Oral bandage and oral preparations

• US 4,772,470 A
• Filed: 04/25/1986
• Issued: 09/20/1988
• Est. Priority Date: 04/27/1985
• Status: Expired due to Term

• Current Assignee: Nitto Electric Industrial Co., Ltd. (Nitto Denko Corporation), Sunstar Incorporated 3-1 Asahi-Cho Takatsuki-Shi Osaka Japan
• Original Assignee: Sunstar Incorporated (Hosei Gijuku Luxembourg SA), Nitto Electric Industrial Co., Ltd. (Nitto Denko Corporation)
• Inventors: Tsuyoshi, Takashi, Hsaegawa, Kenji, Inoue, Yuichi, Nakashima, Koichi, Horiuchi, Tetuo
• Primary Examiner(s): Schofer, Joseph L.
• Assistant Examiner(s): Kulkosky, Peter F.
• Application Number:
  US06/855,565
• Time in Patent Office: 879 Days
• Field of Search: 424/434, 424/435, 424/448, 424/81
• US Class Current: 424/435
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61L 15/225 Mixtures of macromolecular compounds
• CPC Class Codes: C08L 31/04 Homopolymers or copolymers of vinyl acetate

Abstract

An oral bandage comprising a soft adhesive film comprising a mixture of a polycarboxylic acid and/or a polycarboxylic acid anhydride and a vinyl acetate polymer in a compatible state, and an oral preparation comprising such an oral bandage having incorporated therein a topical drug are disclosed. The oral bandage or preparation exhibits strong adhesion of long duration when applied to the oral mucosa or teeth.

Claims

1. An oral bandage comprising a soft adhesive film having a thickness of at least 5 μ

m consisting essentially of a polycarboxylic acid and/or a polycarboxylic acid anhydride and a vinyl acetate polymer in a compatible state, wherein the polycarboxylic acid and/or the polycarboxylic acid anhydride and the vinyl acetate polymer are uniformly dissolved in each other without forming individual regions due to phase separation.

2. An oral bandage as in claim 1, wherein a mixing ratio of the polycarboxylic acid and/or polycarboxylic acid anhydride to vinyl acetate polymer is such that the value as obtained from the following formula ranges from 15 to 45:

##EQU2##

3. An oral bandage as in claim 1, wherein said mixture in a compatible state is obtained by dissolving the polycarboxlyic acid and/or polycarboxylic acid anhydride and the vinyl acetate polymer in a solvent common to both.

4. An oral bandage as in claim 1, wherein said oral bandage further comprises a soft film support.

5. An oral bandage as in claim 1, wherein said adhesive film further comprises a basic substance capable of neutralizing the polycarboxylic acid and/or polycarboxylic acid anhydride in an amount which is effective to relieve irritation to an injured part.

6. An oral bandage as in claim 5, wherein said basic substance is at least one of salts and bases.

7. An oral bandage as in claim 5, wherein said oral bandage further comprises a soft film support.

8. An oral bandage as in claim 1, wherein said polycarboxylic acid contains 20% by weight or more of a --COOH group and said polycarboxylic acid anhydride contains 16% by weight or more of a --CO--O--CO-- group.

9. An oral bandage as in claim 6, whwerein said basic substance is a monovalent metal salt or monovalent base and is used in an amount of from 0.03 to 0.2 equivalent based on the polycarboxylic acid and/or polycarboxylic acid anhydride.

10. An oral bandage as in claim 3, wherein said solvent is selected from lower alcohols, mixed solvents comprising a lower alcohol in a larger proportion and a compatible organic solvent, mixed solvent of a lower alcohol in a larger proportion and water, and a mixed solvent comprising a lower alcohol in a larger proportion, a compatible organic solvent and water.

11. An oral bandage as in claim 10, wherein said mixed solvent of a lower alcohol and an organic solvent contains not more than 30% by weight of the organic solvent.

12. An oral bandage as in claim 10, wherein said mixed solvent of a lower alcohol and water or mixed solvent of a lower alcohol, an organic solvent and water contains not more than 30% by weight of water.

13. An oral preparation comprising a soft adhesive film having a thickness of at least 5 μ

m consisting essentially of a mixture of a polycarboxylic acid and/or a polycarboxylic acid anhydride and a vinyl acetate polymer in a compatible state and topical drug incorporated therein, wherein the polycarboxylic acid and/or the polycarboxylic acid anhydride and the vinyl acetate polymer are uniformly dissolved in each other without forming individual regions due to phase separation.

14. An oral preparation as in claim 13, wherein a mixing ratio of the polycarboxylic acid and/or polycarboxylic acid anhydride to vinyl acetate polymer is such that the value as obtained from the following formula ranges from 15 to 45:

##EQU3##

15. An oral preparation as in claim 13, wherein said mixture in a compatible state is obtained by dissolving the polycarboxylic acid and/or polycarboxylic acid anhydride and the vinyl acetate polymer in a solvent common to both.

16. An oral preparation as in claim 13, wherein said adhesive film further comprises a basic substance capable of neutralizing the polycarboxylic acid and/or polycarboxylic acid anhydride in an amount which is effective to relieve irritation to an injured part.

17. An oral preparation as in claim 16, wherein said basic substance is at least one of salts and bases.

18. An oral preparation as in claim 13, wherein said oral preparation further comprises a soft film support.

19. An oral preparation as in claim 16, wherein said oral preparation further comprises a soft film support.

20. An oral preparation as in claim 18, wherein the film support contains a topical drug.

21. An oral preparation as in claim 19, wherein the film support contains a topical drug.

22. An oral preparation as in claim 13, wherein said polycarboxylic acid contains 20% by weight or more of a --COOH group and said polycarboxylic acid anhydride contains 16% by weight or more of a --CO--O--CO-- group.

23. An oral bandage as in claim 13, wherein said vinyl acetate polymer has a viscosity-average molecular weight of not less than 60,000.

24. An oral bandage as in claim 17, wherein said basic substance is a monovalent metal salt or a monovalent base and is used in an amount of from 0.03 to 0.2 equivalent based on the polycarboxylic acid and/or polycarboxylic acid anhydride.

25. An oral bandage as in claim 15, wherein said sovlent is selected from lower alcohols, mixed solvents comprising a lower alcohol in a larger proportion and a compatible organic solvent, mixed solvent of a lower alcohol in a larger proportion and water, and a mixed solvent comprising a lower alcohol in a larger proportion, a compatible organic solvent and water.

26. An oral bandage as in claim 25, wherein said mixed solvent of a lower alcohol and an organic solvent contains not more than 30% by weight of the organic solvent.

27. An oral bandage as in claim 25, wherein said mixed solvent of a lower alcohol and water or mixed solvent of a lower alcohol, an organic solvent and water contains not more than 30% by weight of water.