Drug delivery device

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

Reexamination Certificate

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Details

C424S443000, C424S444000, C424S445000, C424S446000, C424S447000, C424S448000, C514S179000, C514S282000

Reexamination Certificate

active

06277401

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to a drug delivery device for the topical delivery of a hydrophilic drug or drug-containing composition.
A transdermal drug delivery device, also variously referred to as a medical bandage, treatment pad, drug patch, etc., is known. See, e.g., U.S. Pat. Nos. 4,627,429; 4,710,191; 4,839,174; 4,849,224; 4,983,395; 5,264,218; 5,503,844; 5,536,263; 5,629,014; 5,716,621; 5,741,510; 5,770,220; 5,820,876 and 5,820,877. In general, a drug delivery device will include a drug depot, or reservoir, in the form of a drug-storing matrix or carrier and an adhesive for attaching or securing the device to a surface of unbroken skin.
SUMMARY OF THE INVENTION
In accordance with the present invention, a drug delivery device is provided which comprises:
a) a moisture vapor permeable, liquid impermeable flexible thermoplastic backing layer possessing upper and lower surfaces;
b) a moisture vapor permeable, flexible, oleophilic thermoplastic foam layer possessing upper and lower surfaces, the upper surface of the foam layer being nonadhesively bonded to, and substantially coextensive with, the lower surface of the backing layer;
c) a pressure sensitive adhesive layer applied to, and substantially coextensive with, the lower surface of the foam layer; and,
d) a drug reservoir containing a medicinally effective amount of at least one hydrophilic drug composition and possessing a moisture vapor permeable, but hydrophilic drug composition impermeable, barrier layer applied to one surface thereof, the drug reservoir being applied to a portion of the adhesive layer such that the barrier layer lies between the hydrophilic drug composition and the adhesive layer and prevents any significant migration of such drug composition from the drug reservoir into the adhesive layer.
The foregoing drug delivery device effectively resists delamination when pulled from the skin and since its hydrophilic drug component remains separated from the adhesive component by a hydrophilic drug composition barrier layer when the drug is contained in the drug reservoir, there is little, if any, likelihood of the hydrophilic drug composition migrating into the adhesive layer and impairing its effectiveness.


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