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Method for preparing oral disintegrating preparation containing solid dispersion of dextro-hydroxypiracetam

A technology of dexoxypyramide and solid dispersion, which is applied in the field of dexoxypyramide orally disintegrating preparations, and can solve the problem of reducing the pharmacological activity and pharmacological Unstable effects, increased safety risks and other issues, to achieve the effect of ensuring drug efficacy, small tablet weight differences, and moderate hardness

Inactive Publication Date: 2018-11-02
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the actual research and development process, the inventors found that the orally disintegrating preparation prepared with dexoxypyridine as the active ingredient has unstable pharmacological effects, and a large amount of dextrooxypyridamine dissolves in the stomach, and with the retention in the stomach Prolonged time, it will be decomposed in large quantities by gastric acid, and it will be difficult to be effectively absorbed by the intestinal tract, thus greatly reducing the pharmacological activity of dextrooxypyridamide orally disintegrating tablets, and at the same time increasing the safety risk

Method used

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  • Method for preparing oral disintegrating preparation containing solid dispersion of dextro-hydroxypiracetam
  • Method for preparing oral disintegrating preparation containing solid dispersion of dextro-hydroxypiracetam

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Embodiment 1

[0029]Get 20 parts of absolute ethanol, under stirring state, add 1 part of dextrooxypyridamide chemical bulk drug (provided by Chongqing Dongze Pharmaceutical Technology Co., Ltd., purity 99.5%) and 5 parts of hydroxymethylpropyl cellulose acetate Succinate (provided by Guangzhou Shuoheng Biotechnology Co., Ltd.), stirred until dissolved, and then spray-dried in a spray dryer (produced by Huawei Technology Co., Ltd.). The air outlet temperature is 79-80°C; the dried dextrooxypyridamine solid dispersion is pulverized to obtain the product.

Embodiment 2

[0032] Take 25 parts of absolute ethanol, add 1 part of oxypyridamide chemical raw material and 7 parts of hydroxymethylpropylcellulose succinate under stirring, stir until dissolved, and then spray in a spray dryer Drying, the inlet air temperature of spray drying is 155°C, and the outlet air temperature is 90°C; the dried oxypyridine solid dispersion is pulverized to obtain the product.

Embodiment 3

[0034] Take 15 parts of absolute ethanol, add 1 part of oxypyridamide chemical raw material drug and 3 parts of hydroxymethylpropylcellulose succinate under stirring state, stir until dissolved, and then spray in the spray dryer Drying, the inlet air temperature of spray drying is 128°C, and the outlet air temperature is 68°C; the dried oxypyridine solid dispersion is pulverized to obtain the product.

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Abstract

The invention provides a method for preparing an orally disintegrating preparation containing a solid dispersion of dextro-hydroxypiracetam. The oral disintegrating preparation is prepared through wetgranulation and tabletting of a solid dispersion of dextro-hydroxypiracetam as an active ingredient assisted with a carefully selected adjuvant proportioned. By controlling a series of parameters such as particle size, temperature, and charge of a material, the method provided by the invention effectively solves the problem that the material is easy to agglomerate in a wet granulation process dueto a large dosage of the dextro-hydroxypiracetam prescription, excellent water solubility and strong hygroscopicity, and most of the material is stuck on a wall of a granulation pan, resulting in uneven particles; and the prepared dextro-hydroxypiracetam particles are fine and uniform, moderate in hardness and small in sheet weight difference. The preparation method provided by the invention is simple and suitable for industrial production.

Description

technical field [0001] The invention relates to an orally disintegrating preparation of dexoxypyridine, in particular to a method for preparing an orally disintegrating preparation containing a solid dispersion of dexoxypyramide. Background technique [0002] D-oxypyridine (CAS No.: 68252-28-8) is the dextrorotary form of oxypyridine. Studies have shown that it can promote the transport of acetylcholine in the cerebral cortex and hippocampus, and increase the absorption of choline. Affinity and activity of brain phosphatase A1, it has good activity in epilepsy, especially acute epilepsy, and has the possibility of being further developed into an antiepileptic drug. At present, the preparations of dextropyridine are still in the research and development stage, and the oral preparations developed are mainly capsules and ordinary tablets. Whether it is a capsule or an ordinary tablet, the onset of action is slow and the bioavailability is low; at the same time, for patients wi...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K31/4015A61P25/08
CPCA61K9/2054A61K9/0002A61K9/0056A61K9/2059A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD