Amisulpride transdermal patch

An amisulpride and transdermal patch technology, applied in the field of transdermal patches, can solve problems such as unfavorable and flexible dosage adjustment, and achieve the effects of reducing gastrointestinal irritation, meeting drug needs, and avoiding first-pass effect

Pending Publication Date: 2021-04-30
安徽京茗药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing specifications of amisulpride tablets are 200mg and 50mg. Tablets with fixed specifications are not conducive to flexible adjustment of dosage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Amisulpride 3%

[0015] The total consumption of penetration enhancer is 4%, and the weight ratio of propylene glycol, oleic acid and menthol is 10:1:0.1; the hot-melt pressure-sensitive adhesive matrix of the remainder,

[0016] The preparation method is as follows

[0017] 1) Mix propylene glycol, oleic acid and menthol, add the prescribed amount of amisulpride, and stir until dissolved.

[0018] 2) Add the solution of step 1) into the hot-melt pressure-sensitive adhesive matrix, stir evenly, apply on the anti-adhesive layer, dry at 65-85°C, compound with the backing layer, and cut into patches to obtain the product.

Embodiment 2

[0020] Amisulpride 4%

[0021] The total consumption of penetration enhancer is 5%, and the weight ratio of propylene glycol, oleic acid and menthol is 10:3:0.2; the hot-melt pressure-sensitive adhesive matrix of the remainder,

[0022] The preparation method is as follows

[0023] 1) Mix propylene glycol, oleic acid and menthol, add the prescribed amount of amisulpride, and stir until dissolved.

[0024] 2) Add the solution of step 1) into the hot-melt pressure-sensitive adhesive matrix, stir evenly, apply on the anti-adhesive layer, dry at 65-85°C, compound with the backing layer, and cut into patches to obtain the product.

Embodiment 3

[0026] Amisulpride 5%

[0027] The total consumption of penetration enhancer is 6%, and the weight ratio of propylene glycol, oleic acid and menthol is 10:1.5:0.1; the hot-melt pressure-sensitive adhesive matrix of the remainder,

[0028] The preparation method is as follows

[0029] 1) Mix propylene glycol, oleic acid and menthol, add the prescribed amount of amisulpride, and stir until dissolved.

[0030] 2) Add the solution of step 1) into the hot-melt pressure-sensitive adhesive matrix, stir evenly, apply on the anti-adhesive layer, dry at 65-85°C, compound with the backing layer, and cut into patches to obtain the product.

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Abstract

The amisulpride transdermal patch comprises a medicine carrying layer, a backing layer and an anti-sticking layer, and the medicine carrying layer is composed of amisulpride, a penetration enhancer and a pressure-sensitive adhesive matrix. The weight percentage content of amisulpride in the medicine carrying layer is 3%-5%. The weight percentage content of the penetration enhancer in the medicine carrying layer is 4-6%, and the penetration enhancer is propylene glycol, oleic acid and menthol in a weight ratio of 10: (1-3): (0.1-0.2). The pressure-sensitive adhesive matrix is a hot-melt pressure-sensitive adhesive matrix.

Description

technical field [0001] The invention relates to a transdermal drug delivery preparation, in particular to a transdermal patch with amisulpride as an active ingredient. Background technique [0002] Amisulpride (4-amino-N-[(1-ethyl-2-pyrrolidine)methyl]-5-ethylsulfonyl-2-methoxybenzamide, CAS: 71675-85-9 ) is an antipsychotic drug, which is mainly used clinically to treat schizophrenia. When amisulpride tablets are used for treatment, the dose must be adjusted to the minimum effective dose according to the patient's response. The existing specifications of amisulpride tablets are 200 mg and 50 mg, and tablets with fixed specifications are not conducive to flexible adjustment of dosage. Transdermal patch, as a percutaneous absorption preparation, can be administered through skin application. The active ingredient is absorbed through the skin and enters the blood circulation of the whole body, which can prolong the action time, reduce the frequency of medication, facilitate m...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/40A61K47/10A61K47/12A61P25/18
CPCA61K9/7038A61K31/40A61K47/10A61K47/12A61P25/18
Inventor 杨红伟李斐菲姚永波
Owner 安徽京茗药业有限公司
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