US4983395A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for administering an active agent to the skin or mucosa
Assignee: Actavis Laboratories UT Inc
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Filing: 1989-03-21
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Granted: 1991-01-08
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Expires: 2009-03-21
Abstract
Abstract A transdermal drug delivery device comprising a drug formulation-containing reservoir defined by a backing layer and a drug-permeable membrane layer, a peelable inner liner that underlies the reservoir and a portion of the backing/membrane outwardly of the reservoir periphery, an adhesive layer that underlies the inner liner and outwardly extending portions of the membrane/backing layers, and a peelable release liner layer that underlies the adhesive layer with a first permanent heat seal between the backing and the membrane about the perimeter of the reservoir and another concentric peelable (impermanent) heat seal between the membrane and the inner liner positioned underlying and at a radius not less than the first permanent heat seal, the heat seals and peelable barrier layer providing barriers that isolate the drug formulation from the adhesive.
Inventors
- 👤 Yunik Chang
- 👤 Dinesh C. Patel
- 👤 Charles D. Ebert
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 15:44
CPC Classifications
A; A61; A61F; A61F13/00; A61F13/02; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084
Claims Analysis
Total Claims: 7
Claim 1
Independent Claim
264 words
A device for administering an active agent to the skin or mucosa of an individual comprising a laminated composite of: (a) a backing layer; (b) an active agent-permeable membrane, the backing layer and membrane defining (c) a reservoir therebetween that contains a formulation of the active agent, said reservoir having a smaller periphery than the backing layer and membrane such that a portion of the backing layer and membrane extends outwardly of the periphery of the reservoir; (d) a first peelable active agent formulation-impermeable layer that underlies the reservoir and a portion of said outwardly extending portion of the backing layer and membrane; (e) an adhesive layer that underlies and covers the first peelable active agent formulation-impermeable layer and said outwardly extending portion of the backing layer and membrane; (f) a second peelable active agent formulation-impermeable layer that underlies and covers the adhesive layer; (g) a permanent heat seal about the periphery of the reservoir between the backing layer and the membrane; and (h) a peelable heat seal between the membrane and the first peelable active agent formulation-impermeable layer located underneath and at a radius not less than that of the permanent heat seal, said permanent and peelable heat seals providing barriers to migration of components of the active agent formulation from the reservoir into the adhesive layer and said first and second peelable active agent impermeable layers being bonded together such that when the second peelable layer is removed from the device the peelable heat seal is broken and the first peelable layer and underlying portion of the adhesive layer is removed therewith.
Claim 2
Independent Claim
264 words
A device for administering an active agent to the skin or mucosa of an individual comprising a laminated composite of: (a) a backing layer; (b) an active agent-permeable membrane, the backing layer and membrane defining (c) a reservoir therebetween that contains a formulation of the active agent, said reservoir having a smaller periphery than the backing layer and membrane such that a portion of the backing layer and membrane extends outwardly of the periphery of the reservoir; (d) a first peelable active agent formulation-impermeable layer that underlies the reservoir and a portion of said outwardly extending portion of the backing layer and membrane; (e) an adhesive layer that underlies and covers the first peelable active agent formulation-impermeable layer and said outwardly extending portion of the backing layer and membrane; (f) a second peelable active agent formulation-impermeable layer that underlies and covers the adhesive layer; (g) a permanent heat seal about the periphery of the reservoir between the backing layer and the membrane; and (h) a peelable heat seal between the membrane and the first peelable active agent formulation-impermeable layer located underneath and at a radius not less than that of the permanent heat seal, said permanent and peelable heat seals providing barriers to migration of components of the active agent formulation from the reservoir into the adhesive layer and said first and second peelable active agent impermeable layers being bonded together such that when the second peelable layer is removed from the device the peelable heat seal is broken and the first peelable layer and underlying portion of the adhesive layer is removed therewith.
Claim 3
Dependent Claim
30 words
The device of claim 1 wherein the adhesive is incompatible with one or more of the components of the formulation that permeate through the membrane to the skin or mucosa.
Claim 4
Dependent Claim
29 words
The device of claim 1 wherein the backing layer is a laminated composite of at least one layer that is impermeable to the formulation and an inner heat-sealable layer.
Claim 5
Dependent Claim
27 words
The device of claim 1 wherein the adhesive is an acrylic adhesive, the active agent is pindolol hydrochloride, and the formulation includes ethyl alcohol and glycerol monooleate.
Claim 6
Dependent Claim
27 words
The device of claim 1 wherein the adhesive is an acrylic adhesive, the active agent is nicardipine hydrochloride, and the formulation includes ethyl alcohol and glycerol monooleate.
Claim 7
Dependent Claim
26 words
The device of claim 1 wherein the adhesive is a silicone adhesive, the active agent is calcitriol and the formulation includes ethanol, methyl laurate, and water.
References Cited (Backward Citations)
US4849224A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-01-07 | 1994-07-09 | 1995-01-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-01-07 | 1998-07-09 | 1999-01-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-01-07 | 2002-07-09 | 2003-01-08 | $7700.00 | Window Closed / Lapsed |