Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1998-07-17
2001-05-15
Wu, David W. (Department: 1713)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S447000, C524S315000, C524S560000
Reexamination Certificate
active
06231883
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a medical adhesive sheet to be adhered to the skin surface to cover the skin for protection and to continuously administer a drug into a body through the skin, and to the production thereof.
BACKGROUND OF THE INVENTION
Various skin surface adhesion type external agents have been heretofore developed, inclusive of one for covering the surfaces of healthy skin and wounded skin for protection and one for percutaneous administration of a drug into a body through the skin. Since these external agents are adhered to the skin surface, they are required to have superior handling property in application, skin surface movement-following capability, and low irritation to the skin to suppress damages to keratin.
Of these, handling property in application and low irritation to the skin can be dealt with by altering the composition of the adhesive itself to appropriately decrease the adhesive power to the skin or by adding a liquid component (e.g., water and oily component) to the adhesive layer to make a water-containing gel or oily gel, thereby imparting softness to the adhesive layer. In the latter method, a crosslinking agent may be also used to impart a cohesive power to the adhesive to retain the liquid component in the adhesive layer. This crosslinking agent reacts, at plural sites, with the functional group that the adhesive possesses, such as carboxyl group, hydroxyl group and amino group. As a result, the adhesive layer has a net structure that enables retention of the liquid component. In this reaction, when the liquid component, additive, drug and the like have a functional group capable of reacting with the crosslinking agent, the crosslinking agent first reacts with them rather than with the adhesive, because they have low molecular weights and superior dispersibility, and this tends to occur actually. Consequently, due to the absence of crosslinking of the adhesive by the action of a crosslinking agent, the liquid component cannot be retained in the adhesive layer and the inherent effects of the liquid component, additive, drug and the like cannot be exerted.
The present invention aims at solving the above-mentioned problems, and achieves low irritation property by retaining a liquid component in an adhesive layer, and provides a production method thereof.
SUMMARY OF THE INVENTION
As a result of the studies in an attempt to retain a liquid component in an adhesive layer without using a crosslinking agent, the present invention can solve the above-mentioned problems by the use of a polymer having a weight average molecular weight of not less than 2,000,000 as an adhesive. Thus, the present invention provides the following.
(1) A medical adhesive sheet comprising a support and an adhesive layer formed on one side of said support, wherein the adhesive layer comprises an adhesive polymer having a weight average molecular weight of not less than 2,000,000 and at least one plasticizer compatible with said polymer.
(2) The medical adhesive sheet of above (1), wherein the adhesive polymer has a weight average molecular weight of not less than 2,500,000.
(3) The medical adhesive sheet of above (1), wherein the adhesive polymer has a weight average molecular weight of not less than 5,000,000.
(4) The medical adhesive sheet of above (1), wherein the adhesive polymer is an acrylate type polymer.
(5) The medical adhesive sheet of above (4), wherein the acrylate type polymer is a copolymer obtained by copolymerizing alkyl (meth)acrylate as a main component.
(6) The medical adhesive sheet of above (1), wherein the plasticizer is a liquid plasticizer.
(7) The medical adhesive sheet of above (6), wherein the liquid plasticizer is contained in a proportion of 10-100 parts by weight per 100 parts by weight of the adhesive polymer.
(8) The medical adhesive sheet of above (6), wherein the liquid plasticizer is a fatty acid ester obtained by reacting a higher fatty acid having 12 to 16 carbon atoms and a lower monovalent alcohol having 1 to 4 carbon atoms.
(9) The medical adhesive sheet of above (1), wherein the plasticizer comprises a liquid plasticizer and a solid plasticizer.
(10) The medical adhesive sheet of above (9), wherein the liquid plasticizer is contained in a proportion of 10-100 parts by weight per 100 parts by weight of the adhesive polymer.
(11) The medical adhesive sheet of above (9), wherein the liquid plasticizer is a fatty acid ester obtained by reacting a higher fatty acid having 12 to 16 carbon atoms and a lower monovalent alcohol having 1 to 4 carbon atoms, or a combination of said fatty acid ester, a fatty acid having 8 to 10 carbon atoms and glycerol.
(12) The medical adhesive sheet of above (9), wherein the solid plasticizer is contained in a proportion of not more than 10 parts by weight per 100 parts by weight of the adhesive polymer.
(13) The medical adhesive sheet of above (9), wherein the solid plasticizer is a monoglyceride obtained by reacting a fatty acid having 8 to 10 carbon atoms and glycerol.
(14) The medical adhesive sheet of above (1), wherein the adhesive layer further contains a drug for percutaneous absorption.
(15) A method for producing a medical adhesive sheet, which comprises (a) applying a solution containing a composition comprising an adhesive polymer having a weight average molecular weight of not less than 2,000,000 and at least one plasticizer compatible with said polymer, on one surface of a support and (b) drying same to form an adhesive layer.
(16) The method of above (15) wherein the adhesive polymer is prepared by emulsion polymerization.
REFERENCES:
patent: 4750482 (1988-06-01), Sieverding
patent: 5176916 (1993-01-01), Yamanka et al.
patent: 5556636 (1996-09-01), Yano et al.
patent: 5645855 (1997-07-01), Lorenz
patent: 0201102A2 (1986-12-01), None
patent: 0 661 302 (1995-07-01), None
patent: 0 711 551 (1996-05-01), None
WO 98 13035 Abstract, Apr. 2, 1998 (Derwent Publications Ltd., AN 1998-286399 XP002143206).
Akemi Hitoshi
Inosaka Keigo
Inoue Yuichi
Muraoka Takateru
Otsuka Saburo
Egwim Kelechi C.
Nitto Denko Corporation
Sughrue Mion Zinn Macpeak & Seas, PLLC
Wu David W.
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