Levetiracetam medicinal composition and preparation method thereof

A technology of composition and medicine, which is applied in the field of preparation of hot melt technology, can solve problems such as increasing labor intensity, and achieve the effects of cost saving, simple preparation method and good stability

Active Publication Date: 2011-09-21
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Increased labor intensity, time and energy

Method used

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  • Levetiracetam medicinal composition and preparation method thereof
  • Levetiracetam medicinal composition and preparation method thereof
  • Levetiracetam medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Levetiracetam is pulverized through an 80-mesh sieve, and 250 parts by weight of levetiracetam and 10 parts by weight of colloidal silicon dioxide, 5 parts by weight of croscarmellose sodium, and 15 parts by weight of polyethylene glycol are weighed. 6000 in a fluidized bed, set the air intake frequency to 30Hz, the material temperature to 52°C, and the heating time to 10min for hot-melt granulation, and finally add 0.3 parts by weight of magnesium stearate to mix for 2 minutes, press into 1000 tablets, and then use Film coated.

Embodiment 2

[0051]Levetiracetam is pulverized through an 80-mesh sieve, and 250 parts by weight of levetiracetam, 1 part by weight of silicon dioxide, 1 part by weight of crospovidone, and 5 parts by weight of polyethylene glycol 6000 are weighed and fluidized In the bed, set the air inlet frequency to 40Hz, the material temperature to 65°C, and the heating time to 10min to carry out hot-melt granulation, and finally add 0.5 parts by weight of magnesium stearate to mix for 2 minutes, press into 1000 tablets, and then use Film coated.

Embodiment 3

[0053] Levetiracetam was pulverized through an 80 mesh sieve, and 250 parts by weight of levetiracetam, 5 parts by weight of silicon dioxide, 3 parts by weight of sodium carboxymethyl starch, and 10 parts by weight of polyethylene glycol 6000 were weighed and fluidized In the bed, set the air inlet frequency to 50Hz, the material temperature to 76°C, and the heating time to 10min for hot-melt granulation, and finally add 0.1 parts by weight of magnesium stearate to mix for 2 minutes, press into 1000 tablets, and then use Film coated.

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Abstract

The invention provides a Levetiracetam medicinal composition and a preparation method thereof. The composition mainly comprises Levetiracetam, polyethylene glycol 6,000 serving as a melting agent and other excipients. The preparation method mainly comprises: preparing medicine particles through a hot melting granulation technique; and pressing into tablets or filling into capsules.

Description

【Technical field】 [0001] The invention belongs to the technical field of pharmaceutical preparations, and more specifically, the invention relates to a preparation method of an antiepileptic drug composition containing levetiracetam by hot-melt technology. 【Background technique】 [0002] Levetiracetam, whose chemical name is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, is mainly used to aggravate partial seizures in adults and children over 4 years old. Use treatment. Tablets are mainly used clinically at present. [0003] Since levetiracetam is a crystalline powder with poor fluidity, the conventional preparation process is wet granulation or dry granulation. In the patent (application number 200680001279.9), UCB Pharmaceutical Co., Ltd. compared the two preparation processes of levetiracetam wet granulation and dry granulation. After 6 months of accelerated experiment (40°C, 75%), the The dissolution rate of the tablet prepared by the wet granulation process was significan...

Claims

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Application Information

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IPC IPC(8): A61K31/4015A61K9/36A61K47/34A61K47/36A61K47/38A61K47/44A61P25/08
Inventor 王文峰王再全刘博雅刘喜纲杨琰刘蕴秀
Owner CHINA RESOURCES SAIKE PHARMA
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