Pharmaceutical composition of levetiracetam and preparation method thereof

A composition and drug technology, applied in the pharmaceutical composition of levetiracetam and its preparation field, can solve problems such as easy pitting, cross-contamination risk, increased labor intensity and labor intensity, and reduce the number of material handling , Short operating time and low labor intensity

Inactive Publication Date: 2021-01-26
ZHEJIANG JIANGBEI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the patent (application number 200680001279.9), UCB Pharmaceutical Co., Ltd. used dry granulation process to prepare tablets for levetiracetam. Considering that the dry granulation process is cumbersome and requires cyclic granulation and sieving, the obtained granules Generally hard and irregular, prone to pitting after tableting, and the process produces a lot of dust, which increases the risk of contamination and cross-contamination
[0005] There are many wet granulation processes, which increase labor intensity, labor intensity, time and energy

Method used

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  • Pharmaceutical composition of levetiracetam and preparation method thereof
  • Pharmaceutical composition of levetiracetam and preparation method thereof
  • Pharmaceutical composition of levetiracetam and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A pharmaceutical composition of levetiracetam, comprising 0.3 parts of croscarmellose sodium, 3 parts of polyethylene glycol 6000, 4 parts of colloidal silicon dioxide, 0.1 part of magnesium stearate, and 92.6 parts of levetiracetam Sitan.

[0026] The preparation method of the pharmaceutical composition of described levetiracetam is as follows:

[0027] S1. Add levetiracetam, colloidal silicon dioxide, and croscarmellose sodium into the granulator to sieve, set the granulator speed to 600rpm, aperture 1.2mm, gasket 4.0mm and open until the material Stop running after all sieving and granulation;

[0028] S2. Add polyethylene glycol 6000 to 117 parts of purified water to prepare a binder solution.

[0029] S3. Put the material that has been sieved and granulated in step S1 into the dryer, set the air inlet temperature of the dryer to 60, the exhaust frequency to 10 Hz, and turn on the heating. When the temperature of the material reaches 40°C, spray the binder solutio...

Embodiment 2

[0034] A pharmaceutical composition of levetiracetam, comprising 3.5 parts of croscarmellose sodium, 1.5 parts of polyethylene glycol 6000, 2 parts of colloidal silicon dioxide, 0.4 parts of magnesium stearate, and 92.6 parts of levetiracetam Sitan.

[0035] The preparation method of the pharmaceutical composition of described levetiracetam is as follows:

[0036] S1. Add levetiracetam, colloidal silicon dioxide, and croscarmellose sodium into the granulator to sieve, set the granulator speed to 600rpm, aperture 1.2mm, gasket 4.0mm and open until the material Stop running after all sieving and granulation;

[0037] S2. Add polyethylene glycol 6000 to 58.5 parts of purified water to prepare a binder solution.

[0038] S3. Put the sieved and granulated material in step S1 into the dryer, set the air inlet temperature of the dryer to 65°C, the exhaust frequency to 22Hz, and turn on the heating. When the temperature of the material reaches 42°C, spray the binder solution , set ...

Embodiment 3

[0043] A pharmaceutical composition of levetiracetam, comprising 6 parts of croscarmellose sodium, 0.3 part of polyethylene glycol 6000, 0.5 part of colloidal silicon dioxide, 0.6 part of magnesium stearate, 92.6 parts of levetiracetam Sitan.

[0044] The preparation method of the pharmaceutical composition of described levetiracetam is as follows:

[0045] S1. Add levetiracetam, colloidal silicon dioxide, and croscarmellose sodium into the granulator to sieve, set the granulator speed to 600rpm, aperture 1.2mm, gasket 4.0mm and open until the material Stop running after all sieving and granulation;

[0046] S2. Add polyethylene glycol 6000 to 35.1 parts of purified water to prepare a binder solution.

[0047] S3. Put the material that has been screened and granulated in step S1 into the dryer, set the air inlet temperature of the dryer to 70°C, and the exhaust frequency to 35Hz, and turn on the heating. When the temperature of the material reaches 45°C, spray the binder sol...

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Abstract

The invention relates to a pharmaceutical composition of levetiracetam and a preparation method thereof. The pharmaceutical composition comprises the following components in parts by weight: 0.3-6 parts of a disintegrating agent, 0.3-3 parts of an adhesive, 0.5-4 parts of a flow aid, 0.1-0.6 part of a lubricant and 92.6 parts of levetiracetam. The pharmaceutical composition of levetiracetam prepared by the invention has high stability; compared with the existing wet granulation and dry granulation, the disclosed preparation method has the characteristics of simple process, short operation time, low labor intensity and the like; and the prepared intermediate particles have good fluidity, and the pressed tablets are stable.

Description

technical field [0001] The invention relates to a pharmaceutical composition of levetiracetam and a preparation method thereof. Background technique [0002] Levetiracetam (Levetiracetam), its chemical name is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, molecular formula is C8H14N2O2, molecular weight is 170.20900, is an antiepileptic drug, mainly used for Adjunctive treatment of partial-onset seizures in adults and children over 4 years of age with epilepsy. Tablets are mainly used clinically at present. [0003] Since levetiracetam is a crystalline powder with poor fluidity, the conventional preparation process is wet granulation, dry granulation, and melt granulation. [0004] In the patent (application number 200680001279.9), UCB Pharmaceutical Co., Ltd. used dry granulation process to prepare tablets for levetiracetam. Considering that the dry granulation process is cumbersome and requires cyclic granulation and sieving, the obtained granules Generally hard and irregul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/10A61K47/04A61K31/4015A61P25/08
CPCA61K9/28A61K9/2054A61K9/2031A61K9/2009A61K9/2095A61K31/4015A61P25/08
Inventor 唐宏渊岳东风孔令荣李建琴窦少华钟龙君
Owner ZHEJIANG JIANGBEI PHARMA
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