Medicament composition of levetiracetam and preparation process

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 ...

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

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