Transdermal Delivery System For Use With Basic Permeation Enhancers
First Claim
1. A transdermal delivery system for administering an active agent through the body surface, comprising:
- (a) a polymeric matrix that serves as both an active agent reservoir and a skin contact adhesive layer, wherein the matrix comprises a substantially homogeneous mixture of a polyisobutylene rubber and an insoluble hydrophilic polymer in the form of a powder having a particle size in the range of about 1 micron to 300 microns;
(b) a pharmaceutical formulation absorbed in the polymeric matrix which comprises a therapeutically effective amount of the active agent, an effective flux-enhancing amount of a basic permeation enhancing composition, and a pharmaceutically acceptable aqueous vehicle; and
(c) a backing layer laminated to the polymeric matrix that serves as the outer surface of the device use.
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Accused Products
Abstract
The present invention includes transdermal delivery systems having a polymeric active agent reservoir fabricated from an admixture of polyisobutylene and an insoluble hydrophilic polymer in powdered form, which provide numerous advantages in the transdermal delivery of active agents using basic enhancer compositions. For example, the systems of the invention provide for (1) increased permeation of the active agent through the skin, (2) an improved capability of extracting the active agent and enhancer from the transdermal systems, (3) enhanced structural integrity, (4) good chemical stability, (5) reduced phase separation, and (6) decreased cold flow.
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Citations
39 Claims
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1. A transdermal delivery system for administering an active agent through the body surface, comprising:
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(a) a polymeric matrix that serves as both an active agent reservoir and a skin contact adhesive layer, wherein the matrix comprises a substantially homogeneous mixture of a polyisobutylene rubber and an insoluble hydrophilic polymer in the form of a powder having a particle size in the range of about 1 micron to 300 microns; (b) a pharmaceutical formulation absorbed in the polymeric matrix which comprises a therapeutically effective amount of the active agent, an effective flux-enhancing amount of a basic permeation enhancing composition, and a pharmaceutically acceptable aqueous vehicle; and (c) a backing layer laminated to the polymeric matrix that serves as the outer surface of the device use. - View Dependent Claims (2, 3, 4, 5, 6, 9, 10, 11, 12, 13, 14, 30, 31, 32, 33, 34, 35, 36)
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7. (canceled)
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8. (canceled)
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15-21. -21. (canceled)
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37. An active agent reservoir comprising:
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(a) a polymeric matrix that comprises a substantially homogeneous mixture of a polyisobutylene rubber and an insoluble hydrophilic polymer in the form of a powder having a particle size in the range of approximately 1 micron to 300 microns; (b) a pharmaceutical formulation absorbed in the polymeric matrix which comprises a therapeutically effective amount of an active agent, an effective flux-enhancing amount of a basic permeation enhancing composition, and a pharmaceutically acceptable aqueous vehicle.
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38. A method for transdermally administering an active agent, which comprises affixing a transdermal delivery system to a localized region of a human patient'"'"'s body surface such that a body surface-delivery system interface is formed, wherein the system comprises:
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(a) a polymeric matrix that serves as both an active agent reservoir and a skin contact adhesive layer, wherein the matrix comprises a substantially homogeneous mixture of a polyisobutylene rubber and an insoluble hydrophilic polymer in the form of a powder having a particle size in the range of approximately 1 micron to 300 microns; (b) a pharmaceutical formulation absorbed in the polymeric matrix which comprises a therapeutically effective amount of the active agent, an effective flux-enhancing amount of a basic permeation enhancing composition, and a pharmaceutically acceptable aqueous vehicle; and (c) a backing layer laminated to the polymeric matrix that serves as the outer surface of the device use.
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39-77. -77. (canceled)
Specification