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Method for producing patch, and patch

A manufacturing method and a technology for an adhesive, which are applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of coloration of the adhesive layer, poor storage stability, etc., and reduce the Uneven skin permeability and excellent skin permeability

Active Publication Date: 2014-01-08
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the free form of the drug described in Patent Documents 8 to 12 has a problem that the storage stability is inferior to that of the salt form of the drug, and the adhesive layer is colored during the storage of the patch.

Method used

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  • Method for producing patch, and patch
  • Method for producing patch, and patch
  • Method for producing patch, and patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0120] First, 10.0 parts by mass of sodium diacetate, 5.0 parts by mass of emedastine fumarate, 18.0 parts by mass of styrene-isoprene-styrene block copolymer (SIS), 5.0 parts by mass of methacrylate copolymer (trade name: Eudragit, manufactured by Romfarma), 8.0 parts by mass of polyisobutylene (PIB), 39.0 parts by mass of petroleum-based tackifying resin (trade name: Alcon, manufactured by Arakawa Chemical Industry Co., Ltd.), 5.0 parts by mass of sucrose fatty acid ester, 5.0 parts by mass of sorbitan trioleate, and 5.0 parts by mass of diisopropanolamine are mixed in toluene and stirred by a propeller mixer to obtain a uniform adhesive Layer composition (concentration of non-volatile components: 50% by mass). Next, the pressure-sensitive adhesive layer composition was applied on one side of a release liner layer made of polyethylene terephthalate having a thickness of 75 μm so that the thickness after drying became 100 μm, and dried at 60° C. 20 minutes to form an adhesiv...

Embodiment 2～4

[0122] A patch was obtained in the same manner as in Example 1 except that the composition of the adhesive layer composition was the composition shown in Table 1. In addition, in the adhesive layer of the patch obtained, the molar ratio of emedastine fumarate to sodium diacetate (the number of moles of emedastine fumarate: the molar number of sodium diacetate) Number) is 1:7.5 in embodiment 2, is 1:6 in embodiment 3. In addition, the molar ratio of spatriptyline maleate to sodium diacetate in Example 4 (the number of moles of spatriptyline maleate:the number of moles of sodium diacetate) was 1:10.5.

Embodiment 5

[0127] (Example 5, Comparative Example 5)

[0128] Patch preparations were obtained in the same manner as in Example 1, except that the composition of the adhesive layer composition was the composition shown in Table 2 below. In addition, in the adhesive layer of the patch obtained in Example 5, the molar ratio of oxybutynin hydrochloride to sodium diacetate (the number of moles of oxybutynin hydrochloride:the number of moles of sodium diacetate) was 1 :5.

[0129] [Table 2]

[0130] Composition (parts by mass)

Example 5

Comparative Example 5

Sodium diacetate

18.0

-

sodium acetate

-

9.0

citric acid

-

2.5

liquid paraffin

20.0

10.5

Petroleum-based tackifying resin

34.7

32.0

SIS

17.3

18.0

PIB

-

13.0

Oxybutynin Hydrochloride

10.0

15.0

total

100.0

100.0

[0131] The skin penetration test was performed on the patches obtaine...

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Abstract

A method for producing a patch including a support layer and an adhesive layer, comprising the step of forming the adhesive layer with use of an adhesive layer composition obtained by mixing an alkali metal diacetate, a drug, and a nonaqueous adhesive base such that the molar ratio between the drug and the alkali metal diacetate (the number of moles of the drug: the number of moles of the alkali metal diacetate) is from 1:0.5 to 1:15.

Description

technical field [0001] The invention relates to a method for manufacturing an adhesive and the adhesive. Background technique [0002] Conventionally, various patches have been developed for the purpose of improving the skin permeability of the drug contained in the patch. As such patches, it is known that there are organic acids and / or organic acid salts together with the drug. of adhesives. [0003] For example, Japanese Patent Application Laid-Open No. 11-302161 (Patent Document 1) describes a patch containing a basic drug salt and an organic acid salt, and sodium acetate is described as the organic acid salt. In addition, International Publication No. 01 / 07018 (Patent Document 2) describes patch preparations containing acid addition salts of basic drugs, organic acids, and organic acid salts, and acetic acid, lactic acid, etc. are described as the above-mentioned organic acids. , sodium acetate and the like are described as the above-mentioned organic acid salts. Furt...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/435A61K31/551A61K47/12A61K47/32A61K47/34A61P11/02A61P17/04A61P37/08A61P43/00
CPCA61K31/551A61K31/216A61K31/5513A61K9/7038A61K31/4353A61K9/7061A61K47/12A61K9/7053A61K31/435A61P11/02A61P13/10A61P17/04A61P25/24A61P37/08A61P43/00
Inventor 桥本英治萩原勋仲晋永长野英治
Owner HISAMITSU PHARM CO INC
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