Dexzopiclone oral fast-dissolving film and preparation method thereof

A technology of eszopiclone and oral instant film, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Simple process, pure sweetness effect

Inactive Publication Date: 2016-02-24
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a kind of fast melting in the oral cavity, absorption, easy to take, good patient compliance, simple preparation process, low cost oral instant film and preparation method thereof, to overcome existing preparations. The problem of inconvenient medicine

Method used

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  • Dexzopiclone oral fast-dissolving film and preparation method thereof
  • Dexzopiclone oral fast-dissolving film and preparation method thereof
  • Dexzopiclone oral fast-dissolving film and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] Prescription composition:

[0039]

[0040]

[0041] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.

[0042] Preparation Process:

[0043] (1) Accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, respectively, heat the β-cyclodextrin with water to 50°C and dissolve it into a saturated solution. The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;

[0044] (2), accurately weigh the recipe quantity KollicoatProtect, dissolve in purified water under heating and stirring conditions at 60~70 ℃, then add malic acid, sucralose and menthol in turn, and stir to obtain blank glue;

[0045] (3), the eszopiclone clathrate powder in...

Embodiment 2

[0048] Prescription composition:

[0049]

[0050] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.

[0051] Preparation Process:

[0052] (1) Accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, respectively, heat the β-cyclodextrin with water to 70°C and dissolve it into a saturated solution. The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;

[0053] (2), accurately weigh the recipe quantity PVAMowiol4-88, dissolve in purified water under heating and stirring conditions at 60~70°C, then add sorbitol, PEG400, citric acid, sucralose and lemon essence successively, stir well to obtain blank glue;

[0054] (3), take the eszopiclo...

Embodiment 3

[0057] Prescription composition:

[0058]

[0059] The eszopiclone inclusion complex is prepared by spray drying with eszopiclone and β-cyclodextrin in a molar ratio of 1:1.

[0060] Preparation Process:

[0061] (1), respectively accurately weigh 29.2 g of β-cyclodextrin and 10.0 g of eszopiclone with a molar ratio of 1:1, heat the β-cyclodextrin with water to 60°C to dissolve it into a saturated solution, and eszopiclone The clone was dissolved in 150 ml of acetone and slowly added to the above saturated solution of β-cyclodextrin, stirred in a constant temperature water bath at 65°C for 4-6 hours, and then the solution was spray-dried in a spray dryer to obtain eszopiclone inclusion complex powder;

[0062] (2), accurately weigh the recipe quantity HPMCE5, dissolve in purified water under heating and stirring conditions at 60~70 ℃, then add glycerin, tartaric acid, sucralose and sweet orange essence successively, and stir to obtain blank glue;

[0063] (3), disperse th...

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Abstract

The invention belongs to the field of a pharmaceutical preparation, and in particular relates to a dexzopiclone oral fast-dissolving film and a preparation method thereof. The film mainly consists of such ingredients as a dexzopiclone inclusion compound, a film-forming material, a filling agent, a plasticizer, a flavoring agent and an antioxidant. The preparation method comprises the following processes: (1) preparing the dexzopiclone inclusion compound; (2) preparing a blank glue solution; (3) preparing a dexzopiclone drug-containing glue solution; and (4) coating and drying the drug-containing glue solution. The oral fast-dissolving film is capable of masking the bitterness of the dexzopiclone, and the film is unnecessary to be taken with water and is suitable for children, old people and insomnia patients having difficulty in swallowing; and moreover, the oral fast-dissolving film is good in flexibility and not easy to become broken, and the film is capable of fast dissolving in an oral cavity and is high in bioavailability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dosage form combining inclusion technology and oral instant film technology and a preparation method thereof, and more particularly to an eszopiclone oral instant film and a preparation method thereof. Background technique [0002] Insomnia is a manifestation of sleep disorders. The clinical manifestations are difficulty in falling asleep, not deep sleep, easy to wake up, early awakening, dreaminess, fatigue after waking up, or lack of wakefulness, sleepiness during the day, etc. When sleep is seriously lacking, it will lead to low immune function of the human body and various diseases. According to the statistics of the World Health Organization, nearly 1 / 4 of the people in the world have suffered from insomnia to varying degrees. In the United States, more than 80 million people have poor sleep quality, and more than 10% of people in my country have sleep disorders....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K31/4985A61K9/06A61P25/20
Inventor 张颖杨江勇任丽霞贺霞
Owner JINAN KANGHE MEDICAL TECH
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