Method of transdermal drug delivery
First Claim
1. A transdermal drug delivery system, which system comprises:
- (a) an impervious backing sheet;
(b) the reservoir containing a transdermal drug delivery composition, which comprises;
(i) a dermatologically-acceptable, semi-solid or solid base material, which base material is selected on application to the skin of the user to melt or liquefy and form a thin, liquid film and to occlude the skin of the user and to force hydration of the stratum corneum layer with water from the lower layers of the epidermis of the user in use;
(ii) a plurality of solid polymeric microparticles generally uniformly dispersed and suspended in the base material in the reservoir, the microparticles having a particle size of less than about 1000 microns and containing an effective, therapeutic amount of a drug for transdermal delivery in a controlled release pattern, the active drug material for transdermal delivery and the base material being compatible to form a compatible transport relationship; and
whereby, on application to the skin of a user the base material melts or liquefies to form a thin, liquid film on the skin of the user, while the drug is released at a controlled release rate from the suspended microparticles into the solid or semi-solid base material and through the liquid film directly into the skin of the user.
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Accused Products
Abstract
A transdermal drug delivery system useful for the controlled, for example, zero order, release of one or more drugs to a selected skin area of a user, which system comprises a reservoir containing a transdermal delivery composition. The reservoir contains a composition which comprises a base material, which is a solid but which melts or liquefies upon contact with the skin of a user and selected to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user and a plurality of solid microparticles, generally uniformly dispersed and suspended in the base material, the microparticles containing an effective, therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid. In use, the base material forms a thermodynamically stable thin film layer in intimate contact with the skin while the drug is released from the microparticles into the base material and transdermally into the user through the thin liquid film of the base material.
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Citations
23 Claims
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1. A transdermal drug delivery system, which system comprises:
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(a) an impervious backing sheet; (b) the reservoir containing a transdermal drug delivery composition, which comprises; (i) a dermatologically-acceptable, semi-solid or solid base material, which base material is selected on application to the skin of the user to melt or liquefy and form a thin, liquid film and to occlude the skin of the user and to force hydration of the stratum corneum layer with water from the lower layers of the epidermis of the user in use; (ii) a plurality of solid polymeric microparticles generally uniformly dispersed and suspended in the base material in the reservoir, the microparticles having a particle size of less than about 1000 microns and containing an effective, therapeutic amount of a drug for transdermal delivery in a controlled release pattern, the active drug material for transdermal delivery and the base material being compatible to form a compatible transport relationship; and whereby, on application to the skin of a user the base material melts or liquefies to form a thin, liquid film on the skin of the user, while the drug is released at a controlled release rate from the suspended microparticles into the solid or semi-solid base material and through the liquid film directly into the skin of the user. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A composition for the accelerated transdermal controlled delivery of a drug to a user, which composition comprises:
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(a) a meltable semi-solid or solid base material, which, on application to the skin of the user, melts to form a thin liquid film and selected to occlude the skin of the user and to force hydration of the stratum corneum layer with water from the lower layers of the epidermis of the user in use; and (b) a plurality of solid polymeric microparticles generally uniformly dispersed and suspended in the base material, the microparticles having a particle size of less than about 1000 microns and containing an effective, therapeutic amount of a drug for transdermal delivery, the active drug material for transdermal delivery and the base material being compatible to form a compatible transport relationship; whereby, on application to the skin of a user of the transdermal drug composition the drug is released at a controlled rate from the suspended microparticles into the base material and into the skin of the user. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification