Medicament composition of levetiracetam and preparation process
A composition and drug technology, applied in the field of pharmaceutical composition containing levetiracetam and its preparation, can solve the problems of hard and irregular granules, cumbersome production process of dry granulation and tabletting, etc.
Active Publication Date: 2012-06-06
CHINA RESOURCES SAIKE PHARMA
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- 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.
[0004] The purpose of the present invention is to overcome the potential risks brought by the prior art to product stability in the preparation process of wet granulation and tabletting, or the defects of cumbersome production process and high production cost of dry granulation and tabletting
Method used
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Examples
Experimental program
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Effect test
Embodiment 1
[0023] 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
[0025] 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
[0027] 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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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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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