Medicament composition of levetiracetam and preparation process

A technology of composition and medicine, which is applied in the field of pharmaceutical composition containing levetiracetam and its preparation, and can solve the problems of high production cost, cumbersome operation process, and pockmarked surface

Active Publication Date: 2010-04-14
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the dry granulation process requires the use of special equipment such as a dry granulator, and the operation process is cumbersome, requiring cyclic granulation and sieving. The resulting granules are generally hard and irregular, and are prone to pockmarks after tableting.
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Method used

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  • Medicament composition of levetiracetam and preparation process
  • Medicament composition of levetiracetam and preparation process
  • Medicament composition of levetiracetam and preparation process

Examples

Experimental program
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Effect test

Embodiment 1

[0024] Grind levetiracetam through an 80-mesh sieve, weigh the prescribed amount of levetiracetam and silicon dioxide and mix in a mixer for 5 minutes, add sodium carboxymethyl starch, starch, PEG6000 and mix for 5 minutes, and finally add Magnesium stearate was mixed for 2 minutes, pressed into 1000 tablets, and then film-coated.

Embodiment 2

[0026] Weigh the prescribed amount of levetiracetam and silicon dioxide and mix in a mixer for 5 minutes, add crospovidone, MCC, PEG6000 and mix for another 5 minutes, finally add magnesium stearate and mix for 2 minutes, press into 1000 tablets , and then film-coated.

Embodiment 3

[0028] Weigh the prescribed amount of levetiracetam and silicon dioxide and mix in a mixer for 5 minutes, add croscarmellose sodium, lactose, PEG6000 and mix for another 5 minutes, finally add magnesium stearate and mix for 2 minutes, press Into 1000 pieces, and then film-coated.

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PUM

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Abstract

The invention provides a medicament composition containing active component of levetiracetam and a preparation process thereof. The preparation process does not need producing pallets, and directly presses powder into tablets or fills powder into capsules.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing levetiracetam and a preparation method thereof. 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, and the preparation has a relatively large specification, the conventional preparation process is wet granulation or dry granulation. In the patent CN101068534A, UCB Pharmaceutical Co., Ltd. compared the two preparation processes of wet granulation and dry granulation. The results showed that after 6 months of acceleration (40°C, 75%), the tablets prepared by the wet granulation process were significantly dissolved. slowed down, and the tablet prepared by ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K9/48A61K31/4015A61K47/38A61K47/36A61K47/34A61K47/32A61P25/08A61K47/10
Inventor 王再全杨琰刘博雅
Owner CHINA RESOURCES SAIKE PHARMA
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