AU2005225220A1 - Stabilized peroxide compositions - Google Patents

Description

WO 2005/092278 PCT/IB2005/000450 STABILIZED PEROXIDE COMPOSITIONS FIELD OF THE INVENTION 5 This continuation-in-part application claims the benefit of United States Patent Application No. 10/792,370, filed on March 3, 2004, the entirety of which is hereby incorporated by reference as if fully set forth herein. This invention relates to a stabilized, oral composition, and more particularly, to such composition comprising peroxide compounds. 10 BACKGROUND OF THE INVENTION Hydrogen peroxide is a well known antiseptic which has been extensively employed in aqueous solution for the treatment of infectious processes in both human and veterinary topical therapy. The agent can be used in its original form after suitable dilution, or it can be derived from those solid compounds which form salts or additive 15 compounds with hydrogen peroxide. Included among these are sodium perborate, sodium carbonate peroxide, sodium peroxyphosphate, urea peroxide, potassium persulfate, and others. When added to water, these compounds hydrolyze into hydrogen peroxide and the corresponding carrying salt. Although extensively employed for treating all parts of the body, hydrogen 20 peroxide has proved especially valuable for treating the mucous membranes of the oral cavity. Partly as a consequence of oxygen tissue metabolic and reparative requirements (by a mechanism which is not clearly understood), partly as a consequence of its broad antibacterial effects against gram positive and gram negative cocci, bacillus and spirochetal forms as well as many varieties of yeasts and fungi, 25 and partly because of its cleaning and hemostatic effects, hydrogen peroxide is extensively recommended and used for bacterial and viral infections and for tissue inflammations of non-microorganic origin. The principal limitations of commonly used peroxide aqueous solutions, however, are their poor shelf stability caused by the decomposition of hydrogen 30 peroxide into gaseous oxygen and water at room temperature, and the transitory contact of the active oxygenating agent with the affected tissue. In addition, when WO 2005/092278 PCT/IB2005/000450 2 such compositions are formed of additive compounds with hydrogen peroxide, it is common to prepare the adduct composition before incorporating it into the desired composition. Attempting to address this limitation, the inventors of the present invention 5 have discovered that oral compositions incorporating at least two water soluble gums in addition to the peroxide component have improved peroxide stability. Accordingly an aspect of the present invention is to provide improved oral compositions. Another aspect of the present invention is to provide oral compositions 10 providing improved peroxide stability. Still one other aspect of the present invention is to provide oral compositions comprising at least two water-soluble gums and a peroxide compound having improved peroxide stability. Still yet one other aspect of the present invention is to provide improved oral 15 teeth whitening compositions, especially films. These and other objects and features of the invention will be made apparent from the following description thereof. SUMMARY OF THE INVENTION 20 The present invention relates to oral compositions or solid oral compositions comprising at least two water soluble gums and a peroxide compound wherein the composition, when dried, contains less than about 10% of an hydroalcoholic component. The active, oxygen- generating peroxide component in the composition 25 is stabilized in the oral composition. DETAILED DESCRIPTION OF THE PRESENT INVENTION The oral compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described 30 herein, as well any of the additional or optional ingredients, components, or limitations described herein.

WO 2005/092278 PCT/IB2005/000450 3 All percentages, parts and ratios are based upon the total weight of the oral composition of the present invention prior to drying, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include carriers or by-products that may be included in commercially 5 available materials, unless otherwise specified. The term "safe and effective amount" as used herein means an amount of a compound or composition such as a topical or system active sufficient to significantly induce a positive benefit, for example, a teeth whitening, antimicrobial and/or analgesic benefit, including independently the benefits disclosed herein, but low 10 enough to avoid serious side effects, i.e., to provide a reasonable benefit to risk ratio, within the scope of sound judgment of the skilled artisan. The term "adhesive" as used herein, means any material or composition that is capable of sticking to the site of topical application or administration and includes, but is no limited to, mucoadhesives, pressure-sensitive adhesive (adheres upon 15 application of pressure), moistenable adhesives (adheres in the presence of water) and tachy or sticky type adhesives (adheres upon immediate contact with a surface). The term "foreign substances" as used herein means dirt, infectious microorganisms and the like. Optionally, the film compositions of the present invention are clear. The term 20 "clear" as defined herein ranges from transparent to translucent as observed with the naked eye. The film compositions of the present invention, including the essential and optional components thereof, are described in detail hereinafter. Essential Ingredients 25 Water soluble Gums The compositions of the present invention preferably contain a water-soluble, synthetic or natural gum. Gums suitable for use herein include, but are not limited to algin, alginic acid, alginate salts, camitine, carrageenan, karaya gum, dextrin (starch gum), guar gum, gellan gum, irish moss, veegum (regular), tara gum, okra gum, gum 30 arabic, acacia gum, amylopectin, pectina or pecitin, ghatti gum, natto gum, tragacanth gum, xanthan gum, sclerotium gum, kelp, locust bean gum, psyllium seed, tamarind WO 2005/092278 PCT/IB2005/000450 4 gum, destria gum, chitosan, esters thereof (such as hydroxypropyl chitosan and hydroxypropyl guar), salts thereof (such as ammonium alginate, amylopectin, calcium alginate, calcium carrageenan, guar hydroxypropyltrimonium), and mixtures thereof. Additional gums or salts or derivatives thereof can be found in US patent 6,551,604 to 5 Beck et al. which is herein incorporated by reference in its entirety. In certain embodiments, the water soluble gum can includes xanthan gum (supplied by CP Kelco, Chicago, IL), locust bean gum (supplied by Degussa Texturant System, Atlanta, GA), carrageenan (supplied by FMC Biopolymer, Philadelphia, PA) or mixtures thereof. 10 When incorporated into the oral compositions of the present invention, the water soluble gum is present at a concentration of from about 0.01% to about 10% optionally, from about 0.1% to about 5% optionally, from about 0.1% to about 1%, and, optionally, from about 0.1% to about 2%, by weight, of the wet film composition. 15 Peroxide Compounds Also incorporated into the compositions of the present invention is a peroxide compound. Suitable peroxide compounds include, but is not limited to, hydrogen peroxide, calcium peroxide, urea peroxide, carbamide peroxide, and mixtures thereof. In certain embodiments, the peroxide is hydrogen peroxide. 20 The effectiveness of peroxide materials can, optionally, be enhanced by means of a catalyst, i.e. a two-component peroxide- catalyst system. Useful peroxide catalysts or catalytic agents can be found in US 6, 440,396 to McLaughlin, Gerald, herein incorporated by reference in its entirety. When incorporated into the oral compositions of the present invention, the 25 peroxide is present at a concentration of from about 0.1% to about 20%, optionally from about 0.5% to about 15% optionally, from about 1% to about 12%, and, optionally, from about 5% to about 10%, by weight, of the wet film composition. In certain embodiments, the ratio of the water-soluble gum to the peroxide component is at least about 1:25, optionally, from about 1:25 to about 1:5, optionally, 30 from about 1:20 to about 1:7 and, optionally, from about 1:16 to about 1:10. Hydroalcoholic component.

WO 2005/092278 PCT/IB2005/000450 5 The solid oral compositions of the present invention, when dried, are substantially free of hydroalcoholic components. As used herein the term "hydroalcoholic" means water or alcohol or mixtures thereof. In certain embodiments of the present invention, the compositions of the present invention contain less than 5 10% (or about 10%), optionally, less than 6% (or about 6%), and, optionally, less than 3% (or about 3%) of an hydroalcoholic component. Optional Ingredients Various other actives, especially oral care actives, can also be incorporated into the oral compositions of the present invention. Examples of the conditions these o10 actives may address include, but are not limited to one or more of, appearance and structural changes to teeth, whitening, stain bleaching, stain removal, plaque removal, tartar removal, cavity prevention and treatment, inflamed and/or bleeding gums, mucosal wounds, lesions, ulcers, aphthous ulcers, cold sores, tooth abscesses, tooth and/or gum pain, tooth sensitivity (e.g. to temperature changes), teeth strengthening 15 and the elimination of mouth malodour resulting from the conditions above and other causes such as microbial proliferation.. Additionally, the films of the present invention are useful for treating and/or preventing wounds, lesions, ulcers, cold sores and the like of the lips and skin generally. Suitable topical actives for use in and around the oral cavity include any 20 substance that is generally considered as safe for use in the oral cavity and that provides a change to the overall health of the oral cavity. The level of topical oral care active in the present invention may generally be from about 0.01% to about 40% or, optionally, from about 0.1% to 20% by weight of the wet film. The topical oral care actives of the present invention may include many of the 25 actives previously disclosed in the art. The following is a non all- inclusive list of oral care actives that may be used in the present invention. Essential oils may be included in or associated with the films the present invention. Essential oils suitable for use herein are described in detail in US patents 6,596,298 to Leung et al., previously incorporated by reference in its entirety. 30 Additional teeth whitening actives may be included in the oral compositions of the present invention. The additional actives suitable for whitening are selected from WO 2005/092278 PCT/IB2005/000450 6 the group consisting of metal chlorites, perforates, percarbonates, peroxyacids, and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite and potassium chlorite. Hypochlorite and chlorine dioxide may also be incorporated into the compositions of 5 the present invention. A preferred chlorite is sodium chlorite. Anti-tartar agents useful herein include: phosphates. Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. Pyrophosphates are among the best known for use in dental care products. Pyrophosphate ions delivered to the teeth derive from pyrophosphate salts. The 10 pyrophosphate salts useful in the present compositions include the dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof Disodium dihydrogen pyrophosphate (Na 2

H

2

P

2 07), tetrasodium pyrophosphate (Na 4

P

2 0 7 ), and tetrapotassium pyrophosphate (K 4

P

2 0 7 ) in their unhydrated as well as hydrated forms are preferred. Anticalculus phosphates include potassium and sodium 15 pyrophosphates; sodium tripolyphosphate; diphosphonates, such as ethane-l-hydroxy 1,1-diphosphonate; 1-azacycloheptane- 1,1-diphosphonate; and linear alkyl diphosphonates; linear carboxylic acids and sodium and zinc citrate. Agents that may be used in place of or in combination with the pyrophosphate salt include materials such as synthetic anionic polymers including polyacrylates and 20 copolymers of mnaleic anhydride or acid and methyl vinyl ether (e.g. Gantrez, as described, for example, in U.S. Patent 4,627, 977, to Gaffar et al. herein incorporated by reference in its entirety, as well as e.g. polyamino propane sulfonic acid (AMPS), zinc citrate trihydrate, polyphosphates (e.g. tripolyphosphate; hexametaphosphate), diphosphonates (e.g. EHDP, AMP), polypeptides (such as polyaspartic and 25 polyglutamnic acids), and mixtures thereof. One of more fluoride ion sources incorporated into the film compositions as anticaries agents. Fluoride ions are included in many oral care compositions for this purpose, and similarly may be incorporated in the invention in the same way. Detailed examples of such fluoride ion sources can be found in US patent 6,121,315 30 to Nair et al., herein incorporated by reference in its entirety. Antimicrobial agents can also be present in the film compositions of the present invention as oral agents or topical skin and/or systemic actives. Such agents WO 2005/092278 PCT/IB2005/000450 7 may include, but are not limited to, 5-chloro-2-(2,4-dichlorophenoxy)- phenol, commonly referred to as trielosan, chlorhexidine, alexidine, hexetidine, sanguinarine, benzalkonium chloride, salicylamide, domiphen bromide, cetylpyridium chloride (CPC), tetradecyl pyridinium chloride (TPC); N-tetradecyl-4- ethyl pyridinium 5 chloride (TDEPC); octenidine; delmopinol, octapinol, and other piperidino derivatives, niacin preparations; zinc/stannous ion agents; and analogs, derivatives and salts of the above antimicrobial agents and mixtures thereof. Anesthetic agent may also be incorporated herein. Examples of suitable anesthetic agents include, but are not limited to, benzocaine, betoxycaine, 10 biphenamine, bupivacaine, butacaine, dibucaine hydrochloride, dyclonine, lidocaine, mepivacaine, procaine, propanidid, propanocaine, proparacaine, propipocaine, propofol, propoxycaine hydrochloride, pseudococaine, tetracaine hydrochloride and mixtures thereof. Additional useful actives can be found in US patent 6,638,528 herein 15 incorporated by reference in its entirety. An additional carrier material may also be added to the oral care film composition. These materials are generally humectants and include glycerin, sorbitol, polyethylene glycol and the like. The oral healthcare film may comprise the active substance itself, together with one or more active substance enhancers, for example 20 catalysts and/or potentiators to modify the release and/or activity of the active substance. The film compositions of the invention may, optionally, comprise additional substances such as flavors, colors etc. which may for example be deposited onto the surface of the film or impregnated into the bulk of the film. 25 For example a gel containing additional substances or actives may be deposited directly as a layer on a surface of a film layer. Alternatively additional substances or actives may be absorbed into the above-described film layer, or impregnated into the bulk of the film material, or deposited between layers of a multiple layered film. 30 A pH adjusting agent may also be added to optimise the storage stability of the gel and to make the substance safe for the oral tissues. These pH adjusting agents, or buffers, can be any material which is suitable to adjust the pH of the oral care WO 2005/092278 PCT/IB2005/000450 8 substance. Suitable materials include sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate, and combinations thereof. The pH adjusting agents are added in sufficient amounts so as to adjust the pH of the substance or composition 5 to a suitable value, e.g. about 4.5 to about 11, preferably from about 5.5 to about 8.5, and more preferably from about 6 to about 7. The pH adjusting agents are generally present in an amount of from about 0.01% to about 15% and preferably from about I 0.05% to about 5%, by weight of the oral care substance. Methods of depositing active substances mentioned above or additional 10 actives upon the surfaces of film materials are known, for example printing, e.g. silo screen printing, passing between impregnated rollers, dosing, a pump and nozzle, spraying, dipping etc. Methods of impregnating substances into the bulk of film materials are also known, for example admixing the substance into the strip material and then forming the strip, or exposure of the strip to the substance under conditions 15 which cause the substance to be impregnated into the strip. Alternatively, one example of the film material may be a foam material, particularly an open-cell foam material, and the substance may be impregnated into the strip material by introducing the substance into the cells of the foam. The device of the invention may be marked with one or more visible symbol, 20 e.g. text matter, a trade mark, a company logo, an area of color, or an alignment feature such as a visible line or notch etc. to assist the user in applying the device to the teeth in a proper alignment. Such an alignment feature may for example comprise a symbol to show the user which way up the device should be whilst applying the device to the teeth, or which of a pair of the devices is intended for the upper teeth 25 and which for the lower teeth. This way the device may be made more visually attractive and/or easier to use. Such symbol(s) may be applied by conventional printing or embossing processes, e.g. silk screen printing, inkjet printing etc. to the surface of the plastically deformnable material opposite to the surface on which is attached the layer of an absorbent material. 30 If such a visible symbol is applied to this surface, a cover layer can, optionally, be applied over the symbol, for example to protect it. This cover layer may be transparent or translucent to allow visible symbols to be seen through this WO 2005/092278 PCT/IB2005/000450 9 layer. Such a cover layer can, optionally, be applied to the film by pressing, e.g. rolling, the material of the cover layer in contact with the film. The film layers of the present application are manufactured using conventional film making technologies such as that disclosed in US patents 6,596,298 to Leung et 5 al. and 6,419,903 to Xu et al., both of which are herein incorporated by reference in their entirety. Additionally the film layers of the present invention can be manufactured using hot melt extrusion techniques such as that described in US patent 6,375,963 B 1 to Repka et al. herein incorporated by reference in their entirety. 10 Methods for Delivering Topical and Systemic Actives The present invention can be used where retention of peroxides and additional topical or systemic actives is required for topical activity or adequate systemic absorption. The film compositions of the present invention are particularly useful for 15 whitening tooth surfaces. Generally, the delivery of the peroxide, with or without additional actives, involves topically applying the inventive film containing a safe and containing effective amount of such compounds/actives to a tooth or teeth and gums in a manner described in US patents 5,894,017; 5,891,453; 6,045,811; and 6,419,906, each of which is herein incorporated by reference in its entirety. The frequency of 20 application and the period of use will vary widely depending upon the level of treatment required or desired, e.g., the degree of teeth whitening and/or degree of topical wound healing/disinfection desired. Examples 25 The film compositions illustrated in following examples illustrate specific embodiments of the film compositions of the present invention, but are not intended to be limiting thereof. Other modifications can be undertaken by the skilled artisan without departing from the spirit and scope of this invention. All exemplified film compositions can be prepared by conventional 30 formulation and mixing techniques. Component amounts are listed as weight percents and exclude minor materials such as diluents, filler, and so forth. The listed WO 2005/092278 PCT/IB2005/000450 10 formulations, therefore, comprise the listed components and any minor materials associated with such components. Example I 5 The following is an example of a bi-layer, teeth whitening film of the present invention. Adhesive Layer INGREDIENT AMOUNT (weight percent) XANTHAN GUM 1 0.0174% w/w LOCUST BEAN GUM', CLARIFIED 0.0348% w/w CARRAGEENAN 0.1740% w/w

PULLULAN

4 4.1000% w/w POVIDONE, USP K-90 5 12.4000% w/w

SUCRALOSE

6 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35%7 5.7100% w/w FLAVOR 2.5890% w/w POLYSORBATE 80 NF/EP 0.3550% w/w

EMULSIFIER

9 0.3550% w/w GLYCERIN USP SPECIAL 1.0000% w/w Backing Layer PHARMACEUTICAL GLAZE, 4-LB CUT NF' 0 55.0000% w/w SILICA" (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE' 2 1.0000% w/w Supplied under the name Keltrol T by CP Kelco, Chicago, IL 2 Sold under the name Viscogum BCR 20/80 by Degussa Texturant 10 Systems, Atlanta, GA 3 Supplied under the name Viscarin SD339 by FMC Biopolymer, Philadelphia, PA. 4 PI-20 grade supplied by Hayashibara. * Polyvinylpyrrolidone, USP K-90, International Specialties 15 6 Products(ISP), Wayne, NJ. SALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa.

WO 2005/092278 PCT/IB2005/000450 11 7 Supplied under the trade name Splenda®, by McNeil Pharmaceuticals, New Brunswick, NJ. 8 Tween 80, supplied by Quest, Hoffinannma Estates, Ill. 9 mixture of mono- and di-oleates supplied under name Atmos 300 by 5 American Ingredients, Kansas City, Mo. 10 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. 11 Supplied under the trade name Cabosil® by Cabot, Tuscola, Ill. 12 Supplied as Mono- and Diglycerides of fats and oils (disposable grade) by Lonza Inc., Fair Lawn, NJ. 10 In a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous. In a separate beaker (beaker B), xanthan gum, locust bean gum, carrageenan, pullulan and Povidone K-90 are mixed as a dry mix until the mixture is homogenous. The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The 15 combined mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing. In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The 20 pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous. The contents of beaker D is then east at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth 25 whitening film. The contents of beaker A is then cast at desired thickness over the above described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film. Where the film of the present invention is in the form of a multi-layer or bi 30 layer film, the thickness of this first or backing layer can optionally range from about 1 micron to about 20 microns, optionally from about 3 microns to about 15 microns, optionally from about 5 microns to about 12 microns. The thicknesses of any additional layers can equal the range of thickness of the first or backing layer or range WO 2005/092278 PCT/IB2005/000450 12 from about 30 microns to about 150 microns, optionally from about 45 microns to about 130 microns, optionally from about 70 microns to about 120 microns. Example II The following is an example of a bi-layer, teeth whitening film of the present 5 invention. Adhesive Layer INGREDIENT AMOUNT (weight percent) XANTHAN GUM' 0.02308% w/w LOCUST BEAN GUM 2 , CLARIFIED 0.04616% w/w

CARRAGEENAN

3 0.2308% w/w POVIDONE, USP K-90 4 16.426% w/w SUCRALOSE' 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35%6 5.7100% w/w FLAVOR 2.5890% w/w POLYSORBATE 80 NF/EP 7 0.3550% w/w EMULSIFIER' 0.3550% w/w GLYCERIN USP SPECIAL 1.0000% w/w WO 2005/092278 PCT/IB2005/000450 13 Backing Layer PHARMACEUTICAL GLAZE, 4-LB CUT NF 55.0000% w/w SILICAlo (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE" 1.0000% w/w SSupplied under the name Keltrol T by CP Kelco, Chicago, IL 2 Supplied under the name Viscogum BCR 20/80 by D)egussa Texturant Systems, Atlanta, GA 5 3 Supplied under the name Viscarin SD339 by FMC Biopolymer, Philadelphia, PA. 4 Polyvinylpyrrolidone, USP K-90, International Specialties Products(ISP), Wayne, NJ. 5 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa. 10 6 Supplied under the trade name Splenda®, by N4cNeil Pharmaceuticals, 1Tew Brunswick, NJ. 7 Tween 80, supplied- by Quest, Hoffinann Estates, Ill. 8 mixture of mono- and di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo. 15 9 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. 10 Supplied under the trade name Cabosil® by Cabot, Tuscola, Ill. "11 Supplied as Mono- and Diglycerides of fats and oils (disposable grade) by Lonza lac., Fair Lawn, NJ. In a suitable beaker (bealcer A), water, sucralose, potassium phosphate 20 monobasic are added with mixing unLtil the mixture is homogenous. In a separate beaker (beaker B), xanthan gum, locust bean gum, carrageenan and Povidone K-90 are mixed as a dry mix until the mixture is homogenous. The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To the combined nlixture, 25 the hydrogen peroxide is added slowly with mixing. In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. 30 In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.

WO 2005/092278 PCT/IB2005/000450 14 The contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film. 5 The contents of beaker A is then cast at desired thickness over the above described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film. Example III The following is an example of a bi-layer, teeth whitening film of the present 10 invention. Adhesive Layer INGREDIENT AMOUNT (weight percent) XANTHAN GUM' 0.0674% w/w LOCUST BEAN GUM, CLARIFIED 2 0.0848% w/w

PULLULAN

3 4.1740% w/w POVIDONE, USP K-90 4 12.4000% w/w

SUCRALOSE

5 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35%6 5.7100% w/w FLAVOR 2.5890% w/w POLYSORBATE 80 NF/EP 7 0.3550% w/w EMULSIFIER' 0.3550% w/w GLYCERIN USP SPECIAL 1.0000% w/w Backing Layer PHARMACEUTICAL GLAZE, 4-LB CUT NF 9 55.0000% w/w

SILICA'

0 (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE" 1.0000% w/w Supplied under the name Keltrol T by CP Kelco, Chicago, IL WO 2005/092278 PCT/IB2005/000450 15 2 Supplied under the name Viscogum BCR 20/80 by Degussa Texturant Systems, Atlanta, GA SPI-20 grade supplied by Hayashi-bara. 4 Polyvinylpyrrolidone, USP K-90, International Specialties 5 Products(ISP), Wayne, NJ. 6 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa. Supplied under the trade name Splenda®, by McNeil Pharmaceuticals, New Brunswick, NJ. 10 7 Tween 80, supplied by Quest, Hoffinann Estates, Ill. 8 mixture of mono- and di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo. 9 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. lOSupplied under the trade name Cabosil® by Cabot, Tuscola, Ill. 15 " Supplied as Mono- and Digly-cerides of fats and oils (disposable grade) by Lonza Inc., Fair Lawn, NJ. In a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous. In a separate beaker (beaker B), xanthan gum, locust bean gum, pullulan and 20 povidone K-90 are mixed as a dry mix until the mixture is homogenous. The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing. In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and 25 Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous. 30 The contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film. The contents of beaker A is then cast at desired thickness over the above described first layer at room temperature to form the second layer of the bi-layer, 35 teeth whitening film.

WO 2005/092278 PCT/IB2005/000450 16 Example IV The following is an example of a bi-layer, teeth whitening film of the present invention. 5 Adhesive Layer INGREDIENT AMOUNT (weight percent) PECTIN' 1.9674% w/w GUM ARABIC 0.1848% w/w PULLULAN3 2.1740% w/w POVIDONE, USP K-90 12.4000% w/w

SUCRALOSE

5 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35%" 5.7100% w/w FLAVOR 2.5890% w/w POLYSORBATE 80 NF/EP 7 0.3550% w/w EMULSIFIER" 0.3550% w/w GLYCERIN USP SPECIAL 1.0000% w/w Backing Layer PHARMACEUTICAL GLAZE, 4-LIB CUT NF 9 55.0000% w/w

SILICA

0 (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE" 1.0000% w/w Supplied under the name GenuPectin by CP Kelco, Chicago, IL. 2 Supplied under the name Brigrt Gum Arabic Spray Dry FCC/NF Powder by TIC Gums, Beleamp, MD. 10 3 PI-20 grade supplied by Hayashib)ara. 4 Polyvinylpyrrolidone, USP K-90, International Specialties Produets(ISP), Wayne, NJ. 5 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa. 6Supplied under the trade name Splenda®, by McNeil 15 Pharmaceuticals, New Brunswick, NJ. 7 Tween 80, supplied by Quest, Hoffinann Estates, Ill. 8 mixture of mono- and di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo.

WO 2005/092278 PCT/IB2005/000450 17 9 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. 1 oSupplied under the trade name Cabosil® by Cabot, Tuscola, Ill. 1 Supplied as Mono- and Diglycerides of fats and oils (disposable grade) by Lonza Inc., Fair Lawn, NJ. 5 In a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous. In a separate beaker (beaker B), starch gum, gum arabic, pullulan and povidone K-90 are mixed as a dry mix until the mixture is homogenous. The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined 10 mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing. In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The 15 pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous. The contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth 20 whitening film. The contents of beaker A is then cast at desired thickness over the above described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.

WO 2005/092278 PCT/IB2005/000450 18 Example V The following is an example of a bi-layer, teeth whitening film of the present invention. 5 Adhesive Layer INGREDIENT AMOUNT (weight percent) XANTHAN GUM' 0.0174% w/w GUM ARABIC 2 0.1848% w/w

PULLULAN

3 16.344% w/w

CARRAGEENAN

4 0.1800 0 /ow/w

SUCRALOSE

5 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% -w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35%' 5.7100% w/w FLAVOR 2.5890% -w/w POLYSORBATE 80 NF/EP 7 0.3550% w/w

EMULSIFIER

8 0.3550% "w/w GLYCERIN USP SPECIAL 1.0000% w/w Backing Layer PHARMACEUTICAL GLAZE, 4-LB CUT NF' 55.0000% -w/w

SILICA

l 0 (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE" 1.0000% rv/w Supplied under the name Keltrol T by CP Kelco, Chicago, IL 2 Supplied under the name Bright Gum Arabic Spray Dry FCC/NF Powder by TIC Gums, Belcamp, MD 10 4 PI-20 grade supplied by Hayashibara. 4 Supplied under the name Viscarin SD339 by FMC Biopolymer, Philadelphia, PA. 5 Supplied under the trade name Splenda®, by McNeil Pharmaceuticals, New Brunswick, NJ. 15 6 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa. 7 Tween 80, supplied by Quest, Hoffmann Estates, Ill. 8 mixture of mono- and di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo.

WO 2005/092278 PCT/IB2005/000450 19 9 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. 10 Supplied under the trade name Cabosil® by Cabot, Tuscola, Ill. "11 Supplied as Mono- and Diglycerides of fats and oils (disposable grade) by Lonza Inc., Fair Lawn, NJ. 5 In a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous. In a separate beaker (beaker B), xanthan gum, gum arabic, pullulan, and carrageenan are mixed as a dry mix until the mixture is homogenous. The contents of 10 beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing. In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then 15 poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous. The contents of beaker D is then cast at desired thickness on a non-stick at 20 room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film. The contents of beaker A is then cast at desired thickness over the above described first layer at room temperature to form the second layer of the bi-layer, 25 teeth whitening film.

WO 2005/092278 PCT/IB2005/000450 20 Example V The following is an example of a bi-layer, teeth whitening film of the present invention. 5 Adhesive Layer INGREDIENT AMOUNT (weight percent) XANTHAN GUM 1 0.0174% w/w GUM ARABIC 2 0.1848% w/w

STARCH

3 16.344% w/w

CARRAGEENAN

4 0.1800%w/w SUCRALOSE' 0.7000% w/w POTASSIUM PHOSPHATE MONOBASIC NF 0.0700% w/w PURIFIED WATER, USP/EP 72.4948% w/w HYDROGEN PEROXIDE 35% 6 5.7100% w/w FLAVOR 2.5890% w/w POLYSORBATE 80 NF/EP 7 0.3550% w/w EMULSIFIER' 0.3550% w/w GLYCERIN USP SPECIAL 1.0000% w/w Backing Layer PHARMACEUTICAL GLAZE, 4-LB CUT NF 9 55.0000% w/w

SILICA

1 0 (fumed untreated) 4.0000% w/w ALCOHOL USP/EP 40.0000% w/w GLYCERYL STEARATE SE" 1.0000% w/w Supplied under the name Keltrol T by CP Kelco, Chicago, IL 2 Supplied under the name Bright Gum Arabic Spray Dry FCC/NMF 10 Powder by TIC Gums, Belcamp, MD SSupplied under the trade name of Pure-Cote B760, supplied by Grain processing Corporation, Muscatine, IA. 4 Supplied under the name Viscarin SD339 by FMC Biopolymer, Philadelphia, PA. 15 s Supplied under the trade name Splenda®, by McNeil Pharmaceuticals, New Brunswick, NJ. 6 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, P' a. 7 Tween 80, supplied by Quest, Hoffmann Estates, Ill.

WO 2005/092278 PCT/IB2005/000450 21 8 mixture of mono- and di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo. 9 Shellac supplied by Mantrose Haeser Co., Attleboro, Ma. 10 Supplied under the trade name Cabosil® by Cabot, Tuscola, Ill. 5 " Supplied as Mono- and Diglycerides of fats and oils (disposable grade) by Lonza Inc., Fair Lawn, NJ. In a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous. 10 In a separate beaker (beaker B), xanthan gum, gum arabic, starch, and carrageenan are mixed as a dry mix until the mixture is homogenous. The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing. 15 In a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide. In still another separate beaker (beaker D), the pharmaceutical glaze, Cabosil, 20 alcohol and glyceryl sterate is mixed until uniform and homogenous. The contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film. The contents of beaker A is then cast at desired thickness over the above 25 described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.

Claims (15)

1. An oral composition comprising: a.) at least two water soluble gums; and 5 b.) at least one peroxide compound wherein the composition, when dried, contains less than about 10% of an hydroalcoholic component.

2. An oral composition according to Claim 1, wherein the concentration of the at 10 least two water soluble polymers is from about 0.01% to about 10%.

3. An oral composition according to Claim 1, wherein the concentration of the at least one peroxide compound is from about 0.1% to about 20%. 15

4. An oral composition according to Claim 1 wherein the water soluble gum is selected from the group consisting of algin, alginic acid, alginate salts, camitine, carrageenan, dextrin, karaya gum, guar gum, gellan gum, irish moss, veegum (regular), tara gum, okra gum, gum arabic, acacia gum, amylopectin, pectina or pecitin, ghatti gum, natto gum, tragacanth gum, xanthan gum, 20 sclerotium gum, kelp, locust bean gum, psyllium seed, tamarind gum, destria gum, chitosan, esters thereof, salts thereof and mixtures thereof..

5. An oral composition according to Claim 4 wherein the water soluble gum is xanthan gum, locust bean gum, carrageenan, dextrin, gum arabic and mixtures 25 thereof.

6. An oral composition according to Claim 1 wherein the peroxide compound is selected from the group consisting of hydrogen peroxide, calcium peroxide, urea peroxide, carbamide peroxide, and mixtures thereof. 30

7. An oral composition according to Claim 6 wherein the peroxide is hydrogen peroxide. WO 2005/092278 PCT/IB2005/000450 23

8. An oral composition according to Claim 1 further comprising an active agent 5 wherein the topical or systemic active is selected from the group consisting of additional whitening agents, antitartar agents, fluoride ion sources, antimicrobial agents, anesthetic agents and mixtures thereof.

9. A mono- or multi-layer film composition comprising at least one layer 10 comprising: a.) at least two water soluble gums and b.) at least one peroxide compound wherein the composition, when dried, contains less than about 10% hydroalcoholic components. 15

10. A film composition according to Claim 9 wherein the water soluble gum is selected from the group consisting of algin, alginic acid, alginate salts, camitine, carrageenan, dextrin, karaya gum, guar gum, gellan gum, irish moss, veegum (regular), tara gum, okra gum, gum arabic, acacia gum, amylopectin, 20 pectina or pecitin, ghatti gum, natto gum, tragacanth gum, xanthan gum, sclerotium gum, kelp, locust bean gum, psyllium seed, tamarind gum, destria gum, chitosan, esters thereof, salts thereof and mixtures thereof..

11. A film composition according to Claim 10 wherein the peroxide is xanthan 25 gum, locust bean gum, carrageenan, dextrin, gum arabic and mixtures thereof.

12. A film composition according to Claim 9 wherein the peroxide compound is selected from the group consisting of hydrogen peroxide, calcium peroxide, urea peroxide, carbamide peroxide, and mixtures thereof. 30

13. A film composition according to Claim 12 wherein the peroxide is hydrogen peroxide. WO 2005/092278 PCT/IB2005/000450 24

14. An oral composition comprising: a.) at least two water soluble gums; and 5 b.) at least one peroxide compound wherein the composition, when dried, contains less than about 10% of an hydroalcoholic component and wherein the ratio of the water soluble gum to peroxide is at least about 1:25. 10

15. An oral composition according to Claim 14, wherein the ratio of water soluble gum to peroxide is from about 1:25 to about 1:5.