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Levetiracetam tablet and preparation method thereof

A tablet and filler technology, applied in the field of pharmaceutical preparations, can solve the problems of complex process, poor fluidity, drug failure, etc., and achieve the effects of stable preparation process, reduced production cost, and strong industrial feasibility

Inactive Publication Date: 2016-03-30
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] (1) Since levetiracetam is a crystalline powder with poor fluidity and compression formability, and the dosage specification is large, the proportion of excipients that can be added is small, so it is difficult to industrialize through granulation processes other than dry granulation production, but the dry granulation 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 industrialized mass production
The above factors limit the application of levetiracetam
[0008] (2) During the storage process, the dissolution kinetics of levetiracetam, the active ingredient in the levetiracetam preparation, changes over time, which may lead to the dissolution of the active ingredient levetiracetam Slower, and thus less stable formulations, and one consequence of this less stability is earlier failure of the drug

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

[0049] Embodiment 1: levetiracetam tablet

[0050] prescription:

[0051]

[0052] Preparation:

[0053] (1) The raw and auxiliary materials are respectively pulverized and passed through a 100-mesh sieve for subsequent use;

[0054] (2) take povidone K30, be mixed with 10% (weight) aqueous solution;

[0055] (3) Accurately weigh each raw and auxiliary material according to the prescription amount, mix levetiracetam with lactose, starch, and sodium carboxymethyl starch, add an appropriate amount of 10% povidone K30 aqueous solution, and make a soft material;

[0056] (4) Soft materials are passed through a 20-mesh sieve to prepare wet granules, and dried at 60°C until the moisture content of the granules is 2-4%;

[0057] (5) The dry granules are granulated through a 20-mesh sieve, and the prescription amount of magnesium stearate and silicon dioxide are added, and mixed uniformly;

[0058] (6) Determination of main drug content, calculation of tablet weight;

[0059] ...

Embodiment 2

[0060] Embodiment 2: Levetiracetam film-coated tablet

[0061] Coating Solution Prescription:

[0062]

[0063] Coating process:

[0064] (1) Coating liquid preparation: add the calculated purified water into the liquid preparation container, start the agitator, the height of the stirring blade from the bottom of the container is 1 / 3 of the liquid height, so that the liquid is completely stirred, and the liquid surface just forms a vortex Without splashing the liquid, sprinkle the coating powder on the vortex liquid surface at a steady speed, keep stirring for 45 minutes until the coating agent is completely dissolved, pass through a 100-mesh sieve, and set aside;

[0065] (2) Coating: Add the tablet core obtained in Example 1 to the coating pot, adjust the pot speed, start the hot air system, preheat, open the spray gun and spray the prepared coating powder solution, check the coating of the plain tablet at any time. To the degree of coating, control the weight gain of the...

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Abstract

The present invention discloses a levetiracetam tablet and a preparation method thereof. The levetiracetam tablet is reasonable in formulation and stable in preparation process, achieves better auxiliary material selection effect, and is low in production cost.

Description

technical field [0001] The invention relates to a levetiracetam tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Levetiracetam (Levetiracetam) is a high-efficiency broad-spectrum anti-epileptic drug developed by UCB Company in Belgium. FDA) registration, and has been applied clinically. Levetiracetam has a unique mechanism of action, long duration of curative effect, less adverse reactions, good safety and tolerability, and can be used for addition therapy, adjuvant therapy or monotherapy of various types of epileptic seizures, and has a wide range of clinical applications. Application prospects. [0003] The chemical name of levetiracetam is: (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide; its English name is: (S)-α-Ethyl-2-oxo-1- pyrrolidineacetamide; its molecular formula is: C 8 h 14 N 2 o 2 , molecular weight is: 170.21, and structural formula is as shown in formula (I): [0004] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4015A61P25/08A61K47/36
Inventor 易崇勤励华邹明琛李育巧郭曙刚赵璨
Owner PEKING UNIV FOUNDER GRP CO LTD
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