Levetiracetam sustained-release tablets and preparation method thereof

A technology of sustained-release tablets and sustained-release materials, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations of inactive ingredients, etc., can solve the problem of the reduced overall application effect of levetiracetam sustained-release tablets, and the release porosity. In order to achieve the effect of maintaining sustained release effect, simple operation and easy control, and stable content of active ingredients

Pending Publication Date: 2020-06-09
上海峰林生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the above application documents, the preparation method of levetiracetam sustained-release tablets does not need to use organic solvents such as ethanol, and the particle size distribution and particle hardness of the intermediate material levetiracetam particles obtained in the preparation process are suitable and have good fluidity, but The release rate of levetiracetam sustained-release tablets is easily affected by the porosity of the gel layer. If the porosity is larger, the release rate will become faster, while if the porosity is smaller, the release rate will be slower, which will lead to The actual pharmacological effect is greatly reduced, so that the overall application effect of levetiracetam sustained-release tablets is greatly reduced, therefore, a new scheme needs to be proposed to solve the above problems

Method used

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  • Levetiracetam sustained-release tablets and preparation method thereof
  • Levetiracetam sustained-release tablets and preparation method thereof
  • Levetiracetam sustained-release tablets and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0050] Embodiment 1: a kind of levetiracetam slow-release tablet, each component and corresponding parts by weight thereof are as shown in Table 1, and the preparation process of levetiracetam slow-release tablet (specification: 750mg) is as follows :

[0051] (1) Pretreatment: use a pulverizer to pulverize each material, and control the particle size of each material at 100-180 μm;

[0052] (2) Preparation of binder solution: Take 0.5 g of hypromellose E5, add 30 mL of boiling water, stir vigorously, add the remaining amount of hypromellose, make up 100 g with cold water, and stir evenly to obtain a mass concentration of 1%. Hypromellose aqueous solution;

[0053] (3) Granulation: according to the ratio, take all the raw materials and slow-release materials and mix them in a wet granulator. The mixing time is 10 minutes. Add the binder solution at a uniform speed and granulate with a 24 mesh sieve. Drying, the moisture content of the granules is controlled below 2%; then us...

Embodiment 2

[0058] Embodiment 2: a kind of levetiracetam slow-release tablet, each component and its corresponding parts by weight are as shown in Table 2, the preparation process of levetiracetam slow-release tablet (specification: 750mg) is as follows :

[0059] (1) Pretreatment: use a pulverizer to pulverize each material, and control the particle size of each material at 100-180 μm;

[0060] (2) Granulation: according to the ratio, take the raw material drug and hypromellose K15M with a ratio of 50% and place it in a fluidized bed granulation coating dryer for mixing. , until the powder is in a fluidized state, dry at 40°C, and control the moisture content of the granules below 2%; then use a 32-mesh sieve to sieve the granules;

[0061] (3) Mixing: Take the granules in proportion and mix them with the remaining slow-release materials, glidants, anti-sticking agents and lubricants in a mixer, and the mixing time is 20 minutes;

[0062] (4) Tablet compression: The tablet weight was c...

Embodiment 3

[0065] Embodiment 3: a kind of levetiracetam slow-release tablet, each component and its corresponding parts by weight are as shown in Table 3, the preparation process of levetiracetam slow-release tablet (specification: 750mg) is as follows :

[0066] (1) Pretreatment: use a pulverizer to pulverize each material, and control the particle size of each material at 100-180 μm;

[0067] (2) Granulation: Take the raw material according to the proportion and place it in a fluidized bed granulation coating dryer, spray water into it at a constant speed through a peristaltic pump until the powder is in a fluidized state, dry at 40°C, and control the moisture content of the granules at 2%. Below; then granulate with 32 mesh sieve;

[0068] (3) Mixing: Take the granules in proportion and mix them with slow-release materials, glidants, anti-sticking agents and lubricants in a mixer, and the mixing time is 20 minutes;

[0069] (4) Tablet compression: The tablet weight was controlled ac...

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Abstract

The invention discloses levetiracetam sustained-release tablets and a preparation method thereof, relates to the technical field of pharmaceutical preparations, and solves the problems that due to a poor release rate of levetiracetam sustained-release tablets, the actual pharmacological effect is greatly reduced, and the application effect is greatly reduced. The levetiracetam sustained-release tablets include the following components in percentages by weight: 45%-85% of levetiracetam, 1%-5% of a binder, 10%-50% of a sustained-release material, 0-2% of a flow aid, 0-2% of an anti-sticking agent, and 0-0.1% of a lubricant. The levetiracetam sustained-release tablets provided by the invention are easy to form as a whole, and have excellent release behavior and stable overall quality.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a levetiracetam sustained-release tablet and a preparation method thereof. Background technique [0002] Epilepsy has become the second most common disease in neurology after headache. Due to congenital genetics, brain diseases, systemic or systemic diseases and other causes, epilepsy runs through all ages of infants, adolescents, adults and the elderly. At present, a variety of antiepileptic drugs with different mechanisms of action have been used for treatment and control, including traditional drugs such as carbamazepine and sodium valproate, and new drugs such as levetiracetam and lamotrigine. Compared with traditional antiepileptic drugs, levetiracetam has its unique advantages. Its oral absorption is fast and complete, with low protein binding rate, good pharmacokinetic characteristics, high bioavailability, and does not need to be metabolized by the li...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38A61K31/4015A61P25/08
CPCA61K9/2054A61K9/2095A61K31/4015A61P25/08
Inventor 郑玉林张佳茹陈玉双
Owner 上海峰林生物科技有限公司
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