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Method for preparing dextrorotatory oxiracetam oral dissolving films by solvent casting

A technology of dextran-olamide and dispersing film, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, nervous system diseases, etc., can solve the problem of low drug loading, difficult control of disintegration time and tensile strength, Restricting the development and application of oral instant film, achieving the effect of simple preparation method, improving bioavailability and avoiding elimination effect

Inactive Publication Date: 2018-11-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • Method for preparing dextrorotatory oxiracetam oral dissolving films by solvent casting
  • Method for preparing dextrorotatory oxiracetam oral dissolving films by solvent casting

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prescription: 26g dextro-olamide, 18g PVA, 36g maltodextrin, PEG4008g, 9g pregelatinized starch, 2g malic acid, 1g xylitol.

[0029] Preparation:

[0030] (1) Dissolve PVA and maltodextrin in 80mL deionized water to form a homogeneous viscous liquid, then add PEG400 and mix to form material I;

[0031] (2) Mix dexolamide, pregelatinized starch, malic acid and xylitol, and disperse with 50mL of absolute ethanol to form material II;

[0032] (3) Mix the material II with the material I, and stir at a speed of 750r / min to 800r / min for 70-75min to form a viscous suspension of D-olaramide without bubbles;

[0033](4) Cast the D-olaramide non-bubble suspension viscous liquid prepared in step (3) on a mold, dry at 83-85°C, cool at room temperature, form a film, and cut to obtain D-olaramide oral film.

Embodiment 2

[0035] Prescription: 33g of D-olaramide, 12g of PVA, 36g of maltodextrin, 10g of PEG400, 5g of low-substituted hydroxypropyl cellulose, 3g of ascorbic acid, and 1g of fructose.

[0036] Preparation:

[0037] (1) Dissolve PVA and maltodextrin in 70mL deionized water to form a homogeneous viscous liquid, then add PEG400 and mix well to form material I;

[0038] (2) Mix D-olamide, low-substituted hydroxypropyl cellulose, ascorbic acid and fructose, and disperse with 65mL of absolute ethanol to form material II;

[0039] (3) Mix the material II with the material I, and stir at a speed of 500r / min to 550r / min for 95-100min to form a viscous suspension of D-olaramide without bubbles;

[0040] (4) Cast the D-olaramide non-bubble suspension viscous liquid prepared in step (3) on a mold, dry at 65-70°C, cool at room temperature, form a film, and cut to obtain D-olaramide oral film.

Embodiment 3

[0042] Prescription: 40g of dextro-olamide, 15g of PVA, 30g of maltodextrin, 5g of triethyl citrate, 6g of low-substituted hydroxypropyl cellulose, 2g of citric acid, and 1g of glucose.

[0043] Preparation:

[0044] (1) Dissolve PVA and maltodextrin in 50mL deionized water to form a homogeneous viscous liquid, then add triethyl citrate and mix well to form material I;

[0045] (2) Mix D-olamide, low-substituted hydroxypropyl cellulose, citric acid, and glucose, and disperse them with 60mL of absolute ethanol to form material II;

[0046] (3) Mix the material II with the material I, and stir at a speed of 850r / min to 900r / min for 60-65min to form a viscous suspension of D-olaramide without bubbles;

[0047] (4) Cast the D-olaramide non-bubble suspension viscous liquid prepared in step (3) on a mold, dry at 90-95°C, cool at room temperature, form a film, and cut to obtain D-olaramide oral film.

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Abstract

The invention provides a method for preparing dextrorotatory oxiracetam oral dissolving films by solvent casting. The dextrorotatory oxiracetam oral dissolving films comprise 20%-50% of dextrorotatoryoxiracetam, 30%-65% of film-forming materials, 5%-12% of plasticizers, 0%-15% of filling agents and 2%-5% of cosolvent. The method effectively solves the technical problems that the films are prone to breakage, poor in strength and toughness, slow in disintegration, long in dissolving time, non-beneficial to medicament absorption and the like, and the prepared dextrorotatory oxiracetam oral dissolving films are good in demoulding performance, soft, less prone to breakage, short in melting time, free from bubbles, low in moisture content and suitable for storage. The method for preparing the dextrorotatory oxiracetam oral dissolving films by solvent casting is simple, has no need for large equipment and is applicable to industrial production.

Description

technical field [0001] The invention relates to a preparation method of an orodispersible film of dextro-olamide, in particular to a method for preparing a dextralamide orodispersible film by solvent casting. Background technique [0002] Oxiracetam, a nootropic drug first synthesized by the Italian company Skrbechem in 1974, is a derivative of hydroxyaminobutyric acid (GABOB), which can promote learning, enhance memory, and protect damaged nerves Cellular Nervous System Drugs. CN102552125A discloses that it can improve the memory and learning function of patients with mental retardation; it is also suitable for memory and mental retardation caused by mild to moderate vascular dementia, senile dementia and traumatic brain injury or as an auxiliary therapeutic drug. Studies have shown that the dextrorotatory form of olaamide (CAS No.: 68252-28-8) is less effective in treating cognitive dysfunction and improving learning and memory; but it has antiepileptic pharmacology acti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4015A61K47/32A61K47/36A61P25/08
CPCA61K31/4015A61K9/0056A61K9/7007A61K47/32A61K47/36
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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