Transdermal administration of steroid drugs using hydroxide-releasing agents as permeation enhancers
First Claim
1. 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.
6 Assignments
0 Petitions
Accused Products
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.
29 Citations
68 Claims
- 1. 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.
- 4. 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.
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47. A composition of matter useful for the delivery of a steroid drug through a body surface, comprising an aqueous formulation of:
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(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. - View Dependent Claims (49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
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48. A composition of matter useful for the delivery of a combination of steroid drugs through a body surface, comprising an aqueous formulation of:
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(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.
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63. A system for the topical or transdermal administration of a steroidal drug, comprising:
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(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. - View Dependent Claims (64, 65, 66, 67, 68)
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Specification