CA2214764A1 - Delivery of substance to the mouth - Google Patents

Delivery of substance to the mouth Download PDF

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Publication number
CA2214764A1
CA2214764A1 CA002214764A CA2214764A CA2214764A1 CA 2214764 A1 CA2214764 A1 CA 2214764A1 CA 002214764 A CA002214764 A CA 002214764A CA 2214764 A CA2214764 A CA 2214764A CA 2214764 A1 CA2214764 A1 CA 2214764A1
Authority
CA
Canada
Prior art keywords
water
composite
tip
substance
irrigator
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002214764A
Other languages
French (fr)
Inventor
Jean L. Spencer
Mingchih M. Tseng
Thomas Craig Masterman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gillette Canada Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2214764A1 publication Critical patent/CA2214764A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/02Rinsing or air-blowing devices, e.g. using fluid jets or comprising liquid medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/02Rinsing or air-blowing devices, e.g. using fluid jets or comprising liquid medication
    • A61C17/0205Container filling apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00Dental auxiliary appliances
    • A61C19/06Implements for therapeutic treatment
    • A61C19/063Medicament applicators for teeth or gums, e.g. treatment with fluorides

Abstract

A method of introducing a substance into a mouth, including flowing water into contact with a composite and then into the mouth, the composite including a substance that is released from the composite when water contacts the composite, the substance being released from the composite when contacted with the flowing water and carried by the flowing water into the mouth. In practice, in an oral irrigative system (10) an extruded composite (29) of adequate shape in the form of a renewable cartridge is disposed in the water flow path so that the medications contained in the composite are released and delivered in the patient's mouth.

Description

CA 02214764 1997-09-0~
W 096t27344 PC~AUSg6~03202 DE~IVERY OF SUBSTANCE TO THE MOUTH
The invention relates to the delivery of a substance into the mouth.
Tooth decay and periodontal disease are common problems caused by bacteria and plaque present in the mouth. Reducing decay-causing bacteria and pla~ue has long been the target of per~ons working in the health care field. The most common way to reduce bacteria is to bru~h and floss the teeth regularly and to visit a dental hygienist to have the teeth and gums cleaned regularly.
Oral irrigation ~ystems are known in the dental field. Denti ts and oral hygienists have long used oral irrigation systems for lavage, tissue stimulation and oral rinsing. More recently, home versions of oral irrigation systems have become available for everyday use. Most oral irrigation systems for home use re~uire the use of water. By forcing water through a hand-held tip, a jet stream is created which removes food particles from between the teeth, while also stimulating and massaging the gums.
Antimicrobial agents (sometimes called antibacterial agents) are known for treatment of plaque and decay-promoting bacteria.
The invention relates to delivering a selected substance to the mouth. The substance can be, for example, an antimicrobial agent, a whitener, a flavoring, a fluoride compound, a foaming agent, a desensitizing agent, a nutritional agent, an odor-SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
W O 96127344 PCTrUS96/03202 preventing agent, a remineralizing agent, an anticalculus agent, an anti-inflammatory agent, a salivary gland stimulator, an antifungal agent, or an antiviral agent. The invention uses a composite including the substance, and is designed ~o that the substance is released from the composite when the composite is contacted with water.
There are a number of aspects to the invention.
One aspect features an oral irrigator for delivering a substance to the mouth when water flows through the irrigator. The irrigator includes a tip portion for delivering water into the mouth, a flow path that delivers water through the irrigator, including the tip, and a composite that includes a substance that is released when the composite is contacted with water. The composite preferably is molded or extruded, and is positioned in the irrigator ~o that water flowing through the irrigator contacts the composite. As a result, during use of the irrigator the substance leaches out of the composite into the water and is carried into the mouth.
A preferred composite includes a water-insoluble polymer that functions as a ~upport resin, a water-soluble polymer (e.g., polyethylene oxide or polyacrylic acid), and the substance. Alternatively, a water-swellable polymer or a water-soluble - ~ ~~ic species may be used instead of or in addition to the water-soluble polymer. The water-~oluble material ~nh~n~es the release of the substance from the composite because the material dissolves from the composite when the composite is contacted with water, causing channels to form in the composite through which the substance can leach into the water. The water-swellable material absorbs water and swells, ~nh~ncingthe release of the substance from the composite. Thus, both water-soluble materials and water-swellable SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
WO 96/27344 PCT~US96~03202 material~ facilitate release of the substance from the composite into the flow path.
Another preferred composite includes a water-soluble polymer (e.g., polyethylene oxide or polyacrylic acid) and the substance.
~ A preferred composite is tube-shaped and has a central opening through which water can pass.
In another a~pect, the invention ~eatures a tip that is suitable for att~c' t to an oral irrigator. The tip includes one of the composites described above.
In another aspect, the invention features a method of introducing a substance into the mouth. The method include~ flowing water over a composite including the substance, and then into the mouth. The substance is relea~ed into the water and delivered to the mouth.
In another aspect, the invention features an oral irrigator or tip ~or an oral irrigator tha~
includes a solid composition including a bisguanide such as chlorhexidine or alexidine, or a quaternary ammonium salt such as cetyl pyridium chloride, that act~ as an antimicrobial agent. The composition is positioned in the irrigator or tip 80 that water flowing through the irrigator contacts the composition, causing the release of the bisguanide into the water and, ultimately, into the mouth. The invention also featuren using the oral irrigator or tip to deliver the bisquanide or quaternary ~o~;um salt to the mouth.
The invention provides a simple way to deliver a wide variety of substances to the mouth. The composites are easy to manufacture. They can, for example, be co-extruded or two-color molded along with the tip or other portion of the irrigator.
Alternatively, the composites can be extruded or molded to a shape suitable to fit, for example, at any point along the flow path in an oral irrigator. The SUB5TITUTE SHEET (~ULE 26) CA 02214764 1997-09-0~
W 096/27344 PCTrUS96/03202 composite can be inserted pe~n~ntly into the irrigator during manufacture, or the composite can be sized and shaped 80 that a user can in~3ert or ~ -ve it from the irrigator. In the latter embodiment the user can simply replace a used composite with a new composite when necessary. Also, when the irrigator includes a replaceable tip and the composite is included in the t$p, the tip may be replaced when the original composite is used up. Alternatively, the composite may include a c~ _~nent that when released along with the substance causes a color change in the composite.
The composite including a water-soluble material in particular can be designed to release a targeted dosage of a substance when the composite contacts water. The rate of release of the substance from the composite can be adjusted by varying the quantity of the substance and the water-soluble material in the composite. The more ~ubstance and/or water-soluble material in the composite, the h~gh~t' the rate of release. Release can also be controlled by ~;ng extra water-insoluble components. Changing the surface area of the insert that contacts water during use of the oral irrigator can also change the rate of release.
The composite may also include a colorant that leaches from the composite at a rate correspo~; ng to the rate of release of the substance. Thus, most of the colorant will have been released by the composite at about the same time most of the substance has been released. A user then can observe by the color change that the composite is used up.
The term "water", as used herein, encompasses pure water, housewater, and an aqueous solution, dispersion, etc. that include other components in addition to water.
The term "composite~, as used herein, m~An~ a SUBSTITUTE SHEET(RULE 26) _ CA 02214764 1997-09-0~
W 096127344 PCT/U~f'~02 solid composition that includes a blend of the substance and at least one other chemically distinct component (e.g., a water insoluble polymer or a water-soluble polymer).
Other features and advantages of the invention will be apparent from the description of the preferred ~ -~; ts thereof, ~nd from the claims.
FIG. 1 i~ a per~pecti~e ~iew of an oral irrigator.
FIG. 2 i~ a tip for an oral irrigator.
FIG. 3 is a perQpective ~iew of a composite.
FIG. 4 i~ a cross-sectional view B of the composite, viewed along the longitl~; n~l A axis.
Referring to Figure 1 an oral irrigator 10 includes water source 12, a flow path (not shown), a hand-held portion ~4 and a tip portion 16. Water from the water source 12 is forced through the housing 18 of the oral irrigator, through a tube 20 connecting the housing 18 to the tip portion 16. The water exits the tip portion at exit 22. Depicted i8 the commercially available Braun Oral-B Plak Control~ Oral Irrigator, Model MD5000.
Referring to Figure 2, the tip portion include~ a fluid entrance 24, a fluid exit 22, and a shaft 26 connecting the fluid entrance and the exit.
Locking clips 28 allows the tip portion to be detachably coupled to the oral irrigator. A molded or extruded composite (not shown in Figure 2) is disposed in the fluid path of the tip portion.
Referring to Figures 3 and 4, the molded or extruded composite 29 is tube-shaped and includes a water insoluble support resin, a water-soluble polymer, a water-soluble ~ ~me~ic specie~, and/or a polymer only swollen by water; and an antimicrobial agent, flavoring, whitener, fluoride compound, an anticalculus agent and/or fo~; ng agent. The composite has an outer bore 30 and an inner bore 32. When inserted in the SUBSTITUTE SHEET (RULE 26) CA 022l4764 l997-09-0~
W 096/27344 PcT/U~G~3202 tip, water flows through the hollow center portion 34 of the composite, contacting the inner bore 32. The composite may be formed as a single unit with the tip portion, or it may be formed as a discrete unit 80 that it may be inserted and ~ ~ved easily.
The water insoluble support resin can be, e.g., polystyrene, polyurethane, ethylene vinyl acetate (EVA), polyethylene, styrene/rubber, ethylene/
propylene, or other acceptable, commercially available polymers. The water in~oluble support resin is the backbone of the composite and has negligible ~olubility in water. It provides the composite with structural integrity when the other components of the composite leach out during uAe.
A sufficient amount, preferably greater than 25% by weight, of the water insoluble support resin should be included in the composite 80 that when other c _ ~nts leach out there is still enough resin present to maintain the structure of the composite. Of course, not 80 much should be included that the compo~ite cannot be loaded with a ~ufficient amount of the other components. Pre$erably, the c _~site includes less than 90% by weight of the support resin.
A preferred support resin is EVA, which has low toxicity and is available in grades that have a low processing temperature. The preferred EVA includes between 5% and 50% by weight vinyl acetate. If the polymer includes too little vinyl acetate, the composite may be too stiff and re~uire higher processing temperatures. If the polymer includes too much vinyl acetate, the composite may be rubber-like and too ~oft to process.
The water-soluble polymer can be, e.g., starches, polyvinyl alcohols, polyethylene oxides, hydroxyalkyl starches, hydroxyethyl and hydroxypropyl celluloses, polyacrylic acids, and gelatins. Most preferred are polyethylene oxide~ having a molecular SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
W 096l27344 PCTAUS9C/03202 weight between 100,000 and 5,000,000, e.g., Polyox~
water-~oluble resins, and polyacrylic acids, e.g., Carbopol~ (available from the BF Goodrich ~mp~y).
Polyox water-soluble polymers are non-ionic ethylene oxide homopolymers that range in molecular weight from about 100,000 to 5,000,000. Polyox has a very low degree of toxicity, and grade8 are a~ailable that have a low processing temperature, and are completely water-soluble in cold and warm water.
The preferred Polyox, available from Union Carbide is WSR N-750, which has a molecular weight of 300,000. Alternatively, WSR N-80 (MW 200,000) can be u8ed. WSR N-750 ha a water solubility that is suf~icient to provide a controlled release of the antimicrobial agent from the composite at bactericidal levels, but the solubility in the compo ite is low enough that it dissolves out 810wly over a period of many use~.
A water-soluble ~ ic species may be an organic ~ d or inorganic compound. ~Y~rle~ of organic compound8 include fatty acids and carbo-hydrates. Examples of inorganic compounds include ; - ;um salts.
The compo~ite preferably contains between 2%
and 50% by weight, more preferably between 5% and 35%
or 40%, of the water-soluble component. I$ too much is included, the antimicrobial agent may leach out too guickly, and the structural integrity of the composite once most of the polymer has le~ch~ out may be adversely affected. If too little is included, too low a quantity of the antimicrobial agent may be released from the composite during use.
A water-swellable polymer is a polymer which is relatively insoluble (less than 1000 ppm at 22~C.) in water but which ~an absorb at least 2 times its weight in water. Preferred water-swellable polymers can absorb 2 to 50 times their weight in water at 22~C.

SU13STITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
W 096/27344 PCTnUS96/03202 Commercially available polymers sometimes include small quantities of impuritie~, such as the starting materials used to synthesize the polymers, or uncross-linked polymers. The cross-linked polymers should be at least 99.9% pure when det~rm;n~ng whether a particular polymer absorbs a sufficient quantity of water and is sufficiently insoluble in water to qualify as a water-swellable polymer.
Examples of water-swellable polymers include water-absorbing acrylics such as Salsorb 84, Salsorb 88, and Salsorb 90, all of which are a~ailable from Allied Colloids Corporation; cross-linked starch/sodium polyacrylate copolymers such as Sanwet COS-960, Sanwet COS-915, and Sanwet COS-930, all of which are available from the Hoechst ~el~ne~e Corporation, and Waterlock A-180, which i8 available from Grain Processing Corporation; hydroxypropylmethylcelluloses such as Methocel, which is available from Dow Chemical Corporation; polyacrylic acids such as Carbopol 940, which is available $rom B.F. Goodrich C _-ny;
microcrys~ll;~e celluloses such as Avicel, which is available from FMC Corporation; chitosan ~y olidone carboxylic acids such as Kytamer PC, which is available from Amerchol Corporatio~; acrylic acid/acrylonitrogen copolymers such as Hypan-SA-lOOE, which is available from gingston Xydrogels Corporation; cross-linked potassium acrylates such as Liqua-Gel, which is available from Miller Chem. ~ Fertilizer Corporation;
carboxymethylcelluloses such as Aquasorb B-315 (Na salt) and AQU-D3236 (Al/Na salt), both of which are available from Aqualen Corporation; and cross-linked polyacrylic acid polyalcohol grafted copolymer~ such as FAVOR SAB 800, which i~ available from Stockhausen Company. Two further example~ of water-swellable polymers are Ultrasponge (available from MicroVesicular Systems Inc.), and Costech (available from Costech Corporation). The more preferred water-swellable SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
WO 96127344 PCT/~JS96/03202 g polymers are the SanWets and Salsorbs.
A sufficient quantity of the water-swellable polymer should be included in the composite such that, o when the composite is contacted with water, the welling of the polymer causes an increase in the J release of the sub~tance from the composite. When water-swellable polymer~ are u8ed, the composite preferably include~ between 0.2% to 50%, more preferably between 3% and 15%, and most preferably 10 between 4% and 8~, of the water-Awellable polymer by weight.
Examples of ~ubstanceR that can be included in the composite for eventual release include antimicrobial agents, flavorants, whitener~, fluoride 15 co ~u~dA, foaming agents, de8en8itizing agents, nutritional agents, odor-pre~enting agents, ~ ~alizing agents, anticalculus agents, anti-inflammatory agents, sali~ary gland ~timulators, antifungal agents, and antiviral sgents. The amount of 20 a particular substance included in the composite depends on the le~el of the desired dosage, which is it~elf dependent on the amount of water-soluble polymer; the compo~ite may include, for example, between 1% and 40% (or even between 1% and 60%) of the 25 substance by weight. If too high a level of the substance is included, the compo~ite may become brittle. Of course, a sufficient amount of the substance should be included 80 that enough is released during use to cause the desired result.
Examples of antimicrobial agents that can be used in the co~posite include bi~guanides such as chlorhexidine and alexidine; quaternary ~m~ i um compounds such as cetylpyridinium chloride, domiphen bromide, and benz~lko~;um chloride; zinc salts such as zinc chloride and zinc citrate; antibioticR such as chlortetracycline, tetracycline, actinobolin, streptomycin, k:~rr ycin, neomycin, niddamycin, SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
W O 96/27344 PCTrUS96/03202 bacitraain, erythromycin, penicillin, ranaemycin, gramicidin, saramycin, and polym;Y;~ B; as well as antiplaque enzymes such as mucinases, pancreatin, fungal enzymes, protease-amylase, dextranase, moimnase, zendium, amylogluaosidase, and glucose oxidase. The preferred antimiarobial agents for use in the aomposite are ahlorhexidine and triclosan. When chlorhexidine is used, it is preferred to use its digluconate salt; the hydrochloride and diaaetate salts can also be used.
Examples of flavorants include, e.g., peppermint, sp~rm;nt, or cinnamon, added as oils or compounded with structural plastia (e.g., PolyIff~).
These flavorants are available from International Flavors and Fragranaes (I~F).
Examples of whiteners inalude hydrogen peroxide, peroxyborate ~ ohydrate, and other peroxy aompounds.
Examples of fluoride compounds include sodium fluoride, alkyl - ~um fluorides, stannous fluoride, sodium monofluorophosphate, etc.
Examples of foaming agents include surfactants like various Pluronics, which are available from BASF, and Tween.
Examples of desensitizing agents include strontium ahloride, strontium aitrate, aalaium oxalate, potassium nitrate, and potassium oxalate.
Examples of nutritional agents include Vitamin C and Vitamin E.
Examples of odor-~le~e..ting agents include zinc salts (e.g., zinc chloride and zinc citrate) and ahlorophyll aompounds.
Examples of remineralizing agents include various aalaium/phosphate systems.
Examples of anticalculus agents include zinc salts (e.g., zinc chloride and zinc aitrate), tetrasodium pyrophosphate, and disodium dihydrogen pyrophosphate.

SUBSTITUTE SHEET (RULE 26) W 096127344 PCTAUS96~032~2 Examples of anti-inflammatory agents include steroids (e.g., triamcinolone diacetate), ~alicylates (e.g., acetylsalicylic acid), and ho~mo~Q (e.g., cortisone acetate).
Examples of salivary gland stimulators include citric acid and pilocarpine.
Example~ of antifungal agents include ny8tatin~ e~o~A~ole nitrate, and clotrimazole.
Examples of antiviral agents include ~ZT and trifluridine.
The composite may include other ingredients like dispersing agents (e.g., glycerol di~tearate) that can help provide a more uniform distribution of the substance throughout the composite. The composite may include, e.g., from 2% to 8% dispersing agent by weight.
An example of a composite including 51% by weight EVA as the water-insoluble support resin, 40% by weight chlorhexidi~e digluconate, and 9% by weight Carbopolff~ (a preferred water-soluble polymer) was prepared accordi~g to the following procedure.
~L~ ~ RT~T..~
~ ~hlo-h~Y;~ Digluconate A 20 percent solution of chlorhexidine digluconate, available from Pliva ph~rm~ceutical, Chemical~ Food and Cosmetic Industry of Zagreb, Yugoslavia, or ICI, was freeze-dried as follows:
1. ~easure 500 ml of chlorhexidine digluconate in a graduated cylinder and transfer it to a liter flask.
2. Adjust volume to 1 liter with double distilled filtered water and mix together.
3. Transfer 300 ml. portions of mixture to glass evaporating dishes (8 inch diameter).
4. Place all evaporating dishes in the freeze-drying apparatus until all water is removed.
5. Transfer the chlorhexidine freeze-dried Sl.JBSTITUTE SHEET (RULE 26) CA 022l4764 l997-09-0~
W 096/27344 PCTnUS96/03202 powder to a 1 liter glass bottle and cap.
6. Store the bottle in a refrigerator or a dark room at approximately 4~C.
Optionally, chlorhexidine digluconate can be bought already freeze-dried from Pliva.
b. Ethylene Vinyl Acetate t The most preferred ethylene vinyl acetate i8 sold by DuPont under the tradename ELVAX 360, and has a vinyl acetate content of 25 percent by weight; a tensile strength of 18.0 Mpa at 23~C. (ASTM D638); an elongation of 800 percent at 23~C. ~ASTM D638); a softening temperature of 53~C. (ASTM D1525); and a flexural ~ U8 of 26 Mpa at 23~C. (ASTM D790).
ELVAX 360 contain~ 500 ppm BHT a~ an anti-oxidant.
In order to mix with chlorhexidine and Carbopol~, ELVAX 360 pellets are ground into powders with particle sizes of less than 250 microns with a Glen Mill Granulator (Model #CS 150/100-2) installed with a screen plate having 1 mm screen holes. A
suction system is added to the gr;n~;ng chamher to f~cilitate the v~l of powders from the chamber to a cont~;ner. During gr;n~;ng~ the material is recycled through the grinder as many times as necessary (usually two or three passe~) to meet the size requirement. A
sieve ~h~ke~ manufactured by the W.S Tyler Co. is used to control the sizes as needed.
c. Carbopol~
Carbopol~ 934PNF, pharmaceutical grade, i~
available from B.F. Goodrich Company. The Carbopol~ is used as received and m; Ye~ with other components to form the composite.
d. Bl~n~; n~ of Materials The ELVAX 360, Carbopol~, and chlorhexidine digluconate are mixed in a blender. Each component i~
first weighed and then poured into a glass jar with a capacity of 0.5 kiloyl- ~. The jar is then placed on a ball-mill rotator and mixed for approximately 1/2 hour.

SUBSTITUTE SHEET (RULE 26) CA 02214764 1997-09-0~
WO 96/27341 PCT~JS96/03202 For a quantity greater than 0.5 kilograms, a V-blender manufact~red by Patterson-Relly Co. Inc. is used. The blended material should be stored in a dry, cool room.
e. Proce~ing The conventional equipment that can be used to produce the composite includes an extruder, a cooling plate, a puller, and an extrusion die. Each die is supplied with a sensor for the recording of melt pressure and temperature. Pulling speed iB adjusted to produce the appropriate sample.
Samples can be made with either a twin-screw or a single-screw extruder. The Werner & Pfleiderer 30 mm twin-~crew extruder is based on a corotating and int~rm~sh;ng twin-screw system. To ~;n;m; ze degrad-ation during proce~sing, the twin-screw extruder consi~ts of only two high-shear kn~A~;ng elements and ~he rest being low-shear cGIv~ying screw elements; the screw speed and processing temperatures are reduced to a _;n;mllm. The mixture is fed using a K-tron twin-screw feeder (MoAe.l T-20).
Alternatively, a Haake 3/4 inch single-screw extruder equipped with a 5HP drive motor i8 employed.
When -k; n~ the most preferred composite, the extruder was operated with a screw speed of 35 rpm, a barrel pressure of 70 psi, a die pressure of 80 psi, a barrel temperature of 113~C., and a die temperature of 113~C.
The blend of materials is fed to either extruder and the tube produced i~ pulled onto a rod.
The tube is cooled by blowing dry compressed air into the tube. The finished product should be kept in a cool, dry room.
The composites can also be made by other conventional processes, such as by in~ection molding, compression molding, the forming, and casting.
A composite prepared as described above wa~
inserted in the tip portion and connected to the oral irrigator. The irrigator was charged with 250 ml of SUBSTITUTE SHEET (RULE 26) , CA 022l4764 l997-09-0~
W 096/27344 PCTnUS96/03202 water and allowed to run (at a speed of 5) until all of the water had passed through the inner bore of the composite in the tip portion. Water contacts the composite and dissolves the Carbopol~ polyacrylic acid.
Channels form within the support, causing the chlorhexidine to be released into the flow path. The solution was collected and analyzed for its chlorhexidine content. Repeatedly, 3 mg (+/-1 mg) of chlorhexidine was present in the solution. Thus, a steady release of chlorhexidine was achieved. After 28 consecutive trials, no significant amount of chlorhexidine was detected. When the chlorhexidine iB
expired, the composite (or the entire tip) may be replaced.
Other embs~; ~ts are within the claims. For example, the composite can be shaped as a tapered tube, instead of the straight tube illustrated in the figures. Moreover, the central opening through the tube can be, e.g., star shaped to provide more surface area for water contact. Similarly, the outer surface of the tube can ha~e ridges 80 that when the tube is positioned in the flow path water can pass through channels between the exterior surface of the composite and the wall defining the flow path. Composites having other shapes, e.g., a flat strip, can be positioned in the flow path and used in place of or in combination with a tube-shaped composite.
In addition, the composite itself can be formed of more than one layer. Each layer, for example, may include a different substance for release in response to contact with water. Further, the sub~tance to be released may be microencap~ulated.
This can provide increased ease of proces~ing, particularly when processing involves high temperature.
The composite also may include the substance to be released and a water-soluble polymer, but not include a water-insoluble support resin. The compo~ite SUBSTITUTE SHE~T (RULE 26) W 096127344 PC~AUS96J~32~2 may include, for example, between 1% and 99% (or between I0% and 99% or between 30% and 90%) of the substance by weight and between 1% and 99% (or between 10% and 99%, or between 30% and 90%) of the water-soluble polymer by weight. The water-soluble polymer dissolves over time when the composite is contacted with water. An advantage of a composite including the subRtance and a water-soluble polymer is that a high quantity (e.g., 80% or more) of the substance can be included in the composite. For example, the composite may include 90% chlorhexidene digluconate and 10%
Polyox~ compre~sion molded at ambient temperatures into the desired shape. The composite may also i~clude, for example, 35% chlorhexidene diglucanate and 65% Polyox~.
The composite can be in~erted into or otherwise be surrounded by a support layer made, for example, of a plastic material.
In another embodiment, the water irrigator may include more than one composite each, including a substance (the same or dif~erent) that is released when the composites are contacted with water.
In another embodiment, the insert for the tip or irrigator consists only o~ the bisguanide or a quaternary ~- - ;um compound.

SUBSTITUTE SHEET (RULE 26)

Claims (34)

C L A I M S
1. An oral irrigator for delivering a substance to the mouth when water flows through the irrigator, said irrigator comprising:
a tip portion for dispensing water into the mouth;
a flow path that delivers water through said irrigator, including said tip portion, to said mouth;
and a composite comprising a substance that is released from the composite when the composite is contacted with water, positioned in said irrigator so that water flowing through said irrigator contacts said composite.
2. The oral irrigator of claim 1, wherein said composite is positioned in said tip portion.
3. The oral irrigator of claim 2, wherein said composite is tube-shaped and has an opening through which water can pass.
4. The oral irrigator of claim 1, wherein said substance is an antimicrobial agent.
5. The oral irrigator of claim 4, wherein said antimicrobial agent is chlorhexidine.
6. The oral irrigator of claim 1, wherein said substance is selected from the group consisting of tooth whiteners, flavorants, fluoride-containing compounds, foaming agents, desensitizing agents, nutritional agents, odor-preventing agents, remineralizing agents, anticalculus agents, anti-inflammatory agents, salivary gland stimulators, antifungal agents, and antiviral agents.
7. The oral irrigator of claim 1, wherein said composite further comprises a water insoluble polymer.
8. The oral irrigator of claim 7, wherein said composite further comprises a release-enhancing material comprising a water-soluble or water-swellable material.
9. The oral irrigator of claim 8, wherein said release-enhancing material comprises a water-soluble polymer.
10. The oral irrigator of claim 9, wherein said water-soluble polymer comprises a polymer selected from the group consisting of polyethylene oxide and polyacrylic acid.
11. The oral irrigator of claim 9, wherein said substance comprises an antimicrobial agent and wherein said composite comprises from 25 to 90 percent by weight water-insoluble polymer, from 5 to 40 percent by weight water-soluble polymer, and from 1 to 60 percent by weight antimicrobial agent.
12. The oral irrigator of claim 11, wherein said antimicrobial agent comprises chlorhexidine.
13. The oral irrigator of claim 1, wherein said composite further comprises a water-soluble polymer.
14. The oral irrigator of claim 13, wherein said substance comprises an antimicrobial agent.
15. The oral irrigator of claim 14 wherein said antimicrobial agent comprises chlorhexidine.
16. A tip suitable for attachment to an oral irrigator, said tip comprising:
a body including a water entrance, a water exit, a flow path connecting said entrance and said exit, and a composite comprising a substance that is released from said composite for delivery to a mouth when said composite is contacted with water, said composite being positioned in said tip so that water flowing through said flow path contacts said composite.
17. The tip of claim 16, wherein said composite is tube-shaped and is located in said flow path.
18. The tip of claim 16, wherein said substance comprises an antimicrobial agent.
19. The tip of claim 18, wherein said antimicrobial agent comprises chlorhexidine.
20. The tip of claim 16, wherein said composite further comprises a water-soluble polymer.
21. The tip of claim 20, wherein said substance comprises chlorhexidine.
22. The tip of claim 16, wherein said composite further comprises a water insoluble polymer.
23. The tip of claim 22, wherein said composite further comprises a release enhancing agent selected from the group consisting of water-soluble polymers and water-swellable polymers.
24. The tip of claim 23, wherein said release enhancing material is a water-soluble polymer.
25. The tip of claim 24, wherein said water-soluble polymer comprises a polymer selected from the group consisting of polyethylene oxide and polyacrylic acid.
26. The tip of claim 24, wherein said substance is an antimicrobial agent and wherein said composite comprises from 25 to 90 percent by weight water-insoluble polymer, from 5 to 40 percent by weight water-soluble polymer, and from 1 to 60 percent by weight antimicrobial agent.
27. The tip of claim 26, wherein said antimicrobial agent comprises chlorhexidine.
28. The tip of claim 16, wherein said substance is selected from the group consisting of tooth whiteners, flavorants, fluoride-containing compounds, foaming agents, desensitizing agents, nutritional agents, odor-preventing agents, remineralizing agents, anticalculus agents, anti- inflammatory agents, salivary gland stimulators, antifungal agents, antiviral agents.
29. A method of introducing a substance into a mouth, comprising flowing water into contact with a composite and then into said mouth, said composite comprising a substance that is released from said composite when water contacts said composite, said substance being released from said composite when contacted with said flowing water and carried by said flowing water into said mouth.
30. The method of claim 29, wherein said composite further comprises a water-insoluble polymer.
31. The method of claim 29, wherein said composite further comprises a water-soluble polymer.
32. The method of claim 29, wherein said composite is extended or molded prior to flowing water into contact with said composite to release the substance into the mouth.
33. An oral irrigator for delivering a substance to the mouth when water flows through the irrigator, said irrigator comprising:
a tip portion for dispensing water into the mouth;
a flow path that delivers water through said irrigator, including said tip portion, to said mouth;
and a bisguanide or a quaternary ammonium compound positioned in said irrigator so that water flowing through said irrigator contacts said bisguanide.
34. A tip suitable for attachment to an oral irrigator, said tip comprising:
a body including a water entrance, a water exit, a flow path connecting said entrance and said exit, and a bisguanide positioned in said tip so that water flowing through said flow path contacts said bisguanide or a quaternary ammonium compound.
CA002214764A 1995-03-08 1996-03-07 Delivery of substance to the mouth Abandoned CA2214764A1 (en)

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US40061195A 1995-03-08 1995-03-08
US400,611 1995-03-08
US08/594,694 US5779471A (en) 1995-03-08 1996-01-31 Delivery of substance to the mouth
US594,694 1996-01-31

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AT (1) ATE186632T1 (en)
AU (1) AU5187796A (en)
CA (1) CA2214764A1 (en)
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WO (1) WO1996027344A1 (en)

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DE69605184T2 (en) 2000-05-25
WO1996027344A1 (en) 1996-09-12
EP0813395B1 (en) 1999-11-17
DE69605184D1 (en) 1999-12-23
ATE186632T1 (en) 1999-12-15
AU5187796A (en) 1996-09-23
EP0813395A1 (en) 1997-12-29
US5779471A (en) 1998-07-14

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