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Claims for Patent: 5,234,957

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Claims for Patent: 5,234,957

Title: Compositions and methods for topical administration of pharmaceutically active agents
Abstract:A composition for topical application comprising a therapeutically effective amount of a pharmaceutical agent(s), a flexible, finite, pharmaceutically acceptable, bioadhesive carrier, and a solvent for the pharmaceutical agent(s) in the carrier and a method of administering the pharmaceutical agent to a mammal are disclosed.
Inventor(s): Mantelle; Juan A. (Miami, FL)
Assignee: Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:07/813,196
Patent Claims: 1. A composition for topical application comprising:

a. a therapeutically effective amount of at least one local anesthetic;

b. a pharmaceutically acceptable solvent for the anesthetic, in an amount from about 5 to about 70 weight percent based on the weight of the whole composition;

c. in admixture with the anesthetic agent in the solvent, a flexible, finite, pharmaceutically acceptable polysaccharide bioadhesive carrier in an amount from about 20 to about 50 weight percent based on the weight of the whole composition;

wherein said composition contains less than 10% by weight water, is substantially water insoluble and is a bioadhesive.

2. The composition of claim 1, wherein the anesthetic agent is selected from the group consisting of procaine, lidocaine, prilocaine, mepivacaine, dyclonine, dibucaine, benzocaine, chloroprocaine, tetracaine, bupivacaine, and etidocaine.

3. The composition of claim 2, wherein the anesthetic agent is in the form of the base or an acid-addition salt or both forms.

4. The composition of claim 3, wherein the acid-addition salt is hydrochloride.

5. The composition of claim 1, wherein the bioadhesive is selected from the group consisting of gums and celluloses.

6. The composition of claim 5, wherein the gum is selected from the group consisting of karaya gum, tragacanth gum, pectin gum, xanthan gum, guar gum, cellulose, and cellulose derivatives.

7. The composition of claim 1, wherein the solvent for the anesthetic agent is at least one polyhydric alcohol.

8. The composition of claim 7, wherein the polyhydric alcohol is a polyalkylene glycol.

9. The composition of claim 8, wherein the glycol is selected from the group consisting of dipropylene glycol, propylene glycol, ethylene glycol, polyethylene glycol, glycerin, butylene glycol, hexylene glycol, polypropylene glycol, and sorbitol.

10. The composition of claim 1, further comprising a backing material conforming to the size and shape of a single dosage of the composition.

11. A composition for topical application comprising:

a. a therapeutically effective amount of a first local anesthetic agent in base form;

b. a therapeutically effective amount of a different, second local anesthetic agent in acid-addition salt form;

c. a solvent for the first and second local anesthetic agents in an amount from about 5 to about 70 weight percent based on the weight of the whole composition; and

d. in an admixture with the anesthetic agents in the solvent, a flexible, finite, pharmaceutically acceptable, bioadhesive carrier in an amount from about 20 to about 50 weight percent based on the weight of the whole composition;

wherein the composition is substantially free of water and is substantially water insoluble.

12. The composition of claim 11, wherein the first local anesthetic agent in base form is selected from the group consisting of procaine, lidocaine, prilocaine, mepivacaine, dyclonine, dibucaine, benzocaine, propoxycaine, and chloroprocaine.

13. The composition of claim 11, wherein the second local anesthetic agent in acid-addition salt form is selected from the group consisting of a dyclonine salt, a prilocaine salt, a tetracaine salt, a bupivacaine salt, a mepivacaine salt, a lidocaine salt, a procaine salt, an etidocaine salt and a dibucaine salt.

14. The composition of claim 11, wherein the first local anesthetic agent in base form is selected from the group consisting of procaine, dyclonine, lidocaine, prilocaine, mepivacaine, benzocaine, propoxycaine and chloroprocaine and the second local anesthetic agent in acid-addition salt form is selected from the group consisting of a dyclonine salt, a prilocaine salt, a tetracaine salt, a bupivacaine salt, a mepivacaine salt, a lidocaine salt, a procaine salt, an etidocaine salt, and a dibucaine salt.

15. The composition of claim 14, wherein the acid-addition salt is the hydrochloride.

16. The composition of claim 15, wherein the bioadhesive is selected from the group consisting of polyacrylates, polyacrylic acids, gums and celluloses.

17. The composition of claim 16, wherein the gum is selected from the group consisting of karaya gum, tragacanth gum, pectin gum, xanthan gum and guar gum.

18. The composition of claim 11, wherein the solvent for the anesthetic agents is at least one polyhydric alcohol.

19. The composition of claim 18, wherein the polyhydric alcohol is a polyalkylene glycol.

20. The composition of claim 19, wherein the glycol is selected from the group consisting of dipropylene glycol, propylene glycol, ethylene glycol, polyethylene glycol, glycerin, butylene glycol, hexylene glycol, polypropylene glycol, and sorbitol.

21. The composition of claim 11 further comprising a backing material which conforms to the size and shape of a single dosage of the composition.

22. The composition of claim 1, wherein said composition contains less than 5% by weight water.

23. The composition of claim 1, wherein said composition contains less than 3% by weight water.
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