L-oxiracetam oral dispersible membrane and preparation method thereof

Abstract

The invention relates to an L-oxiracetam oral dispersible membrane and a preparation method thereof. The L-oxiracetam oral dispersible membrane is prepared from L-oxiracetam, a membrane-forming material, a filler, a plasticizer, a saliva stimulant and a corrigent. The prepared L-oxiracetam oral dispersible membrane can be dissolved by a small amount of saliva in the oral cavity, and can be taken without water for delivery, so administration is convenient; moreover, after being stuck to the tongue, the L-oxiracetam oral dispersible membrane cannot be easily spit out, and therefore is suitable for patients with dysphagia. Furthermore, because the L-oxiracetam oral dispersible 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.

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...

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 injection, and vascular inflammation caused by intravenous injection are all problems in clinical application.

[0005] CN101732251A discloses a liposome of oxiracetam, which is prepared from oxiracetam, phospholipids, cholesterol, Tween 80 and an appropriate amount of osmotic pressure regulator and buffer solution; the liposome has good stability and encapsulation efficiency High, low toxicity and side effects; but the liposome preparation process is complicated, not suitable for large-scale production; more importantly, the curative effect of liposomes in the human body remains to be further studied, and there are few liposome preparations for clinical use in China at present

Although the orodispersible film has many advantages, the limitations of its film-forming materials and preparation technology lead to low drug loading, difficult control of disintegration time and tensile strength, and the need to mask taste in most cases, which restricts orodispersion Development and application of film agent

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