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US5342623A Expired / Lapsed US ⏱️ 0.0 years remaining

Subsaturated transdermal therapeutic system having improved release characteristics

Assignee: Alza Corp
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Filing: 1993-06-18
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Granted: 1994-08-30
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Expires: 2013-06-18
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Abstract

Abstract Rate controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent or a plasticizer for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation, and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and preferably at least 75% initial equilibrated agent loading is in the reservoir layer. The devices are usable to deliver agents which are liquid at body temperatures such as benztropine, secoverine, nicotine, arecoline, polyethylene glycol monolaurate, glycerol monolaurate, glycerol monooleate and ethanol, for example.

Inventors

  • 👤 David J. Enscore
  • 👤 Patricia S. Campbell
  • 👤 James L. Osborne
  • 👤 Melinda K. Smart
  • 👤 Su I. Yum

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 18:41
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/46

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 166 words
A medical device utilizing an in-line adhesive for the transdermal administration of an agent that is a solvent for said adhesive, said device being adapted to deliver said agent throughout a predetermined administration period said device comprising, in combination: a) an agent reservoir comprising said agent dissolved in a solvent at a concentration less than saturation and at an initial equilibrated agent loading sufficient to prevent the activity of said agent in said solvent from decreasing by more than 75% during said administration period; b) agent release rate controlling means disposed in the path of agent migration from said reservoir to the skin, said rate controlling means being permeable to said agent and substantially impermeable to said solvent; and c) adhesive means disposed in the path of agent migration from said release rate controlling means to the skin, said adhesive being soluble in said agent the initial equilibrated concentration of said agent in said reservoir being at a level at which the adhesive maintains adhesive properties.
Claim 2
Dependent Claim 166 words
A medical device utilizing an in-line adhesive for the transdermal administration of an agent that is a solvent for said adhesive, said device being adapted to deliver said agent throughout a predetermined administration period said device comprising, in combination: a) an agent reservoir comprising said agent dissolved in a solvent at a concentration less than saturation and at an initial equilibrated agent loading sufficient to prevent the activity of said agent in said solvent from decreasing by more than 75% during said administration period; b) agent release rate controlling means disposed in the path of agent migration from said reservoir to the skin, said rate controlling means being permeable to said agent and substantially impermeable to said solvent; and c) adhesive means disposed in the path of agent migration from said release rate controlling means to the skin, said adhesive being soluble in said agent the initial equilibrated concentration of said agent in said reservoir being at a level at which the adhesive maintains adhesive properties.
Claim 3
Dependent Claim 24 words
The device of claim 1 wherein at least 50% of the initial loading of the agent in the device is in the agent reservoir.
Claim 4
Dependent Claim 15 words
The device of claim 1 wherein said decrease in activity is no greater than 25%.
Claim 5
Dependent Claim 18 words
The device of claim 1 wherein at least 75% of the initial agent loading is in the reservoir.
Claim 6
Dependent Claim 17 words
The device of claim 1 wherein said agent is an oily, non-polar material, liquid at body temperature.
Claim 7
Dependent Claim 27 words
The device of claim 1 wherein said reservoir contains more than one agent at least one of which is an oily, nonpolar material, liquid at body temperature.
Claim 8
Dependent Claim 11 words
The device of claim 1 wherein said agent solubilizes said adhesive.
Claim 9
Dependent Claim 11 words
The device of claim 1 wherein said agent plasticizes said adhesive.
Claim 10
Dependent Claim 19 words
The device of claim 1 wherein the activity of the agent in the reservoir is no greater than 0.50.
Claim 11
Dependent Claim 19 words
The device of claim 2 wherein the activity of the agent in the reservoir is no greater than 0.50.
Claim 12
Dependent Claim 19 words
The device of claim 3 wherein the activity of the agent in the reservoir is no greater than 0.50.
Claim 13
Dependent Claim 19 words
The device of claim 4 wherein the activity of the agent in the reservoir is no greater than 0.50.
Claim 14
Dependent Claim 19 words
The device of claim 1 wherein the activity of the agent in the reservoir is no greater than 0.25.
Claim 15
Dependent Claim 19 words
The device of claim 2 wherein the activity of the agent in the reservoir is no greater than 0.25.
Claim 16
Dependent Claim 19 words
The device of claim 3 wherein the activity of the agent in the reservoir is no greater than 0.25.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1997-08-29 1998-02-28 1998-08-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2001-08-29 2002-02-28 2002-08-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2005-08-29 2006-02-28 2006-08-30 $7700.00 Window Closed / Lapsed

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