Pharmaceutical composition

A technology of calcium hydrogen phosphate dihydrate and eszopiclone, which is applied in the field of medicine, can solve the problems of large differences in the dissolution rate of eszopiclone tablets, and achieve the effect of improving the operating environment

Inactive Publication Date: 2015-06-17
WEIHAI DISU PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to solve the content uniformity problem of eszopiclone tablet; Another object of the present invention is to solve the dissolution of different batches of eszopiclone tablet problems with large differences

Method used

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  • Pharmaceutical composition

Examples

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Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1, accurately weighed 3g of eszopiclone (using a jet mill to micronize it, control D 90 =30um), microcrystalline cellulose 113g, calcium hydrogen phosphate dihydrate 180g, croscarmellose sodium 3g, magnesium stearate 1.5g, mix well, and directly make 1000 tablets.

Embodiment 2

[0018] Embodiment 2, accurately weighed eszopiclone 3g (D 90 =30um), microcrystalline cellulose 60g, calcium hydrogen phosphate dihydrate 232.5g, croscarmellose sodium 3g, magnesium stearate 1.5g, mix well, and directly make 1000 tablets.

Embodiment 3

[0019] Embodiment 3, accurately weighed eszopiclone 3g (D 90 =30um), microcrystalline cellulose 292.5g, croscarmellose sodium 3g, magnesium stearate 1.5g, mix well, and directly make 1000 tablets.

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Abstract

The invention relates to a pharmaceutical composition containing a dexzopiclone tablet, belonging to the technical field of medicine. Commercially available dexzopiclone tablets are of three specifications, i.e., 1 mg, 2 mg and 3 mg. Due to small specifications of the dexzopiclone tablets, content uniformity of prepared tablets can hardly achieve standards; and since the dexzopiclone is hardly soluble in water, reproducibility of the dissolution data of tablets of different batches is poor. The technical scheme of the invention is as follows: the dexzopiclone tablet is characterized by containing, by mass, 1% of dexzopiclone with D90 of below 30 mu m, 0 to 77.5% of dicalcium phosphate dihydrate, 20 to 97.5% of microcrystalline cellulose, 1% of croscarmellose sodium and 0.5% of magnesium stearate. The technical scheme of the invention overcomes the above-mentioned problems in the prior art.

Description

technical field [0001] The invention relates to a preparation composition containing eszopiclone tablets, which belongs to the technical field of medicine. 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 for marketing by the US FDA. [0003] Eszopiclone is a poorly soluble substance and is almost insoluble in water. The specifications of commercially available eszopiclone tablets are 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 order ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4985A61K47/38A61P25/20
Inventor 连艳菊许蕾
Owner WEIHAI DISU PHARMA CO LTD
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