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Rotigotine transdermal absorption patch

A rotigotine, transdermal technology, applied in the directions of drug combination, nervous system diseases, organic active ingredients, etc., can solve the problem that rotigotine is prone to crystallization, the release degree of rotigotine is reduced, and the Transdermal absorption patch is unstable and other problems, to achieve the effect of not easy to fall off, increase adhesion, and ensure quality

Pending Publication Date: 2022-07-05
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a rotigotine transdermal absorption patch, which aims to overcome the instability of the rotigotine transdermal absorption patch during storage, the problem that rotigotine is prone to crystallization, and the rotigotine transdermal absorption patch. The problem of reduced release

Method used

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  • Rotigotine transdermal absorption patch
  • Rotigotine transdermal absorption patch
  • Rotigotine transdermal absorption patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] composition Dosage (g) rotigotine 9 Silicone pressure sensitive adhesive 4301 65 Silicone pressure sensitive adhesive 4201 43 Lauryl Lactate 3 Povidone 4 ascorbyl palmitate 0.02 Tocopherol 0.05 Sodium metabisulfite 0.0006

[0030] Preparation:

[0031] (1) dissolving sodium metabisulfite in purified water to obtain 10% sodium metabisulfite solution; dissolving 10% sodium metabisulfite solution, ascorbyl palmitate, tocopherol, povidone and lauryl lactate in ethanol to obtain an auxiliary material solution, spare;

[0032] (2) adding rotigotine to the auxiliary material solution obtained in step (1), stirring and dissolving completely, and then stirring with silicone pressure-sensitive adhesive 4301 and silicone pressure-sensitive adhesive 4201 to obtain a drug-containing colloidal solution;

[0033] (3) Coating the drug-containing colloid solution obtained in step (2) with a coating machine, and cutting to o...

Embodiment 2

[0035]

[0036]

[0037] Preparation:

[0038] (1) ascorbic acid, butylated hydroxytoluene, propyl gallate, povidone and 1-dodecyl-azazol-2-one are dissolved in ethanol to obtain auxiliary material solution, for subsequent use;

[0039] (2) heating the auxiliary material solution obtained in step (1), adding rotigotine when the temperature is 30-40 ℃, heating up to 50-60 ℃, adding silicone pressure-sensitive adhesive 4301 and silicone pressure-sensitive adhesive 4201, The rotation speed is 40-100RPM for uniform stirring, and then the rotation speed is 1500-3000RPM for uniform stirring to obtain a drug-containing colloid solution;

[0040] (3) Coating the drug-containing colloid solution obtained in step (2) with a coating machine, and cutting to obtain it.

Embodiment 3

[0042] composition Dosage (g) rotigotine 10 Silicone pressure sensitive adhesive 4301 46 Silicone pressure sensitive adhesive 4201 34 Lauryl Lactate 2 Menthol heptyl ester 2 Povidone 5.5 Butyl Hydroxyanisole 0.35 Vitamin E 0.15

[0043] Preparation:

[0044] (1) butylated hydroxyanisole, vitamin E, povidone, lauryl lactate and menthol heptyl ester are dissolved in ethanol to obtain auxiliary material solution, for subsequent use;

[0045](2) heating the auxiliary material solution obtained in step (1), adding rotigotine when the temperature is 30-40 ℃, heating up to 50-60 ℃, adding silicone pressure-sensitive adhesive 4301 and silicone pressure-sensitive adhesive 4201, The rotation speed is 40-100RPM for uniform stirring, and then the rotation speed is 1500-3000RPM for uniform stirring to obtain a drug-containing colloid solution;

[0046] (3) Coating the drug-containing colloid solution obtained in step (2) with ...

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Abstract

The invention provides a rotigotine transdermal absorption patch which comprises a backing layer, a drug-containing matrix layer and an anti-sticking layer, the drug-containing matrix layer comprises rotigotine, a silicone pressure-sensitive adhesive, an antioxidant, povidone and a penetration enhancer, and the penetration enhancer is one or more of 1-dodecyl-azazole-2-ketone, lauryl lactate and menthol heptyl ester. According to the present invention, the obtained rotigotine transdermal absorption patch has good stability, such that the rotigotine is not easily devitrified during the storage and use process, the high release rate of the rotigotine is ensured, and the drug quality and the drug treatment effect are ensured.

Description

technical field [0001] The invention relates to a transdermal drug delivery system, in particular to a rotigotine transdermal absorption patch and a preparation method of the patch. Background technique [0002] The chemical name for rotigotine is (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]-amino]-1-naphthanol, The specific structure is as follows: [0003] [0004] Rotigotine is a dopamine receptor agonist used to treat Parkinson's disease. Clinical studies have shown that rotigotine cannot be simply administered orally after being orally administered into the body due to the inactivation of the liver's first-pass effect. If administered by ordinary injection, as a long-term treatment drug, one or more daily injections will obviously increase the pain and discomfort of patients, and there is evidence that pulsatile administration can cause clinical manifestations of "dyskinesis". Dyskinesias are characterized by periods of "on" (dyskinesia) alternating with ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/381A61K47/14A61K47/22A61K47/32A61K47/34A61P25/16
CPCA61K9/7069A61K9/7076A61K31/381A61K47/34A61K47/32A61K47/14A61K47/22A61P25/16
Inventor 高健龙刘营营产运霞耿玉先
Owner BEIJING WINSUNNY PHARMA CO LTD
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