Levetiracetam sustained release tablet as well as preparation method thereof

A sustained-release tablet and tablet core technology, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients. and other problems, to achieve the effect of simple product prescription, low production cost and good fluidity

Active Publication Date: 2015-05-06
SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The wet granulation process is a more commonly used process, with popular equipment and simple operation, but for this product, there are still the following problems in wet granulation: 1. Due to the strong viscosity of high-viscosity hypromellose, it is difficult to use water-based solvents. Adhesive, so polyvinylpyrrolidone alcohol solution is usually used as the adhesive to prepare granules (this method is used in Volume 35 of Pharmaceutical Progress 2011), this method not only increases the cost, but also brings many safety hazards to production
2. If the skeleton material high-viscosity hypromellose participates in the granulation process, changes in process parameters, such...

Method used

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  • Levetiracetam sustained release tablet as well as preparation method thereof
  • Levetiracetam sustained release tablet as well as preparation method thereof
  • Levetiracetam sustained release tablet as well as preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Table 1 Recipes using two different framework materials

[0021]

[0022] Preparation:

[0023] (1) Granulation: Weigh the prescribed amount of levetiracetam, add 25g of low-viscosity hypromellose (HPMC E50) 3% w / w aqueous solution to make soft material, granulate with a 20-mesh sieve, boil and dry, 10 mesh sieve;

[0024] The parameters of boiling drying are: fan power: 30-50Hz; blowback interval: 3-20 seconds; inlet air temperature: 40-60°C; material temperature: 30-40°C, measure the moisture of the mixture, and control the moisture by 0.5-1.5%;

[0025] (2) Mixing: Weigh the prescribed amount of levetiracetam granules, skeleton material and glidant and mix for 15-20 minutes, then add lubricant and mix for 2-3 minutes;

[0026] (3) Tablet compression: compress the mixed materials into tablet cores with a tablet hardness of 13-15kg;

[0027] (4) Preparation of coating solution: disperse 20g of Opadry 295F in 113g of water, stir for 40-50 minutes, and prepare a 15% ...

Embodiment 2

[0031] Table 2 Recipe using a separate framework material

[0032]

[0033] Preparation:

[0034] (1) Granulation: Weigh the prescribed amount of levetiracetam, add 25g of low-viscosity hypromellose (HPMC E50) 3% w / w aqueous solution to make soft material, granulate with a 30-mesh sieve, boil and dry, 20 mesh sieve;

[0035] The parameters of boiling drying are: fan power: 30-50Hz; blowback interval: 3-20 seconds; inlet air temperature: 40-60°C; material temperature: 30-40°C, measure the moisture of the mixture, and control the moisture by 0.5-1.5%;

[0036] (2) Mixing: Weigh the prescribed amount of levetiracetam granules, skeleton material and glidant and mix for 15-20 minutes, then add lubricant and mix for 2-3 minutes;

[0037] (3) Tablet compression: compress the mixed materials into tablet cores with a tablet hardness of 13-15kg;

[0038] (4) Preparation of coating solution: disperse 22g of Opadry 295F in 115g of water, stir for 40-50 minutes, and prepare a 16% coa...

Embodiment 3

[0041] Table 3 Prescriptions using different amounts of lubricants

[0042]

[0043] Preparation:

[0044] (1) Granulation: Weigh the prescribed amount of levetiracetam, add 25g of low-viscosity hypromellose (HPMC E50) 3% w / w aqueous solution to make a soft material, granulate with a 20-mesh sieve, boil and dry, 20 mesh sieve;

[0045] The parameters of boiling drying are: fan power: 30-50Hz; blowback interval: 3-20 seconds; inlet air temperature: 40-60°C; material temperature: 30-40°C, measure the moisture of the mixture, and control the moisture by 0.5-1.5%;

[0046] (2) Mixing: Weigh the prescribed amount of levetiracetam granules, skeleton material and glidant and mix for 15-20 minutes, then add lubricant and mix for 2-3 minutes;

[0047] (3) Tablet compression: compress the mixed materials into tablet cores with a tablet hardness of 13-15kg;

[0048] (4) Preparation of coating solution: disperse 20g of Opadry 295F in 91g of water, stir for 40-50 minutes, and prepare...

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Abstract

The invention relates to a levetiracetam sustained release tablet as well as a preparation method thereof in the field of pharmaceutical preparations. The sustained release tablet comprises a tablet core and a coating, wherein the table core is prepared from levetiracetam, a framework material, a flow aid, a binder and a lubricant. The sustained release tablet is prepared from the following components in percentage by weight: 55-80% of levetiracetam, 15-35% of the framework material, 0.05-0.20% of the binder, 0.8-2% of the flow aid, 2-7% of the lubricant and 2-4% of the coating. The preparation method comprises the following steps: (1) granulating; (2) mixing; (3) tabletting; (4) preparing a coating solution; and (5) coating. The product is simple in prescription, good in dissolution effect and good in stability. The preparation method is free of organic solvents such as ethanol and the like and has the characteristics of simple and convenient preparation process, easily operation and low production cost. The product is particularly suitable for industrial large-scaled production and can be widely applied to the field of pharmaceutical preparations.

Description

technical field [0001] The invention relates to a levetiracetam sustained-release tablet in the field of pharmaceutical preparations and a preparation method thereof. Background technique [0002] Levetiracetam is a pyrrolidone derivative whose chemical structure is not related to existing antiepileptic drugs. The exact mechanism of levetiracetam's antiepileptic effect is unknown. The antiepileptic effects of levetiracetam have been evaluated in various animal models of epilepsy. Levetiracetam has no inhibitory effect on isolated seizures induced by maximal stimulation with electric current or various startling agents, and shows only weak activity in submaximal stimulation and threshold tests. However, protection was observed against generalized seizures secondary to focal seizures induced by pilocarpine and kainic acid, two chemical convulsants that mimic the properties of complex partial seizures with secondary generalized seizures in some individuals . Levetiracetam h...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4015A61K47/38
Inventor 姜海涛陈雅琴石秀芹赵娟王虹王金晶
Owner SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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