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US4797284A Expired / Lapsed US ⏱️ 0.0 years remaining

Transdermal drug delivery system

Assignee: Merck and Co Inc
•
Filing: 1986-03-12
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Granted: 1989-01-10
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Expires: 2006-03-12
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Abstract

Abstract A multilaminate transdermal drug delivery system containing only dissolved drug in the drug reservoir is described. The delivery system comprises a backing layer, a reservoir layer and a membrane layer, wherein the drug in the reservoir is completely dissolved and the control of delivery is effected by the joint action of reservoir and membrane.

Inventors

  • 👤 Alice E. Loper
  • 👤 Anup K. Majumdar

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-08 07:54
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 235 words
A transdermal drug delivery system for administering a drug, chemically identifiable as (1a,2,3,4a,5,6-hexahydro-9-hydroxy-4-propyl-4H-naphth[1,2-b]-1,-oxazine, over an extended period comprising, (a) a backing layer substantially impermeable to the drug and forming the top or outer surface of a bandage employing the delivery system, (b) a resevoir layer comprising drug in a completely dissolved form in a continuous matrix of a carrier, (c) a membrane layer comprising a structure exhibiting some rate controlling property, wherein a substantially constant release rate is achieved over a substantial part of the wear period by the combined action of the reservoir layer and the membrane layer wherein: ##EQU9## are satisfied simultaneously, and wherein: h is membrane thickness K is partition coefficient between membrane and reservoir D m is diffusion coefficient of drug in membrane x max is reservoir thickness D r is diffusion coefficient of drug in reservoir T is the desired wear time of the bandage, α is a design parameter ranging from but not including 0 to and including 0.67, and representing the fractional drop in the theoretical flux from time zero to the end of the wear period T and β is a design parameter ranging from but not including 0 to and including 1, which allows adjustments to shape of release profile, initial concentration, C o , fraction of total drug depleted from the reservoir, h and x max ; and ≧ signifies equal to or greater than.
Claim 2
Dependent Claim 235 words
A transdermal drug delivery system for administering a drug, chemically identifiable as (1a,2,3,4a,5,6-hexahydro-9-hydroxy-4-propyl-4H-naphth[1,2-b]-1,-oxazine, over an extended period comprising, (a) a backing layer substantially impermeable to the drug and forming the top or outer surface of a bandage employing the delivery system, (b) a resevoir layer comprising drug in a completely dissolved form in a continuous matrix of a carrier, (c) a membrane layer comprising a structure exhibiting some rate controlling property, wherein a substantially constant release rate is achieved over a substantial part of the wear period by the combined action of the reservoir layer and the membrane layer wherein: ##EQU9## are satisfied simultaneously, and wherein: h is membrane thickness K is partition coefficient between membrane and reservoir D m is diffusion coefficient of drug in membrane x max is reservoir thickness D r is diffusion coefficient of drug in reservoir T is the desired wear time of the bandage, α is a design parameter ranging from but not including 0 to and including 0.67, and representing the fractional drop in the theoretical flux from time zero to the end of the wear period T and β is a design parameter ranging from but not including 0 to and including 1, which allows adjustments to shape of release profile, initial concentration, C o , fraction of total drug depleted from the reservoir, h and x max ; and ≧ signifies equal to or greater than.
Claim 3
Dependent Claim 23 words
A transdermal delivery system according to claim 1 wherein α is in the range of from and including 0.01 to and including 0.67.
Claim 4
Dependent Claim 23 words
A transdermal delivery system according to claim 1 wherein α is in the range of from and including 0.01 to and including 0.3.
Claim 5
Dependent Claim 15 words
A transdermal delivery system of claim 1 wherein the membrane layer is a semipermeable membrane.
Claim 6
Dependent Claim 169 words
A transdermal delivery system of claim 1 wherein the membrane layer is a primed microporous membrane and wherein ##EQU10## τ is the tortuosity of the diffusion path through the membrane h is membrane thickness E is the fractional porosity of the membrane K' is the drug partition coefficient between material in the micropores and the reservoir material D m' is drug diffusion coefficient in the material in the micropores of the membrane x max is reservoir thickness D r is diffusion coefficient of drug in reservoir α is a design parameter ranging from but not including 0 to and including 0.67, and representing the fractional drop in the theoretical flux from time zero to the end of the wear period β is a design parameter ranging from but not including 0 to and including 1, which allows adjustments to shape of release profile, initial concentration, C o , fraction of total drug depleted from the reservoir h and x max ; and ≧ signifies equal to or greater than.
Claim 7
Dependent Claim 19 words
A transdermal delivery system according to claim 5 wherein α ranges from and including 0.01 to and including 0.67.
Claim 8
Dependent Claim 16 words
A transdermal delivery system of claim 1 wherein the continuous matrix of the reservoir is solid.
Claim 9
Dependent Claim 21 words
A transdermal delivery system of claim 1 wherein the continuous matrix of the reservoir is a gel contained in a walled-container.
Claim 10
Dependent Claim 17 words
A transdermal delivery system comprising a system in accordance with claim 1 in which β is 1.0.
Claim 11
Dependent Claim 17 words
A transdermal delivery system comprising a system in accordance with claim 5 in which β is 1.0.
Claim 12
Dependent Claim 26 words
A transdermal delivery system comprising a system in accordance with claim 1 in which β ranges from but not including 0 to but not including 1.
Claim 13
Dependent Claim 26 words
A transdermal delivery system comprising a system in accordance with claim 5 in which β ranges from but not including 0 to but not including 1.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1992-01-10 1992-07-11 1993-01-10 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1996-01-10 1996-07-11 1997-01-10 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2000-01-10 2000-07-11 2001-01-10 $7700.00 Window Closed / Lapsed

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