A kind of levoxiracetam oral fast-dissolving film and preparation method thereof

Abstract

The invention relates to an L-oxiracetam oral instant membrane, which is prepared from 3 to 20 parts of L-oxiracetam, 40 to 70 parts of membrane-forming material, 10 to 30 parts of filter, 5 to 20 parts of plasticizer and 2 to 4 parts of corrigent, wherein the membrane-forming material is maltodextrin. The L-oxiracetam oral instant 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. After being stuck to the tongue, the L-oxiracetam oral instant membrane cannot be easily spit out, and therefore is suitable for children with dysphagia. Moreover, because the L-oxiracetam oral instant 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 method of the invention is simple, the process cost is low, and therefore the preparation method is suitable for mass production.

Description

Technical field [0001] The invention relates to an oxiracetam, in particular to a levo-oxiracetam oral instant film and a preparation method thereof. Background technique [0002] Oxiracetam, whose chemical name is 4-hydroxy-2-oxo-1-pyrrolidine acetamide, is a nootropic drug first synthesized in 1974 by the Italian company Smith Kbeechem. It is a hydroxyl group GABA (GABOB) derivatives, a central nervous system drug that can promote learning, enhance memory, and protect damaged nerve cells. Its structure is as follows: [0003] [0004] CN102552125A announced that it can improve memory and the memory and learning function of patients with intellectual disability; it is also suitable for memory and intellectual disability caused by mild to moderate vascular dementia, senile dementia, and brain trauma, or as an auxiliary treatment drug. CN102600130A discloses its new clinical application for treating epilepsy. At present, clinically, Oxiracetam is mainly available in injections, ca...

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 oral film has many advantages, the limitations of its film-forming materials and preparation technology lead to low drug loading, the disintegration time and tensile strength are not easy to control, and most of the time it needs to mask the taste, which restricts the oral film. development and application of

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