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A transdermal patch containing pramipexole

A transdermal patch and pramipexole technology, which is applied in the field of medicine, can solve the problems of difficult control of the preparation process, complicated preparation process of the reservoir type transdermal patch, etc., achieves improved uniformity, is beneficial to dissolution and release, The effect of good solubility

Active Publication Date: 2015-10-28
GUANGDONG HONGSHANHU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The system can continuously release an effective dose of pramipexole until 4-7 days, and 40% of the pramipexole in the reservoir layer exists in the form of dispersion or crystallization. The preparation process of the reservoir type transdermal patch is complex, Preparation process control is relatively difficult

Method used

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  • A transdermal patch containing pramipexole
  • A transdermal patch containing pramipexole
  • A transdermal patch containing pramipexole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prepare the pramipexole transdermal patch according to the following prescription, conduct the transdermal test, and obtain the cumulative transdermal amount in 24 hours.

[0039]

Embodiment 2

[0041] The pramipexole transdermal patch was prepared by using pressure-sensitive adhesives containing different groups, placed in an accelerated test box (40°C, 75%RH), and the crystallization of the drug was observed under a microscope to investigate the solubility of pramipexole in the pressure-sensitive adhesive .

[0042]

[0043]

[0044] "—": no crystallization (the same below); "√": crystallization (the same below).

Embodiment 3

[0046] Dissolving pramipexole transdermal patches (containing 3%wt pramipexole) were prepared, and the stability of pramipexole in pressure-sensitive adhesives was investigated under accelerated conditions (40°C, 75%RH).

[0047]

[0048] "N.D.": Not detected (same below).

[0049] Comprehensive embodiment 1~3 result can be found:

[0050] 1. Pramipexole has higher percutaneous permeability in pressure-sensitive adhesives containing hydroxyl groups;

[0051] 2. Pramipexole has high solubility and stability in pressure-sensitive adhesives containing carboxyl functional groups;

[0052] Based on the advantages of carboxyl group-containing pressure-sensitive adhesives over pramipexole in terms of solubility and stability, and the advantages of hydroxyl-group-containing pressure-sensitive adhesives in drug release and transdermal properties, the two types of pressure-sensitive adhesives were used in different ways. Proportions were mixed, and the percutaneous permeability, so...

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Abstract

The invention discloses a transdermal patch containing pramipexole. The transdermal patch comprises a medicine carrying pressure-sensitive adhesive layer, the pramipexole, solvent and penetration enhancer, wherein the medicine carrying pressure-sensitive adhesive layer comprises acrylate pressure-sensitive adhesive containing carboxyl base groups and acrylate pressure-sensitive adhesive containing hydroxyl base groups, which form mixed pressure-sensitive adhesive; the pramipexole is dissolved in the acrylate mixed pressure-sensitive adhesive, with the content being 10 to 30 weight percent; the content of the mixed pressure-sensitive adhesive is 50 to 80 weight percent; the content of the solvent is 5 to 20 weight percent; the content of the penetration enhancer is 2 to 15 weight percent. The pramipexole can be dissolved in a mixed pressure-sensitive adhesive patch in a high concentration way and is not crystallized, the medicine availability is high, the pramipexole has good stability in pressure-sensitive adhesive matrix, and can be continuously administrated for 5 to 7 days in a transdermal way at a relatively stable permeation rate of being larger than 5.0 micrograms / cm2 / h, and the application area of a pramipexole patch is smaller than 40cm2.

Description

technical field [0001] The invention relates to the field of medical technology, and in particular provides a transdermal drug delivery system for dopamine receptor agonist pramipexole, specifically a pramipexole transdermal patch. Background technique [0002] Parkinson's disease (PD) is a neurological disease common in middle-aged and elderly people, and it is the second most common neurodegenerative disease after Alzheimer's disease. Its pathological feature is the degeneration and death of dopaminergic neurons in the nigrostriatal system of the midbrain, resulting in the reduction of dopamine neurotransmitters in the brain, and clinical manifestations such as resting tremor, muscle stiffness, and slow movement. Therefore, its symptomatic treatment is currently mainly using dopamine receptor agonists, such as levodopa, pramipexole, rotivatin, ropinirole, etc., [0003] Pramipexole, chemical name: (S)-2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole; chemical structu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/428A61K47/32A61P25/16
Inventor 汪晴蒲婷婷李晓晖
Owner GUANGDONG HONGSHANHU PHARM CO LTD
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