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A kind of pramipexole weekly effect transdermal patch and preparation method thereof

A technology of pramipexole and transdermal patch, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of poor fat solubility and poor penetration through the skin

Active Publication Date: 2021-04-27
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the raw material drug used to make the patch is water-soluble pramipexole hydrochloride, which has poor fat solubility and poor skin penetration ability, and can only maintain an effective dose for three days

Method used

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  • A kind of pramipexole weekly effect transdermal patch and preparation method thereof
  • A kind of pramipexole weekly effect transdermal patch and preparation method thereof
  • A kind of pramipexole weekly effect transdermal patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1.5 g of polyvinyl alcohol (PVA17-88), 0.3 g of polyvinylpyrrolidone (PVP), 0.2 g of propylene glycol, 0.2 g of glycerin, 0.1 g of disodium edetate, and 40 mg of pramipexole were used to prepare pramipexole patches.

[0043] Polyvinyl alcohol (PVA17-88) 1.5g, polyvinylpyrrolidone (PVP) 0.3g, propylene glycol 0.2g, glycerin 0.2g, edetate disodium 0.1g, pramipexole hydrochloride 40mg, prepare pramipexole hydrochloride paste piece.

[0044] Preparation method: fully swell polyvinyl alcohol and polyvinylpyrrolidone with 60% ethanol, add propylene glycol and glycerin, stir magnetically in a water bath at 70°C to fully dissolve and mix, add the drug solution when the temperature drops to 40°C, mix well, and let stand Until the air bubbles disappear, the film is laid by casting method, dried, formed and cooled, then compounded, covered with polyethylene-aluminum-polyethylene composite film and polyethylene anti-adhesive layer, and prepared in divided doses to contain pramipexo...

Embodiment 2

[0047] Polyvinyl alcohol (PVA17-88) 1.6g, polyvinylpyrrolidone (PVP) 0.4g, eucalyptus oil 0.2g, glycerol 0.1g, edetate disodium 0.1g, pramipexole 100mg, prepare pramipexole paste agent.

[0048] Preparation method: fully swell polyvinyl alcohol and polyvinylpyrrolidone with 60% ethanol, add glycerin and penetration enhancer, stir magnetically in a water bath at 70°C to fully dissolve and mix, add the drug solution when the temperature drops to 40°C, and mix evenly. Let it stand until the bubbles disappear, lay the film by casting method, dry and form it and then compound after cooling, cover the polyethylene-aluminum-polyethylene composite film and polyethylene anti-adhesive layer, and divide the dose to prepare pramipexole containing 10.0mg / cm 2 patch.

[0049] A modified Franz diffusion cell was used to measure the permeability of the transdermal patch on the inner skin of the rabbit ear, and the area of ​​the patch used in the transdermal diffusion experiment was 2.92cm 2...

Embodiment 3

[0051] The composition of the first layer (close to the release layer): 2.8g polyvinyl alcohol (PVA17-88), 0.4g polyvinylpyrrolidone (PVP), 0.3g eucalyptus oil, 0.2g propylene glycol, 0.3g glycerin, ethylene glycol Disodium amine tetraacetate 0.2g, pramipexole free base 40mg.

[0052] The composition of the second layer (close to the backing layer): polyvinyl alcohol (PVA17-88) 1.6g, polyvinylpyrrolidone (PVP) 0.5g, eucalyptus oil 0.4g, propylene glycol 0.1g, glycerin 0.2g, ethylenediaminetetra Disodium acetate 0.1g, pramipexole free base 120mg.

[0053] Preparation method: fully swell polyvinyl alcohol and polyvinylpyrrolidone with 60% ethanol, add propylene glycol and glycerin, and magnetically stir in a water bath at 70°C to fully dissolve and mix. When the temperature drops to 40°C, add the drug and penetration enhancer solution, and mix well After that, let it stand until the air bubbles disappear, lay the film by casting method, dry and form it and then compound after c...

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Abstract

The invention specifically relates to a pramipexole weekly transdermal patch and a preparation method thereof, belonging to the field of pharmaceutical preparations. The pramipexole weekly transdermal patch comprises three parts: a drug reservoir, an anti-adhesive layer and a backing layer. The invention adopts the hydrophilic substrate mixed penetration enhancer and the lamination pouring method to prepare the double-layer patch, which effectively solves the problem in the preparation of the multi-layer film, and can ensure the constant-speed release of the drug within seven days. Animal experiments show that it is non-irritating and sensitizing to the skin. The patch of the invention has the advantages of clear curative effect, stable quality, good safety and convenient use, and is used for the treatment of Parkinson's disease.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pramipexole weekly transdermal patch and a preparation method thereof. In particular it relates to pramipexole transdermal patches capable of sustained release of the active ingredient pramipexole over a longer period of time, preferably seven days. [0002] technical background [0003] Pramipexole, whose chemical name is (S)-2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole, the active ingredient is chemically a base, and the dosage form currently used clinically Pramipexole Hydrochloride Immediate Release Tablets and pramipexole hydrochloride extended-release tablets Both are in the form of their hydrochloride salts. Pramipexole is a new generation of non-ergot alkaloid selective dopamine D2 and D3 receptor agonists approved by FDA in 1997 for the treatment of primary Parkinson's disease (PD). Pramipexole, as the first-line drug recommended by current PD d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/428A61K47/34A61K47/32A61P25/16
Inventor 刘建平宋文婷李莹陈彤
Owner CHINA PHARM UNIV
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