Levo oxiracetam oral cavity dispersing film preparation, and preparation method thereof

A technology for dispersing film and oral cavity, which is applied in the field of levoracetam orodispersible film and its preparation, which can solve the difficulty of controlling disintegration time and tensile strength, which restricts the development and application of orodispersible film, liposome Complicated preparation process and other issues to achieve the effect of improving bioavailability, avoiding elimination effect, and uniform and complete appearance

Inactive Publication Date: 2017-06-16
CHONGQING RUNZE PHARM CO LTD
View PDF7 Cites 1 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, inability to administer drugs by the patient, local induration of inje

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
  • Levo oxiracetam oral cavity dispersing film preparation, and preparation method thereof
  • Levo oxiracetam oral cavity dispersing film preparation, and preparation method thereof
  • Levo oxiracetam oral cavity dispersing film preparation, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Mix 8 parts of levoxiracetam, 93 parts of hydroxypropylmethylcellulose, 8 parts of triethyl citrate, 5 parts of citric acid, and 2 parts of fructose, grind them thoroughly, mix them evenly, and pass them through a hot-melt laminating machine The feed zone of the feeder is sent to the hot melting zone, where it is melted at 80-85°C, and the molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

Embodiment 2

[0049] Mix 10 parts of levoxiracetam, 94 parts of hydroxypropylmethylcellulose, 8 parts of triethyl citrate, 5 parts of malic acid, and 3 parts of glucose, thoroughly grind and mix evenly, and pass through a hot-melt laminating machine The feeding zone of the feed zone is sent to the hot melting zone, where it is melted at 85-90°C, and the molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

[0050] The hot-melt lamination process can be carried out with reference to the following documents: Repka MA, Battu SK, Upadhye SB, etal. Pharmaceutical applications of hot-melt extrusion: part II [J]. Drug DevIndPharm, 2007, 33 (10): 1043-1057.

Embodiment 3

[0052] Mix 12 parts of levoxiracetam, 95 parts of polyoxyethylene, 8 parts of propylene glycol, 4 parts of saliva stimulant, and 3 parts of xylitol. Go to the hot-melt zone, heat-melt at 85-90°C, and the molten mixture is continuously output through the metering zone, poured into the mold, and forms a film after cooling.

[0053] With reference to Examples 1-3, the following examples are prepared: (amounts in the following table are parts by weight)

[0054]

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

The invention discloses a levo oxiracetam oral cavity dispersing film preparation. The levo oxiracetam oral cavity dispersing film preparation comprises 1 to 15 parts of levo oxiracetam, 85 to 95 parts of a film forming material, 5 to 10 parts of a plasticizer, and 2 to 5 parts of a saliva irritant. According to the preparation method, the above raw materials are subjected to full grinding and uniform mixing, and are delivered into a hot-melt lamination machine for extrusion so as to obtain a finished product. The appearance of the obtained levo oxiracetam oral cavity dispersing film preparation is complete, color is uniform, thickness is uniform, physical and chemical properties are stable, in oral cavity, the levo oxiracetam oral cavity dispersing film preparation can be dissolved with a small amount of saliva, taking of the levo oxiracetam oral cavity dispersing film preparation with water is not necessary, the levo oxiracetam oral cavity dispersing film preparation is convenient to eat, and the preparation method is simple, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to a levo-oxiracetam orodispersible 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 co...

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): A61K9/70A61K31/4015A61K47/38A61K47/36A61K47/10A61K47/14A61K47/26A61K47/22A61P25/28
CPCA61K9/006A61K9/7007A61K31/4015A61K47/10A61K47/14A61K47/22A61K47/26A61K47/36A61K47/38
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