Device for transdermal administration of active medicinal agents
First Claim
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1. An agent useful for transdermal administration of a pharmacologically active agent, comprising:
- (a) a matrix of a pharmacologically acceptable crosslinked, silicone elastomer, comprising;
(i) 1-10% by weight of a polydimethylhydrogensiloxane having an average molecular weight of 300-2000;
(ii) 1-10% by weight of a 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane; and
(iii) 10-100 ppm of platinum catalyst in a vinyl group-terminated polydimethylsiloxane having an average molecular weight of 3000-20,000;
(b) a non-flowable, physiologically acceptable gel microdispersed in said matrix, wherein said gel is based on a combination of a gel-forming thickener, water, and a solvent which is a polyhydric alcohol or a polyvalent ether; and
(c) an active agent dissolved in the microdispersed gel phase in a concentration of at least 50 wt. % based on the gel phase, wherein said matrix is in the form of a sheet having a thickness of 0.5 to 5 mm.
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Abstract
A device for transdermal administration of active medicinal agents is based on the active medicinal agent dissolved to an extent of at least 50% in a nonflowable, physiologically acceptable gel, which latter is distributed in a microdisperse mode in a crosslinked silicone elastomer.
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Citations
23 Claims
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1. An agent useful for transdermal administration of a pharmacologically active agent, comprising:
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(a) a matrix of a pharmacologically acceptable crosslinked, silicone elastomer, comprising; (i) 1-10% by weight of a polydimethylhydrogensiloxane having an average molecular weight of 300-2000; (ii) 1-10% by weight of a 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane; and (iii) 10-100 ppm of platinum catalyst in a vinyl group-terminated polydimethylsiloxane having an average molecular weight of 3000-20,000; (b) a non-flowable, physiologically acceptable gel microdispersed in said matrix, wherein said gel is based on a combination of a gel-forming thickener, water, and a solvent which is a polyhydric alcohol or a polyvalent ether; and (c) an active agent dissolved in the microdispersed gel phase in a concentration of at least 50 wt. % based on the gel phase, wherein said matrix is in the form of a sheet having a thickness of 0.5 to 5 mm. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An agent useful for transdermal administration of a pharmacologically active agent, comprising a solid, self-supporting matrix material having dispersed therein a gel with an active agent dissolved therein, wherein:
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said matrix comprises a pharmacologically acceptable, cross-linked, vulcanized silicone elastomer; said gel is physiologically acceptable and is microdispersed within said matrix at particle sizes of from 5-500 μ
m;said active agent is present in the gel phase at a concentration of at least 50 wt. % based on the gel phase; and said matrix material is in the form of a molded sheet having a thickness of 0.5 to 5 mm. - View Dependent Claims (20, 21, 22, 23)
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Specification