Resilient transdermal drug delivery device
First Claim
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.
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Accused Products
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.
253 Citations
21 Claims
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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:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 21)
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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. - View Dependent Claims (20)
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Specification