Levetiracetam tablet and preparation method

Abstract

The invention discloses a Levetiracetam tablet and preparation method thereof. Levetiracetam is a bolus injection medicine with bad compressibility and proportion of supplementary materials which can be added is small. Quality of Levetiracetam is unstable and it is hard to produce Levetiracetam industrially. The invention comprises components of weight percentage content: 70% to 80% of Levetiracetam as active component, 1.5% to 8.0% of plasticizer, 9% to 17% of disintegrant, 3% to 14% of filler, 0.1% to 0.5% of bond and 0.1% to 3% of fluidizer. Addition of plasticizer is added by inner way of wet granulation. Levetiracetam as active component has bad mechanic compressibility. The invention adds plasticizer to solve tablet compression difficulty in industrial embodiment thoroughly, which realizes the purpose of being suitable for coating with stable quality and easy industrial application.

Description

technical field

[0001] The invention relates to the field of pharmacy, in particular to a levetiracetam tablet and a preparation method thereof. Background technique

[0002] Levetiracetam is an antiepileptic drug developed by Belgian United Chemicals (UCB) Co., Ltd., which was approved for sale by the U.S. FDA in 1999 (trade name Keppra). It is a levorotatory compound with a structural expression as follows:

[0003]

[0004] The chemical name of levetiracetam is (S)-2-ethyl-2-oxo-1-pyrrolidineacetamide, and its properties are white to slightly yellow crystalline powder. It is easily soluble in water and can be dissolved in methanol or ethanol. dissolved in. Levetiracetam is an ideal pharmacokinetic antiepileptic drug, easy to absorb when taken orally, high bioavailability, high therapeutic index, no interaction with other antiepileptic drugs, mild side effects, and good tolerance It has good characteristics and is used for single treatment. It is clinically used as a ...

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