Disclosed is a delivery system for delivering an oral care substance to the oral cavity, the delivery system comprising: (a) a removable backing strip having sufficient flexibility so as to be readily conformable to an oral surface when the delivery system is placed thereagainst; and (b) an oral care composition applied to the strip of material such that when the delivery system is placed on the oral surface the oral care composition contacts the oral surface, the oral care composition comprising: (i) an organosiloxane resin; (ii) a theology modifier; and (iii) at least one oral care substance; wherein the oral care composition remains on the oral surface after the backing strip is removed. Further disclosed are such delivery systems in which the oral care composition further comprises fluid diorganopolysiloxane-based polymers; such compositions may further comprise carriers for solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymers. Still further disclosed are methods of using the delivery systems.
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0. 29. A tooth whitening system, comprising:
a backing material comprising a water soluble material that dissolves during use; and
a tooth whitening composition comprising an organosiloxane resin applied to one side of said backing material, wherein the system is sized for application to both front and rear surfaces of a plurality of adjacent teeth.
1. A delivery system for delivering an oral care substance to the oral cavity, the delivery system comprising:
(a) a removable backing strip having sufficient flexibility so as to be readily conformable to an oral surface when the delivery system is placed thereagainst; and
(b) an oral care composition that forms a film when applied to the backing strip such that when the delivery system is placed on the oral surface the oral care composition contacts the oral surface, the oral care composition comprising:
(i) an organosiloxane resin;
(ii) a rheology modifier; and
(iii) at least one oral care substance;
wherein the oral care composition remains on the oral surface after the backing strip is removed.
9. A delivery system for delivering an oral care substance to the oral cavity, the delivery system comprising:
(a) a removable backing strip having sufficient flexibility so as to be readily conformable to an oral surface when the delivery system is placed thereagainst; and
(b) an oral care composition applied to the backing strip such that when the delivery system is placed on the oral surface the oral care composition contacts the oral surface, the oral care composition comprising:
(i) an organosiloxane resin;
(ii) a fluid diorganopolysiloxane-based polymer;
(iii) a rheology modifier; and
(iv) at least one oral care substance;
wherein the oral care composition remains on the oral surface after the backing strip is removed.
2. The delivery system of
3. The delivery system of
4. The delivery system of
5. The delivery system of
6. The delivery system of
7. The delivery system of
8. The delivery system of
10. The delivery system of
11. The delivery system of
12. The delivery system of claim 1 9 wherein the fluid diorganopolysiloxane polymer is poly(dimethylsiloxane).
13. The delivery system of
14. The delivery system of
15. The delivery system of
16. The delivery system of
17. The delivery system of
18. The delivery system of
19. The delivery system of
20. The delivery system of either of
21. The delivery system of
22. The delivery system of
23. The delivery system of either of
24. The delivery system of
25. A method for delivering an oral care substance to at least one surface of the oral cavity, comprising the steps of: (1) applying the backing strip of the delivery system with the oral care composition of either of
26. The method of
27. A method for delivering an oral care substance to at least one surface of the oral cavity, comprising the steps of: (1) applying the backing stip of the delivery system with the oral care composition of either of
28. The method of
0. 30. The tooth whitening system of
0. 31. The tooth whitening system of
0. 32. The tooth whitening system of
0. 33. The tooth whitening system of
0. 34. The tooth whitening system of
0. 35. The tooth whitening system of
0. 36. The tooth whitening system of
0. 37. The tooth whitening system of
0. 38. The tooth whitening system of
0. 39. The tooth whitening system of
0. 40. The tooth whitening system of
0. 41. The tooth whitening system of
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Preferred volatile silicone fluids include cyclomethicones having 3, 4 and 5 membered ring structures corresponding to the formula: ##STR00002##
The general classes of non-hydrocarbon solvents useful herein include esters, ketones, alcohols, fluorocarbons and fluorocarbon ethers having boiling points in the range of 60 to 200° C. Non-hydrocarbon solvents or mixtures thereof particularly useful include those that are capable of-solubilizing the resin and/or the diorganopolysiloxane-based polymer. Such solvents include but are not limited to ethanol, acetone, butanone, ethyl acetate, propyl acetate, amyl acetate, ethyl butyrate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether, and mixtures thereof. These non-hydrocarbon solvents are readily available such as ethyl acetate and methyl ethyl ketone, both supplied by J. T. Baker of Phillispburg, N.J, and HFE (a mixture of methyl nonafluoroisobutyl ether and methyl nonafluorobutyl ether), supplied by the 3M Company.
The oral care substance preferably contains an active at a level where upon directed use, the benefit sought by the wearer is promoted without detriment to the oral surface to which it is applied. Examples of the oral conditions these actives address include, but, are not limited to, 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, and the elimination of mouth malodor resulting from the conditions above and other causes such as microbial proliferation.
Suitable oral care substances include any material that is generally considered safe for use in the oral cavity and that provides changes to the overall appearance and/or health of the oral cavity. The level of oral care substance in the compositions of the present invention is generally, unless specifically noted, from about 0.01% to about 50%, preferably from about 0.1% to about 20%, more preferably from about 0.5% to about 10%, and even more preferably from about 1% to about 7%, by weight of the composition.
Oral care compositions or substances of the present invention may include many of the actives previously disclosed in the art. The following is a non-limiting list of oral care actives that may be used in the present invention.
1. Teeth Whitening Actives
Teeth whitening actives may be included in the oral care substance of the present invention. The actives suitable for whitening are selected from the group consisting of the peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Most preferred is carbamide peroxide. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Additional whitening actives may be hypochlorite and chlorine dioxide. The preferred chlorite is sodium chlorite. A preferred percarbonate is sodium percarbonate. Preferred persulfates are oxones.
2. Anti-tartar Agents
Anti-tartar agents known for use in dental care products include phosphates. Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. Pyrophosphates are among the best known for use in dental care products. Pyrophosphate and polyphosphate ions are delivered to the teeth derive from pyrophosphate polyphosphate salts. The pyrophosphate salts useful in the present compositions include the dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof. Disodium dihydrogen pyrophosphate (Na2H2P2O7), tetrasodium pyrophosphate (Na4P2O7), and tetrapotassium pyrophosphate (K4P2O7) in their unhydrated as well as hydrated forms are the preferred species. While any of the above mentioned pyrophosphate salts may be used, tetrasodium pyrophosphate salt is preferred. Sodium polyphosphate and triethanolamine polyphosphates, for example, are preferred.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 17, Wiley-lnterscience Publishers (1982). Additional anticalculus agents include pyrophosphates or polyphosphates disclosed in U.S. Pat. No. 4,590,066 issued to Parran & Sakkab on May 20, 1986; polyacrylates and other polycarboxylates such as those disclosed in U.S. Pat. No. 3,429,963 issued to Shedlovsky on Feb. 25, 1969 and U.S. Pat. No. 4,304,766 issued to Chang on Dec. 8, 1981; and U.S. Pat. No. 4,661,341 issued to Benedict & Sunberg on Apr. 28, 1987; polyepoxysuccinates such as those disclosed in U.S. Pat. No. 4,846,650 issued to Benedict, Bush & Sunberg on Jul. 11, 1989; ethylenediaminetetraacetic acid as disclosed in British Pat. No. 490,384 dated Feb. 15, 1937; nitrilotriacetic acid and related compounds as disclosed in U.S. Pat. No. 3,678,154 issued to Widder & Briner on Jul. 18, 1972; polyphosphonates as disclosed in U.S. Pat. No. 3,737,533 issued to Francis on Jun. 5, 1973, U.S. Pat. No. 3,988,443 issued to Ploger, Schmidt-Dunker & Gloxhuber on Oct. 26, 1976 and U.S. Pat. No. 4,877,603 issued to Degenhardt & Kozikowski on Oct. 31, 1989. Anticalculus phosphates include potassium and sodium pyrophosphates; sodium tripolyphosphate; diphosphonates, such as ethane-1-hydroxy-1,1-diphosphonate, 1-azacycloheptane-1,1-diphosphonate, and linear alkyl diphosphonates; linear carboxylic acids; and sodium zinc citrate.
Agents that may be used in place of or in combination with the pyrophosphate salt include such known materials as synthetic anionic polymers including polyacrylates and copolymers of maleic anhydride or acid and methyl vinyl ether (e.g., Gantrez), as described, for example, in U.S. Pat. No. 4,627,977, to Gaffar et al.; as well as, e.g., polyamino propoane sulfonic acid (AMPS), zinc citrate trihydrate, polyphosphates (e.g., tnpolyphosphate; hexametaphosphate), diphosphonates (e.g., EHDP; AHP), polypeptides (such as polyaspartic and polyglutamic acids), and mixtures thereof.
3. Fluoride Ion Source
Fluoride ion sources are well known for use in oral care compositions as anticaries agents. Fluoride ions are contained in a number of oral care compositions for this purpose, particularly toothpastes. Patents disclosing such toothpastes include U.S. Pat. No. 3,538,230, Nov. 3, 1970 to Pader et al; U.S. Pat. No. 3,689,637, Sep. 5, 1972 to Pader; U.S. Pat. No. 3,711,604, Jan 16, 1973 to Colodney et al; U.S. Pat. No. 3,911,104, Oct. 7, 1975 to Harrison; U.S. Pat. No. 3,935,306, Jan. 27, 1976 to Roberts et al; and U.S. Pat. No. 4,040,858, Aug. 9, 1977 to Wason.
Application of fluoride ions to dental enamel serves to protect teeth against decay. A wide variety of fluoride ion-yielding materials can be employed as sources of soluble fluoride in the instant compositions. Examples of suitable fluoride ion-yielding materials are found in Briner et al; U.S. Pat. No. 3,535,421; issued Oct. 20, 1970 and Widder et al; U.S. Pat. No. 3,678,154; issued Jul. 18, 1972. Preferred fluoride ion sources for use herein include sodium fluoride, potassium fluoride and ammonium fluoride. Sodium fluoride is particularly preferred. Preferably the instant compositions provide from about 50 ppm to 10,000 ppm, more preferably from about 100 to 3000 ppm, of fluoride ions in the compositions that contact dental surfaces when used with the delivery system of the present invention.
4. Anti-microbial Agents
Anti-microbial agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, 5-chloro-2-(2,4-dichlorophenoxy)phenol, commonly referred to as triclosan, and described in The Merck Index, 11th ed. (1989), pp. 1529 (entry no. 9573) in U.S. Pat. No. 3,506,720, and in European Pat. Application No. 0,251,591 of Beecham Group, PLC, published Jan. 7, 1988; phthalic acid and its salts including, but not limited to those disclosed in U.S. Pat. No. 4,994,262, Feb. 19, 1991, preferably magnesium monopotassium phthalate, chlorhexidine (Merck Index, no. 2090), alexidine (Merck Index, no. 222; hexetidine (Merck Index, no. 4624); sanguinarine (Merck Index, no. 8320); benzalkonium chloride (Merck Index, no. 1066); salicylanilide (Merck Index, no. 8299); domiphen bromide (Merck Index, no. 3411); cetylpyridinium chloride (CPC) (Merck Index, no. 2024; tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridinium chloride (TDEPC); octenidine; delmopinol, octapinol, and other piperidino derivatives; nicin preparations; zincistannous ion agents; antibiotics such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above; essential oils including thymol, geraniol, carvacrol, citral, hinokitiol, eucalyptol, catechol (particularly 4-allyl catechol) and mixtures thereof; methyl salicylate; hydrogen peroxide; metal salts of chlorite and mixtures of all of the above.
5. Anti-inflammatory Agents
Anti-inflammatory agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, non-steroidal anti-inflammatory agents or NSAIDs such as ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, ketoprofen, piroxicam and meclofenamic acid. Use of NSAIDs such as Ketorolac are claimed in U.S. Pat. No. 5,626,838, issued May 6, 1997. Disclosed therein are methods of preventing and, or treating primary and reoccurring squamous cell carcinoma of the oral cavity or oropharynx by topical administration to the oral cavity or oropharynx an effective amount of an NSAID.
6. Nutrients
Nutrients may improve the condition of the oral cavity and can be included in the oral care compositions or substances of the present invention. Nutrients include minerals, vitamins, oral nutritional supplements, enteral nutritional supplements, and mixtures thereof.
Minerals that can be included with the compositions of the present invention include calcium, phosphorus, fluoride, zinc, manganese, potassium and mixtures thereof. These minerals are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., © 1997, pp. 10-17.
Vitamins can be included with minerals or used separately. Vitamins include Vitamins C and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid, nicotinamide, pyridoxine, cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures thereof. Such vitamins are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., ©1997, pp. 3-10.
Oral nutritional supplements include amino acids, lipotropics, fish oil, and mixtures thereof, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., ©1997, pp. 54-54e. Amino acids include, but, are not limited to L-Tryptophan, L-Lysine, Methionine, Threonine, Levocamitine or L- carnitine and mixtures thereof. Lipotropics include, but, are not limited to choline, inositol, betaine, linoleic acid, linolenic acid, and mixtures thereof. Fish oil contains large amounts of Omega-3 (N-3) Polyunsaturated fatty acids, eicosapentaenoic acid and docosahexaenoic acid.
Entenal nutritional supplements include, but, are not limited to protein products, glucose polymers, com oil, safflower oil, medium chain triglycerides as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., ©1997, pp. 55-57.
7. Mouth and Throat Products
Other materials that can be used with the present invention include commonly known mouth and throat products. Such products are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., ©1997, pp. 520b-527. These products include, but, are not limited to anti-fungal, antibiotic and analgesic agents.
8. Antioxidants
Antioxidants are generally recognized as useful in compositions such as those of the present invention. Antioxidants are disclosed in texts such as Cadenas and Packer, The Handbook of Antioxidants, ©1996 by Marcel Dekker. Inc. Antioxidants that may be included in the oral care composition or substance of the present invention include, but are not limited to Vitamin E, ascorbic acid, Uric acid, carotenoids, Vitamin A, flavonoids and polyphenols, herbal antioxidants, melatonin, aminoindoles, lipoic acids and mixtures thereof.
9. H-2 Antagonists
Histamine-2 (H-2 or H2) receptor antagonist compounds (H-2 antagonists) may be used in the oral care composition of the present invention. As used herein, selective H-2 antagonists are compounds that block H-2 receptors, but do not have meaningful activity in blocking histamine-1 (H-1 or H1) receptors. Selective H-2 antagonists stimulates the contraction of smooth muscle from various organs, such as the gut and bronchi; this effect can be suppressed by low concentrations of mepyramine—a typical antihistaminic drug. The pharmacological receptors involved in these mepyramine-sensitive histamine responses have been denned as H-1 receptors (Ash, A.S.F. & H.O. Schild, Brit. J. Pharmacol Chemother., Vol. 27 (1966), p. 427. Histamine also stimulates the secretion of acid by the stomach (Loew, E.R. & O. Chickering, Proc. Soc. Exp. Biol. Med., Vol. 48 (1941), p. 65), increases the heart rate (Trendelenburg, U., J. Pharmacol., Vol. 130 (1960), p. 450), and inhibits contractions in the rat uterus (Dews, P. B. & J. D. P. Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p. 278); these actions cannot be antagonized by mepyramine and related drugs. The H-2 antagonists useful in the oral care compositions or substances are those that blockade the receptors involved in mepyramine-insensitive, non-H-1 (H-2), histamine responses, and do not blockade the receptors involved in mepyramine- sensitive histamine responses.
Selective H-2 antagonists are those compounds found to be H-2 antagonists through their performance in classical preclinical screening tests for H-2 antagonist function. Selective H-2 antagonists are identified as compounds which can be demonstrated to function as competitive or non-competitive inhibitors of histamine-mediated effects in those screening models specifically dependent upon H-2 receptor function, but to lack significant histamine antagonist activity in those screening models dependent upon H-1 receptor function. Specifically, this includes compounds that would be classified as described by Black, J. W., W. A. M. Duncan, C. J. Durant, C. R. Ganellin & E. M. Parsons, “Definition and Antagonism of Histamine H2-Receptors”, Nature, Vol. 236 (Apr. 21, 1972), pp. 385-390 (Black), as H-2 antagonists if assessed as described by Black through testing with the guinea pig spontaneously beating right atria in vitro assay and the rat gastric acid secretion in vivo assay, but shown to lack in significant H-1 antagonist activity relative to H-2 antagonist activity, if assessed as described by Black with either the guinea pig ileum contraction in vitro assay or the rat stomach muscle contraction in vivo assay. Preferably selective H-2 antagonists demonstrate no significant H-1 activity at reasonable dosage levels in the above H-1 assays. Typical reasonable dosage level is the lowest dosage level at which 90% inhibition of histamine, preferably 99% inhibition of histamine, is achieved in the above H-2 assays.
Selective H-2 antagonists include compounds meeting the above criteria which are disclosed in U.S. Pat. Nos. 5,294,433 and 5,364,616 Singer et al., issued Mar. 15, 1994 and Nov. 15, 1994 respectively and assigned to Procter & Gamble, wherein the selective H-2 antagonist is selected from the group consisting of cimetidine, etintidine, ranitidine, ICIA-5165, tiotidine, ORF-17578, lupitidine, donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-52368 (SKF-94482), BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728, and HB-408. 4. Particularly preferred is cimetidine (SKF-92334), N-cyano-N′-methyl-N″-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine: ##STR00003##
Cimetidine is also disclosed in the Merck Index, 11th edition (1989), p. 354 (entry no. 2279), and Physicians' Desk Reference, 46th edition (1992), p. 2228. Related preferred H-2 antagonists include burimamide and metiamide.
10. Analgesic Actives
Anti-pain or desensitizing agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, strontium chloride, potassium nitrate, natural herbs such as gall nut, Asarum, Cubebin, Galanga, scutellaria, Liangmianzhen, Baizhi, etc.
11. Anti-viral Actives
Antiviral actives useful in the present composition include any know actives that are routinely use to treat viral infections. Such anti-viral actives are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., ©1997, pp. 402(a)-407(z), incorporated herein by reference in its entirety. Specific examples include anti-viral actives disclosed in U.S. Pat. No. 5,747,070, issued May 5, 1998 to Satyanarayana Majeti, incorporated herein by reference in its entirety. Said Patent discloses the use of stannous salts to control viruses. Stannous salts and other anti-viral actives are described in detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 23, Wiley-lnterscience Publishers (1982), pp. 42-71, incorporated herein by reference in its entirety. The stannous salts that may be used in the present invention would include organic stannous carboxylates and inorganic stannous halides. While stannous fluoride may be used, it is typically used only in combination with another stannous halide or one or more stannous carboxylates or another therapeutic agent.
12. Other Ingredients
In addition to the above materials of the composition of the present invention, a number of other components may desirably be added to the oral care substance. Additional components include, but are not limited to, flavoring agents, sweetening agents, xylitol, opacifiers, coloring agents, surfactants, and chelants such as ethylenediaminetetraacetic acid. Suitable flavoring agents include, but are not limited to, oil of peppermint, oil of sassafras, clove bud oil, peppermint, menthol, anethole, thymol, methyl salicylate, eucalyptol, cassia, 1-menthyl acetate, sage, eugenol, parsley oil, oxanone, oil of wintergreen, alpha-irisone, oil of spearmint, marjoram, lemon, orange, banana, propenyl guaethol, innamon, and mixtures thereof.
Pigments may also added to the compositions herein to more precisely indicate the locations at which the composition has actually been applied, allowing the user to apply the composition more thoroughly or evenly. However, such pigments are not intended to mask stains that may exist on the tooth surfaces.
These additional ingredients can also be used in place of the compounds disclosed above.
The optional release liner may be formed from any material which exhibits less affinity for the oral care substance than the oral care substance exhibits for itself and for the backing strip. The release liner preferably comprises a rigid sheet of material such as polyethylene, paper, polyester, or other material which is then coated with a non-stick type material. The release liner material may be coated with wax, silicone, teflon, fluoropolymers, or other non-stick type materials. A preferred release liner is Scotchpak®, produced by 3M. The release liner may be cut to substantially the same size and shape as the backing strip or the release liner may be cut larger than the backing strip to provide a readily accessible means for separating the material from the backing strip. The release liner may be formed from a brittle material which cracks when the backing strip is flexed or from multiple pieces of material or a scored piece of material. Alternatively, the release liner may be in two overlapping pieces such as a typical adhesive strip bandage design. A further description of materials suitable as release agents is found in Kirk-Othmer Encyclopedia of Chemical Technology, Fourth Edition, Volume 21, pp. 207-218, incorporated herein by reference.
The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention.
One example of a preferred backing strip is a 0.013 mm thick piece of polyethylene film. The backing strip may be provided with an array of shallow pockets, typically 0.4 mm across and 0.1 mm deep. The backing strip has a flexural stiffness of about 0.6 grams/centimeter as measured on a Handle-O-Meter, model #211-300, available from Thwing-Albert Instrument Co. of Philadelphia, Pa., as per test method ASTM D2923-95.
Another example of a preferred backing strip is a 0.3 mm thick piece of substantially water soluble material such as rice paper. Another example of a preferred backing strip is a 0.3 mm thick piece of pullulan paper.
Any of the oral care compositions described below can be used with any of the backing strips described herein.
TABLE 1
Hydrophobic Oral Care Composition
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ex. 6
Organosiloxane Resin1
25
25
24.6
25
25
25
Silicone Gum2
12.5
4.2
3.5
2.5
1.8
—
Oral Care Substance3
17
17
17
17
17
17
Carrier4
44.5
52.8
53.9
54.5
55.2
57.0
Bentone Clay5
1
1
1
1
1
1
100
100
100
100
100
100
1E.g., MQ resin available as 1170-002 from General Electric.
2E.g., Dimethicone gum available as SE 30 or SE 63 from General Electric.
3E.g., Sodium percarbonate as a dry powder.
4E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE. The percentage of each individual solvent component in the mixed solvent systems can vary from 0 to 100%, respectively.
5Bentone 27 available from Rheox.
TABLE 2
Hydrophobic Oral Care Composition
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Organosiloxane Resin1
33.43
33.43
35.14
33.43
Silicone Gum2
5.57
5.57
5.86
5.57
Oral Care Substance3
19.00
12.00
19.00
19.00
Ethyl acetate
8.00
8.50
8.00
8.00
Bentone Gel4
10.00
10.00
10.00
10.00
DC-200/350 cst5
1.00
1.00
2.00
1.00
HFE-71006
21.00
26.00
—
19.50
N-propyl acetate
2.00
2.00
—
2.00
2-butanone
—
—
19.00
—
Aerosil 2007 (SiO2)
—
—
1.00
—
Flavor
—
1.50
—
1.50
TOTAL
100
100
100
100
1E.g., MQ resin available as 1170-002 from General Electric.
2E.g., Dimethicone gum available as SE 30 from General Electric.
3E.g., Sodium percarbonate as a dry powder.
4Bentone Gel IPM available from Rheox.
5DC-200/350 is: dimethylpolysiloxane, CAS# 9016-00-6, from Dow Corning.
6HFE-7100 is a mixture of Methyl Nonafluoroisobutyl Ether, CAS# 163702-08-7 and Methyl Nonafluorobutyl Ether, CAS# 163702-07-6 manufactured by 3M Co.
7Aerosil 200 is silicon dioxide (chemically prepared), CAS# 112945-52-5, from Degussa AG.
The compositions of Tables 1 and 2 are non-aqueous. The oral care substances are dispersed or dissolved in a solution comprising the organosiloxane resin, the fluid diorganopolysiloxane polymer, the carrier, and the rheology modifier.
The hydrophobic compositions of Tables 1 and 2 are suitably prepared as follows. Three hundred (300) grams of organosiloxane resin solution (for example, 43.7% MQ resin in isododecane, or in a 50/50 mixture of ethyl acetate and butanone, or in a mixture of ethyl acetate, propyl acetate and HFE) are mixed with 147.30 grams of fluid diorganopolysiloxane polymer solution (for example, 50% SE30 silicone gum in isododecane or, a 50/50 mixture of ethyl acetate and butanone, or a mixture of ethyl acetate, propyl acetate, and HFE.). The oral care substances are then dispersed in the resin/gum mixture. This method may be carried out without the presence of the silicone gum.
All oral care substances described herein can formulated as described above.
TABLE 3
Whitening Compositions
Component
Ex. 1
Ex. 2
Ex. 3
Organosiloxane Resin1
48.00
48.00
36.00
Silicone Gum2
8.00
6.86
9.00
Oral Care Substance3
19.00
12.00
19.00
Rheology Modifier4
13.00
15.00
10.00
DC-200/350 cst5
5.00
10.00
25.00
Surfactant6
6.00
8.14
—
Flavor
1.00
—
1.00
1E.g., MQ resin available as 1170-002 from General Electric.
2E.g., Dimethicone gum available as SE 30 from General Electric.
3E.g., Sodium percarbonate as a dry powder.
4Bentone Gel IPM available from Rheox.
5DC-200/350 is: dimethylpolysiloxane, CAS# 9016-00-6, from Dow Corning.
6Can be anionic, cationic, or neutral
The compositions of Table 3 may be prepared as above, except that a carrier is not added, and the surfactant and flavorant are added after the resin and silicone gum have been mixed until completely dissolved.
All oral care substances described herein can formulated as described above.
TABLE 4
Whitening Compositions
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ex. 6
Ethyl Acetate
18.00
14.85
22.25
20.88
18.96
18.00
2-Butanone
18.00
13.00
13.10
20.88
10.00
18.00
Isododecane
—
10.00
—
—
11.54
—
Limonene
—
4.35
—
—
5.00
—
MQ Resin
28.00
32.50
26.50
27.33
36.00
31.50
SE 30 Silicon
7.00
—
8.80
13.67
—
—
Gum
Silicone Visc-
—
—
—
—
—
3.50
100M
Silicone Fluid
—
6.50
—
—
9.00
—
10 cStk
Bentone Gel
10.00
—
6.40
9.95
—
10.00
ISD
Claytone HY
—
2.45
—
—
3.00
—
Cab-o-Sil
—
—
1.50
—
—
—
Sodium
19.00
—
19.00
7.00
—
19.00
Percarbonate
Carbamide
—
15.00
—
—
5.00
—
Peroxide
Bismuth
—
1.15
—
—
—
—
Oxychloride
Titanium
—
—
1.00
—
1.50
—
Dioxide
Flavor Oil
—
—
0.15
—
—
—
Sodium
—
—
1.00
—
—
—
Fluoride
Sodium
—
0.20
0.30
0.30
—
—
Saccharin
100.00
100.00
100.00
100.00
100.00
100.00
TABLE 5
Oral Care Compositions
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ethyl Acetate
24.50
27.75
22.00
19.96
21.10
2-Butanone
24.50
16.30
22.00
10.00
21.10
Isododecane
—
—
—
11.54
—
Limonene
—
—
—
5.00
—
MQ Resin
30.40
33.00
28.80
36.00
32.84
SE 30 Silicon Gum
7.60
11.00
14.40
—
8.21
Silicone Fluid 10 cStk
—
—
—
9.00
—
Bentone Gel ISD
10.00
8.00
10.50
—
11.75
Claytone HY
—
—
—
3.00
—
Cab-o-Sil
—
1.50
—
—
—
Bismuth Oxychloride
—
1.00
—
—
—
Titanium Dioxide
—
—
—
2.00
—
Flavor Oil
—
0.15
—
—
—
Potassium Nitrate
—
—
—
—
5.00
Sodium Chlorite
3.00
—
—
—
—
Tripolyphosphate
—
—
—
2.50
—
Sodium Fluoride
—
1.00
—
1.00
—
Chlorhexidine
—
—
2.00
—
—
Gluconate
Sodium Saccharin
—
0.30
0.30
—
—
100.00
100.00
100.00
100.00
100.00
TABLE 6
Oral Care Compositions
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ex. 6
Ethyl Acetate
26.00
22.00
35.00
28.00
25.77
23.00
2-Butanone
25.95
17.00
9.00
14.50
25.50
23.45
Isododecane
—
10.00
—
—
5.00
—
Limonene
—
4.00
—
—
—
—
MQ Resin
28.00
32.50
33.00
35.00
27.00
28.00
SE 30 Silicon
7.00
—
11.00
5.00
3.00
7.00
Gum
Silicone Fluid
—
6.50
—
—
—
—
10 cStk
Bentone Gel
10.00
—
8.00
10.00
10.00
—
ISD
Claytone HY
—
2.00
—
—
—
7.00
Cab-o-Sil M7D
—
—
1.50
—
—
—
Bismuth
—
5.00
—
—
—
10.00
Oxychloride
Titanium
3.00
—
1.00
5.00
2.00
—
Dioxide
Flavor Oil
—
—
0.10
—
0.15
0.15
Polymethylsil-
—
—
1.00
—
—
—
sesquioxane
Polymethyl-
3.00
1.00
—
—
0.50
—
methyacrylate
Nylon 12
—
—
—
2.00
—
1.00
Silica
—
—
—
—
0.50
—
FD&C Yellow
0.05
—
0.10
—
0.05
0.10
#5 Al Lake
Iron Oxide,
—
—
—
0.50
0.03
—
Red
Sodium
—
—
0.30
13
0.50
0.30
Saccharin
100.00
100.00
100.00
100.00
100.00
100.00
TABLE 7
Ethanol Based Compositions
Component
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ex. 6
Ethanol
20.90
35.80
41.70
25.89
23.10
23.55
Ethyl Acetate
—
—
—
—
4.95
—
Ethyl Butyrate
10.30
—
—
12.74
11.75
10.9
Isoamyl
—
—
—
—
—
2.65
Acetate
Isododecane
—
13.00
—
—
—
—
MQ Resin
35.10
32.85
42.75
47.00
42.00
41.80
Silicone Visc-
—
—
—
—
7.15
—
100M
Silicone Fluid
7.80
—
—
9.65
—
8.55
100 cSt
Silicone Fluid
3.90
—
11.40
—
4.00
—
10 cStk
Silwet L-7500
—
—
—
—
—
6.58
Bentone 27
1.50
—
2.00
1.85
1.35
1.97
Claytone APA
—
2.00
—
—
—
—
Cab-o-Sil
—
—
—
—
0.45
—
Sodium
19.00
—
—
—
—
—
Percarbonate
Carbamide
—
15.00
—
—
—
—
Peroxide
Potassium
—
—
—
—
5.00
—
Nitrate
Tripoly-
—
—
—
—
—
2.50
phosphate
Chlorhexidine
—
—
—
2.57
—
—
Digluconate
Titanium
1.50
—
2.00
—
—
1.50
Dioxide
Flavor Oil
—
—
0.05
—
—
—
Sodium
—
—
0.10
—
0.25
—
Fluoride
Sodium
—
0.20
13
0.30
—
—
Saccharin
100.00
100.00
100.00
100.00
100.00
100.00
The compositions of Tables 4-7 are suitably prepared as follows. Add the solvents into a container suitable to minimize solvent loss. Add the rheology modifiers and mix until well dispersed. Add the silicone resin and mix until completely dissolved. Add the silicone gum and/or silicone fluids and mix until completely dissolved. At this time add any salts such as sodium percarbonate and/or other oral care actives, aesthetic ingredients such as opacifiers, sweeteners, dyes, and flavors. Continue mixing until homogeneous. Additional high shear mixing may be used to promote the mixing. Pack into airtight containers.
Alternatively premixes of the silicone resin and/or the silicone gum may be prepared prior to incorporation into the final blending step to facilitate silicone dissolution and ease of manufacturing. Depending on the formula composition, the order of ingredient addition may also vary such as the addition of the rheology modifier(s) may be moved to a later step allowing lower viscosity to be maintained until the later stages of the blending step.
After making the composition according to the any of the methods described above, cast the composition onto a piece of backing strip material (rice paper, for example). Then dry it for about 10-60 minutes to allow some of the volatile component of the carrier, if present, to volatize. A adhesive film will form on the backing strip material. The thickness of adhesive film can be controlled by the amount of the composition used when the composition is cast onto the backing strip. Then cut the backing strip into the desired shape and size.
Methods of Use
In practicing the present invention, a backing strip is applied to the desired oral surface by the wearer. The side of the strip facing the oral surface is coated with an oral care composition that is preferably in a highly viscous state.
The backing strip readily conforms to the oral care surface during application by lightly pressing it there against. The backing strip can be left in oral cavity if it is substantially water soluble or can be peeled off if it is substantially water insoluble. After the strip has dissolved in-situ or has been peeled away by the user, the oral care composition remains on the oral surfaces as a thin a film.
In practicing the present invention, the user need only apply a backing strip that has been coated with composition herein that contains the oral care substance or substances necessary in order to obtain a desired effect, e.g., whitening, breath freshening, caries prevention, pain relief, gum health, tartar control, etc. to the tooth surfaces in the areas desired. The compositions may also be applied to other surfaces of the oral cavity, such as the gingival or mucosal tissues, or to any other oral cavity surface.
Prolonged delivery of the oral care substance is made possible as the oral care substance is released from the film over time. Then, any residual oral care substance may be easily removed by wiping, brushing or rinsing the oral surface after a desired period of time has elapsed, or in the normal course of tooth brushing or other oral care activities. Without being bound by theory, it is believed that the film will last from about 2 hours to 8 hours regardless of the reactivity of the oral care substance. Preferably, the compositions are almost unnoticeable when applied to the oral cavity.
It is not necessary to prepare the oral cavity before using the system of the present invention. For example, the user may or may not choose to brush the teeth or rinse the mouth before using the system. The surfaces of the oral cavity are neither required to be rigorously dried nor to be excessively wet with saliva or water before the system is used. However, it is believed that adhesion to the tooth enamel surfaces will be improved if the teeth are dry when the system is applied.
It should be understood that the present invention relates not only to methods for delivering an oral care substance to the oral cavity of a human, but also to methods of delivering an oral care substance to the oral cavity of an animal, e.g., household pets or other domestic animals, or animals kept in captivity.
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to one skilled in the art without departing from the scope of the present invention.
Ye, Hai, Buckley, Christopher David, Yue, Jiang
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