Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1999-06-23
2001-01-23
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S448000, C424S449000
Reexamination Certificate
active
06177098
ABSTRACT:
TECHNICAL FIELD
This invention relates to plasters for percutaneous absorption, using the laminated backing of polyester film and non-woven fabric of vinylon with the appropriate strength as a support of the plaster, more specifically, to the plaster in which an adhesive base material containing an active ingredient as being applied on the non-woven fabric of vinylon side of the laminated backing.
Even more specifically, the present invention relates to the plaster for percutaneous absorption using the laminated backing which is composed of polyester film and non-woven fabric of vinylon, and the opposite side of laminated polyester film with non-woven fabric pasted to is emboss treated. Furthermore, by using the laminated backing having elasticity ratio of more than 5%, and pulling severance weight of more than 0.5 kg/10 mm under JIS (Japan Industrial Standard)-K6732 testing method, the plasters of the present invention may have elasticity, may be easy to handle, and possesses the stable releasing of the active ingredient for the long period of time.
BACKGROUND ART
The backing for the conventional plasters for percutaneous absorption may be polyvinyl chloride film; olefin films such as polyethylene and polypropylene; polyurethane film; polyester/polyethylene-vinyl acetate copolymer (EVA) laminated film; EVA
on-woven fabric (rayon) laminated film or non-woven fabric of polyester/polyester laminated film, and these are very thin.
These backings except for polyester/EVA laminated film are used to produce the plaster for the active ingredient having systemic effect such as isosorbide dinitarate and amyl nitrite which possess the characteristic of sublimation and fugacity. However, there are same cases that the active ingredient in the adhesive base material is absorbed by the backing, and diffused from the adhesive base material. Therefore, the plasters have to be stored in sealed condition. However, during the storage, the active ingredient contained in the adhesive base material may decrease by diffusing and absorbed to the container. As a result, the stable drug releasing from the adhesive layer may not be obtained.
On the other hand, to prevent diffusion and absorption of the active ingredient to the backing, the polyester/EVA laminated film can be used to the backing of the plasters. However, because the close, adhesion to the skin is expected, the plaster must be laminated in thin layered composition preferably having thickness from 15 to 40 &mgr;m. Therefore, the plaster using the polyester/EVA laminated film as backing has same problems of the curl caused by static electricity and internal stress when applied to the skin.
To overcome these disadvantages, it has been proposed to use the backing which is laminated with polyester film and non-woven fabric of polyester (Japanese Patent Publication No. Hei 5-309128). Nevertheless, even in the case of using the proposed backing, there are still same disadvantages. For example, in the case of containing the oily absorption accelerant, such as oleic acid, isopropyl myristate or crotamiton in the adhesive base material, these oily substance may be absorbed to the non-woven fabric of polyester. Therefore, the releasing capability of the active ingredient from the adhesive base material decreases as the time passes by. Additionally, the plaster may be torn when the polyester film is thin (i.e. less than 1.5 &mgr;m), and the unit weight of non-woven fabric of polyester is less than 6 g/m
2
. As a result, the backing for the plaster satisfied all expectations has not been available.
DISCLOSURE OF THE INVENTION
The inventors of the present invention had made intensive studies to overcome above-mentioned problems, and succeeded to discover the present invention. That is, the present inventors found out that the plasters for percutaneous absorption using a backing composed by non-woven fabric of vinylon pasted together with polyester film (laminated structured backing) possesses the excellent elasticity, easy handling, and the stable releasing of the active ingredient over the long period of time.
Therefore, the purpose of this invention is to provide the plasters for percutaneous absorption using a laminated backing of polyester film and non-woven fabric of vinylon with the appropriate strength as a support of the plaster.
One aspect of the present invention is to provide the plasters for percutaneous absorption using the laminated backing which is composed of polyester film and non-woven fabric of vinylon, having elasticity ratio of more than 5%, and pulling severance weight of more than 0.5 kg/10 mm under JIS-K6732 testing method.
In above condition, this invention provides the plasters for percutaneous absorption with the thickness of the polyester film of the laminated backing being 1.5-6.0 &mgr;m, more preferably 2.0-3.5 &mgr;m, and the unit weight of the non-woven fabric of vinylon being 3-12 g/m
2
, more preferably 6-8 g/m
2
.
Therefore, the most preferred embodiment of the present invention is to provide the plasters for percutaneous absorption using polyester
on-woven fabric of vinylon laminated backing with the elasticity ratio of more than 5%, and pulling severance weight of more than 0.5 kg/10 mm under JIS-K6732 testing method, and said polyester film having the thickness of 1.5-6.0 &mgr;m, more preferably 2.0-3.5 &mgr;m, and said non-woven fabric of vinylon with the unit weight of 3-12 g/m
2
, more preferably 6-8 g/m
2
.
Furthermore, in the preferred embodiment, this invention provides the plaster for percutaneous absorption using the laminated backing of polyester film and non-woven fabric of vinylon in which the opposite side of laminated polyester film with non-woven fabric pasted to is emboss treated.
Therefore, in the another embodiment, this invention provides the plaster for percutaneous absorption which comprising the adhesive base material containing the active ingredient spread onto the non-woven fabric side of the above-mentioned laminated backing.
The plaster for percutaneous absorption using the backing comprising of polyester film
on-woven fabric of vinylon, and the adhesive base material containing the active ingredient spread onto the said backing shows excellent performance. That is, barrier ability of the active ingredient contained in the base material, close adhesion to the skin, occlusive dressing technique (ODT) effect, and easy handling. Furthermore, these features are kept stable for long time period. Thus the plasters of the present invention may be the excellent transdermal preparation for the various kinds of medicine.
REFERENCES:
patent: 5419912 (1995-05-01), Morimoto et al.
patent: 5683710 (1997-11-01), Akemi et al.
patent: 5773028 (1998-06-01), Inagi et al.
patent: 5876745 (1999-03-01), Muraoka et al.
Kawaji Toshikuni
Yamaji Masahiro
Evenson, McKeown, Edwards & Lenahan P.L.L.C.
Page Thurman K.
Teikoku Seiyaku Co., Ltd.
Tran Susan
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