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Oxiracetam oral membrane preparation and preparation method thereof

An oral film and filler technology, which is applied in the field of oxiracetam oral film and its preparation, can solve the problem that disintegration time and tensile strength are not easy to control, restrict the development and application of oral film, and prepare liposomes. Complex process and other problems, to achieve the effect of improving bioavailability, avoiding elimination effect, and uniform and complete appearance

Inactive Publication Date: 2017-06-13
CHONGQING RUNZE PHARM CO LTD
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  • 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 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

Method used

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  • Oxiracetam oral membrane preparation and preparation method thereof
  • Oxiracetam oral membrane preparation and preparation method thereof
  • Oxiracetam oral membrane preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] A preparation method of oxiracetam oral film, adopts following steps:

[0083] 1) Dissolve 40-65 parts of ethyl cellulose in absolute ethanol to form a homogeneous viscous liquid, then add 10-25 parts of glycerin and mix well to form material I;

[0084] 2) Mix 1-20 parts of oxiracetam and 5-30 parts of filler, and disperse with absolute ethanol to form material II;

[0085] 3) Mix the material II with the material I, and stir at a stirring rate of 500r / min to 800r / min for 60min to 120min to form oxiracetam bubble-free suspension viscous liquid;

[0086] 4) Cast the oxiracetam bubble-free suspension viscous liquid prepared in step 3) on a mold, dry at 55-90° C., cool at room temperature, form a film, and cut to obtain the oxiracetam oral film.

Embodiment 2

[0088] A preparation method of levoxiracetam oral film, adopts following steps:

[0089] 1) Dissolve 35-60 parts of ethyl cellulose in purified water to form a homogeneous viscous liquid, then add 15-30 parts of propylene glycol and mix to form material I;

[0090] 2) Mix 1-20 parts of levoxiracetam and 5-30 parts of filler, and disperse with purified water to form material II;

[0091] 3) Mix material II with material I, and stir for 70-130 min at a stirring rate of 500r / min to 700r / min to form levoxiracetam suspension viscous liquid without bubbles;

[0092] 4) Cast the levo-oxiracetam bubble-free suspension viscous liquid prepared in step 3) on a mold, dry at 45-85°C, cool at room temperature, form a film, and cut to obtain the levo-oxiracetam oral film agent.

Embodiment 3

[0094]

[0095] 1) Dissolving ethyl cellulose in absolute ethanol to form a homogeneous viscous liquid, then adding glycerin and mixing to form material I;

[0096] 2) Mix oxiracetam and microcrystalline cellulose, and disperse with absolute ethanol to form material II;

[0097] 3) Mix the material II with the material I, stir, the stirring speed is 500r / min~600r / min, the stirring time is 80min~90min, and form oxiracetam non-bubble suspension viscous liquid;

[0098] 4) Cast the oxiracetam bubble-free suspension viscous liquid obtained in step 3) on a mold, dry at 72-75° C., cool at room temperature, form a film, and cut to obtain the oxiracetam oral film.

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Abstract

The invention relates to an oxiracetam oral membrane preparation and a preparation method thereof. The oxiracetam oral dispersion membrane preparation is prepared from Oxiracetam, a membrane forming material, a plasticizing agent and a filling agent. The oxiracetam oral membrane preparation has the advantages that the preparation can be dissolved by less saliva in an oral cavity, and can be taken without using water, so that the taking is convenient; the easiness in vomiting is avoided after sticking onto a tongue, and the oxiracetam oral preparation is suitable for old people with difficulty in swallowing; by utilizing mucosae to absorb, the first pass elimination effect is avoided, the bioavailability is improved, the medicine dosage is reduced, and the side effect is decreased. The preparation method has the advantages that the preparation is simple, the technology cost is low, and the preparation method is suitable for industrialized production.

Description

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

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4015A61K47/38A61K47/36A61K47/10A61P25/28
CPCA61K9/006A61K31/4015A61K47/10A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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