Transdermal formulations for administering prazosin
AssigneeCygnus, Inc.
InventorsTsung-Min Hsu, Eric J. Roos
Life of this patent
Estimating the term…
Abstract
Prazosin is formulated in solution with a akin permeation enhancer composition of: a sulfhydryl-containing compound, a fatty acid eater, and a polar solvent for transdermal administration to treat hypertension or benign prostatic hypertrophy. The formulation is employed in the form of a skin patch comprising (a) an impermeable backing layer, (b) a reservoir of the prazosin-enhancer solution, (c) a porous support member that retains the solution but is not a permeation barrier to the solution, a peripheral adhesive layer for affixing the patch to the skin, and a release liner layer.
Claims16
A method for administering prazosin to an individual in therapeutically effective amounts comprising administering prazosin transdermally to the individual over a prolonged period in combination with a skin permeation enhancer composition comprising
- (a) at least one nontoxic sulfhydryl-containing compound from the group of N-(2-mercaptopropionyl)glycine, thioglycerol, thioacetic acid, thiosalicylic acid, bucillamine, acetylcysteine and mercaptomenthone,
- (b) a nontoxic fatty acid ester;
- (c) a nontoxic polar solvent to an area of unbroken skin of about 20 to about 60 cm.sup.2 over said period at a rate that provides at least about 50 .mu.g prazosin per hour to the individual.
A formulation of prazosin for transdermal administration comprising a therapeutically effective amount of prazosin in combination with a skin permeation enhancer composition comprising
- (a) at least one nontoxic sulfhydryl-containing compound from the group of N-(2-mercaptopropionyl)glycine, thioglycerol, thioacetic acid, thiosalicylic acid, bucillamine, acetylcysteine and mercaptomenthone,
- (b) a nontoxic fatty acid ester, and
- (c) a nontoxic polar solvent.
A skin patch for administering prazosin transdermally in therapeutically effective amounts over a prolonged period comprising in combination
- (a) an impermeable backing layer;
- (b) a reservoir of a solution of prazosin in a skin permeation enhancer composition comprising:
- (i) at least one nontoxic sulfhydryl-containing compound from the group of N-(2-mercaptopropionyl)glycine, thioglycerol, thioacetic acid, thiosalicylic acid, bucillamine, acetylcysteine and mercaptomenthone,
- (ii) a nontoxic fatty acid ester;
- (iii) a nontoxic polar solvent;
- (c) a porous support member underlying the reservoir that retains the solution but is not a substantial permeation barrier to the solution;
- and
- (d) means for affixing the patch to the skin, said patch having an effective basal surface area of about 20 to 60 cm.sup.2 and providing prazosin skin flux via said effective basal surface area of at least about 50 .mu.g/hr over said period.
Dependencies are inferred from the claim text.