate and triethanolamine polyphosphates, for example, are preferred.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 17, Wiley-lnterscience Publishers (1982). Additional anticalculus agents include pyrophosphates or polyphosphates disclosed in U.S. Patent No. 4,590,066 issued to Parran & Sakkab on May 20, 1986; polyacrylates and other polycarboxyEates such as those disclosed in U.S. Patent No. 3,429,963 Issued to Shedlovsky on February 25, 1969 artd U.S. Patent No. 4,304,766 issued to Chang on December 8, 1981; and U.S. Patent No. 4,661,341 issued to Benedict & Sunberg on Apri! 28, 1987; polyepoxysuccinates such as thase disclosed in s U.S. Patent No. 4,846,650 issued to Benedict, Bush & Sunberg on July 11, 1989; ethylenediaminetetraacetic acid as disclosed in British Patent No.
490,384 dated February 15, 1937; nrtrilotriaceac acid and related compounds as disclosed In U.S. Pgtent No. 3,678,154 issued to Widder & Briner on July 18, 1972; potyphosphonates as disclosed in U.S. Patent No. 3,737,533 issued to ao Francis on June 5, 1973, U.S. Patent No. 3,988,443 issued to Ptoger.
Schmidt-Dunker & Gioxhuber on October 26. 1976 and U.S. Patent No. 4,877,603 issued to Degenhardt & Kozikowski on October 31, 1989. Anticalculus phosphates Include potassium and sodium pyrophosphates; sadium tripolyphosphate;
diphosphonates. such as ethane-l-hydnoxy1,1-diphosphonate, 1-is azacycloheptarle-l,l-diphosphonate, and linear alkyl diphosphonates; linear carboxylic acids: and sodiurr121nc citrate.
Agents that may be used In place of or in combination with the pyrophosphate saft include such known materials as synthetic anionic polymers induding polyacrylates and copolymers of maleic anhydride or acid and methyl 2o vinyl ether (e.g., +Gantrezj, as described, for example, in U.S. Patent 4,627,977, to Gatfiar at al.; as weit as, e.g., poly$mino propoane sulfonic acic! (AMPS), zinc citrate trihydrate, polyphosphates (e.g., tripoiyphosphate; -hexametaphosphate), diphosphonates (e.g.. EHDP; AHP). polypeptides (such as polyaapartic and polyglutamic acids), and mixtures thereof.
26 3. F'luo ' ion Squ=, Fluoride ion sources are well known for use in oral care compositions as antiaaries agents. Fluoride ions 'are oontained In a number of oral care compositions for this purpose, particularly toothpasteg. Patents disclosing such toothpastes include U.S. Pat No. 3,538,230, Nov. 3. 1970 to Pader et at; U.S.
so F'at. No. 3,689.637, 3ept. 5, 1972 to Pader; U.S. Pat. Na. 3,711,604. Jan 16, 1973 to Colodney et al; U.S. Pat. No. 3.911,104, Oct. 7, 1975 to Harrison;
U.S.
Pat. No. 3,935,306, Jan. 27, 1976 to Roberts et al; and U.S. Pat. No_ 4,040,858, Aug. 9, 1977 to Wason.
Applioatlon of liuoride ians to dental ename! serves to protect teeth 35 . againet decay. A wide variety of ffiuoride ion yielding materiai9 can be employed as soun;as of soluble fluoride in the instant compovsitions: Examples of suitable " Trade-mark fltsoride ion-yieiding materials are found In Briner at al; U.S. Pat. No.
3,535,421;
issued Oct. 20, 1970 and Widder et al; U.S. Pat. No. 3,678.154; issued July 18, 1972. Preferred fluoride ion sources for use herein inciude svdiurn fluoride, potassium fluoride and ammonium fluoride. Sodium fluoride Is particuiarty S preferred. Pref"biy the Instant cofnpositions provide from about 50 ppm to 90,000 ppm, more preferably from about 100 to 3000 ppm, of fluoride Ions in the compositions that contact dental suifaces when used with the defivery system of the present invention.
4. Anti-microbial Aaents ta Anti-mictobiai agents can also be present in the oral care composifians or substances of the present invention. Such agents may include, but are not iimi#ed to, 5-chlero-2-(2,4-dichiorophenoxy)-phenol, commonly referred to as triciosan, and described in "[lie MeTA Index 11th ed. (1989). pp. 1529 (entry no:
9573) in U.S. Patent No. 3,506,720, and in European Patent Appiicafion No.
is 0,251,591 of Beecham Group, PLC, published January 7, 1988; phthalic acid and its salts inciuding, but not iirnited to those disclosed in U.S. F'at.
4,994,262, Feb. 19, 1991, prefsrabfy magnesium monopotassium phthaiate, chiwhexidine (Merch Index, no. 2090), alexidine (Merok Index. no. 222; hexetidine (M-qmk Index, no. 4524); sanguinarine (Merck.index. no. 8320); benzalkonium chloride 20 (MoM index. no. 1488); saiicytaniiide (Merck lradm, no. 8299); domiphen bromide (Merck Index, no. 3411); cetyipyridinium chioricie (CPC) (Merek lrdõP.x.
no. 2024; tetr8decyipyridinium chioride (TPC); N-tetradecyl-4-ethyipyridinium chloride (TDi=PC);. cx tenidine; de4 mopinoi, oetapinoi, and othet piperidinp derivatives; nicin preparations; zinclstannmis ion agents; antibiotics such as 25 augmentin, amoxiciliin, tetracydine, doxycyciine, minocycline, and metrQrudazote; and analogs and. salts of the above; essential oiis including thymol, geranioi, carvacroi, citral, hinoFatioi, eucalyptoi, catechol (particufarly 4 allyt catechof) and mixtures thereof; methyl saiicyiate; hydroVen peroxide;
metgi salts of cHorite and mixtures of all of the above.
30 S. (jnti4n8ammgYQry Agents Anti-inflammatory agents can also be present in the oral care eompositions or substanaes of=the present invention. Such agents may include, but are not Iimited to, non-steroidai anti-inflammatory agents or NSAIDs such as ketoroiac, flurbiprofen. ibuprofen, naproxen: indQnYethacin, aspirin;
ketoprofen.
s5 p4roxicam and meclofenamlc acid. klse of NSAIDs such as Ketorolac are ciairned in U.S. Patent 5,626,838, issued May 6, 1997. Disciosed= therein are " Trade-mark methods of preventing and, or treating primary and reoccurring squamous cell carcinoma of the oral cavity or oropharynx by topical administration to the oral cavity or oropharynx an effective amount of an NSAID.
6. Nutrients Nutrients may improve the condition of the oral cavity and can be included in the oral care compositions or substances of the present invention.
Nutrients include minerals, vitamins, oral nutritional supplements, enteral nutritional supplements, and mixtures thereof.
Minerals that can be included with the compositions of the present 1o invention include calcium, phosphorus, fluoride, zinc, manganese, potassium and mixtures thereof. These minerals are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St.
Louis, Mo., 1997, pp10-17.
Vitamins can be included with minerals or used separately. Vitamins include Vitamins C and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid, nicotinamide, pyridoxine, cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures thereof. Such vitamins are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 3-10.
Oral nutritional supplements include amino acids, lipotropics, fish oil, and mixtures thereof, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 54-54e.
Amino acids include, but, are not limited to L-Tryptophan, L-Lysine, Methionine, Threonine, Levocarnitine or L- carnitine and mixtures thereof. Lipotropics include, but, are not limited to choline, inositol, betaine, linoleic acid, linolenic acid, and mixtures thereof. Fish oil contains large amounts of Omega-3 (N-3) Polyunsaturated fatty acids, eicosapentaenoic acid and docosahexaenoic acid.
Entenal nutritional supplements include, but, are not limited to protein products, glucose polymers, corn oil, safflower oil, medium chain triglycerides as 3o disclosed in Druca Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 55-57.
7. Mouth and Throat Products Other materials that can be used with the present invention include commonly known mouth and throat products. Such products are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 520b-527. These products include, but, are not limited to anti-fungal, antibiotic and analgesic agents.
8. Antioxidants Antioxidants are generally recognized as useful in compositions such as those of the present invention. Antioxidants are disclosed in texts such as Cadenas and Packer, The Handbook of Antioxidants, 1996 by Marcel Dekker, Inc. Antioxidants that may be included in the oral care composition or substance of the present invention include, but are not limited to Vitamin E, ascorbic acid, Uric acid, carotenoids, Vitamin A, flavonoids and polyphenols, herbal 1o antioxidants, melatonin, aminoindoles, lipoic acids and mixtures thereof.
9. H-2 Antagonists Histamine-2 (H-2 or H2) receptor antagonist compounds (H-2 antagonists) may be used in the oral care composition of the present invention. As used herein, selective H-2 antagonists are compounds that block H-2 receptors, but do not have meaningful activity in blocking histamine-1 (H-1 or H1) receptors.
Selective H-2 antagonists stimulates the contraction of smooth muscle from various organs, such as the gut and bronchi; this effect can be suppressed by low concentrations of mepyramine - a typical antihistaminic drug. The pharmacological receptors involved in these mepyramine-sensitive histamine 2o responses have been defined as H-1 receptors (Ash, A.S.F. & H.O. Schild, Brit.
J. Pharmacol Chemother., Vol. 27 (1966), p. 427. Histamine also stimulates the secretion of acid by the stomach (Loew, E.R. & O. Chickering, Proc. Soc. Exp.
Biol. Med., Vol. 48 (1941), p. 65), increases the heart rate (Trendelenburg, U., J.
Pharmacol., Vol. 130 (1960), p. 450), and inhibits contractions in the rat uterus (Dews, P.B. & J.D.P. Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p.
278); these actions cannot be antagonized by mepyramine and related drugs.
The H-2 antagonists useful in the oral care compositions or substances are those that blockade the receptors involved in mepyramine-insensitive, non-H-1 (H-2), histamine responses, and do not blockade the receptors involved in mepyramine-sensitive histamine responses.
Selective H-2 antagonists are those compounds found to be H-2 antagonists through their performance in classical preclinical screening tests for H-2 antagonist function. Selective H-2 antagonists are identified as compounds which can be demonstrated to function as competitive or non-competitive inhibitors of histamine-mediated effects in those screening models specifically dependent upon H-2 receptor function, but to lack significant histamine antagonist activity in those screening models dependent upon H-1 receptor function. Specifically, this includes compounds that would be classified as described by Black, J.W., W.A.M. Duncan, C.J. Durant, C.R. Ganellin & E.M.
Parsons, "Definition and Antagonism of Histamine H2-Receptors", Nature, Vol.
236 (April 21, 1972), pp. 385-390 (Black), as H-2 antagonists if assessed as described by Black through testing with the guinea pig spontaneously beating right atria in vitro assay and the rat gastric acid secretion in vivo assay, but shown to lack in significant H-1 antagonist activity relative to H-2 antagonist activity, if assessed as described by Black with either the guinea pig ileum 1o contraction in vitro assay or the rat stomach muscle contraction in vivo assay.
Preferably selective H-2 antagonists demonstrate no significant H-1 activity at reasonable dosage levels in the above H-1 assays. Typical reasonable dosage level is the lowest dosage level at which 90% inhibition of histamine, preferably 99% inhibition of histamine, is achieved in the above H-2 assays.
Selective H-2 antagonists include compounds meeting the above criteria which are disclosed in U.S. Patents 5,294,433 and 5,364,616 Singer et al., issued 3/15/94 and 11/15/94 respectively and assigned to Procter & Gamble, wherein the selective H-2 antagonist is selected from the group consisting of cimetidine, etintidine, ranitidine, ICIA-5165, tiotidine, ORF-17578, lupitidine, 2o donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-52368 (SKF-94482), BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728, and HB-408. 4. Particularly preferred is cimetidine (SKF-92334), N-cyano-N'-methyl-N"-(2-(((5-methyl-1 H-imidazol-4-yl)methyl)thio)ethyl)guanidine:
NC=N
H N~N
Cimetidine is also disclosed in the Merck Index, 11th edition (1989), p.
354 (entry no. 2279), and Physicians' Desk Reference, 46th edition (1992), p.
2228. Related preferred H-2 antagonists include burimamide and metiamide.
Selective H-2 antagonists stimulates the contraction of smooth muscle from various organs, such as the gut and bronchi; this effect can be suppressed by low concentrations of mepyramine - a typical antihistaminic drug. The pharmacological receptors involved in these mepyramine-sensitive histamine 2o responses have been defined as H-1 receptors (Ash, A.S.F. & H.O. Schild, Brit.
J. Pharmacol Chemother., Vol. 27 (1966), p. 427. Histamine also stimulates the secretion of acid by the stomach (Loew, E.R. & O. Chickering, Proc. Soc. Exp.
Biol. Med., Vol. 48 (1941), p. 65), increases the heart rate (Trendelenburg, U., J.
Pharmacol., Vol. 130 (1960), p. 450), and inhibits contractions in the rat uterus (Dews, P.B. & J.D.P. Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p.
278); these actions cannot be antagonized by mepyramine and related drugs.
The H-2 antagonists useful in the oral care compositions or substances are those that blockade the receptors involved in mepyramine-insensitive, non-H-1 (H-2), histamine responses, and do not blockade the receptors involved in mepyramine-sensitive histamine responses.
Selective H-2 antagonists are those compounds found to be H-2 antagonists through their performance in classical preclinical screening tests for H-2 antagonist function. Selective H-2 antagonists are identified as compounds which can be demonstrated to function as competitive or non-competitive inhibitors of histamine-mediated effects in those screening models specifically dependent upon H-2 receptor function, but to lack significant histamine antagonist activity in those screening models dependent upon H-1 receptor function. Specifically, this includes compounds that would be classified as described by Black, J.W., W.A.M. Duncan, C.J. Durant, C.R. Ganellin & E.M.
Parsons, "Definition and Antagonism of Histamine H2-Receptors", Nature, Vol.
236 (April 21, 1972), pp. 385-390 (Black), as H-2 antagonists if assessed as described by Black through testing with the guinea pig spontaneously beating right atria in vitro assay and the rat gastric acid secretion in vivo assay, but shown to lack in significant H-1 antagonist activity relative to H-2 antagonist activity, if assessed as described by Black with either the guinea pig ileum 1o contraction in vitro assay or the rat stomach muscle contraction in vivo assay.
Preferably selective H-2 antagonists demonstrate no significant H-1 activity at reasonable dosage levels in the above H-1 assays. Typical reasonable dosage level is the lowest dosage level at which 90% inhibition of histamine, preferably 99% inhibition of histamine, is achieved in the above H-2 assays.
Selective H-2 antagonists include compounds meeting the above criteria which are disclosed in U.S. Patents 5,294,433 and 5,364,616 Singer et al., issued 3/15/94 and 11/15/94 respectively and assigned to Procter & Gamble, wherein the selective H-2 antagonist is selected from the group consisting of cimetidine, etintidine, ranitidine, ICIA-5165, tiotidine, ORF-17578, lupitidine, 2o donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-52368 (SKF-94482), BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728, and HB-408. 4. Particularly preferred is cimetidine (SKF-92334), N-cyano-N'-methyl-N"-(2-(((5-methyl-1 H-imidazol-4-yl)methyl)thio)ethyl)guanidine:
NC=N
H N~N
Cimetidine is also disclosed in the Merck Index, 11th edition (1989), p.
354 (entry no. 2279), and Physicians' Desk Reference, 46th edition (1992), p.
2228. Related preferred H-2 antagonists include burimamide and metiamide.
10. Analgesic Actives Anti-pain or desensitizing agents can also be present in the oral care compositions or substances of the present invention. Suoh agents may include, but are not limited to, strontium chloride, potassium nitrate, natural herbs such as gall nut, Asarum, Cubobin, Galanga, scutellaria, Liangmianzhen, Baizhi, etc.
11. 8=1-virai Actives Antiviral actives useful -in the present composition include any know actives that are routinely use to treat viral infections. Such anZl-virat actives are discloseri in DvgFacts and Cornoadsons (loose leaf dnag information service), Wolters Kiuer Company, St. Louis, Mo., cD1997, pp. 402(a).407(z)..
to Specific examples inciude anbi-virai actives =disciosod in U.S. Patent 5,747.070, issued May 5, 1998 to Satyanarayana M~jeti= Sald Patent discloses the use of stannous salts to control vi.ruses. Stannous salts and other anti-viral actives are ddscribed in detail in Kirk & Othmer. Encyclopedia of Ctiemicai is Technology, Third Edif+on, Volume 23, Vlfiiey-interscience Publishers (1982), pp.
42-71. . The stannous satts that may be used In the present invention would include organlc st=annous carboacytates and inorganic stannous halides. Whiie stannous fluoride may be used, it is typicaiiy used only in combination with another stannous halide or one 20 or more stannous carboxylates or another therapeutlc agent.
to Specific examples inciude anbi-virai actives =disciosod in U.S. Patent 5,747.070, issued May 5, 1998 to Satyanarayana M~jeti= Sald Patent discloses the use of stannous salts to control vi.ruses. Stannous salts and other anti-viral actives are ddscribed in detail in Kirk & Othmer. Encyclopedia of Ctiemicai is Technology, Third Edif+on, Volume 23, Vlfiiey-interscience Publishers (1982), pp.
42-71. . The stannous satts that may be used In the present invention would include organlc st=annous carboacytates and inorganic stannous halides. Whiie stannous fluoride may be used, it is typicaiiy used only in combination with another stannous halide or one 20 or more stannous carboxylates or another therapeutlc agent.
12. OtheE lIIflrediicta In addition to the above materials of the composition of the prosent invention, a number of other components may dosirabiy be added to the oral care substance. Additional components IncEude. but are not limited to, flavoring 25 agents, swestening agents, xylitol, opacifiers, coloring agents, surfactants, and chelsnts such as ethylenediaminetetraacetic acid. Suitable flavoring agents include, but are not limited to, oil of peppermint, oil of sassafras, dove bud oii, peppermint, menthol, anethole, thymol, methyl sallcylAte, eucalyptol, cassia, menthyl acetate, sage, eugenol, parsley oil, oxanone, oii of wintergr+een, alpha-30 irisone, oil of spearmint, marjoram, lemon, orange, propenyl guaethol, cinnamon, and mixiures thereof.
Pigments may also added to the compositions herein to more precisely indicate the looatfons at which the composition has actually been applied, alkswing the user to apply the oomposition more thoroughly or eveniy. Howgver, as such - pigments are not intended to mask stains that may exist on the toath surfaces.
These additional ingredients can also be used in place of the compounds disclosed above.
EXAMPLES
The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention.
Table 1: H dro hobic Delive Composition Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Organosiloxane 25 25 24.6 25 25 25 Resin' Silicone Gum2 12.5 4.2 3.5 2.5 1.8 --Oral Care 17 17 17 17 17 17 Substance3 Volatile Carrier4 44.5 52.8 53.9 54.5 55.2 57.0 Bentone Clay5 1 1 1 1 1 1 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 30 or SE 63 from General Electric.
3. E.g., Sodium percarbonate as a dry powder.
4. E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE. The percentage of each individual solvent component in the mixed solvent systems can vary from 0 to 100%, respectively.
5. Bentone 27 available from Rheox.
Table 2: H dro hobic Delivery Composition Component Ex.1 Ex.2 Ex.3 Ex.4 Organosiloxane Resin' 33.43 33.43 35.14 33.43 Silicone Gum2 5.57 5.57 5.86 5.57 Oral Care Substance3 19.00 12.00 19.00 19.00 Ethyl acetate 8.00 8.50 8.00 8.00 WO 01/01942 PCT[USOO/18189 Bentone Gel4 10.00 10.00 10.00 10.00 DC-200/350cst.5 1.00 1.00 2.00 1.00 HFE-71006 21.00 26.00 - 19.50 N- ro I acetate 2.00 2.00 - 2.00 2-butanone - - 19.00 -Aerosi1200' (Si02) - - 1.00 -Flavor - 1.50 - 1.50 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 30 from General Electric.
3. E.g., Sodium percarbonate as a dry powder.
4. Bentone Gel IPM available from Rheox.
5. DC-200/350 is: dimethylpolysiloxane, CAS# 9016-00-6, from Dow Corning.
6. HFE-7100 is a mixture of Methyl Nonafluoroisobutyl Ether, CAS# 163702-08-7 and Methyl Nonafluorobutyl Ether, CAS# 163702-07-6, manufactured by 3M Co.
7. Aerosil 200 is silicon dioxide (chemically prepared), CAS# 112945-52-5, from 1o Degussa AG.
Method of Preparation The delivery compositions of Tables 1 and 2 are non-aqueous. The oral care substances are dispersed or dissolved in a solution comprising the organosiloxane resin, the fluid diorganopolysiloxane-based polymer, the volatile carrier, and the rheology modifier.
The compositions of Tables 1 and 2 are suitably prepared as follows.
Three hundred (300) grams of organosiloxane resin solution (for example, 43.7%
MQ resin solution in isododecane or in a 50/50 mixture of ethyl acetate and butanone (or in a mixture of ethyl acetate, propyl acetate and HFE) are mixed with 147.30 grams of fluid diorganopolysiloxane polymer solution (for example, 50% SE30 silicone gum solution in isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE).
The oral care substances are then dispersed in the resin/gum mixture. This method may be carried out without the presence of the silicone gum.
All oral care substances described herein can formulated as described above.
Table 3: Whitening Delivery Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethyl Acetate 18.00 14.85 22.25 20.88 18.96 18.00 2-Butanone 18.00 13.00 13.10 20.88 10.00 18.00 Isododecane -- 10.00 -- -- 11.54 --Limonene -- 4.35 -- -- 5.00 --MQ Resin 28.00 32.50 26.50 27.33 36.00 31.50 SE 30 Silicon 7.00 -- 8.80 13.67 -- --Gum Silicone Visc- -- -- -- -- -- 3.50 Silicone Fluid -- 6.50 -- -- 9.00 --10cStk Bentone Gel ISD 10.00 -- 6.40 9.95 -- 10.00 Claytone HY -- 2.45 -- -- 3.00 --Cab-o-Sil -- -- 1.50 -- -- --Sodium 19.00 -- 19.00 7.00 -- 19.00 Percarbonate Carbamide -- 15.00 -- -- 5.00 --Peroxide Bismuth -- 1.15 -- -- -- --Ox chloride Titanium Dioxide -- -- 1.00 -- 1.50 --Flavor Oil -- -- 0.15 -- -- --Sodium Fluoride -- -- 1.00 -- -- --Sodium -- 0.20 0.30 0.30 -- --Saccharin TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 Table 4: Oral Care Delivery Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ethyl Acetate 24.50 27.75 22.00 19.96 21.10 2-Butanone 24.50 16.30 22.00 10.00 21.10 Isododecane -- -- -- 11.54 --Limonene -- -- -- 5.00 --MQ Resin 30.40 33.00 28.80 36.00 32.84 SE 30 Silicone 7.60 11.00 14.40 -- 8.21 Gum Silicone Fluid -- -- -- 9.00 --10cStk Bentone Gel ISD 10.00 8.00 10.50 -- 11.75 Claytone HY -- -- -- 3.00 --Cab-o-Sil -- 1.50 -- -- --Bismuth -- 1.00 -- -- --Ox chloride Titanium Dioxide -- -- -- 2.00 --Flavor Oil -- 0.15 -- -- --Potassium Nitrate -- -- -- -- 5.00 Sodium Chlorite 3.00 -- -- -- --Tripolyphosp hate -- -- -- 2.50 --Sodium Fluoride -- 1.00 -- 1.00 --Chlorhexidine -- -- 2.00 -- --Gluconate Sodium -- 0.30 0.30 -- --Saccharin TOTAL 100.00 100.00 100.00 100.00 100.00 WO 01/01942 CA 02373983 2001-12-27 pCT/US00/18189 Table 5: Oral Care Delivery Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethyl Acetate 26.00 22.00 35.00 28.00 25.77 23.00 2-Butanone 25.95 17.00 9.00 14.50 25.50 23.45 Isododecane -- 10.00 -- -- 5.00 --Limonene -- 4.00 -- -- -- --MQ Resin 28.00 32.50 33.00 35.00 27.00 28.00 SE 30 Silicone Gum 7.00 -- 11.00 5.00 3.00 7.00 Silicone Fluid lOcStk -- 6.50 -- -- -- --Bentone Gel ISD 10.00 -- 8.00 10.00 10.00 --Cla one HY -- 2.00 -- -- -- 7.00 Cab-o-Sil M7D -- -- 1.50 -- -- --Bismuth Oxychloride -- 5.00 -- -- -- 10.00 Titanium Dioxide 3.00 -- 1.00 5.00 2.00 --Flavor Oil -- -- 0.10 -- 0.15 0.15 Polymethylsilsesquio -- -- 1.00 -- -- --xane Polymethylmethyacry 3.00 1.00 -- -- 0.50 --late Nylon 12 -- -- -- 2.00 -- 1.00 Silica -- -- -- -- 0.50 --FD&C Yellow #5 Al 0.05 -- 0.10 -- 0.05 0.10 Lake Iron Oxide, Red -- -- -- 0.50 0.03 --Sodium Saccharin -- -- 0.30 -- 0.50 0.30 TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 Table 6: Ethanol Based Delive Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethanol 20.90 35.80 41.70 25.89 23.10 23.55 Ethyl Acetate -- -- -- -- 4.95 --Ethyl Butyrate 10.30 -- -- 12.74 11.75 10.9 Isoam I Acetate -- -- -- -- -- 2.65 Isododecane -- 13.00 -- -- -- --MQ Resin 35.10 32.85 42.75 47.00 42.00 41.80 Silicone Visc-100M -- -- -- -- 7.15 --Silicone Fluid 100 cSt 7.80 -- -- 9.65 -- 8.55 Silicone Fluid 10 cStk 3.90 -- 11.40 -- 4.00 --Silwet L-7500 -- -- -- -- -- 6.58 Bentone 27 1.50 -- 2.00 1.85 1.35 1.97 Cta tone APA -- 2.00 -- -- -- --Cab-o-Sil -- -- -- -- 0.45 --Sodium Percarbonate 19.00 -- -- -- -- --Carbamide Peroxide -- 15.00 -- -- -- --Potassium Nitrate -- -- -- -- 5.00 --Tri ol hos hate -- -- -- -- -- 2.50 Chlorhexidine -- -- -- 2.57 -- --Digluconate Titanium Dioxide 1.50 -- 2.00 -- -- 1.50 Flavor Oil -- -- 0.05 -- -- --Sodium Fluoride -- -- 0.10 -- 0.25 --Sodium Saccharin -- 0.20 -- 0.30 -- --100.00 100.00 100.00 100.00 100.00 100.00 Method of Preparation The delivery compositions of Tables 3-6 are suitably prepared as follows.
Add the solvents into a container suitable to minimize solvent loss. Add the rheology modifiers and mix until well dispersed. Add the silicone resin and mix until completely dissolved. Add the silicone gum and/or silicone fluids and mix until completely dissolved. At this time add any salts such as sodium percarbonate and/or other oral care actives, aesthetic ingredients such as opacifiers, sweeteners, dyes, and flavors. Continue mixing until homogeneous.
Additional high shear mixing may be used to promote the mixing. Pack into airtight containers.
Alternatively premixes of the silicone resin and/or the silicone gum may be prepared prior to incorporation into the final blending step to facilitate silicone dissolution and ease of manufacturing. Depending on the formula composition, the order of ingredient addition may also vary such as the addition of the rheology modifier(s) may be moved to a later step allowing lower viscosity to be maintained until the later stages of the blending step.
The embodiments disclosed and represented by the examples of the previous Tables have many advantages. For example, they provide better durability and subsequent delivery of oral care substances, particularly to the surfaces of the teeth. They also provide a convenient, discrete, and easy to use product form which can deliver benefits that are significantly different from those that can be achieved by conventional product forms. In addition, oral care actives that would exhibit instability in an aqueous-based film system can be lo incorporated into the compositions herein without compromising stability.
Table 7: Protective Com osition Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Organosiloxane Resin' 36.3 39.5 39.5 40.5 41 42 Silicon Gum2 18.2 6.7 5.6 4.0 2.8 --Volatile Carrier3 44.5 52.8 53.9 54.5 55.2 57.0 Bentone CIa 1 1 1 1 1 1 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum (2,500,000 cSt) available as SE63 from General Electric.
3. E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone. The percentage of ethyl acetate and butanone in the mixed system can vary from 0 to 100%, respectively; or a mixture of HFE, propyl acetate, and ethyl acetate.
4. E.g., Bentone 27 available from Rheox.
Method of Use In practicing the system of the present invention, the user need only apply a delivery composition that contains the oral care substance or substances necessary in order to obtain a desired effect, e.g., whitening, breath freshening, caries prevention, pain relief, gum health, tartar control, etc., followed by a protective composition to the tooth surfaces in the areas desired. The compositions herein may also be applied to other surfaces of the oral cavity, such as the gingival or mucosal tissues, or to any other oral cavity surface.
The compositions herein can be applied with a brush, a pen applicator, a doe's foot applicator, or the like, or even with the fingers.
A film containing the oral care substance quickly forms on the surface to which the delivery composition has been applied. Then, the user applies the protective composition to the same surfaces, on top of the delivery composition.
Similarly, the protective composition quickly forms a film.
Prolonged delivery of the oral care substance is made possible as the oral care substance is released from the film formed by the delivery composition over time. The protective composition protects the delivery composition from wearing 1o off to prolong the wear of the delivery compositions and therefore to prolong the presence of the oral care substance in the oral cavity. In addition, the protective compositions force the oral care substance being released to act on the applied area, and inhibit it from being released elsewhere in the oral cavity or from being worn away by saliva, eating, etc.
Without being bound by theory, it is believed that the protection efficacy provided by the protective composition depends on the amount of resin present, as well as the resin to polymer ratio and the polymer concentration in those compositions further comprising a fluid diorganopolysiloxane-based polymer. It is further believed that the protection efficacy is influenced by the specific oral care substance that is present in the delivery composition.
Then, any residual oral care substance or film may be easily removed by wiping, brushing or rinsing the oral surface after a desired period of time has elapsed, or in the normal course of tooth brushing or other oral care activities.
Without being bound by theory, it is believed that the wear time of the systems herein is from about 2 hours to 10 hours, regardless of the reactivity of the oral care substance. Preferably, the systems are almost unnoticeable when applied to the oral cavity.
It is not necessary to prepare the oral cavity before using the system of the present invention. For example, the user may or may not choose to brush the teeth or rinse the mouth before applying the compositions. The surfaces of the oral cavity are neither required to be dried nor to be excessively wet with saliva or water before the compositions are applied. However, it is believed that adhesion to the tooth enamel surfaces will be improved if the teeth are dry when the compositions are applied.
It should be understood that the present invention relates not only to methods for delivering an oral care substance to the oral cavity of a human, but also to methods of delivering an oral care substance to the oral cavity of an animal, e.g., household pets or other domestic animals, or animals kept in captivity.
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to one skilled in the art without departing from the scope of the present invention.
Pigments may also added to the compositions herein to more precisely indicate the looatfons at which the composition has actually been applied, alkswing the user to apply the oomposition more thoroughly or eveniy. Howgver, as such - pigments are not intended to mask stains that may exist on the toath surfaces.
These additional ingredients can also be used in place of the compounds disclosed above.
EXAMPLES
The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention.
Table 1: H dro hobic Delive Composition Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Organosiloxane 25 25 24.6 25 25 25 Resin' Silicone Gum2 12.5 4.2 3.5 2.5 1.8 --Oral Care 17 17 17 17 17 17 Substance3 Volatile Carrier4 44.5 52.8 53.9 54.5 55.2 57.0 Bentone Clay5 1 1 1 1 1 1 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 30 or SE 63 from General Electric.
3. E.g., Sodium percarbonate as a dry powder.
4. E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE. The percentage of each individual solvent component in the mixed solvent systems can vary from 0 to 100%, respectively.
5. Bentone 27 available from Rheox.
Table 2: H dro hobic Delivery Composition Component Ex.1 Ex.2 Ex.3 Ex.4 Organosiloxane Resin' 33.43 33.43 35.14 33.43 Silicone Gum2 5.57 5.57 5.86 5.57 Oral Care Substance3 19.00 12.00 19.00 19.00 Ethyl acetate 8.00 8.50 8.00 8.00 WO 01/01942 PCT[USOO/18189 Bentone Gel4 10.00 10.00 10.00 10.00 DC-200/350cst.5 1.00 1.00 2.00 1.00 HFE-71006 21.00 26.00 - 19.50 N- ro I acetate 2.00 2.00 - 2.00 2-butanone - - 19.00 -Aerosi1200' (Si02) - - 1.00 -Flavor - 1.50 - 1.50 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 30 from General Electric.
3. E.g., Sodium percarbonate as a dry powder.
4. Bentone Gel IPM available from Rheox.
5. DC-200/350 is: dimethylpolysiloxane, CAS# 9016-00-6, from Dow Corning.
6. HFE-7100 is a mixture of Methyl Nonafluoroisobutyl Ether, CAS# 163702-08-7 and Methyl Nonafluorobutyl Ether, CAS# 163702-07-6, manufactured by 3M Co.
7. Aerosil 200 is silicon dioxide (chemically prepared), CAS# 112945-52-5, from 1o Degussa AG.
Method of Preparation The delivery compositions of Tables 1 and 2 are non-aqueous. The oral care substances are dispersed or dissolved in a solution comprising the organosiloxane resin, the fluid diorganopolysiloxane-based polymer, the volatile carrier, and the rheology modifier.
The compositions of Tables 1 and 2 are suitably prepared as follows.
Three hundred (300) grams of organosiloxane resin solution (for example, 43.7%
MQ resin solution in isododecane or in a 50/50 mixture of ethyl acetate and butanone (or in a mixture of ethyl acetate, propyl acetate and HFE) are mixed with 147.30 grams of fluid diorganopolysiloxane polymer solution (for example, 50% SE30 silicone gum solution in isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE).
The oral care substances are then dispersed in the resin/gum mixture. This method may be carried out without the presence of the silicone gum.
All oral care substances described herein can formulated as described above.
Table 3: Whitening Delivery Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethyl Acetate 18.00 14.85 22.25 20.88 18.96 18.00 2-Butanone 18.00 13.00 13.10 20.88 10.00 18.00 Isododecane -- 10.00 -- -- 11.54 --Limonene -- 4.35 -- -- 5.00 --MQ Resin 28.00 32.50 26.50 27.33 36.00 31.50 SE 30 Silicon 7.00 -- 8.80 13.67 -- --Gum Silicone Visc- -- -- -- -- -- 3.50 Silicone Fluid -- 6.50 -- -- 9.00 --10cStk Bentone Gel ISD 10.00 -- 6.40 9.95 -- 10.00 Claytone HY -- 2.45 -- -- 3.00 --Cab-o-Sil -- -- 1.50 -- -- --Sodium 19.00 -- 19.00 7.00 -- 19.00 Percarbonate Carbamide -- 15.00 -- -- 5.00 --Peroxide Bismuth -- 1.15 -- -- -- --Ox chloride Titanium Dioxide -- -- 1.00 -- 1.50 --Flavor Oil -- -- 0.15 -- -- --Sodium Fluoride -- -- 1.00 -- -- --Sodium -- 0.20 0.30 0.30 -- --Saccharin TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 Table 4: Oral Care Delivery Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ethyl Acetate 24.50 27.75 22.00 19.96 21.10 2-Butanone 24.50 16.30 22.00 10.00 21.10 Isododecane -- -- -- 11.54 --Limonene -- -- -- 5.00 --MQ Resin 30.40 33.00 28.80 36.00 32.84 SE 30 Silicone 7.60 11.00 14.40 -- 8.21 Gum Silicone Fluid -- -- -- 9.00 --10cStk Bentone Gel ISD 10.00 8.00 10.50 -- 11.75 Claytone HY -- -- -- 3.00 --Cab-o-Sil -- 1.50 -- -- --Bismuth -- 1.00 -- -- --Ox chloride Titanium Dioxide -- -- -- 2.00 --Flavor Oil -- 0.15 -- -- --Potassium Nitrate -- -- -- -- 5.00 Sodium Chlorite 3.00 -- -- -- --Tripolyphosp hate -- -- -- 2.50 --Sodium Fluoride -- 1.00 -- 1.00 --Chlorhexidine -- -- 2.00 -- --Gluconate Sodium -- 0.30 0.30 -- --Saccharin TOTAL 100.00 100.00 100.00 100.00 100.00 WO 01/01942 CA 02373983 2001-12-27 pCT/US00/18189 Table 5: Oral Care Delivery Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethyl Acetate 26.00 22.00 35.00 28.00 25.77 23.00 2-Butanone 25.95 17.00 9.00 14.50 25.50 23.45 Isododecane -- 10.00 -- -- 5.00 --Limonene -- 4.00 -- -- -- --MQ Resin 28.00 32.50 33.00 35.00 27.00 28.00 SE 30 Silicone Gum 7.00 -- 11.00 5.00 3.00 7.00 Silicone Fluid lOcStk -- 6.50 -- -- -- --Bentone Gel ISD 10.00 -- 8.00 10.00 10.00 --Cla one HY -- 2.00 -- -- -- 7.00 Cab-o-Sil M7D -- -- 1.50 -- -- --Bismuth Oxychloride -- 5.00 -- -- -- 10.00 Titanium Dioxide 3.00 -- 1.00 5.00 2.00 --Flavor Oil -- -- 0.10 -- 0.15 0.15 Polymethylsilsesquio -- -- 1.00 -- -- --xane Polymethylmethyacry 3.00 1.00 -- -- 0.50 --late Nylon 12 -- -- -- 2.00 -- 1.00 Silica -- -- -- -- 0.50 --FD&C Yellow #5 Al 0.05 -- 0.10 -- 0.05 0.10 Lake Iron Oxide, Red -- -- -- 0.50 0.03 --Sodium Saccharin -- -- 0.30 -- 0.50 0.30 TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 Table 6: Ethanol Based Delive Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethanol 20.90 35.80 41.70 25.89 23.10 23.55 Ethyl Acetate -- -- -- -- 4.95 --Ethyl Butyrate 10.30 -- -- 12.74 11.75 10.9 Isoam I Acetate -- -- -- -- -- 2.65 Isododecane -- 13.00 -- -- -- --MQ Resin 35.10 32.85 42.75 47.00 42.00 41.80 Silicone Visc-100M -- -- -- -- 7.15 --Silicone Fluid 100 cSt 7.80 -- -- 9.65 -- 8.55 Silicone Fluid 10 cStk 3.90 -- 11.40 -- 4.00 --Silwet L-7500 -- -- -- -- -- 6.58 Bentone 27 1.50 -- 2.00 1.85 1.35 1.97 Cta tone APA -- 2.00 -- -- -- --Cab-o-Sil -- -- -- -- 0.45 --Sodium Percarbonate 19.00 -- -- -- -- --Carbamide Peroxide -- 15.00 -- -- -- --Potassium Nitrate -- -- -- -- 5.00 --Tri ol hos hate -- -- -- -- -- 2.50 Chlorhexidine -- -- -- 2.57 -- --Digluconate Titanium Dioxide 1.50 -- 2.00 -- -- 1.50 Flavor Oil -- -- 0.05 -- -- --Sodium Fluoride -- -- 0.10 -- 0.25 --Sodium Saccharin -- 0.20 -- 0.30 -- --100.00 100.00 100.00 100.00 100.00 100.00 Method of Preparation The delivery compositions of Tables 3-6 are suitably prepared as follows.
Add the solvents into a container suitable to minimize solvent loss. Add the rheology modifiers and mix until well dispersed. Add the silicone resin and mix until completely dissolved. Add the silicone gum and/or silicone fluids and mix until completely dissolved. At this time add any salts such as sodium percarbonate and/or other oral care actives, aesthetic ingredients such as opacifiers, sweeteners, dyes, and flavors. Continue mixing until homogeneous.
Additional high shear mixing may be used to promote the mixing. Pack into airtight containers.
Alternatively premixes of the silicone resin and/or the silicone gum may be prepared prior to incorporation into the final blending step to facilitate silicone dissolution and ease of manufacturing. Depending on the formula composition, the order of ingredient addition may also vary such as the addition of the rheology modifier(s) may be moved to a later step allowing lower viscosity to be maintained until the later stages of the blending step.
The embodiments disclosed and represented by the examples of the previous Tables have many advantages. For example, they provide better durability and subsequent delivery of oral care substances, particularly to the surfaces of the teeth. They also provide a convenient, discrete, and easy to use product form which can deliver benefits that are significantly different from those that can be achieved by conventional product forms. In addition, oral care actives that would exhibit instability in an aqueous-based film system can be lo incorporated into the compositions herein without compromising stability.
Table 7: Protective Com osition Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Organosiloxane Resin' 36.3 39.5 39.5 40.5 41 42 Silicon Gum2 18.2 6.7 5.6 4.0 2.8 --Volatile Carrier3 44.5 52.8 53.9 54.5 55.2 57.0 Bentone CIa 1 1 1 1 1 1 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum (2,500,000 cSt) available as SE63 from General Electric.
3. E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone. The percentage of ethyl acetate and butanone in the mixed system can vary from 0 to 100%, respectively; or a mixture of HFE, propyl acetate, and ethyl acetate.
4. E.g., Bentone 27 available from Rheox.
Method of Use In practicing the system of the present invention, the user need only apply a delivery composition that contains the oral care substance or substances necessary in order to obtain a desired effect, e.g., whitening, breath freshening, caries prevention, pain relief, gum health, tartar control, etc., followed by a protective composition to the tooth surfaces in the areas desired. The compositions herein may also be applied to other surfaces of the oral cavity, such as the gingival or mucosal tissues, or to any other oral cavity surface.
The compositions herein can be applied with a brush, a pen applicator, a doe's foot applicator, or the like, or even with the fingers.
A film containing the oral care substance quickly forms on the surface to which the delivery composition has been applied. Then, the user applies the protective composition to the same surfaces, on top of the delivery composition.
Similarly, the protective composition quickly forms a film.
Prolonged delivery of the oral care substance is made possible as the oral care substance is released from the film formed by the delivery composition over time. The protective composition protects the delivery composition from wearing 1o off to prolong the wear of the delivery compositions and therefore to prolong the presence of the oral care substance in the oral cavity. In addition, the protective compositions force the oral care substance being released to act on the applied area, and inhibit it from being released elsewhere in the oral cavity or from being worn away by saliva, eating, etc.
Without being bound by theory, it is believed that the protection efficacy provided by the protective composition depends on the amount of resin present, as well as the resin to polymer ratio and the polymer concentration in those compositions further comprising a fluid diorganopolysiloxane-based polymer. It is further believed that the protection efficacy is influenced by the specific oral care substance that is present in the delivery composition.
Then, any residual oral care substance or film may be easily removed by wiping, brushing or rinsing the oral surface after a desired period of time has elapsed, or in the normal course of tooth brushing or other oral care activities.
Without being bound by theory, it is believed that the wear time of the systems herein is from about 2 hours to 10 hours, regardless of the reactivity of the oral care substance. Preferably, the systems are almost unnoticeable when applied to the oral cavity.
It is not necessary to prepare the oral cavity before using the system of the present invention. For example, the user may or may not choose to brush the teeth or rinse the mouth before applying the compositions. The surfaces of the oral cavity are neither required to be dried nor to be excessively wet with saliva or water before the compositions are applied. However, it is believed that adhesion to the tooth enamel surfaces will be improved if the teeth are dry when the compositions are applied.
It should be understood that the present invention relates not only to methods for delivering an oral care substance to the oral cavity of a human, but also to methods of delivering an oral care substance to the oral cavity of an animal, e.g., household pets or other domestic animals, or animals kept in captivity.
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to one skilled in the art without departing from the scope of the present invention.
Claims (33)
1. A system for delivering an oral care substance to the oral cavity comprising:
(a) a delivery composition comprised of:
(i) an organosiloxane resin;
(ii) a volatile carrier capable of solubilizing the organosiloxane resin;
(iii) a rheology modifier;
(iv) and at least one oral care substance; and (b) a protective composition comprised of:
(i) an organosiloxane resin: and (H) a volatile carrier capable of solubilizing the organosiloxane resin.
(a) a delivery composition comprised of:
(i) an organosiloxane resin;
(ii) a volatile carrier capable of solubilizing the organosiloxane resin;
(iii) a rheology modifier;
(iv) and at least one oral care substance; and (b) a protective composition comprised of:
(i) an organosiloxane resin: and (H) a volatile carrier capable of solubilizing the organosiloxane resin.
2. The system of Claim I wherein the protective composition further comprises a fluid diorganflpolysiloxane-based polymer.
3. The system of Claim 1 or Claim 2 wherein the protective composition further comprises a rheology modifier.
4. The system of Claim 1 wherein the organosiloxane resin in the delivery and protective compositions is present at a level of from about 5% to about 70%.
5. The system of Claim 4 wherein the organosiloxane resin comprises repeating monomer units selected from the group consisting of (CH3)3SiO0.5 "M" units, (CH3)2SiO "D" units. (CH3)SiO1.5 "T" units, SiO2 "Q" units, and mixtures thereof.
6. The system of Claim 5 wherein the organosiloxane resin is comprised of MQ units. wherein the M:Q ratio is from about 0.5:1.0 to about 1.51Ø
7. The system of Claim 1 wherein the volatile carrier in the delivery and protective compositions is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.
8. The system of Claim 7 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.
9. The system of Claim 1 wherein the oral tare substance in the delivery composition includes at least one oral care active selected from the group consisting of a teeth whitening active, an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, an anti-fungal agent, an antibiotic, an antioxidant, an H2 antagonist, an analgesic active, an anti-viral agent, flavoring agents, sweetening agents, xylitol, opacifiers;, coloring agents, chelants, surfactants, pigments, and mixtures thereof.
10. The system of Claim 9 wherein the delivery composition comprises from about 0.01% to about 50% of the oral care substance.
11. The system of Claim 10 wherein the oral care substance is a teeth whitening active selected from the group consisting peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.
12. The system of Claim 3 wherein the rheology modifier in the delivery and protective compositions is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.
13. The system of Claim 12 wherein the rheology modifier is present in the delivery and protective compositions at a level of from about 0.1% to about 30%.
14. A system for delivering an oral care substance to the oral cavity comprising:
(a) a delivery composition comprised of:
(i) an organosiloxane resin;
(ii) a fluid diorganopolysiloxane-based polymer:
(iii) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer.
(iv) a rheology modifier; and (v) at least one oral care substance: and (b) a protective composition comprised of:
(i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin.
(a) a delivery composition comprised of:
(i) an organosiloxane resin;
(ii) a fluid diorganopolysiloxane-based polymer:
(iii) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer.
(iv) a rheology modifier; and (v) at least one oral care substance: and (b) a protective composition comprised of:
(i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin.
15. The system of Claim 14 wherein the protective composition further comprises a fluid diorganopolysiloxane-based polymer.
18. The system of Claim 14 or 15 wherein the fluid diorganopolysiloxane-based polymer in the delivery and protective compositions comprises repeating units of the formula (R2SiO), where R is a monovalent hydrocarbon radical group containing from 1 to 6 carbon atoms.
17. The system of Claim 16 wherein said hydrocarbon radical group is selected from the group consisting of methyl, ethyl, propyl, isopropyl, butyl.
isobutyl, t-butyl, amyl. hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl and mixtures thereof.
isobutyl, t-butyl, amyl. hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl and mixtures thereof.
18. The system of Claim 17 wherein the fluid diorganopolysiloxane-based polymer is terminated by triorganosilyl groups of the formula (R'3Si) where R' is a monovalent hydrocarbon radical selected from the group consisting of 1 to 6 carbon atoms, hydroxyl groups, alkoxyl groups and mixtures thereof.
19. The system of Claim 18 wherein the fluid diorganopolysiloxane-based polymer is poly(dimethylsiloxane).
20. The system of Claim 14 or 15 wherein the ratio of organosiloxane resin to fluid diorganopolysiloxane-based polymer in the delivery and protective compositions is from about 15:1 to about 1:15.
21. The system of Claim 14 or 15 wherein the volatile carrier in the delivery and protective compositions is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.
22. The system of Claim 21 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone. ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.
23. The system of Claim 14 wherein the oral care substance in the delivery composition includes at least one oral care active selected from the group consisting of a teeth whitening active, an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, an anti-fungal agent, an antibiotic, an antioxidant, an H2 antagonist, an analgesic active, an anti-viral agent, flavoring agents, sweetening agents, xylitol, opacifiers, coloring agents, chelants, surfactants, pigments, and mixtures thereof.
24. The system of Claim 23 wherein the delivery composition comprises from about 0 01% to about 50% of the oral care active.
25. The system of Claim 24 wherein the oral care active is a teeth whitening active selected from the group consisting peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.
26. The system of Claim 14 or Claim 15 wherein the protective composition further comprises a rheology modifier.
27. The system of Claim 26 wherein the rheology modifier in the delivery and protective compositions is selected from the group consisting of organo modified days, silicas, polyethylene, and mixtures thereof.
28. The system of Claim 27 wherein the rheology modifier is present in the delivery an protective compositions at a level of from about 0.1% to 30%.
29. The use of an organosiloxane resin in the manufacture of a system according to any one of Claims 1-28 for the delivery of an oral care substance to at least one surface of the oral cavity.
30. The use of Claim 29 wherein the delivery composition comprises a teeth whitening active and wherein the oral cavity surface is enamel of the teeth.
31. The use of a system according to any one of claims 1 to 28 wherein the delivery composition comprises a tooth whitening active.
32. The use of a system according to any one of claims 1 to 28 wherein the delivery composition comprises a tooth whitening active and wherein the oral cavity is the enamel of at least one tooth.
33. The use according to claim 31 or 32 wherein the delivery composition is used in the establishment of a film on the enamel of at least one tooth.
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
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US9915131 | 1999-07-02 | ||
US9915130 | 1999-07-02 | ||
USPCT/US99/15131 | 1999-07-02 | ||
USPCT/US99/15130 | 1999-07-02 | ||
USPCT/US00/15890 | 2000-06-09 | ||
PCT/US2000/015891 WO2001001940A1 (en) | 1999-07-02 | 2000-06-09 | Compositions comprising organosiloxane resins for delivering oral care substances |
USPCT/US00/15891 | 2000-06-09 | ||
PCT/US2000/015890 WO2001001939A1 (en) | 1999-07-02 | 2000-06-09 | Compositions comprising organosiloxane resins for delivering oral care substances |
PCT/US2000/018189 WO2001001942A1 (en) | 1999-07-02 | 2000-06-30 | Systems comprising organosiloxane resins for delivering oral care substances and for prolonging such delivery |
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CA2373983A1 CA2373983A1 (en) | 2001-01-11 |
CA2373983C true CA2373983C (en) | 2007-11-13 |
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CA002375093A Expired - Fee Related CA2375093C (en) | 1999-07-02 | 2000-06-30 | Delivery system for oral care compositions comprising organosiloxane resins using a removable backing strip |
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CA002375093A Expired - Fee Related CA2375093C (en) | 1999-07-02 | 2000-06-30 | Delivery system for oral care compositions comprising organosiloxane resins using a removable backing strip |
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EP (2) | EP1196137B1 (en) |
JP (1) | JP3927030B2 (en) |
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2000
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- 2000-06-30 AU AU59075/00A patent/AU5907500A/en not_active Abandoned
- 2000-06-30 CZ CZ20014709A patent/CZ20014709A3/en unknown
- 2000-06-30 US US10/927,655 patent/USRE42126E1/en not_active Expired - Fee Related
- 2000-06-30 RU RU2002102710/15A patent/RU2223746C2/en not_active IP Right Cessation
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- 2000-06-30 MX MXPA02000262A patent/MXPA02000262A/en active IP Right Grant
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- 2000-06-30 EP EP00945085A patent/EP1196137B1/en not_active Expired - Lifetime
- 2000-06-30 EP EP00945084A patent/EP1200064B1/en not_active Expired - Lifetime
- 2000-06-30 KR KR1020027000033A patent/KR20020032521A/en not_active Application Discontinuation
- 2000-06-30 AT AT00945084T patent/ATE238766T1/en not_active IP Right Cessation
- 2000-06-30 CA CA002375093A patent/CA2375093C/en not_active Expired - Fee Related
- 2000-06-30 WO PCT/US2000/018189 patent/WO2001001942A1/en active IP Right Grant
- 2000-06-30 AU AU59074/00A patent/AU768471B2/en not_active Ceased
- 2000-06-30 BR BR0012145-2A patent/BR0012145A/en not_active IP Right Cessation
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- 2000-06-30 JP JP2001507453A patent/JP3927030B2/en not_active Expired - Lifetime
- 2000-06-30 WO PCT/US2000/018187 patent/WO2001001941A1/en active Application Filing
- 2000-06-30 DE DE60016927T patent/DE60016927T2/en not_active Expired - Lifetime
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2002
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