Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1996-03-04
1998-12-22
Schofer, Joseph L.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
424449, 156252, A61F 1300, B32B 3100, A61K 970
Patent
active
058515496
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates generally to systems for applying substances and, specifically, to a system, including a patch, for applying transdermally and/or topically deliverable substances such as medications to a localized area of a patient such as a point of irritation, injury, infection and the like while preventing excess medication from being applied to the area, and an apparatus and method for making such a drug delivery system.
BACKGROUND OF THE INVENTION
Transdermal drug delivery systems have, in recent years, become an increasingly important means of administering drugs. Such systems offer advantages clearly not achievable by other modes of administration such as avoiding introduction of the drug through the gastro-intestinal tract or punctures in the skin to name a few. An example of which involves the application of a topical anesthetic to provide localized relief, as disclosed in U.S. Pat. No. 3,814,095 (Lubens).
A variety of transdermal drug delivery systems or patches are commercially available and well known in the art. One such system is known as the TTS Nitro.TM. patch (Ciba Geigy). Such a patch includes a reservoir containing the medication, which is in the form of a viscous substance. The patch also includes a backing material which can be peeled away and discarded prior to topical application of the patch. In addition, the patch includes a size exclusion membrane covering the medication, which comes in contact with the area to which the patch is applied. The membrane also maintains the medication in the patch and permits passage of the medication through the membrane into the applied area. However, problems and limitation have been associated with such patches, including limits on the rate of delivery of the medication, i.e., nitroglycerine, as a result of the permeability of the membrane.
Thus, there has been a need for a system for applying substances such as medications to an applied area, wherein the rate of delivery of the medication is limited only by the permeability of the area to which the patch is applied. In addition, there has been a need for an apparatus and a method of making such a patch.
SUMMARY OF THE INVENTION
In contrast to the prior systems discussed above, it has been found that a system including a patch for transdermally and/or topically applying a substance such as a medication can be constructed in accordance with the present invention. In addition, the patch is easily activated by the user to administer the medication, which can be forced from the patch and located or otherwise situated at the area to be applied. Such users may include the patient as well as doctors, nurses and the like.
The patch of the present invention for applying a substance such as a transdermal medication topically to an applied area includes a first material having a reservoir formed therein, a dosage of medication contained in the reservoir, and a second material covering the reservoir with at least one opening formed therein through which the medication may pass for application to the applied area.
In the preferred embodiment, the patch also includes a porous material situated between the second material and the dose of medication. The porous material may include a layer of non-woven material. In addition, the second material includes a layer of an adhesive material and a release liner covering the layer of adhesive material with the adhesive material sandwiched between the release liner and the diaphragm, with at least either the first material or the second material includes a heat seal coating. Further, the reservoir is defined by a dimple formed in the first material with a cavity therein.
In an alternative embodiment of the patch, the second material includes a diaphragm and wherein-the at least one opening includes a plurality of slits formed in the diaphragm.
The method of the present invention of making a patch for topically applying a substance to an applied area of a patient includes the steps of forming a reservoir in a backing material, cu
REFERENCES:
patent: 4556441 (1985-12-01), Faase, Jr.
patent: 4666441 (1987-05-01), Andriola et al.
patent: 5064422 (1991-11-01), Wick
patent: 5503843 (1996-04-01), Santus et al.
Becton Dickinson and Company
Schofer Joseph L.
Shelborne Kathryne E.
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