Dextrorotatory oxiracetam soluble oral membrane and preparation method thereof

A technology of oral instant film and co-solvent, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, nervous system diseases, etc., and can solve the problems of low drug loading, difficult control of disintegration time and tensile strength, and constraints Problems such as the development and application of oral instant film, to achieve the effect of simple preparation method, improved bioavailability, and avoiding elimination effect

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 loading, disintegration time and tensile strength are not easy to control, which restricts the development and application of oral instant film

Method used

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  • Dextrorotatory oxiracetam soluble oral membrane and preparation method thereof
  • Dextrorotatory oxiracetam soluble oral membrane and preparation method thereof
  • Dextrorotatory oxiracetam soluble oral membrane and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Mix 48 parts of dexoxiracetam, 30 parts of maltodextrin, 10 parts of ethyl cellulose, 2 parts of propylene glycol, 6 parts of dibutyl phthalate, 3 parts of citric acid, and 1 part of fructose, and mix well , sent to the hot-melt zone through the feed zone of the hot-melt film laminator, hot-melted at 80-85°C, the molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

Embodiment 2

[0039] Mix 40 parts of dexoxiracetam, 24 parts of maltodextrin, 16 parts of polyoxyethylene, 8 parts of pectin, 6 parts of glycerin, 3 parts of triethyl citrate, 2 parts of malic acid, and 1 part of sucrose Finally, it is sent to the hot-melt zone through the feeding zone of the hot-melt film laminator, and is melted at 85-90°C. The molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

Embodiment 3

[0041] Mix 55 parts of dexoxiracetam, 25 parts of maltodextrin, 5 parts of ethyl cellulose, 4 parts of propylene glycol, 4 parts of dibutyl phthalate, 5 parts of lactic acid, 2 parts of aspartame, mix After uniformity, it is sent to the hot-melt zone through the feeding zone of the hot-melt film laminator, and is 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 dextrorotatory oxiracetam soluble oral membrane which is prepared from dextrorotatory oxiracetam, membrane forming materials, a plasticizer and a cosolvent. As the preparationprocess is performed without presence of water or organic solvents, the problems about air bubbles caused by presence of solvents and high moisture content of the membrane are avoided, and homogeneity of the dextrorotatory oxiracetam soluble oral membrane is guaranteed effectively. Besides, the technical problems that conventional membranes are easy to break, poor in strength and toughness, slowin disintegration, long in dissolving, poor in drug absorption effect and the like are solved effectively; the dextrorotatory oxiracetam soluble oral membrane prepared by the method has good strippingperformance, is soft, not easy to break and quick to dissolve. The preparation method is simple and suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition of Dexoxiracetam, in particular to a Dexoxiracetam oral fast-dissolving film and a preparation method thereof. Background technique [0002] Oxiracetam, chemically named 4-hydroxy-2-oxo-1-pyrrolidineacetamide, is a nootropic drug synthesized for the first time in 1974 by the Italian Shi Kebichem company. Aminobutyric 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 oxiracetam (dexoxiracetam) is less effective in treating cognitive dysfunction and improving learning and memory; ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4015A61K47/38A61K47/36A61K47/32A61K47/10A61K47/14A61K47/26A61K47/22A61P25/28
CPCA61K31/4015A61K9/006A61K9/7007A61K47/10A61K47/14A61K47/22A61K47/26A61K47/32A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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