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Levetiracetam sustained release tablet and preparation method thereof

A technology of sustained-release tablets and sustained-release layers, which is applied in the field of levetiracetam sustained-release tablets and its preparation, and can solve problems such as ineffectiveness

Active Publication Date: 2013-12-25
南京亿华药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This extended release tablet does not work well with levetiracetam, which is very water soluble

Method used

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  • Levetiracetam sustained release tablet and preparation method thereof
  • Levetiracetam sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] First, put the raw materials and auxiliary materials at 60°C for 4 hours, pass through an 80-mesh sieve for later use; then, prepare a blank layer: take 200 g of glyceryl behenic acid and 15 g of polyvinylpyrrolidone K30 and mix them uniformly in equal increments. Dry granulation, weighing; preparation of drug-containing sustained-release layer: levetiracetam 500g, behenic acid glyceride 150g, polyvinylglyceride 150g, polyvinylpyrrolidone K3020g were mixed in equal increments, and dry granulated , weighed; Tablet compression: add 1% magnesium stearate to the blank layer and the drug-containing layer and mix them evenly, separate the two hoppers and compress them into 1000 tablets on a double-layer tablet press. Each tablet contains 500mg of levetiracetam.

Embodiment 2

[0033] First, put the raw materials and auxiliary materials at 60°C for 4 hours, pass through an 80-mesh sieve for later use; then, prepare a blank layer: take 300 g of ethyl cellulose and 15 g of polyvinylpyrrolidone K30 and mix them uniformly in equal increments, wet Granulation by method, weighing; preparation of drug-containing sustained-release layer: levetiracetam 500g, ethyl cellulose 200g, polyvinylpyrrolidone K3020g were mixed with equal increments, wet granulation, weighing; tabletting: The blank layer and the drug-containing layer are respectively added with 1% magnesium stearate and mixed evenly, separated into two hoppers and compressed into 1000 tablets on a double-layer tablet press. Each tablet contains 500mg of levetiracetam.

Embodiment 3

[0035] First, put the raw materials and auxiliary materials at 60°C and dry them for 4 hours, pass through an 80-mesh sieve for later use; then, prepare a blank layer: take 180 g of hypromellose and 20 g of polyvinylpyrrolidone K30 and mix them uniformly in equal increments. Dry granulation, weighing; preparation of drug-containing sustained-release layer: levetiracetam 500g hypromellose 150g, polyvinylpyrrolidone K30 20g were mixed with the equal amount increasing method, dry granulation, weighing; 1. Add 1% magnesium stearate to the blank layer and the drug-containing layer and mix them evenly. Separately arrange two hoppers and compress them into 1000 tablets on a double-layer tablet press. Each tablet contains 500mg of levetiracetam.

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Abstract

The invention provides a levetiracetam sustained release tablet and a preparation method thereof. The preparation method provided by the invention is as below: drying raw materials and accessories for sustained release tablets; respectively weighing particles dividing into a blank layer (taking a release material and a binder according to the proportion of the blank layer, mixing uniformly according to an equal incremental method and sieving) and a sustained release layer (taking blending ratio of levetiracetam, a sustained-release material and a binder, according to the proportion of the release layer, mixing uniformly according to an equal incremental method and sieving); adding a lubricant; mixing uniformly; and pressing the mixture in two hopper of a bilayer tablet machine to obtain the tablets.

Description

1. Technical field [0001] The invention relates to levetiracetam sustained-release tablets and a preparation method thereof. 2. Background technology: [0002] Clinically used levetiracetam, due to the nature of the drug itself, is made into ordinary tablets and taken, which will be quickly metabolized in the human body, and sometimes even needs to be taken at night, which has many adverse effects on the therapeutic effect and patients. In order to achieve an effective therapeutic effect, the frequency of taking the drug must be increased. This will cause the shortcomings of many times of taking medicine, large fluctuations in blood drug concentration, and large side effects. In order to improve the curative effect of the drug, reduce the number of times of taking the drug, and ensure the safety of the drug, levetiracetam must be made into a sustained-release tablet. Levetiracetam sustained-release tablets are usually uniform sustained-release tablets made by mixing the ma...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/4015
Inventor 杨鹏辉张胜举丁峰张霞陈广宇
Owner 南京亿华药业有限公司
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