Compositions and methods for topical administration of pharmaceutically active agents
First Claim
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1. A flexible, finite, bioadhesive composition for topical application comprising:
- (a) a therapeutically effective amount of at least one pharmaceutically active agent which is in solid form at ambient temperatures and pressures;
(b) a pharmaceutically acceptable solvent for the pharmaceutically active agent, in an amount from about 5 to about 70 weight percent based on the weight of the whole composition, said solvent including about 5 to about 50 weight percent of a plasticizer;
(c) in admixture with the pharmaceutically active agent in the solvent, a 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 the composition is substantially free of water, substantially water insoluble and is a bioadhesive; and
wherein the pharmaceutically active agent is present in non-crystallized form in the composition.
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Abstract
Compositions for topical application comprising a therapeutically effective amount of a pharmaceutical agent(s), a pharmaceutically acceptable carrier, and a solvent for the pharmaceutical agent(s) in the carrier and methods of administering the pharmaceutical agents to a mammal are disclosed.
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Citations
45 Claims
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1. A flexible, finite, bioadhesive composition for topical application comprising:
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(a) a therapeutically effective amount of at least one pharmaceutically active agent which is in solid form at ambient temperatures and pressures; (b) a pharmaceutically acceptable solvent for the pharmaceutically active agent, in an amount from about 5 to about 70 weight percent based on the weight of the whole composition, said solvent including about 5 to about 50 weight percent of a plasticizer; (c) in admixture with the pharmaceutically active agent in the solvent, a 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 the composition is substantially free of water, substantially water insoluble and is a bioadhesive; and
wherein the pharmaceutically active agent is present in non-crystallized form in the composition. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A composition for topical application comprising:
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(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 non-salicylate acid-addition salt form; and (c) in an admixture with the anesthetic agents, a pharmaceutically acceptable carrier wherein the anesthetic agents comprise about 1 to about 50% by weight of the total composition. - View Dependent Claims (27, 28, 29, 30, 36, 37, 38, 39, 40, 41, 42)
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31. A composition for topical application comprising:
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(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; and (c) in an admixture with the anesthetic agents, a pharmaceutically acceptable carrier which is substantially free of water wherein the anesthetic agents comprise about 1 to about 50% by weight of the total composition and wherein said composition is substantially free of water. - View Dependent Claims (32, 33, 34, 35, 43, 44, 45)
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Specification