L-oxiracetam oral instant membrane and preparation method thereof

An oral fast-dissolving film agent and another technology are applied in the field of levo-oxiracetam, which can solve the problems of low drug loading, complicated development and production processes, and large solid particle agglomeration.

Inactive Publication Date: 2017-06-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This type of preparation is directly injected into tissues or blood vessels, and there is no absorption process or the absorption process is very short, so the blood concentration can quickly reach the peak to play a role; Most require higher equipment conditions, and the drugs in the injection are generally dispersed in water as micron-sized solid particles in the molecular state, with a large degree of dispersion, and high-temperature sterilization often results in drug hydrolysis, oxidation, and solid particle coalescence Stability issues such as large size
At the same time, because the injection directly and quickly enters the human body without the protection of the normal physiological barrier of the human body, if the dosage is improper or the injection is too fast, or there is a problem with the quality of the drug, it may bring harm to the patient, or even cause irreparable consequences.
In addition, injection pain, inability to administer drugs by the patient, local induration o...

Method used

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  • L-oxiracetam oral instant membrane and preparation method thereof
  • L-oxiracetam oral instant membrane and preparation method thereof
  • L-oxiracetam oral instant membrane and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] The preparation of levoxiracetam oral instant film, adopts the following steps:

[0095] 1) Dissolve 60g of film-forming material (combination of PVA and hydroxypropylmethylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 30g) with 80mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0096] 2) Disperse 15g of propylene glycol, 15g of microcrystalline cellulose and 5g of aspartame with 50mL of absolute ethanol to form a dispersion;

[0097] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 5g of levoxiracetam to disperse evenly, and then let it stand to remove air bubbles;

[0098] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 50cm / min, then dry at 65-68°C, and peel off.

Embodiment 2

[0100] The preparation of levoxiracetam oral instant film, adopts the following steps:

[0101] 1) Dissolve 40g of film-forming material (combination of PVA and hydroxypropylmethylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 10g) with 50mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0102] 2) Disperse 20g of glycerin, 20g of low-substituted hydroxypropyl cellulose and 2g of sucralose with 60mL of absolute ethanol to form a dispersion;

[0103] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 18g of levoxiracetam to disperse evenly, then let it stand to remove air bubbles;

[0104] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 80cm / min, then dry at 70-72°C, and peel off.

Embodiment 3

[0106] The preparation of levoxiracetam oral instant film, adopts the following steps:

[0107] 1) Dissolve 49g of film-forming material (combination of PVA and hydroxypropylmethylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 20g) with 50mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0108] 2) Disperse 15g of triethyl citrate, 20g of microcrystalline cellulose and 1g of xylitol with 40mL of absolute ethanol to form a dispersion;

[0109] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 15g of levoxiracetam to disperse evenly, then let it stand to remove air bubbles;

[0110] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 70cm / min, then dry at 80-85°C, and peel off.

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PUM

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Abstract

The invention relates to an L-oxiracetam oral instant membrane, which is prepared by adopting materials, such as a composite membrane-forming material, a plasticizer and a filter. By means of the combination of the specific composite membrane-forming material, the plasticizer and the filler, the invention uses a membrane coating machine to prepare the L-oxiracetam oral instant membrane, and strictly controls the thickness of the oral instant membrane, coating speed and drying temperature, thus stabilizing the process and ensuring the quality of the product, and thereby the brittleness, disintegration time, solution time and other aspects of the L-oxiracetam oral instant membrane are more favorable for clinical application. A preparation method of the invention is simple, and therefore is suitable for industrialized production.

Description

technical field [0001] The invention relates to levo-oxiracetam, in particular to a levo-oxiracetam oral instant film and a preparation method thereof. Background technique [0002] Oxiracetam (Oxiracetam) is a new generation of brain metabolism improving drugs, pyrrolidone (cyclic GABOB) derivatives, piracetam analogs, can promote the synthesis of phosphorylcholine and o-acethanolamine, promote brain metabolism, through the blood brain Barrier has a stimulating effect on specific central nervous pathways, improving intelligence and memory. It has a good curative effect on cerebrovascular disease, brain injury, brain tumor (postoperative), intracranial infection, dementia, and brain degenerative diseases. It is suitable for memory and intellectual impairment caused by mild to moderate vascular dementia, senile dementia and traumatic brain injury. Oxiracetam was synthesized for the first time in 1974 by the Italian Skeleton Bichem Company and launched in 1987. It has better...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/32A61K47/38A61K47/36A61P25/28
CPCA61K9/0056A61K9/006A61K9/7007A61K31/4015A61K47/32A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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