Levetiracetam slow release medicinal composite and preparation method thereof

A sustained-release drug and composition technology, applied in the field of medicine, can solve problems such as complex preparation process, and achieve the effect of simple preparation process, easy reproducibility, and low preparation equipment requirements

Active Publication Date: 2012-03-21
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the controlled-release tablet relies on a controlled-release coating to control the release of the drug, the preparation process is relatively complicated

Method used

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  • Levetiracetam slow release medicinal composite and preparation method thereof
  • Levetiracetam slow release medicinal composite and preparation method thereof
  • Levetiracetam slow release medicinal composite and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045]

[0046] Preparation method: Pass levetiracetam, ethyl cellulose, methyl cellulose and glyceryl behenate through a 60-mesh sieve, mix evenly according to the above ratio, then dry granulate, pass through a 20-mesh sieve for granulation, add the above-mentioned Proportional talcum powder is mixed, compressed into tablets, and the tablet core is coated with an aqueous dispersion of 5% OPADRY (W / V), and the weight of the tablet after coating is increased by 2% compared with that before coating.

Embodiment 2

[0048]

[0049] Preparation method: pass levetiracetam, ethyl cellulose, methyl cellulose, and glyceryl behenate through a 60-mesh sieve, mix uniformly according to the above ratio, and mix ethyl cellulose and 1% of the total weight of the above mixture with Concentration is the solution that the concentration that 95% ethanol configuration forms is 10% (W / W), this solution is added in the mixture, wet granulation, dry, cross 20 mesh sieves, granulate, add the magnesium stearate of above-mentioned ratio, Mix evenly, press into tablets, the tablet core is coated with 5% OPADRY (W / V) aqueous dispersion, the weight of the tablet after coating increases by 2.5% compared with that before coating.

Embodiment 3

[0051]

[0052] Preparation method: pass levetiracetam, ethyl cellulose, methyl cellulose, and glyceryl behenate through a 60-mesh sieve, mix evenly according to the above ratio, and mix PVP-K30 accounting for 0.5% of the total weight of the above mixture with no Water ethanol is configured into a solution with a concentration of 15% (W / W), and the solution is added to the mixture, then wet granulated, dried, passed through a 20 mesh sieve, and added glyceryl behenate accounting for 1% of the total weight of the dry granules With the magnesium stearate of above-mentioned ratio, mix, tabletting, tablet core use concentration is the coating of 6% OPADRY (W / V) water dispersion, the tablet after coating is compared with the weight gain of 2% before coating.

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Abstract

The invention relates to a levetiracetam slow release medicinal composite and a preparation method thereof. The tablet core of the medicinal composite is mainly composed by 55-65% of levetiracetam in weight percentage and 35-45% of non hydrophilia auxiliary material with the slow release function in weight percentage, the non hydrophilia auxiliary material with the slow release function is mixed by one, two or three of ethyl cellulose, methyl cellulose or behenic acid glyceride, and the slow release medicinal composite does not need a functional controlled release coating to adjust the drug release. The levetiracetam medicinal composite has stable drug release performance, good biocompatibility and dissolution performance; and the preparation technology is simple, is easy to reproduce, and is applicable to industrialization production.

Description

technical field [0001] The present invention relates to a sustained-release pharmaceutical composition and a preparation method thereof in the field of medical technology, in particular to a levetiracetam non-hydrophilic skeleton-type sustained-release pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is mainly used for Treat epilepsy. Background technique [0002] Sustained-release preparations refer to a new class of preparations that purposely control the release of drugs to achieve a reasonable therapeutic effect. It enables the human body to obtain a stable therapeutic blood drug concentration and optimizes the therapeutic dose. Compared with ordinary oral preparations, it can stabilize blood concentration, avoid peak and valley phenomena, and help reduce adverse drug reactions; reduce the number of medications, improve patient compliance, and be convenient to use; it can reduce the total dose of medication, and can be compared ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4015A61K47/38A61K47/14A61P25/08
Inventor 熊春德刘相男李凤
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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