EP0368408A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Storage-stable transdermal patch
Assignee: Procter and Gamble Co
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Filing: 1989-11-07
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Granted: —
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Expires: 2009-11-07
Abstract
Abstract A shelf-stable device for transdermally administering an active pharmaceutical to a patient. The device includes a drug reservoir (16) that contains the drug formulation. In one preferred embodiment of the present invention, the drug reservoir (16) is sandwiched between an upper (18) and a lower (20) solvent barrier film that are made from a material such as a polyester that will not absorb the drug and/or skin permeating enhancing solvent, if any, contained within the reservoir. The drug reservoir and solvent barrier films are encapsulated within a hermetically-sealed compartment (22) that protects the drug formulation from common environmental factors such as water vapor, oxygen, and light which can adversely affect the stability and efficacy of the drug formulation. The hermetically-sealed (22) compartment also prevents the drug formulation from coming into contact with and possibly dissolving the adhesive used to secure the device to the patient's skin. In another particularly preferred embodiment of the present invention, the device's drug reservoir is encapsulated within a hermetically-sealed compartment that is made from (combined) solvent/environment barrier films (70) that serve the dual functions of preventing the device's components from absorbing the drug/solvent formulation from the reservoir, and protecting the drug/solvent formulation from common environmental factors.
Inventors
- 👤 Arnold George Benecke
- 👤 Andrew Julian Wnuk
- 👤 Daniel James Kinne
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-02 06:26
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61F; A61F13/00; A61F13/02; A61F13/0203; A61F13/022; A61F13/0259; A61K9/7084
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
201 words
A storage-stable device for the transdermal delivery of an active pharmaceutical, said device being characterized by: a drug reservoir member containing a quantity of a transdermal medicament which medicament includes an effective amount of said pharmaceutical and which medicament may also include skin permeation enhancers and solvent materials, said reservoir member having an upper surface and a lower surface; a lower solvent barrier film in contact with said lower surface of said reservoir member; an upper solvent barrier film in contact with said upper surface of said reservoir member; a hermetically-sealed compartment containing said reservoir member and said first and said second barrier films, said compartment comprising a top cover and a bottom cover hermetically sealed together near their peripheral edges; an outermost coverstock attached to said bottom cover of said compartment, said coverstock having an adhesive coating thereon, said compartment being sealed to prevent said medicament from coming into contact with said adhesive coating on said coverstock; and a release liner attached to said top cover of said compartment and being peelably adhered to the periphery of said coverstock, whereby peeling said release liner from said coverstock opens said compartment, thereby exposing said reservoir member and the medicament contained there.
Claim 2
Dependent Claim
201 words
A storage-stable device for the transdermal delivery of an active pharmaceutical, said device being characterized by: a drug reservoir member containing a quantity of a transdermal medicament which medicament includes an effective amount of said pharmaceutical and which medicament may also include skin permeation enhancers and solvent materials, said reservoir member having an upper surface and a lower surface; a lower solvent barrier film in contact with said lower surface of said reservoir member; an upper solvent barrier film in contact with said upper surface of said reservoir member; a hermetically-sealed compartment containing said reservoir member and said first and said second barrier films, said compartment comprising a top cover and a bottom cover hermetically sealed together near their peripheral edges; an outermost coverstock attached to said bottom cover of said compartment, said coverstock having an adhesive coating thereon, said compartment being sealed to prevent said medicament from coming into contact with said adhesive coating on said coverstock; and a release liner attached to said top cover of said compartment and being peelably adhered to the periphery of said coverstock, whereby peeling said release liner from said coverstock opens said compartment, thereby exposing said reservoir member and the medicament contained there.
Claim 3
Dependent Claim
179 words
A storage-stable device for the transdermal delivery of an active pharmaceutical, said device being characterized by: a drug reservoir member containing a quantity of a transdermal medicament which includes an effective amount of said pharmaceutical, said reservoir member having an upper surface and a lower surface; a lower solvent/environment barrier film in contact with said lower surface of said reservoir member; an upper solvent/environment barrier film in contact with said upper surface of said reservoir member, said lower and said upper solvent/environment barrier films being sealed together near their peripheral edges to define a hermetically sealed compartment therebetween; an outermost coverstock attached to said lower solvent/environment barrier film, said coverstock having an adhesive coating thereon, said hermetically sealed lower and upper solvent/environment barrier films preventing said medicament from coming into contact with said adhesive coating on said coverstock; and a release liner attached to said upper solvent/environment barrier film and adhesively adhered to the periphery of said coverstock, whereby peeling said release liner from said coverstock opens said compartment thereby exposing said reservoir member and the medicament contained therein.
Claim 4
Dependent Claim
179 words
A storage-stable device for the transdermal delivery of an active pharmaceutical, said device being characterized by: a drug reservoir member containing a quantity of a transdermal medicament which includes an effective amount of said pharmaceutical, said reservoir member having an upper surface and a lower surface; a lower solvent/environment barrier film in contact with said lower surface of said reservoir member; an upper solvent/environment barrier film in contact with said upper surface of said reservoir member, said lower and said upper solvent/environment barrier films being sealed together near their peripheral edges to define a hermetically sealed compartment therebetween; an outermost coverstock attached to said lower solvent/environment barrier film, said coverstock having an adhesive coating thereon, said hermetically sealed lower and upper solvent/environment barrier films preventing said medicament from coming into contact with said adhesive coating on said coverstock; and a release liner attached to said upper solvent/environment barrier film and adhesively adhered to the periphery of said coverstock, whereby peeling said release liner from said coverstock opens said compartment thereby exposing said reservoir member and the medicament contained therein.
Claim 5
Dependent Claim
33 words
The transdermal device according to either of Claims 1 and 2 wherein a release tab is interposed between said adhesive-coated coverstock and said release liner at an outer marginal portion of said device.
Claim 6
Dependent Claim
30 words
The transdermal device according to either of Claims 1 and 2, wherein a rate-controlling or nonrate-controlling membrane may optionally be disposed between said reservoir member and said upper barrier film.
Claim 7
Dependent Claim
31 words
The transdermal device according to either of Claims 1 and 2 wherein said barrier films are made from a laminate comprised of an outer heat-sealable layer and an inner reservoir-member-contacting layer.
Claim 8
Dependent Claim
44 words
The transdermal device according to Claim 5 wherein said inner reservoir-member-contacting layer is made from a material selected from the group consisting of polyethylene terephthalate, fluorinated polyethylene terephthalate, a rubber modified acrylonitrile copolymer, nylon, EVOH, styrene acrylonitrile copolymer, polyvinylidine chloride copolymer, and polychlorotrifluoroethylene copolymer.
Claim 9
Dependent Claim
41 words
The transdermal device according to Claim 1 wherein said top cover and said bottom cover of said compartment are made from a laminate comprised of an outer heat-sealable layer, at least one intermediate environment barrier layer, and an inner heat-sealable layer.
Claim 10
Dependent Claim
40 words
The transdermal device according to Claim 7 wherein said environment barrier layer is selected from the group consisting of polyethylene terephthalate, metallized polyethylene terephthalate, metal foils, a polyvinylidine chloride copolymer, a rubber modified acrylonitrile copolymer, nylon, EVOH, and polychlorotrifluoroethylene copolymer.
Claim 11
Dependent Claim
41 words
The transdermal device according to either of Claims 1 and 2 wherein said medicament includes a skin permeation enhancing agent, said skin permeation enhancing agent being selected from the group consisting of polar solvent materials, polar lipid materials, and mixtures thereof.
Claim 12
Dependent Claim
52 words
The transdermal device according to Claim 9 wherein said polar solvent materials are selected from the group consisting of C₃-C₄ diols, C₃-C₆ triols, and mixtures thereof; and wherein said polar lipid materials are selected from the group consisting of fatty alcohols, fatty acids, fatty alcohol esters, fatty acid esters, and mixtures thereof.
Claim 13
Dependent Claim
27 words
The transdermal device according to Claim 9 wherein said polar solvent material is propylene glycol, and wherein said polar lipid material is methyl laurate or methyl caprylate.
References Cited (Backward Citations)
No citation records indexed.
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