Method for preparing oxiracetam oral dispersible film preparation

Abstract

The invention discloses a method for preparing an oxiracetam oral dispersible film preparation. The method comprises the following steps of sufficiently grinding and uniformly mixing 1 to 15 parts of oxiracetam, 80 to 95 parts of film forming material, 5 to 10 parts of plasticizer, 2 to 5 parts of saliva irritant and 1 to 3 parts of sweetener, sending a mixture to a hot melting zone through a feeding zone of a hot-melt film laminator, hot melting the mixture at 70 to 95 DEG C, continuously outputting the molten mixture through a proportioning zone, pouring the molten mixture into a mold, and cooling the mixture to form the film preparation. According to the method, the film forming material of specific type and use level is selected to be combined with the plasticizer; thus, technical problems that the film preparation is easy to break, is poor in strength and toughness, is slow to disintegrate, is longer in dissolution time and is not beneficial to the absorption of a medicine, and the like, are solved; the made oxiracetam oral dispersible film preparation is enabled to be good in demolding performance; a medicinal film is flexible, is uneasy to break, and is short in the dissolution time.

Description

technical field [0001] The invention relates to oxiracetam, in particular to a method for preparing oxiracetam orodispersible film. 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 with ...

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.

[0006] 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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