WO2004098581A2 - Oral spray to reduce cold symptoms and duration of same - Google Patents
Oral spray to reduce cold symptoms and duration of same Download PDFInfo
- Publication number
- WO2004098581A2 WO2004098581A2 PCT/US2004/013425 US2004013425W WO2004098581A2 WO 2004098581 A2 WO2004098581 A2 WO 2004098581A2 US 2004013425 W US2004013425 W US 2004013425W WO 2004098581 A2 WO2004098581 A2 WO 2004098581A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- zinc
- oral
- weight percent
- amount
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/28—Compounds containing heavy metals
- A61K31/315—Zinc compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates generally to a composition formulated to maintain a fherapeutically beneficial ingredient in association with the nasal, oral, and oralpharyngeal membranes to reduce cold symptoms and their duration. More specifically, the present invention relates to an oral spray having a zinc composition for absorption by the nasal, oral, and/or oralpharyngeal membranes to reduce cold symptoms and their duration.
- U.S. Patent No. 4,503,070 issued in 1995 discloses the use of a lozenge containing zinc gluconate to reduce the duration of a cold and his U.S. Patent No. 5,409,905 discloses a composition having a highly ionizable zinc compound which provides sustained release of Zn 2+ ions.
- the highly ionizable zinc compound is selected from zinc acetate, zinc propionate, zinc butyrate, zinc betahydroxybutyrate, zinc benzoate, zinc formate, and mixtures thereof while the composition specifically excludes flavor masking amounts of anethole and strong zinc chelators.
- U.S. Patent No. 6,139,864 was issued to Durr et al in 2000.
- the Durr et al. patent describes foods and pharmaceuticals containing zinc and an antimicrobially effective amount of a sugar alcohol mixture.
- the zinc was identified as being present in the form of zinc gluconate or zinc acetate.
- compositions that include a single zinc compound as the source of zinc ions. Such compositions are thought to be deficient because the zinc compounds are generally configured to provide only slow release of zinc ions. Accordingly, improved methods and compositions for treating cold symptoms are desired.
- the present invention addresses the deficiencies and disadvantages of the prior art is described in greater detail hereinbelow, in general, according to various aspects of the present invention, a method and composition are provided for maintaining a therapeutically beneficial ingredient in association with the nasal, oral, and/or oralpharyngeal membranes to reduce and prevent the common cold and its symptoms.
- the zinc containing composition is formulated to both increase the concentration of zinc and its ionization potential, and to sustain the release of ionizable zinc.
- the oral composition includes a zinc formulation containing both zinc gluconate and zinc acetate.
- the oral spray composition comprises a very low viscosity, similar to that of water, and is administered to the oral cavity via a fine spray mist in a dosage of about four squirts, each containing approximately .25 milliliters, with the dosage administered approximately every three hours.
- the oral spray composition includes one or more of a sweetener, flavoring, and a preservative, in addition to a pharmaceutically acceptable carrier.
- a system for delivering the composition to the oral cavity is provided. More specifically, a spray applicator is provided for administering spray into the oral cavity.
- an oral spray composition which includes two or more zinc salts.
- the zinc from the zinc salts is desirably freely available, i.e. non-chelated and in an ionizable form, to ensure that it is biologically available and can be readily adsorbed.
- the oral spray composition containing the zinc salts When administered to the oral cavity via a fine spray mist, the oral spray composition containing the zinc salts will produce a biological electrical circuit from the mouth, through the oral membranes, the oralpharyngeal membranes, and into the nasal membranes.
- This positive ionic flow of readily ionizable zinc that can be adsorbed into the mucosal membranes is capable of binding to viral ICAM-1 receptors in the nasal passages and inhibits rhinovirus from binding to and infecting nasal mucosal cells.
- the oral spray composition of the present invention reduces the presence and/or duration of symptoms associated with the common cold including, but not limited to, headaches, sore throat, runny and/or congested nose, and coughs. More particularly, the oral spray composition of the present invention functions to treat infections associated with those viruses typically recognized as causing common colds.
- the oral spray of the present invention is preferably used from any time when an individual first notices any signs of a cold up until when the symptoms have cleared.
- the composition contains a zinc salt in an amount of about 2 to 6 weight percent of the composition.
- the zinc formulation contains both zinc gluconate and zinc acetate, and preferably comprises about 2 to 6 weight percent of the oral spray composition.
- zinc gluconate preferably comprises about 2 to 4 weight percent of the oral spray composition and zinc acetate preferably comprises about 0.2 to 2.0 weight percent of the oral spray composition.
- zinc gluconate is present in an amount of about 32 to about 35 mg/ml, preferably about 33.4 mg/ l, and the zinc acetate is present in am amount of about 3 to about 6, preferably about 3.3 mg/ml. Additionally, the combination of the zinc salts provides about 3 to about 7 mg/ml of free ionic zinc, and preferably about 6.1 mg/ml of free ionic zinc.
- the oral spray composition also includes a pharmaceutically acceptable carrier.
- the pharmaceutically acceptable carrier may include any suitable fluid or liquid such as, for example, purified water, or the hke.
- the pharmaceutically acceptable carrier comprises purified water in an amount of about 84.16 to
- the oral spray composition may also include a stabilizer such as glycerin, or the hke which functions to keep the zinc in its ionic form.
- a stabilizer such as glycerin, or the hke which functions to keep the zinc in its ionic form.
- the stabilizer includes glycerin present at a concentration of about 0.8 to 1.2 weight percent of the oral spray composition, and preferably at about 1.0 weight percent of the oral spray composition.
- Glycerin as the preferred stabilizer also functions to add a small amount of flavoring to the oral spray composition.
- sweetener and flavor enhancers may also be included in the oral spray composition.
- Sweeteners may include fructose, dextrose, sucrose or the like.
- Non-artificial sweeteners work best with a preferred embodiment including fructose in an amount of about
- One preferred embodiment of the oral spray composition includes a flavor enhancer, such as peppermint, for example, in an amount of about 0.5 to 2.0 weight percent of the oral spray composition, and preferably at about 1 weight percent of the oral composition.
- a preservative may be added to the oral composition to facilitate stability of the various ingredients.
- Any suitable preservative may be used in accordance with the present invention such as, for example, benzalkonium chloride, benzyl alcohol, and disodium EDTA.
- the preservative includes a 50% solution of benzalkonium chloride admixed into the oral composition at a concentration of about 0.01 to 0.02 percent by weight, and preferably about 0.015 percent by weight.
- the composition of the present invention is preferably delivered to the oral cavity through the mouth by way of a fine spray mist.
- the method includes the steps of obtaining an oral composition in accordance with the present invention for deHvery into the oral cavity.
- the method further includes the step of applying the oral composition to the oral cavity with a spray applicator.
- any suitable applicator may be used.
- the applicator is available from Pfeiffer of America, 12 Roszel Road, Suite C-104, Princeton, New Jersey 08540 as Item #63922. This applicator is configured to hold about 120 metered 0.25 ml doses, of the composition.
- the composition may be delivered to an individual in any suitable dosage.
- the oral spray applicator is configured to supply a unit dose of about .25 mis of composition to the individual each time a pump associated with the spray applicator is activated (.25 mis/spray).
- the composition is delivered by applying about 4 sprays in the mouth approximately every 3 hours during waking hours until the cold symptoms have subsided.
- An exemplary oral spray composition for delivering an active zinc compound to the oral cavity to reduce the presence and duration of cold symptoms is prepared by admixing the following ingredients:
- Another exemplary oral spray composition for delivering an active zinc compound to the oral cavity is prepared by admixing the following ingredients:
- compositions include about 33.40 mg/ml of zinc gluconate and about 4.40 mg/ml of zinc acetate to provide approximately 6.10 mg/ml of free ionic zinc for adsorption.
- the oral spray is delivered by way of a fine spray mist through the use of a spray applicator.
- the zinc formulation included in the oral spray contains zinc or a zinc combination which functions to increase the zinc concentration and the ionization potential of zinc, and to sustain the availability of ionizable zinc for adsorption into the oral, oralpharyngeal, and/or nasal membranes.
- reference to oral, oralpharyngeal, and nasal membranes includes any interior surface of the oral and nasal cavities permitting delivery of an active substance, such as the zinc formulation, to the body, including the epithelial layer of the membranes or mucous of the epithelial layer of the membranes.
- an active substance such as the zinc formulation
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE602004009049T DE602004009049T2 (en) | 2003-04-30 | 2004-04-30 | ORAL SPRAY AGAINST RECYCLING SYMPTOMS AND THEIR DURATION |
AU2004235732A AU2004235732B2 (en) | 2003-04-30 | 2004-04-30 | Oral spray to reduce cold symptoms and duration of same |
CA2524074A CA2524074C (en) | 2003-04-30 | 2004-04-30 | Oral composition to reduce cold symptoms and duration of same |
EP04751020A EP1617817B1 (en) | 2003-04-30 | 2004-04-30 | Oral spray to reduce cold symptoms and duration of same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US46721703P | 2003-04-30 | 2003-04-30 | |
US60/467,217 | 2003-04-30 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004098581A2 true WO2004098581A2 (en) | 2004-11-18 |
WO2004098581A3 WO2004098581A3 (en) | 2004-12-09 |
Family
ID=33435040
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/013425 WO2004098581A2 (en) | 2003-04-30 | 2004-04-30 | Oral spray to reduce cold symptoms and duration of same |
Country Status (7)
Country | Link |
---|---|
US (2) | US7754763B2 (en) |
EP (1) | EP1617817B1 (en) |
AT (1) | ATE373468T1 (en) |
AU (1) | AU2004235732B2 (en) |
CA (1) | CA2524074C (en) |
DE (1) | DE602004009049T2 (en) |
WO (1) | WO2004098581A2 (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9034401B1 (en) | 2014-01-23 | 2015-05-19 | Matrixx Initiatives, Inc. | Pharmaceutical compositions comprising plant extracts and methods for reducing duration of a common cold using same |
DE102018205160A1 (en) | 2018-01-12 | 2019-07-18 | Ursapharm Arzneimittel Gmbh | Dietary supplements, uses thereof, methods of supplementation and oral spray |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3431727A1 (en) * | 1984-08-29 | 1986-03-13 | Robugen GmbH Pharmazeutische Fabrik, 7300 Esslingen | Nasal spray for coryza and influenza with a content of zinc gluconate |
US4956385A (en) * | 1981-07-31 | 1990-09-11 | Eby Iii George A | Method for reducing the duration of the common cold |
US5409905A (en) * | 1981-01-05 | 1995-04-25 | Eby, Iii; George A. | Cure for commond cold |
DE10124263A1 (en) * | 2001-05-18 | 2003-01-23 | Friedrich A Wetzel | Composition for treating colds comprises zinc sulfate, zinc orotate, zinc gluconate or zinc acetate |
WO2003066001A2 (en) * | 2002-02-07 | 2003-08-14 | The Trustees Of Columbia University In The City Of New York | Zinc salt compositions for the prevention of mucosal irritation from spermicides and microbicides |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4138477A (en) * | 1976-05-28 | 1979-02-06 | Colgate Palmolive Company | Composition to control mouth odor |
US4503070A (en) * | 1981-07-31 | 1985-03-05 | Eby Iii George A | Method for reducing the duration of the common cold |
US5095035A (en) * | 1981-07-31 | 1992-03-10 | Eby Iii George A | Flavor stable zinc acetate compositions for oral absorption |
USRE33465E (en) * | 1981-07-31 | 1990-11-27 | Method for reducing the duration of the common cold | |
DE3587766T2 (en) * | 1984-06-11 | 1994-07-14 | Godfrey Science & Design Inc | IMPROVEMENTS IN TASTE OF ZINC ADDITIVES FOR ORAL USE. |
US4758439A (en) * | 1984-06-11 | 1988-07-19 | Godfrey Science & Design, Inc. | Flavor of zinc supplements for oral use |
US4689214A (en) * | 1985-04-16 | 1987-08-25 | Colgate-Palmolive Company | Composition to counter breath odor |
US5059416A (en) * | 1989-06-26 | 1991-10-22 | Warner-Lambert Company | Zinc compound delivery system with improved taste and texture |
US5094845A (en) * | 1991-03-04 | 1992-03-10 | David G. Vlock | Oral compositions containing zinc gluconate complexes |
US5165914A (en) * | 1991-03-04 | 1992-11-24 | David G. Vlock | Oral compositions containing zinc lactate complexes |
ZA952521B (en) * | 1994-03-28 | 1996-03-15 | Univ Columbia | Composition for inactivating irritants in fluids |
US6121315A (en) * | 1996-09-20 | 2000-09-19 | Warner-Lambert Company | Oral compositions containing a zinc compound |
NZ335780A (en) * | 1996-10-23 | 2001-01-26 | Univ New York State Res Found | Compositions to control oral microbial oxidation-reduction (Eh) levels and treat gingivitis-periodontitis |
US5897891A (en) * | 1996-11-18 | 1999-04-27 | Godfrey; John C. | Flavorful zinc compositions for oral use incorporating copper |
DE19818842C1 (en) * | 1998-04-28 | 2000-01-05 | Suedzucker Ag | Cold remedy containing sugar alcohol mixture such as Isomalt, having immunostimulant and antimicrobial activity |
US6183785B1 (en) * | 1998-11-12 | 2001-02-06 | Geoffrey J. Westfall | Teat disinfectant |
US6169118B1 (en) * | 1998-11-12 | 2001-01-02 | Block Drug Company, Inc. | Flavor blend for masking unpleasant taste of zinc compounds |
US6475526B1 (en) | 2001-06-05 | 2002-11-05 | Jeffrey B. Smith | Zinc containing compositions for anti-viral use |
US20040192587A9 (en) * | 2002-04-23 | 2004-09-30 | Rosenbloom Richard A. | Zinc formulations as a prophylactic treatment for the common cold |
-
2004
- 2004-04-30 EP EP04751020A patent/EP1617817B1/en not_active Not-in-force
- 2004-04-30 CA CA2524074A patent/CA2524074C/en not_active Expired - Fee Related
- 2004-04-30 AT AT04751020T patent/ATE373468T1/en not_active IP Right Cessation
- 2004-04-30 AU AU2004235732A patent/AU2004235732B2/en not_active Ceased
- 2004-04-30 WO PCT/US2004/013425 patent/WO2004098581A2/en active IP Right Grant
- 2004-04-30 US US10/837,078 patent/US7754763B2/en not_active Expired - Fee Related
- 2004-04-30 DE DE602004009049T patent/DE602004009049T2/en active Active
-
2010
- 2010-07-13 US US12/835,646 patent/US8853265B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5409905A (en) * | 1981-01-05 | 1995-04-25 | Eby, Iii; George A. | Cure for commond cold |
US4956385A (en) * | 1981-07-31 | 1990-09-11 | Eby Iii George A | Method for reducing the duration of the common cold |
DE3431727A1 (en) * | 1984-08-29 | 1986-03-13 | Robugen GmbH Pharmazeutische Fabrik, 7300 Esslingen | Nasal spray for coryza and influenza with a content of zinc gluconate |
DE10124263A1 (en) * | 2001-05-18 | 2003-01-23 | Friedrich A Wetzel | Composition for treating colds comprises zinc sulfate, zinc orotate, zinc gluconate or zinc acetate |
WO2003066001A2 (en) * | 2002-02-07 | 2003-08-14 | The Trustees Of Columbia University In The City Of New York | Zinc salt compositions for the prevention of mucosal irritation from spermicides and microbicides |
Also Published As
Publication number | Publication date |
---|---|
ATE373468T1 (en) | 2007-10-15 |
EP1617817A2 (en) | 2006-01-25 |
CA2524074C (en) | 2010-03-23 |
US7754763B2 (en) | 2010-07-13 |
AU2004235732A1 (en) | 2004-11-18 |
WO2004098581A3 (en) | 2004-12-09 |
US20100280106A1 (en) | 2010-11-04 |
US20050043400A1 (en) | 2005-02-24 |
DE602004009049T2 (en) | 2008-06-19 |
CA2524074A1 (en) | 2004-11-18 |
EP1617817B1 (en) | 2007-09-19 |
DE602004009049D1 (en) | 2007-10-31 |
AU2004235732B2 (en) | 2008-04-03 |
US8853265B2 (en) | 2014-10-07 |
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