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Eszopiclone composition

A technology of eszopiclone and its composition, which is applied in the field of eszopiclone composition and its preparation, can solve the problems of prolonging energy consumption, etc., and achieve the effect of remarkable stability and stabilizing effect

Inactive Publication Date: 2018-09-07
DISHA PHARMA GRP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because it is dissolved in an acidic solution, and then the pH value is adjusted back with alkaline auxiliary materials, the energy consumption in the preparation process and the preparation process is prolonged.

Method used

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  • Eszopiclone composition
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1. 1 mg of eszopiclone, 40 mg of microcrystalline cellulose, 8 mg of calcium hydrogen phosphate, 3 mg of croscarmellose sodium, 30 mg of colloidal silicon dioxide, 10 mg of Tween 80, and 1.4 mg of magnesium stearate. Prepare 1000 tablets according to the preparation method described in the technical scheme section. During the tableting process, the bitter taste of eszopiclone did not appear in the air.

Embodiment 2

[0026] Example 2. Eszopiclone 3 mg, microcrystalline cellulose 87 mg, calcium hydrogen phosphate 12 mg, croscarmellose sodium 5 mg, colloidal silicon dioxide 10 mg, polyethylene glycol 400 20 mg, magnesium stearate 2 mg . Prepare 1000 tablets according to the preparation method described in the technical scheme section. During the tableting process, the bitter taste of eszopiclone did not appear in the air.

Embodiment 3

[0027] Example 3. 2 mg of eszopiclone, 72 mg of microcrystalline cellulose, 9 mg of calcium hydrogen phosphate, 3 mg of croscarmellose sodium, 25 mg of colloidal silicon dioxide, 14 mg of lecithin, and 1.5 mg of magnesium stearate. Prepare 1000 tablets according to the preparation method described in the technical scheme section. During the tableting process, the bitter taste of eszopiclone did not appear in the air.

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Abstract

The invention relates to an eszopiclone composition and a preparation method thereof and belongs to the technical field of pharmaceutical preparations. According to the eszopiclone composition provided by the invention, the unit dose of the composition is prepared from 1 to 3mg of eszopiclone, 40 to 87mg of microcrystalline cellulose, 8 to 12mg of dicalcium phosphate, 3 to 5mg of croscarmellose sodium, 10 to 30mg of colloidal silicon dioxide, 10 to 20mg of oily auxiliary material and 1.4 to 2mg of magnesium stearate. According to the technical scheme provided by the invention, the stable and safe eszopiclone tablet composition is obtained.

Description

technical field [0001] The invention relates to an eszopiclone composition and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Eszopiclone (Esopiclone) is a fast-acting short-acting non-benzodiazepine sedative hypnotics developed by Sepracor Corporation of the United States. Therefore, this product has the advantages of strong curative effect and low toxicity compared with the marketed zopiclone. In December 2004, it was approved by the US FDA for marketing. [0003] Eszopiclone is a poorly soluble substance and is almost insoluble in water. The commercially available eszopiclone tablets have three specifications of 1, 2 and 3 mg. Due to the small size of the product, the content uniformity in the prepared tablets is not easy to meet the standard; because eszopiclone is insoluble in water, there is a problem of poor reproducibility of the dissolution data of different batches of products in the tablet. [0004] In ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4985A61K47/38A61K47/24A61K47/04A61K47/10A61K47/26A61K47/44A61P25/20
CPCA61K31/4985A61K9/2009A61K9/2013A61K9/2018A61K9/2031A61K9/2054A61P25/20
Inventor 王海孟庆举
Owner DISHA PHARMA GRP
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