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Levetiracetam tablet and preparation method thereof

A tablet and adhesive technology, applied in the field of levetiracetam tablets and its preparation, can solve the problems that the process is not conducive to cost reduction, many influencing factors, complicated process, etc., and achieve good dissolution kinetic stability , Improving the physical properties and reducing the production cost

Active Publication Date: 2011-05-04
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the complicated process of wet granulation is not conducive to cost reduction, nor is it conducive to the quality control of commercial production
[0008] Although the new pharmaceutical composition disclosed in Chinese patent CN200680001279.9 and its preparation method have improved the stability of the dissolution kinetics of the drug to a certain extent, the method it chooses is called dry granulation in pharmacy. The process is complicated and there are many influencing factors, especially the compaction and particle size distribution of the prepared particles will have a significant impact on product quality, which is not conducive to the quality control of commercial mass production

Method used

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  • Levetiracetam tablet and preparation method thereof
  • Levetiracetam tablet and preparation method thereof
  • Levetiracetam tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] According to the levetiracetam tablet prescription of table 1, prepare levetiracetam tablet according to the following steps:

[0091] a) passing levetiracetam through a 20 mesh sieve,

[0092] b) Mix the sieved levetiracetam with partially pregelatinized starch, copovidone, croscarmellose sodium, and micropowder silica gel,

[0093] c) process the mixed material obtained in step b through a 20 mesh sieve,

[0094] d) adding magnesium stearate to the sieved material obtained in step c, mixing,

[0095] e) compressing the mixture obtained in step d to prepare a tablet,

[0096] f) Coating the resulting tablet with a coating material.

[0097] Table 1

[0098]

[0099] With the levetiracetam sheet A in embodiment 1, and the 250mg specification tablet of prior art product (the Kaiplan of UCB company) Batch number: 049115), after being packed in the same aluminum foil bag, placed under the condition of 60°C / 75% relative humidity, after accelerating for 2 weeks, acc...

Embodiment 2

[0107] According to the levetiracetam tablet prescription of table 3, prepare levetiracetam tablet according to the following steps:

[0108] a) passing levetiracetam through a 20 mesh sieve,

[0109] b) Mix the sieved levetiracetam with microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium and micropowder silica gel evenly,

[0110] c) process the mixed material obtained in step b through a 20 mesh sieve,

[0111] d) adding magnesium stearate to the sieved material obtained in step c, mixing,

[0112] e) compressing the mixture obtained in step d to prepare a tablet,

[0113] f) Coating the resulting tablet with a coating material.

[0114] table 3

[0115]

Embodiment 3

[0117] According to the levetiracetam tablet prescription of table 4, prepare levetiracetam tablet according to the following steps:

[0118] a) passing levetiracetam through a 20 mesh sieve,

[0119] b) Mix the sieved levetiracetam with microcrystalline cellulose, copovidone, croscarmellose sodium and micropowder silica gel evenly,

[0120] c) process the mixed material obtained in step b through a 20 mesh sieve,

[0121] d) adding magnesium stearate to the sieved material obtained in step c, mixing,

[0122] e) compressing the mixture obtained in step d to prepare a tablet,

[0123] f) Coating the resulting tablet with a coating material.

[0124] Table 4

[0125]

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Abstract

The invention relates to a levetiracetam tablet. The levetiracetam tablet at least comprises levetiracetam used as an active component and a binder accounting for more than 6% of the total weight of the tablet. The invention further relates to a preparation method of the levetiracetam tablet. The improved levetiracetam tablet is simple in production technology and low in cost, and is suitable for commercial production.

Description

technical field [0001] The invention relates to levetiracetam tablets and a preparation method thereof. Background technique [0002] Levetiracetam is an antiepileptic drug developed by UCB Company in Belgium. It was approved by the FDA in April 2000 and launched in the United States. It was officially launched in China in March 2007. It is mainly used for adults and children with epilepsy over 4 years old. Add-on treatment for partial seizures. [0003] The chemical name of levetiracetam is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, and its structural formula is: [0004] [0005] Chinese patent application CN200680001279.9 (the applicant is UCB Pharmaceutical Co., Ltd.) discloses a pharmaceutical composition containing levetiracetam and a preparation method thereof. The composition comprises levetiracetam as an active ingredient and 2.0 to 9.0% by weight of a disintegrant relative to the total weight of the pharmaceutical composition, 0.0 to 3.0% by weight of a glidant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/4015A61K47/38A61K47/32A61P25/08
Inventor 胡李斌顾喜燕李巧霞彭俊清胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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