Percutaneously administrable patch preparation

Details Percutaneously administrable patch preparation Percutaneously administrable patch preparation

1996-06-14

1998-10-13

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424446, 424448, A61L 1516, A61K 970

Patent

active

058208771

DESCRIPTION:

BRIEF SUMMARY
This application is a 35 USC 371 of PCT/JP93/01808 filed Dec. 14, 1993.


TECHNICAL FIELD

This invention relates to a field of medicinal remedy using a percutaneously administrable drug preparation. More particularly it relates to a percutaneously administrable patch drug preparation (the preparation being hereinafter referred to as a "percutaneous patch drug preparation" for brevity) which can maintain the stability of a drug contained in the preparation during storage thereof by effectively inhibiting the drug from leaking and evaporation from the preparation.


BACKGROUND ART

Preparations which are percutaneously or permucosally administered have recently been thought much of as a means for administering a drug to patients. Such preparations as above are able to be administered to the systemic and all local portions of the skin of the patients and enable a controlled fixed amount of the drug to be continuously administered for a long period of time.
Preparations which enable their drug to be percutaneously administered, are generally classified into matrix-type ones in which a drug is dispersed in an adhesive layer, and reservoir-type ones which have a drug storage layer. A typical matrix-type percutaneous drug preparation which is well known at present, includes such a one as described in Japanese Patent Gazette No. Sho 57-59806 (or 59806/82), while a typical reservoir-type percutaneous drug preparation known well at present includes such a one as disclosed in Japanese Patent Gazette No. Sho 54-16566 (or 16566/79). The reservoir-type drug preparation has a drug storage layer in which are enclosed a fixed amount of a drug, at least one kind of a solvent, an absorption accelerator, a solubilizer, a stabilizer, a viscosity-enhancing agent and the like, each preliminarily designed or predetermined, for the purpose of administering the drug so that a controlled dose of the drug is continuously circulated in the body for a fixed period of time.
The structure of a conventional reservoir-type drug preparation, however, is such that the drug is likely to leak or evaporate through an inhibitive film of the preparation during storage of the preparation before administration thereof whereby the amount of the drug is lessened as compared with the predetermined one at the time of administering the preparation to a patient. This will result in that the purpose of the percutaneous drug preparation for administering a predetermined amount of the drug systemically and continuously is not attained. In order to solve problems the conventional percutaneous patch drug preparation has had, there are developed, for example, a preparation having a drug reservoir provided at its upper and lower portions respectively with films which protect from solvent, a preparation which has a drug storage layer closely enclosed in a film protecting the drug from various environmental factors and allows the drug storage layer to be exposed by peeling a releasable liner when the preparation is used, and a preparation wherein its drug storage layer is sealed in an aluminum-made laminate film during preservation of the preparation, and the laminate film is removed prior to the use of the preparation thereby to increase the stability of the drug during the storage thereof. The above preparations so developed are each complicated in structure and any of them still do not solve the problems.
In addition, a percutaneous patch drug preparation described in Japanese Pat. Appln. Laid-Open Gazette No. Hei 2-1283 (No. 1283/90) is illustrated in FIG. 9 of the accompanying drawings. This preparation so illustrated is characterized in that the drug is prevented from leaking and evaporation from the preparation during the preservation thereof by providing a second releasable heat-sealed portion 11 around the periphery surrounding an area through which the drug will permeate when the preparation is used. When the preparation is used by a patient, a releasable liner layer 6 together with an inner liner layer 9 is removed since the adhesion strength between

REFERENCES:
patent: 4245630 (1981-01-01), Lloyd et al.
patent: 4687481 (1987-08-01), Nuwayser

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