Pramipexole transdermal delivery system and uses thereof
AssigneeTranswell Biotech Co., Ltd.
InventorsCatherine LEE, Taijung Wu
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Abstract
A pramipexole transdermal patch for treatment of neurological disorders including Parkinson's disease that may be administered on a daily basis. The pramipexole transdermal patch of the present invention preferably comprises a drug-containing layer that comprises pramipexole or a pharmaceutically acceptable salt thereof at 2% to about 15% by weight of the drug—containing layer and at least two acrylic polymers wherein each polymer may further comprise carboxyl and/or hydroxyl functional groups. The pramipexole transdermal patch of the present invention may further comprise two or more permeation enhancers with combined pramipexole solubility of great than 50 mg/mL.
Claims21
1-16. (canceled)
A transdermal patch for administration comprising:
- (i) a drug-containing layer;
- (ii) a backing layer;
- and
- (iii) a protective layer,
- wherein the drug-containing layer comprises
- (a) pramipexole or a pharmaceutically acceptable salt thereof,
- (b) a combination of at least two permeation enhancers, wherein the permeation enhancers are selected from the group consisting of aliphatic alcohols, fatty acids having chain of 8 to 20 carbons, fatty acid esters, alcohol amines, polyhydric alcohol alkyl ethers, polyoxyethylene alkyl ethers, glycerides, middle-chain fatty acid esters of polyhydric alcohols having chain of 8-20 carbon atoms, alkyl esters having chain of 1-6 carbon atoms, acylated amino acids, pyrrolidone, pyrrolidone derivatives, ethoxylated fatty alcohols, pharmaceutically acceptable surfactants and combinations thereof,
- (c) a carboxyl functional group containing acrylic-based polymer comprising an acrylate copolymer of 2-ethylhexyl acrylate, vinyl acetate, butyl acrylate, acrylic acid and a crosslinker, and
- (d) a hydroxyl functional group containing acrylic-based polymer comprising an acrylate copolymer of 2-ethylhexyl acrylate, methyl acrylate and 2-hydroxyethyl acrylate or an acrylate copolymer of 2-ethylhexyl acrylate, vinyl acetate and 2-hydroxyethyl acrylate;
- wherein the carboxyl group-containing acrylic-based polymer and the hydroxyl group-containing acrylic-based polymer are in a ratio of from about 2:1 to about 1:2 by weight, wherein the transdermal patch provides flux rate of between about 6.3 μg/cm2 hr and about 10 μg/cm2 hr.
A transdermal patch for administration comprising:
- (i) a drug-containing layer;
- (ii) a backing layer;
- and
- (iii) a protective layer,
- wherein the drug-containing layer comprises
- (a) pramipexole or a pharmaceutically acceptable salt thereof,
- (b) a combination of at least two permeation enhancers, enhancers, wherein the permeation enhancers are selected from the group consisting of aliphatic alcohols, fatty acids having chain of 8 to 20 carbons, fatty acid esters, alcohol amines, polyhydric alcohol alkyl ethers, polyoxyethylene alkyl ethers, glycerides, middle-chain fatty acid esters of polyhydric alcohols having chain of 8-20 carbon atoms, alkyl esters having chain of 1-6 carbon atoms, acylated amino acids, pyrrolidone, pyrrolidone derivatives, ethoxylated fatty alcohols, pharmaceutically acceptable surfactants and combinations thereof,
- (c) a carboxyl functional group containing acrylic-based polymer comprising an acrylate copolymer of 2-ethylhexyl acrylate, vinyl acetate, butyl acrylate, acrylic acid and a crosslinker;
- and
- (d) a hydroxyl functional group containing acrylic-based polymer comprising an acrylate copolymer of 2-ethylhexyl acrylate, methyl acrylate and 2-hydroxyethyl acrylate or an acrylate copolymer of 2-ethylhexyl acrylate, vinyl acetate and 2-hydroxyethyl acrylate;
- wherein the carboxyl group-containing acrylic-based polymer and the hydroxyl group-containing acrylic-based polymer are in a ratio of from about 2:1 to about 1:2 by weight.
Dependencies are inferred from the claim text.