Transdermal drug delivery sytem for the administration of tamsulosin, and related compositions and methods of use

A drug reservoir comprising:

• at least one polymeric reservoir layer;
• and
• a drug formulation comprised of tamsulosin and a skin permeation enhancer composition effective to facilitate permeation of a therapeutically effective amount of tamsulosin through the skin or mucosal tissue wherein the skin permeation enhancer composition comprises:
• (i) a lipophilic compound having the formula ›RCOO!.sub.n R', wherein n is 1 or 2, and R and R' may be the same or different and are C.sub.1 -C.sub.16 alkyl optionally substituted with 1 or 2 hydroxyl groups, (ii) an acid having the formula CH.sub.3 (CH.sub.2).sub.m COOH where m is an integer in the range of 8 to 16;
• and (iii) a hydrophilic compound selected from the group consisting of diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, propylene glycol, 1,3-butanediol, and butyrolactone optionally substituted with one or two hydroxyl, lower alkyl (C.sub.1 -C.sub.3), lower alkoxy (C.sub.1 -C.sub.3) halogen and amino groups.

A method for transdermally administering tamsulosin by applying a drug deliver system to the skin or mucosal tissue of an individual, wherein the system comprises:

• a backing layer that is substantially impermeable to tamsulosin;
• and
• at least one polymeric reservoir layer containing a drug formulation comprised of tamsulosin and a skin permeation enhancer composition effective to facilitate permeation of a therapeutically effective amount of tamsulosin through the skin or mucosal tissue,
• wherein the skin permeation enhancer composition comprises:
• (i) a lipophilic compound having the formula ›RCOO!.sub.n R', wherein n is 1 or 2, and R and R' may be the same or different and are C.sub.1 -C.sub.16 alkyl optionally substituted with 1 or 2 hydroxyl groups;
• (ii) an acid having the formula CH.sub.3 (CH.sub.2).sub.m COOH where m is an integer in the range of 8 to 16;
• and (iii) a hydrophilic compound selected from the group consisting of diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, propylene glycol, 1,3-butanediol, and butyrolactone optionally substituted with one or two hydroxyl, lower alkyl (C.sub.1 -C.sub.3), lower alkoxy (C.sub.1 -C.sub.3) halogen and amino groups.