EP0272987A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Resilient transdermal drug-delivery device and compositions and devices employing fatty acid esters/ethers or alkanediols as percutaneous absorption enhancers
Assignee: Janssen Pharmaceuticals Inc
•
Filing: 1987-12-21
•
Granted: —
•
Expires: 2007-12-21
Abstract
Abstract A solid state, resilient laminated composite for administering estradiol transdermally consisting of a multiplicity of spaced structural laminas (12, 14, 16) of a resilient elastomer, one of which (12) forms the top of the composite, a viscoelastic hydrophobic polymer lamina (13, 15) containing propylene glycol monolaurate interposed between each structural lamina (12, 14, 16) and a pressure-sensitive adhesive lamina (17) that provides the basal surface of the composite and consists of a blend of a pressure-sensitive adhesive, estradiol, and propylene glycol monolaurate.
Inventors
- 👤 Gary W. Cleary
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-05 00:37
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K31/445; A61K47/00; A61K47/06; A61K47/08; A61K47/14; A61K9/0012; A61K9/0014; A61K9/7038; A61K9/7046; A61K9/7053; A61K9/7061; A61K9/7069
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
294 words
A transdermal drug-delivery device in the form of a solid state laminated composite adapted to be adhered to a predetermined 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 (12, 14, 16) of a resilient polymer, one of which (12) forms the upper face surface of the composite, said laminas providing the composite with said mechanical properties; (b) at least one lamina (13, 15) of a viscoelastic hydrophobic polymer optionally 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 (13, 15) being positioned between the structural laminas (12, 14, 16) with the structural lamina(s) (14, 16) underlying the viscoelastic hydrophobic polymer lamina(s) (13, 15) 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 (17) of a pharmaceutically acceptable pressure-sensitive adhesive optionally 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 (17) 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 (17) providing no rate-controlling barrier to duffision of the drug and/or agent from device to the skin, with the proviso that at least one of said viscoelastic hydrophobic polymer lamina(s) (13,15) and said pressure-sensitive adhesive lamina (17) contains the drug.
Claim 2
Dependent Claim
294 words
A transdermal drug-delivery device in the form of a solid state laminated composite adapted to be adhered to a predetermined 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 (12, 14, 16) of a resilient polymer, one of which (12) forms the upper face surface of the composite, said laminas providing the composite with said mechanical properties; (b) at least one lamina (13, 15) of a viscoelastic hydrophobic polymer optionally 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 (13, 15) being positioned between the structural laminas (12, 14, 16) with the structural lamina(s) (14, 16) underlying the viscoelastic hydrophobic polymer lamina(s) (13, 15) 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 (17) of a pharmaceutically acceptable pressure-sensitive adhesive optionally 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 (17) 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 (17) providing no rate-controlling barrier to duffision of the drug and/or agent from device to the skin, with the proviso that at least one of said viscoelastic hydrophobic polymer lamina(s) (13,15) and said pressure-sensitive adhesive lamina (17) contains the drug.
Claim 3
Dependent Claim
28 words
The device of claim 1 wherein at least one of said lamina(s) (13,15) of viscoelastic hydrophobic polymer and said lamina of pharmaceutically acceptable pressure-sensitive adhesive contains said agent.
Claim 4
Dependent Claim
34 words
The transdermal drug delivery device of claim 1 or 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.
Claim 5
Dependent Claim
18 words
The device of claim 3 wherein said viscoelastic hydrophobic polymer lamina(s) provide(s) said barrier to water vapor transmission.
Claim 6
Dependent Claim
13 words
The device of claim 3 or 4 wherein the drug is a steroid.
Claim 7
Dependent Claim
10 words
The device of claim 5 wherein the drug is estradiol.
Claim 8
Dependent Claim
16 words
The device of claim 3 or 4 wherein the drug is fentanyl or a fentanyl analog.
Claim 9
Dependent Claim
16 words
The transdermal drug delivery device of claim 1 or 2 wherein the device is not occlusive.
Claim 10
Dependent Claim
20 words
The transdermal drug delivery device of claim 8, wherein the water vapor transmission rate of the device is 11-18 g/m²-hr.
Claim 11
Independent Claim
57 words
The device of any of claims 1, 2, 3, 4, 5, 6, 7, 8 or 9 wherein the drug is contained in the lamina (17) of pharmaceutically acceptable pressure-sensitive adhesive and said agent is contained in the lamina (17) of pharmaceutically acceptable pressure-sensitive adhesive and at least one of the lamina(s) (13, 15) of viscoelastic hydrophobic polymer.
Claim 12
Dependent Claim
58 words
The transdermal drug-delivery device of any of claims 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 inclusive, wherein the agent is a fatty acid ester or fatty alcohol ether of a C₂ to C₄ alkanedoil where each fatty acid or fatty alcohor portion of the ester or ether is of 8 to 22 carbon atoms.
Claim 13
Dependent Claim
66 words
The transdermal drug-delivery device of claims wherein the drug is estradiol, fentanyl or a fentanyl analog and the agent is a fatty acid monoester of propylene glucol in which the fatty acid portion is of 8 to 22 carbon atoms or a mixture of said monoester and a fatty acid diester of propylene glycol wherein each fatty acid portion is of 8 to 22 carbon atoms.
Claim 14
Dependent Claim
31 words
The transdermal drug-delivery device of claim 12 wherein the fatty acid monoester of propylene glycol is propylene glycol monolaurate and the fatty acid diester of propylene glycol is propylene glycol dilaurate.
Claim 15
Dependent Claim
58 words
A transdermal drug delivery device comprising a body that contains a drug and a percutaneous absorption enhancer, characterized in that percutaneous absorption enhancer is a fatty acid ester or fatty alcohol ether of a C₂ to C₄ alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of 8 to 22 carbon atoms.
Claim 16
Dependent Claim
58 words
A transdermal drug delivery device comprising a body that contains a drug and a percutaneous absorption enhancer, characterized in that percutaneous absorption enhancer is a fatty acid ester or fatty alcohol ether of a C₂ to C₄ alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of 8 to 22 carbon atoms.
Claim 17
Dependent Claim
14 words
The transdermal drug delivery device of claim 14 wherein the drug is a steroid.
Claim 18
Dependent Claim
13 words
The transdermal drug delivery device of claim 15 wherein the drug is estradiol.
Claim 19
Dependent Claim
17 words
The transdermal drug delivery device of claim 14 wherein the drug is fentanyl or a fentanyl analog.
Claim 20
Dependent Claim
18 words
The transdermal drug delivery device of claims 14, 15, 16 or 17 wherein the alkanediol is propylene glycol.
Claim 21
Dependent Claim
23 words
The transdermal drug delivery device of claim 18 wherein the fatty acid ester of propylene glycol is a monoester, diester or mixtures thereof.
Claim 22
Dependent Claim
19 words
The transdermal drug delivery device of claims 18 or 19 wherein each fatty acid portion contains 12 carbon atoms.
Claim 23
Dependent Claim
61 words
A pharmaceutical composition for administering a drug transdermally comprising a mixture of the drug and a percutaneous absorption enhancer characterized in that the percutaneous absorption enhancer is a fatty acid ester or fatty alcohol ether of a C₂ to C₄ alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of 8 to 22 carbon atoms.
Claim 24
Dependent Claim
61 words
A pharmaceutical composition for administering a drug transdermally comprising a mixture of the drug and a percutaneous absorption enhancer characterized in that the percutaneous absorption enhancer is a fatty acid ester or fatty alcohol ether of a C₂ to C₄ alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of 8 to 22 carbon atoms.
Claim 25
Dependent Claim
12 words
The pharmaceutical composition of claim 21 wherein the drug is a steroid.
Claim 26
Dependent Claim
11 words
The pharmaceutical composition of claim 18 wherein the drug is estradiol.
Claim 27
Dependent Claim
15 words
The pharmaceutical composition of claim 21 wherein the drug is fentanyl or a fentanyl analog.
Claim 28
Dependent Claim
16 words
The pharmaceutical composition of claims 21, 22, 23, or 24 wherein the alkanediol is propylene glycol.
Claim 29
Dependent Claim
21 words
The pharmaceutical composition of claim 25 wherein the fatty acid ester of propylene glycol is a monoester, diester or mixtures thereof.
Claim 30
Dependent Claim
17 words
The pharmaceutical composition of claims 25 or 26 wherein each fatty acid portion contains 12 carbon atoms.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.