Film products having controlled disintegration properties

• US 20050196358A1
• Filed: 03/22/2005
• Published: 09/08/2005
• Est. Priority Date: 03/03/2004
• Status: Abandoned Application

• Current Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Zhang, Zhen, Mody, Seema, Soshinsky, Andre, Georgiades, Constantine
• Application Number:
  US11/086,517
• Publication Number:
  US 20050196358A1
• Time in Patent Office: Days
• US Class Current: 424/53
• CPC Class Codes: A61K 8/02 characterised by special physical form
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/25 Silicon; Compounds thereof
• CPC Class Codes: A61K 8/37 Esters of carboxylic acids
• CPC Class Codes: A61K 8/375 the alcohol moiety containing more than one hydroxy group
• CPC Class Codes: A61K 8/927 of insects, e.g. shellac
• CPC Class Codes: A61K 8/987 of species other than mammals or birds
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

This invention relates generally to films having barrier as well as controlled disintegration properties and, more particularly, to controlled water disintegratable films.

Claims

1. A film composition comprising:

a.) at least one water insoluble polymer;

b.) at least one pH dependent water hydratable polymer;

c.) optionally, a plasticizer

d.) optionally, a water insoluble particle; and

e.) optionally, at least one topical or systemic active

wherein the film is disintegratable in an aqueous environment.

2. A film composition according to claim 1 wherein the water insoluble polymer is selected from the group consisting of hydrogenated vegetable oils, hydrogenated caster oil, polyvinyl chloride, shellac, polyurethane, cellulose, cellulose derivatives, gum rosens, wood rosens, waxes, ammoniomethacrylate copolymer, silicone or mixtures thereof.

3. A film composition according to claim 2 wherein the water insoluble polymer is shellac.

4. A film composition according to claim 1 wherein the plasticizer is selected from the group consisting of citric acid alkyl esters, glycerol esters, phthalic acid alkyl esters, sebacic acid alkyl esters, sucrose esters, sorbitan esters, acetylated monoglycerides, triacetin, glycerols, glycols, fatty acid esters, poloxamers, alkyl aryl phosphates and polyethylene glycols 200 to 12,000 and mixtures thereof.

5. A film composition according to claim 4 wherein the plasticizer is selected from the group consisting of triacetin, glycerol monostearate and mixtures thereof.

6. A film composition according to claim 1 wherein the pH dependent water hydratable polymer is a copolymer derived from (i) at least one anionic monomer comprising at least one carboxylic group, and (ii) at least one neutral non-dissociating monomer.

7. A film composition according to claim 6 wherein the anionic monomer is selected from the group consisting of acrylic acid, methacrylic acid, maleic acid, fumaric acid, and itaconic acid.

8. A film composition according to claim 6, wherein the neutral monomer is selected from the group consisting of C₁-C₂₀ alkyl acrylate, C₁-C₂₀ alkyl methacrylate, C₁-C₂₀ alkyl carboxylic acid vinyl ester, C₁-C₂₀ alkyl vinyl ether, C₁-C₂₀ alkene, styrene, ester derived from a carboxy C₂-C₅ alkene and a polyethyleneglycol(1-30) monosubstituted with C₁-C₃₀ alkyl group.

9. A film composition according to claim 6 wherein the molar ratio of anionic monomers to neutral monomers is from about 1:

10 to about 10;

1.

10. A film composition according to claim 6, wherein the pH dependent water hydratable polymer is methyl methacrylate/methacrylic acid copolymer.

11. A film composition according to claim 1, wherein the water insoluble particle is selected from the group consisting of alumina, talc, titanium dioxide, magnesium stearate, barium titanate, magnesium titanate, calcium titanate, strontium titanate, zinc oxide, silica sand, clay, mica, tabular spar, diatomaceous earth, various inorganic oxide pigments, chromium oxide, cerium oxide, iron red, antimony trioxide, magnesium oxide, zirconium oxide, barium sulfate, barium carbonate, calcium carbonate, silica, silicon carbide, silicon nitride, boron carbide, tungsten carbide, titanium carbide, carbon black and mixtures thereof.

12. A film composition according to claim 1, further comprising at least one topical or systemic active.

13. A film composition according to claim 1 wherein the topical or systemic active is selected from the group consisting of whitening agents, antitartar agents, fluoride ion sources, antimicrobial agents, antiinflammatory agents, upper respiratory agents, gastrointestinal agents, enzymes, antifungals, antibiotics, analgesics, histamine antagonists and mixtures thereof.

21. A method for treating the skin, oral mucosa or teeth comprising the step of applying to such area(s) the film composition of claim 1.

14. A multi-layer film composition comprising at least 2 film layers wherein at least one layer comprises:

a.) at least one water insoluble polymer;

b.) at least one pH dependent water hydratable polymer;

c.) optionally, at least one plasticizer

d.) optionally, a water insoluble particle; and

e.) optionally, at least one topical or systemic active

wherein the film is disintegratable in an aqueous environment.

15. A film composition according to claim 14, further comprising at least one topical or systemic active.

16. A film composition according to claim 15 wherein the topical or systemic active is selected from the group consisting of whitening agents, antitartar agents, fluoride ion sources, antimicrobial agents, antiinflammatory agents, upper respiratory agents, gastrointestinal agents, enzymes, antifungals, antibiotics, analgesics, histamine antagonists and mixtures thereof.

17. A film composition according to claim 16, wherein the topical or systemic active is a whitening agent.

18. A film composition according to claim 17, wherein the whitening agent is selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, and mixtures thereof.

19. A film composition according to claim 18, wherein the whitening agent is hydrogen peroxide.

20. A film composition according to claim 14, wherein the water insoluble particle is selected from the group consisting of alumina, talc, titanium dioxide, magnesium stearate, barium titanate, magnesium titanate, calcium titanate, strontium titanate, zinc oxide, silica sand, clay, mica, tabular spar, diatomaceous earth, various inorganic oxide pigments, chromium oxide, cerium oxide, iron red, antimony trioxide, magnesium oxide, zirconium oxide, barium sulfate, barium carbonate, calcium carbonate, silica, silicon carbide, silicon nitride, boron carbide, tungsten carbide, titanium carbide, carbon black and mixtures thereof.