Transdermal administration of progesterone, estradiol esters, and mixtures thereof
AssigneeAlza Corporation
InventorsRobert M. Gale, David J. Enscore, Diane E. Nedberge, Melinda Nelson, Yu-Ling Cheng, Shari B. Libicki
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Abstract
A transdermal delivery system for the administering of progesterone and an estradiol ester alone or in combination utilizing a polymer matrix having the drug(s) along with a permeation enhancer dispersed throughout.
Claims42
A composition of matter for the transdermal administration of a drug selected from the group consisting of progesterone, an estradiol ester and mixtures thereof, comprising said drug and a skin permeation enhancer selected from the group consisting of sucrose monolaurate, glycerol monooleate, glycerol monolaurate, propylene glycol laurate, and neopentyl glycol dicaprate.
A method for the transdermal administration of a drug selected from the group consisting of progesterone, an estradiol ester and mixtures thereof which comprises placing a matrix containing said drug in drug transmitting relationship to the skin in the presence of a permeation enhancer selected from the group consisting of sucrose monolaurate, glycerol monooleate, glycerol monolaurate, propylene glycol laurate, and neopentyl glycol dicaprate.
A medical device for the transdermal delivery of a drug for a predetermined time period selected from the group consisting of progesterone, an estradiol ester and mixtures thereof comprising in combination:
- (a) a reservoir means containing said drug and a permeation enhancer selected from the group consisting of sucrose monolaurate, glycerol monooleate, glycerol monolaurate, propylene glycol laurate, propylene glycol dipelarginate and neopentyl glycol dicaprate;
- (b) a means for maintaining said reservoir means in drug and permeation enhancer transmitting relationship to the skin at therapeutically effective rates;
- (c) said drug being present in said reservoir means in amounts sufficient to deliver said drug at said therapeutically effective rates for said predetermined time period;
- and
- (d) said permeation enhancer being present in said reservoir means in amounts sufficient to deliver said permeation enhancer at said therapeutically effective rates for said predetermined time period.
A method for the treatment of post-menopausal symptoms in the human female which comprises transdermally administering progesterone and an estradiol ester at therapeutically effective rates nd durations, said rates and durations defining a 28 day therapeutic regimen, and repeating said regimen at the expiration of the preceding 28 day regimen for so long as therapy is desired.
A 28 day transdermal dosage package for the treatment of post-menopausal symptoms comprising in combination, a container containing a plurality of transdermal systems for delivering progesterone and an estradiol ester at therapeutically effective rates and durations, said rates and durations defining a 28 day therapeutic regimen.
Dependencies are inferred from the claim text.