Transdermal administration of steroid drugs using hydroxide-releasing agents as permeation enhancers
AssigneeDermatrends, Inc.
InventorsEric C. Luo, Tsung-Min Hsu
Life of this patent
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Abstract
A method is provided for increasing the permeability of skin or mucosal tissue to transdermally administered steroid drugs. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the drug through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations and drug delivery systems for co-administering a hydroxide-releasing agent with a steroid drug are provided as well. Optimally, the steroid drugs are a combination of an estrogen and progestin that may be administered in female hormone replacement therapy, to provide female contraception, and the like.
Claims68
A method for enhancing the flux of a steroid drug through a body surface, comprising administering the steroid drug to a localized region of a human patient's body surface in combination with a hydroxide-releasing agent applied to the body surface in a predetermined amount effective to enhance the flux of the drug through the localized region of the body surface without causing damage thereto.
A method for transdermally administering a combination of steroid drugs to a female individual, comprising administering a progestin and an estrogen to a localized region of a the individual's body surface in combination with a hydroxide-releasing agent applied to the body surface in a predetermined amount effective to enhance the flux of the drug through the localized region of the body surface without causing damage thereto.
A composition of matter useful for the delivery of a steroid drug through a body surface, comprising an aqueous formulation of:
- (a) a therapeutically effective amount of a steroid drug;
- (b) a hydroxide-releasing agent in an amount effective to enhance the flux of the drug through the body surface without causing damage thereto;
- and
- (c) a pharmaceutically acceptable carrier suitable for topical or transdermal drug administration.
A composition of matter useful for the delivery of a combination of steroid drugs through a body surface, comprising an aqueous formulation of:
- (a) a therapeutically effective amount of a progestin and an estrogen;
- (b) a hydroxide-releasing agent in an amount effective to enhance the flux of the drugs through the body surface without causing damage thereto;
- and
- (c) a pharmaceutically acceptable carrier suitable for topical or transdermal drug administration.
A system for the topical or transdermal administration of a steroidal drug, comprising:
- (a) at least one drug reservoir containing the drug and a hydroxide-releasing agent in an amount effective to enhance the flux of the drug through the body surface without causing damage thereto;
- (b) a means for maintaining the system in drug and enhancer transmitting relationship to the body surface;
- and
- (c) a backing layer that serves as the outer surface of the device during use.
Dependencies are inferred from the claim text.