Oxiracetam oral quick-dissolving membrane preparation and preparation method thereof

An oral instant film and filler technology, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Not suitable for mass production and other issues

Inactive Publication Date: 2017-06-13
CHONGQING RUNZE PHARM CO LTD
View PDF10 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Oxiracetam oral quick-dissolving membrane preparation and preparation method thereof
  • Oxiracetam oral quick-dissolving membrane preparation and preparation method thereof
  • Oxiracetam oral quick-dissolving membrane preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0096] 2) Disperse 15g of propylene glycol, 20g of microcrystalline cellulose, 4g of citric acid and 2g of sorbitol 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 oxiracetam 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 Oxiracetam oral instant film, adopts the following steps:

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

[0102] 2) Disperse 20g of glycerin, 20g of low-substituted hydroxypropyl cellulose, 2g of malic acid and 1g of xylitol 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 oxiracetam to disperse evenly, and 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 Oxiracetam oral instant film, adopts the following steps:

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

[0108] 2) Disperse 15g of triethyl citrate, 20g of microcrystalline cellulose, 3g of ascorbic acid and 1g of sorbitol 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 oxiracetam 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.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

An oxiracetam oral film prepared by oxiracetam, a film-forming material, a filler, a plasticizer, a saliva stimulating agent and a flavoring agent, the prepared oxiracetam oral instant film, which is in It can be dissolved in a small amount of saliva in the mouth, and can be used without water, which is convenient for medication; and it is not easy to spit out after sticking to the tongue, which is suitable for patients with dysphagia, and it is absorbed through the mucosa, avoiding the first-pass elimination effect and improving The bioavailability is improved, the medicinal dosage is reduced, thereby reducing the side effects of the drug. The preparation method of the invention is simple to operate, does not need large-scale industrial equipment, and is suitable for industrial production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to an oxiracetam oral instant 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 oxira...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K9/70A61K31/4015A61K47/32A61K47/38A61K47/36A61P25/28
CPCA61K9/006A61K9/0056A61K9/7007A61K31/4015A61K47/32A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap