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Ropinirole-containing adhesive skin patch and packaged product thereof

一种贴附剂、游离体的技术，应用在含有罗匹尼罗的贴附剂及其包装体领域，能够解决罗匹尼罗的皮肤透过性不充分、症状日间变化强烈等问题，达到皮肤透过性优异、充分粘着性、经时稳定性优异的效果

Inactive Publication Date: 2014-02-05
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, L-Dopa therapy has problems in that long-term continuous administration is necessary, or that the effect of the drug gradually decreases with long-term continuous administration, or that diurnal changes in symptoms become more intense.
However, the patch preparations described in Patent Documents 3 to 4 above have a problem that the skin permeability of ropinirole is not sufficient, and it is difficult to maintain the plasma concentration of ropinirole at a sufficiently high level.

Method used

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  • Ropinirole-containing adhesive skin patch and packaged product thereof
  • Ropinirole-containing adhesive skin patch and packaged product thereof
  • Ropinirole-containing adhesive skin patch and packaged product thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] First, using a mixer, 10.0 parts by mass of ropinirole hydrochloride (8.8 parts by mass converted into ropinirole free body), 1.1 parts by mass of sodium hydroxide (desalting agent), 29.6 parts by mass of liquid paraffin, toluene (solvent ), 29.6 parts by mass of styrene-isoprene-styrene block copolymer (SIS) (SIS5000, manufactured by JSR Corporation), and 29.6 parts by mass of alicyclic hydrocarbon resin were mixed to obtain an adhesive layer composition. The obtained pressure-sensitive adhesive layer composition was spread on a release sheet formed of a film (made of polyester) subjected to mold release treatment with silicone, and the toluene was removed by drying to form a pressure-sensitive adhesive layer. Next, a film (made of polyester) was laminated as a support layer on the surface of the pressure-sensitive adhesive layer opposite to the release sheet to obtain an adhesive patch. Table 1 shows the composition (excluding toluene) of the above pressure-sensitive ...

Embodiment 2

[0102] (Example 2, Comparative Examples 1-2)

[0103] Except having made the composition of the adhesive layer composition into the composition shown in Table 1, it carried out similarly to Example 1, and obtained the patch. With regard to the patch preparations obtained in Examples 1-2 and Comparative Examples 1-2, a skin penetration test and an evaluation test of cohesiveness of the adhesive layer were performed, respectively. The results of the cohesion evaluation test of the adhesive layer are shown in Table 1 together with the composition of the adhesive layer composition in each example and comparative example, and the results of the skin penetration test are shown in Table 1. figure 2 middle.

[0104] [Table 1]

[0105]

[0106] From Table 1 and figure 2 The results shown clearly confirm that the patch of the present invention has excellent skin permeability of ropinirole, and that the cohesive force of the adhesive layer is strong, so that sufficient adhesivene...

Embodiment 3～5

[0108] The composition of the adhesive layer composition was the composition shown in Table 2, and the mass per unit area of ​​the adhesive layer was the mass shown in Table 2, respectively, and the stickers were obtained in the same manner as in Example 1. Attachment. With regard to the patches obtained in Examples 3 to 5, a skin permeation test and a cohesiveness evaluation test of the adhesive layer were respectively performed. The results of the cohesion evaluation test of the adhesive layer are shown in Table 2 together with the composition of the adhesive layer composition in each example, and the results of the skin penetration test are shown in Table 2. image 3 middle.

[0109] [Table 2]

[0110]

[0111] From Table 2 and image 3 The results shown clearly confirm that the patch of the present invention has excellent skin permeability of ropinirole, and that the cohesive force of the adhesive layer is strong, so that sufficient adhesiveness can be exhibited. In...

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PUM

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Abstract

A ropinirole-containing adhesive skin patch comprising an adhesive layer and a support layer, wherein the adhesive layer contains ropinirole and / or a pharmaceutically acceptable salt thereof, and wherein the content of ropinirole and / or the pharmaceutically acceptable salt thereof in terms of free ropinirole content in the adhesive layer fulfills the following two requirements: the content is 5-13.2 mass% relative to the total mass of the adhesive layer; and the content is 0.12-2.7 mg / cm2 per unit area of the adhesive layer.

Description

technical field [0001] The present invention relates to a patch containing ropinirole and its package. Background technique [0002] L-Dopa therapy in which dopamine is supplemented by administering levodopa (L-Dopa) known as a therapeutic preparation thereof has been known as a disease treatment for Parkinson's disease. However, L-Dopa therapy has problems in that long-term continuous administration is necessary, the effect of the drug gradually decreases with long-term continuous administration, or diurnal changes in symptoms become more pronounced. Therefore, ropinirole has been developed as a drug that solves the problems in such L-Dopa therapy. Various studies have been conducted on the formulation of pinirole and / or its pharmaceutically acceptable salts. [0003] For example, Japanese Patent Publication No. 2009-518376 (Patent Document 1) and Japanese Patent Publication No. 2007-516265 (Patent Document 2) disclose ropinirole as an external preparation that can avoid ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4045A61K9/70A61K47/10A61K47/14A61K47/16A61K47/34A61P25/14A61P25/16
CPCA61K9/7053A61K31/4045A61P25/14A61P25/16A61K9/70A61K47/10A61K47/14
Inventor 内田尚志高木祐香山口登志郎
Owner HISAMITSU PHARM CO INC
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