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Claims for Patent: 5,332,576

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Claims for Patent: 5,332,576

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:08/064,587
Patent Claims: 1. A method for administering one or more local anesthetic agents to a subject comprising the steps of:

(a) providing a composition comprising a therapeutically effective amount of at least one local anesthetic; 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;

and 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 is substantially free of water is substantially water insoluble and is a bioadhesive; and

(b) contacting an area of skin or mucous membrane with the composition to administer the local anesthetics.

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

3. The method of claim 1, wherein the anesthetic agent is administered in the form of a free base.

4. The method of claim 1, wherein the anesthetic agent is administered in the form of an acid-addition salt.

5. The method of claim 1, wherein the solvent is at least one polyhydric alcohol.

6. The method of claim 5, wherein the polyhydric alcohol is a polyalkylene glycol.

7. The method of claim 6, wherein the glycol is selected from the group consisting of dipropylene glycol, propylene glycol, polyethylene glycol, glycerin, butylene glycol, hexylene glycol, polypropylene glycol, sorbitol, and ethylene glycol.

8. A method of administering one or more local anesthetic agents to a subject comprising the steps of:

(a) providing a composition comprising a therapeutically effective amount of a first local anesthetic agent in base form; a therapeutically effective amount of a different, second local anesthetic agent in an acid-addition salt form; a pharmaceutically acceptable solvent for the anesthetic in an amount which ranges from about 5 to about 70 weight percent based on the weight of the whole composition; and in admixture with the anesthetic agent 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 said composition is substantially free of water and is substantially water insoluble; and

(b) contacting an area of skin or mucous membrane with the composition to administer the local anesthetics.

9. The method of claim 8, 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.

10. The method of claim 9, wherein the acid-addition salt is hydrochloride.

11. The method of claim 8, wherein the bioadhesive is selected from the group consisting of polyacrylates, polyacrylic acids, gums and celluloses.

12. The method of claim 11, wherein the gum is selected from the group consisting of karaya gum, tragacanth gum, pectin gum, xanthan gum and guar gum.

13. The method of claim 12, wherein the solvent for the anesthetic agents is at least one polyhydric alcohol.

14. The method of claim 13, wherein the polyhydric alcohol is a polyalkylene glycols.

15. The method of claim 14, wherein the glycol is selected from the group consisting of dipropylene glycol, propylene glycol, ethylene glycol, polyethylene glycol, and sorbitol.
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