Rotigotine-containing percutaneous absorption type patch

A patch and transdermal technology, which is applied in the field of lining film and anti-mucosal film, can solve problems such as difficulty in ensuring drug stability, and achieve the effect of increasing skin adhesion and stability

Inactive Publication Date: 2019-09-03
COSMED PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The disadvantage of transdermal formulations containing rotigotine is that it is difficult to ensure the stability of the drug

Method used

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  • Rotigotine-containing percutaneous absorption type patch
  • Rotigotine-containing percutaneous absorption type patch
  • Rotigotine-containing percutaneous absorption type patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0071] Embodiment 1-5, and comparative example 1-9

[0072] Manufacture of transdermal patch

[0073] According to the content ratios listed in Tables 1 and 2, appropriate high-molecular-weight PIB, medium-molecular-weight PIB, alicyclic saturated hydrocarbon, liquid paraffin, etc. were mixed in cyclohexane and stirred to dissolve. Then add the ethanol solution of polyvinylpyrrolidone and / or methylpyrrolidone to the mixture, then further add the rotigotine solution obtained by mixing the tocopherol acetate and the ethyl acetate solution of rotigotine, stir and mix to obtain homogeneous solution. Use a test coater (TransCoat, manufactured by Cosmet Pharmaceutical Co., Ltd., Japan) to prepare a colloid with a drug-containing layer of 50 μm in thickness after evaporating the organic solvent, and make it on a release film (silicon resin-treated PET film, Fujimori Industrial Co., Ltd., Japan) manufacturing) spread evenly. After applying the drug-containing solution, the organic ...

Embodiment 6～10 and 11

[0116] Embodiment 6~10 and 11, comparative example 10~11

[0117] Comparative test of chemical grades of polyvinylpyrrolidone

[0118] In the following Examples 6 to 10 and Comparative Examples 10 and 11, various grades of polyvinylpyrrolidone were used, and through the aforementioned drug stability experiments, it was observed that the drug stability significantly changed depending on the chemical grade of polyvinylpyrrolidone. Measure the stability of the drug after storing the preparation at high temperature, and observe its decomposition product peak (peak E with a retention time of about 23 minutes, see figure 2 ), the area of ​​peak E measured by HPLC is divided by the peak area of ​​rotigotine (i.e. the content percentage of the decomposition product in the main drug) to measure the stability of the preparation. The analysis method is the same as the aforementioned drug stability test. When the formulation was stored under heating at 60° C. for one week, and the rati...

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Abstract

The present invention provides a novel percutaneous absorption type patch containing rotigotine. The percutaneous absorption type patch comprises a support, a drug-containing layer and a release liner, wherein the drug-containing layer contains rotigotine, a polyisobutylene based adhesive, liquid paraffin and polyvinylpyrrolidone; and the percutaneous absorption type patch, wherein said drug-containing layer further contains an acrylic adhesive.

Description

technical field [0001] The transdermal patch of the present invention relates to a backing film, a drug-containing layer containing rotigotine and an anti-adhesive film contained in the transdermal patch. Background technique [0002] Rotigotine, known as Rotigotine in English, is a dopamine receptor D3 / D2 / D1 agonist and has excellent curative effect on Parkinson's disease. Currently, pharmaceutical preparations with rotigotine as an active ingredient are already on the market. For example, Neupro (registered trademark), a transdermal patch containing rotigotine, has been approved for the treatment of Parkinson's disease by more than 70 countries including Europe, the United States, and Japan, and has obtained indication approval in more than 35 countries. Approved for idiopathic restless legs syndrome. . [0003] In addition to the above formulations, Patent Document 1 discloses a rotigotine transdermal absorption patch using an acrylate-based or silicone-based polymer a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/381A61K9/70A61K47/06A61K47/32A61P25/16
CPCA61K9/70A61K31/381A61K47/06A61K47/32A61P25/16
Inventor 权英淑熊本谕神山文男
Owner COSMED PHARMA
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