L-oxiracetam membrane and preparation method thereof

One kind of film and another kind of technology, applied in the field of oxiracetam, can solve the problems of complex development and production process, coalescence of solid particles, self-administration by patients, etc.

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, ina

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] The preparation of levoxiracetam film, adopts the following steps:

[0087] 1) Dissolve 60g of film-forming material (combination of maltodextrin and hydroxypropyl cellulose, wherein the dosage of hydroxypropyl cellulose is 30g) with 80mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0088]2) Disperse 15g of glycerin, 15g of microcrystalline cellulose and 2g of xylitol with 50mL of absolute ethanol to form a dispersion;

[0089] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 8g of levoxiracetam to disperse evenly, then let it stand to remove air bubbles;

[0090] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 60cm / min, then dry at 75-77°C, and peel off.

Embodiment 2

[0092] The preparation of levoxiracetam film, adopts the following steps:

[0093] 1) Dissolve 45g of film-forming material (combination of maltodextrin and hydroxypropyl cellulose, wherein the dosage of hydroxypropyl cellulose is 10g) with 50mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0094] 2) Disperse 15g of propylene glycol, 20g of low-substituted hydroxypropyl cellulose and 2g of acesulfame K with 60mL of absolute ethanol to form a dispersion;

[0095] 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;

[0096] 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

[0098] The preparation of levoxiracetam film, adopts the following steps:

[0099] 1) Dissolve 50g of film-forming material (combination of maltodextrin and hydroxypropyl cellulose, wherein the dosage of hydroxypropyl cellulose is 20g) with 50mL of absolute ethanol, and remove air bubbles to obtain a uniform viscous liquid;

[0100] 2) Disperse 15g of triethyl citrate, 19g of microcrystalline cellulose and 1g of aspartame with 40mL of absolute ethanol to form a dispersion;

[0101] 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;

[0102] 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 83-85°C, and peel off.

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Abstract

The invention relates to an L-oxiracetam membrane, which is prepared by adopting a composite membrane-forming material, a plasticizer, a filler and a corrigent. The L-oxiracetam membrane disclosed by the invention can be dissolved by a small amount of saliva in the oral cavity, and can be taken without water, so administration is convenient. After being stuck to the tongue, the L-oxiracetam membrane cannot be easily spit out, and therefore is suitable for patients with dysphagia. Furthermore, because the L-oxiracetam membrane can be absorbed through the mucous membrane, the first pass elimination effect is prevented, the bioavailability is increased, the dosage of medication is reduced, and thereby the side effect of the medicine is reduced. A preparation process of the invention is simple, and therefore is suitable for industrialized production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to a levo-oxiracetam 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. Its structure is as follows: [0003] [0004] Since it was put on the market, due to its good effect, high safety, wide range of indications, few drug interactions and low toxicity, it has been the leading product in the treatment of dementia drugs, with injections, capsules, tablets and other dosage forms successively Development and listing. [0005] CN104069074A discloses a freeze-dried preparation of oxiracetam for injection, which is obtained by first forming an aqueous solution of oxiracetam wit...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/36A61K47/38A61K47/32A61P25/28
CPCA61K9/006A61K9/007A61K31/4015A61K47/32A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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