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Claims for Patent: 5,006,342

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Claims for Patent: 5,006,342

Title: Resilient transdermal drug delivery device
Abstract:A solid state, resilient laminated composite for administering a drug transdermally consisting of a multiplicity of spaced structural laminas of a resilient elastomer, one of which forms the top of the composite, a viscoelastic hydrophobic polymer lamina containing propylene glycol monolaurate interposed between each structural lamina and a pressure-sensitive adhesive lamina that provides the basal surface of the composite and consists of a blend of a pressure-sensitive adhesive, drug and propylene glycol monolaurate.
Inventor(s): Cleary; Gary W. (San Mateo, CA), Roy; Samir (Redwood City, CA)
Assignee: Cygnus Corporation (Redwood City, CA)
Application Number:07/309,287
Patent Claims: 1. A transdermal drug-delivery device in the form of a solid state laminated composite adapted to be adhered to an area of unbroken skin and having mechanical properties that enable it to expand and contract in concert with the normal expansion and contraction of said area of skin comprising:

(a) at least two spaced structural laminas of a resilient elastomeric polymer, one of which forms the upper face surface of the composite, said laminas providing the composite with said mechanical properties;

(b) at least one lamina of a viscoelastic hydrophobic polymer in which (i) a drug and/or (ii) an agent that enhances the solubility of the drug in the viscoelastic hydrophobic polymer and/or is a percutaneous absorption enhancer that increases the permeability of the skin to the drug is dispersed and at least partly dissolved, the viscoelastic hydrophobic polymer lamina being positioned between the structural laminas with the structural lamina(s) underlying the viscoelastic hydrophobic polymer lamina(s) providing no rate-controlling barrier to diffusion of drug and/or agent from the viscoelastic hydrophobic polymer lamina(s) to the skin; and

(c) a lamina of a pharmaceutically acceptable pressure-sensitive adhesive in which (i) said drug and/or (ii) said agent is dispersed and at least partly dissolved, one face of the pressure-sensitive adhesive lamina defining the basal surface of the composite and contacting and adhering to the area of unbroken skin when the device is in use, said pressure-sensitive adhesive lamina providing no rate-controlling barrier to diffusion of the drug and/or agent from the device to the skin, with the proviso that at least one of said viscoelastic hydrophobic polymer lamina(s) and said pressure-sensitive adhesive lamina contains the drug.

2. The device of claim 1 wherein at least one of said lamina(s) of viscoelastic hydrophobic polymer and said lamina of pharmaceutically acceptable pressure-sensitive adhesive contains said agent.

3. The transdermal drug delivery device of claim 2 wherein the device is a sufficient barrier to water vapor transmission that said area of skin becomes hydrated when the device is placed thereon.

4. The device of claim 3 wherein said viscoelastic hydrophobic polymer lamina(s) provide(s) said barrier to water vapor transmission.

5. The device of claim 3 wherein the drug is a steroid.

6. The device of claim 5 wherein the drug is estradiol.

7. The device of claim 3 wherein the drug is fentanyl or a fentanyl analog.

8. The transdermal drug device of claim 1 wherein the device is not occlusive.

9. The transdermal drug delivery device of claim 8 wherein the water vapor transmission rate of the device is 11-18 g/m.sup.2 -hr.

10. The device of claim 2 wherein the drug is contained in the lamina of pharmaceutically acceptable pressure-sensitive adhesive and said agent is contained in the lamina of pharmaceutically acceptable pressure-sensitive adhesive and at least one of the lamina(s) of viscoelastic hydrophobic polymer.

11. The device of claim 3 wherein the drug is contained in the lamina of pharmaceutically acceptable pressure-sensitive adhesive and said agent is contained in the lamina of pharmaceutically acceptable pressure-sensitive adhesive and at least one of the lamina(s) of viscoelastic hydrophobic polymer.

12. The transdermal drug-delivery device of claim 3 wherein the agent is a fatty acid ester or fatty alcohol ether of a C.sub.2 to C.sub.4 alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of 8 to 22 carbon atoms.

13. The transdermal drug-delivery device of claim 3 wherein the drug is estradiol, fentanyl or a fentanyl analog and the agent is a fatty acid monoester of propylene glycol in which the fatty acid portion is of 8 to 22 carbon atoms or a mixture of said monoester and a fatty acid dieste- of propylene glycol wherein each fatty acid portion is of 8 to 22 carbon atoms.

14. The transdermal drug-delivery device of claim 13 wherein the fatty acid monoester of propylene glycol is propylene glycol monolaurate and the fatty acid diester of propylene glycol is propylene glycol dilaurate.

15. The transdermal drug-delivery device of claim 12 wherein the resilient elastomer is a polyether block amide copolymer, a polyethylene methyl methacrylate block copolymer, a polyurethane, a silicone elastomer, or a polyester block copolymer composed of hard and soft segments.

16. The transdermal drug-delivery device of claim 12 wherein the hydrophobic polymer is a polysiloxane, a polyacrylate, a polyurethane, a rubbery polymer, a plasticized ethylene-vinyl acetate copolymer, or a low molecular weight polyether block amide copolymer.

17. The transdermal drug-delivery device of claim 14 wherein the resilient elastomer is a polyether block amide copolymer or a polyurethane, the hydrophobic polymer is polyisobutene, the pressure-sensitive adhesive is polydimethylsiloxane, the thickness of each of the structural laminas is 10 to 75 microns, the thickness of the viscoelastic hydrophobic polymer laminas is 50 to 100 microns, and the thickness of the pressure-sensitive adhesive lamina is 50 to 100 microns.

18. The transdermal drug-delivery device of claim 17 wherein the loading of estradiol, fentanyl, or fentanyl analog in the pressure-sensitive adhesive lamina is 1% to 20% by weight based on the mixture, the loading of propylene glycol monolaurate in the pressure-sensitive adhesive lamina is 2% to 20% by weight based on the mixture, and the loading of propylene glycol monolaurate or mixture of monolaurate and dilaurate in each viscoelastic hydrophobic polymer layer is 5% to 15% based on the mixture.

19. A transdermal drug delivery drive in the form of a solid laminated composite adapted to be adhered to an area of unbroken skin and having mechanical properties that enable it to expand and contract in concert with the normal expansion and contraction of said area of skin, comprising in the following order

(a) a first structural lamina of a resilient elastomer, one side of which forms the upper face surface of the device;

(b) a first viscoelastic hydrophobic polymer lamina containing 5% to 15% by weight of propylene glycol monolaurate or a mixture of propylene glycol monolaurate and propylene glycol dilaurate;

(c) a second structural lamina of a resilient elastomer which provides no rate-controlling barrier to diffusion of propylene glycol monolaurate or propylene glycol dilaurate from (b);

(d) a second viscoelastic hydrophobic polymer lamina containing 5% to 15% propylene glycol monolaurate;

(e) a third structural lamina of a resilient elastomer which in combination with the first and second structural laminas provides the device with said mechanical properties, said third structural lamina providing no rate-controlling barrier to diffusion of propylene glycol monolaurate or propylene glycol dilaurate from (d);

(f) a lamina of a pharmaceutically acceptable pressure-sensitive adhesive, one face of which defines the basal surface of the composite and adheres to the area of unbroken skin when the device is in use, said lamina or pharmaceutically acceptable pressure-sensitive adhesive containing 1% to 20% by weight estradiol, fentanyl, or fentanyl analog and 2% to 20% by weight of propylene glycol monolaurate or a mixture of propylene glycol monolaurate and propylene glycol dilaurate or propylene glycol dilaurate and providing no rate-controlling barrier to diffusion of estradiol or propylene glycol monolaurate, to the skin.

20. The transdermal drug delivery devices of claim 19 wherein the resilient elastomer is a polyurethane; the viscoelastic hydrophobic polymer is polyisbutene; and the pressure-sensitive adhesive is polydimethylsiloxane.

21. The transdermal drug delivery device of claim 3 wherein the thickness of each structural lamina is 10 to 75 microns, the thickness of each viscoelastic hydrophobic polymer lamina is 50 to 100 microns, and the thickness of the pressure-sensitive adhesive lamina is 50 to 100 microns.
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