US 5,008,110 AGranted

Storage-stable transdermal patch

AssigneeThe Procter & Gamble Company

InventorsArnold G. Benecke, Daniel J. Kinne, Andrew J. Wnuk

Life of this patent

Estimating the term…

Loading patent…

Abstract

A shelf-stable device for transdermally administering an active pharmaceutical to a patient. The device includes a drug reservoir that contains the drug formulation. In one preferred embodiment of the present invention, the drug reservoir is sandwiched between an upper and a lower 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 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 compartment also prevents the drug formulation from coming into contact with and possibly dissolving the adhesive used to secure the device to the patients'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 solvent/environment barrier films 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.

Claims20

Dependent claims

A storage-stable device for the transferal delivery of an active pharmaceutical, said device comprising:

(a) a drug reservoir containing a mixtured of said pharmaceutical and a skin permeation enhancer, said reservoir having an upper surface and a lower surface;
(b) a lower barrier film which is resistant to permeation by and absorption of said pharmaceutical and said skin permeation enhancer in contact with said lower surface of said reservoir;
(c) an upper barrier film which is resistant to permeation by and absorption of said pharmaceutical and said skin permeation enhance in contact with said upper surface of said reservoir;
(d) a compartment containing said drug reservoir and said lower and said upper barrier films, said compartment comprising a top cover located adjacent and secured to said upper barrier film and a bottom cover located adjacent and secured to said lower barrier film, each of said covers being comprised of a material which is resistant to permeation by moisture, oxygen and light, said top cover and aid bottom cover being hermetically sealed together smear their peripheral edges;
(e) an outermost coverstock attached to said bottom cover of said outer compartment, said coverstock having an adhesive coating thereon, said hermetically-sealed compartment and said upper and lower barrier films together preventing said mixture of said pharmaceutical and said skin permeation enhancer from coming into contact with said adhesive coating on said outermost coverstock as well as the entry of moisture, oxygen and light from the surrounding environment into said reservoir;
and
(f) a release liner attached to said top cover of said compartment, said release liner being in contact with the periphery of said outermost coverstock, whereby peeling said release liner from said coverstock breaks said hermetic seal between said top cover and said bottom cover o said compartment, thereby exposing the adhesive at the periphery of said outermost coverstock and the upper surface of said drug reservoir.

4 more elements

A storage-stable device for the transdermal delivery of an active pharmaceutical, said device comprising:

(a) a drug reservoir containing a mixture of said pharmaceutical and a skin permeation enhancer, said reservoir having an upper surface and a lower surface;
(b) a lower barrier film, which is resistant to permeation by and absorption of said pharmaceutical and said skin permeation enhancer as well as resistant to permeation by moisture, oxygen and light, in contact with said lower surface of said reservoir;
(c) an upper barrier film, which is resistant to permeation by and absorption of said pharmaceutical an said skin permeation enhancer as well as resistant to permeation by moisture, oxygen and light, in contact with said upper surface of said reservoir, said lower and said upper barrier films being hermetically sealed together near their peripheral edges;
(d) an outermost coverstock attached to said lower barrier film, said coverstock having an adhesive coating thereon, said hermetically sealed lower and upper barrier films preventing said mixture of said pharmaceutical and said skin permeation enhancer from coming into contact with said adhesive coating on said outermost coverstock as well as the entry of moisture, oxygen and light from the surrounding environment into said reservoir;
and
(e) a release liner attached to said upper barrier film, said release liner being in contact with the periphery of said outermost coverstock, whereby peeling said release liner from said coverstock breaks said hermetic seal between said lower and said upper barrier films, thereby exposing the adhesive at the periphery of said outermost coverstock and the upper surface of said drug reservoir.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 07/269,513Filed 10 Nov 1988
Granted: 16 Apr 1991
Term ends: Not estimatedThe source records don’t support an estimate.

Classification6 codes

A61K 9/703
Transdermal patches and similar drug-containing composite devices, e.g. cataplasms: characterised by shape or structure; Details concerning…
A61F 13/022
With fluid retention members: having more than one layer with different fluid retention characteristics
A61F 13/0259
Adhesive bandages or dressings: characterised by the release liner covering the skin adhering layer
A61K 9/7084
Characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches: transdermal patches…