Isosorbide dinitrate-containing patch using a mixed adhesive

Details Isosorbide dinitrate-containing patch using a mixed adhesive Isosorbide dinitrate-containing patch using a mixed adhesive

1996-08-28

1998-06-09

Phelan, D. Gabrielle

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

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

424449, A61F 1302

Patent

active

057629544

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/JP95/00318, filed Feb. 28, 1995.


TECHNICAL FIELD

The present invention relates to an isosorbide dinitrate (ISDN)-containing patch. More specifically, the present invention relates to a patch in which an adhesive composition having isosorbide nitrate incorporated in a mixed adhesive comprising a silicone-based adhesive and polyvinyl acetate-based adhesive at a specified mixing ratio is formed on a flexible support and has excellent sustained release properties and good percutaneous absorption.


BACKGROUND ART

Drugs such as isosorbide dinitrate are commonly known to be absorbed percutaneously, and numerous products have already been developed as patches containing these drugs. It is indicated, in, for example, Japanese Unexamined Patent Publication No. 57-116011, that pressure-sensitive adhesives such as silicone-based, rubber-based and acrylic-based pressure-sensitive adhesives are preferable as pressure-sensitive adhesives used in these patches. In addition, at the 5th meeting of the Japan Pharmacology Association (Sep. 26-28, 1989), Okuni, et.al. reported that with respect to patches containing ISDN, in comparing acrylic-based, silicone-based and rubber-based pressure-sensitive adhesives, the percutaneous absorption of these three are roughly equal.
In the above-mentioned Japanese Unexamined Patent Publication No. 57-116011, the application was later published after examination (Japanese Examined Patent Publication No. 4-74329) following amendment by stating that acrylic-based pressure-sensitive adhesives are particularly preferable among various types of pressure-sensitive adhesives.
Namely, in conventional isosorbide dinitrate-containing patches, with respect to the relationship between the percutaneous absorption of ISDN and the pressure-sensitive adhesive, it was considered that acrylic-based pressure-sensitive adhesives are preferable, or that the above-mentioned acrylic-based pressure-sensitive adhesives and rubber-based pressure-sensitive adhesives are equally preferable.
However, a shortcoming of patches is the occurrence of rashes on the skin. Various proposals have been made as methods to reduce the occurrence of skin rash. One method involves reducing the size of the preparation so that the portion of the skin where the rash occurs will be smaller. However, it is necessary to increase the amount of percutaneous absorption per unit area in order to accomplish this. Although various types of absorption promoters were then proposed in order to increase percutaneous absorption, due in part to the fact that absorption promoters typically have a low molecular weight, there are many cases in which they are observed to demonstrate skin irritation. In addition, there are also problems including a decrease in the adhesive strength of the resultant adhesive composition when adding large amounts of absorption promoters thereto. Thus, a patch that minimizes the occurrence of skin rash while also offering excellent percutaneous transmission and adhesive strength has not yet to be successfully provided.
Therefore, an object of the present invention is to provide a patch with minimal skin irritation and favorable percutaneous absorption by designing an adhesive having excellent compatibility with isosorbide dinitrate.
Moreover, an object of the present invention is to provide a sustained release patch with minimal skin irritation and favorable percutaneous absorption.
In addition, an object of the present invention is to provide a patch with minimal skin irritation, favorable percutaneous absorption even without using percutaneous absorption promoters, and favorable adhesive strength.
The inventors of the present invention achieved the present invention as a result of earnest research to solve the above-mentioned problems.


DISCLOSURE OF THE INVENTION

More specifically, the present invention relates to an isosorbide dinitrate-containing patch comprising an adhesive layer (A') formed on a flexible support, wherein said layer comprises an adhesive composition comprising ad

REFERENCES:
patent: 4849226 (1989-07-01), Gale
patent: 4956181 (1990-09-01), Bayer
patent: 5300291 (1994-04-01), Sablotsky
patent: 5474783 (1995-12-01), Miranda

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