Method for preparing dextrorotatory oxiracetam oral fast dissolving films by hot-melt extrusion

A technology of dextropiridamide and oral instant film, which is applied in the field of preparation of dexoxypyramide oral instant film by hot-melt extrusion, can solve the problem of difficult control of disintegration time and tensile strength, Restrict the development and application of oral instant film, low drug loading, etc., to achieve the effect of improving bioavailability, avoiding elimination effect, and simple preparation method

Inactive Publication Date: 2018-11-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the oral instant film has many advantages, the limitations of its film-forming materials and preparation technology lead to low drug

Method used

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  • Method for preparing dextrorotatory oxiracetam oral fast dissolving films by hot-melt extrusion
  • Method for preparing dextrorotatory oxiracetam oral fast dissolving films by hot-melt extrusion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Mix 39 parts of dextropyridine, 8 parts of acrylate, 32 parts of pullulan, 10 parts of glycerol triacetate, 10 parts of pregelatinized starch, and 1 part of fructose. The feeding area of ​​the film machine is sent to the hot melting area, where it is melted at 81-83 ° C, and the molten mixture is continuously output through the metering area, poured into the mold, and forms a film after cooling.

Embodiment 2

[0030]Mix 25 parts of dextropyridine, 18 parts of acrylate, 36 parts of pullulan, 10 parts of glycerol triacetate, 10 parts of low-substituted hydroxypropyl cellulose, and 1 part of xylitol, and mix well , sent to the hot-melt zone through the feeding zone of the hot-melt film laminator, hot-melted at 70-72°C, the molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

Embodiment 3

[0032] Mix 55 parts of D-hydroxypyridine, 10 parts of acrylate, 20 parts of pullulan, 7 parts of triethyl citrate, 7 parts of low-substituted hydroxypropyl cellulose, and 1 part of aspartame, After mixing evenly, it is sent to the hot-melt zone through the feed zone of the hot-melt film laminator, and melted at 95-98°C. The molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

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Abstract

The invention provides a method for preparing dextrorotatory oxiracetam oral fast dissolving films by hot-melt extrusion. Dextrorotatory oxiracetam, a film-forming material, a plasticizer and a filling agent are evenly mixed to obtain a mixture, the mixture is added into a hot-melt film laminator, conveyed from a feeding area of the hot-melt film laminator to a hot melting area and then melted gradually and evenly, the melted mixture is discharged through a dosing area continuously and poured into dies, and the films are obtained after the melted mixture in the dies are cooled. The dextrorotatory oxiracetam oral fast dissolving films prepared by the method is moderate in thickness, good in mechanical property and short in disintegration time. The method for preparing the dextrorotatory oxiracetam oral fast dissolving films by hot-melt extrusion is simple and applicable to industrial production.

Description

technical field [0001] The invention relates to a preparation method of dextrooxypyridine oral instant film, in particular to a method for preparing dextrooxypyridine oral instant film by hot-melt extrusion. Background technique [0002] Oxiracetam, whose chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, is a nootropic drug synthesized for the first time in 1974 by the Italian Skelebechem Company. Hydroxyaminobutyric acid (GABOB) derivatives are central nervous system drugs that can promote learning, enhance memory, and protect damaged nerve cells. CN102552125A discloses that it can improve the memory and learning function of patients with mental retardation; it is also suitable for memory and mental retardation caused by mild to moderate vascular dementia, senile dementia and traumatic brain injury or as an auxiliary therapeutic drug. Studies have shown that the dextrorotatory form of oxypyramide (dextroroxypyramide) is less effective in treating cognitive dysfuncti...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/14A61K47/36A61K47/10A61K47/38A61P25/08
CPCA61K9/006A61K9/7007A61K31/4015A61K47/10A61K47/14A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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