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A technology of tablets and disintegrants, applied in the field of levetiracetam tablets and its preparation, can solve the problems of poor mechanical compressibility and difficulty in tablet compression, and achieve stable quality and easy industrial promotion
Inactive Publication Date: 2009-11-25
ZHEJIANG JINGXIN PHARMA
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Abstract
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Problems solved by technology
The active ingredient levetiracetam itself has poor mechanical compressibility, and the present invention completely solves the difficult problem of tablet compression encountered in industrial implementation by adding a plasticizer
Method used
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Embodiment 1
[0022] Prescription composition (dosage per 1000 tablets, specification 250mg)
[0023]
[0024] Mix levetiracetam with polyethylene glycol 4000, microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium, and add 5% hypromellose aqueous solution for granulation. Dry, add additional part of microcrystalline cellulose, pregelatinized starch, croscarmellose sodium and precipitated silicon dioxide, magnesium stearate, mix, compress with conventional tablet machine, use Opadry (Opadry) ) 85G60729 for coating.
Embodiment 2
[0026] Prescription composition (dosage per 1000 tablets, specification 250mg)
[0027]
[0028] Mix levetiracetam with polyethylene glycol 4000, microcrystalline cellulose, starch, and croscarmellose sodium, and add 2% hypromellose aqueous solution to granulate, dry, add Add part of microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, precipitated silicon dioxide, and magnesium stearate, mix, and compress with a conventional tablet machine, using Opadry 85G60729 Coated and ready to serve.
Embodiment 3
[0030] Prescription composition (dosage per 1000 tablets, specification 500mg)
[0031]
[0032] Mix levetiracetam with polyethylene glycol 4000, microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium, and add 3% hypromellose aqueous solution for granulation. Dry, add additional part of microcrystalline cellulose, pregelatinized starch, croscarmellose sodium and precipitated silicon dioxide, magnesium stearate, mix, compress with conventional tablet machine, use Opadry (Opadry) ) 85G62984 for coating.
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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 ...
Claims
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