Levetiracetam sustained-release tablets and preparation method thereof

A slow-release tablet and slow-release technology, applied in the field of medicine, can solve problems such as adverse reactions and difficulty in controlling patients' seizures, and achieve the effects of stable blood drug concentration, good development prospects, and convenient administration

Inactive Publication Date: 2011-05-25
HUZHOU LLISSY BIOLOGY TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In recent years, the efficacy of antiepileptic drugs has increased, but there are still 20% to 30% of patients whose seizures are difficult to control or have obvious adverse reactions

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
Comparison scheme
Effect test

Embodiment Construction

[0021] Below enumerate several representative in specific embodiment, illustrate the specific implementation mode of this method.

[0022] Prescription A:

[0023] Levetiracetam 300g

[0024] HPMC-4M 15g

[0025] Lactose 90g

[0026] 10% PVP 95% ethanol solution 120g

[0027] Glyceryl Behenate 3g

[0028] Preparation process: Pass Levetiracetam and HPMC-4M through 80 mesh sieve, weigh the prescribed amount of Levetiracetam, HPMC-4M and lactose, mix evenly, add 10% PVP 95% ethanol solution in an appropriate amount, granulate, Dry at 60°C, sieve through a 20-mesh sieve, and granulate. Add the prescribed amount of behenic acid glyceride to the dry granules, mix well, and press into tablets.

[0029] Prescription B:

[0030] Levetiracetam 300g

[0031] HPMC-4M 120g

[0032] Lactose 90g

[0033] 8% PVP 95% ethanol solution 100g

[0034] Glyceryl Behenate 3g

[0035] The preparation process is the same as prescription A.

[0036] Prescription C:

[0037] Levetiracetam 3...

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Abstract

The invention discloses levetiracetam sustained-release tablets and a preparation method thereof. The levetiracetam sustained-release tablets consist of levetiracetam, a filler, a sustained-release agent, an adhesion agent and a lubricant according to the weight ratio of 100: 30: (3-60): (30-70): 1. The preparation method comprises the following steps of: pelletizing by the wet method, drying the granules, arranging the granules and adding a proper quantity of lubricant, uniformly mixing and pressing to obtain the levetiracetam sustained-release tablets. Compared with the common preparation, the levetiracetam sustained-release tablets prepared by the preparation method have the advantages of small blood concentration fluctuation range, reduction in toxin and side effect and increase in biddability of patients by oral administration once every day. The sustained-release preparation will be clinically applied to additional treatment on partial seizure of epilepsia patients.

Description

technical field [0001] The invention relates to a preparation method of levetiracetam sustained-release tablets, belonging to the technical field of medicine. Background technique [0002] Levetiracetam is a new pyrrolidone antiepileptic drug, which can effectively control epileptic seizures. It has the characteristics of high therapeutic index, good safety, and mild side effects. It is the only broad-spectrum antiepileptic drug with preventive effect reported so far. Levetiracetam has definite antiepileptic efficacy and good tolerance, and can be used in the treatment of epilepsy, neuralgia and other neurological diseases. Levetiracetam, as an add-on therapy, is effective for all types of epilepsy in children, especially for complex partial seizures and myoclonic seizures, with mild adverse reactions. Levetiracetam is effective in the treatment of partial seizures in adults with drug-resistant epilepsy, and has mild adverse reactions. It is a beneficial choice for patients...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4015A61K47/38A61P25/08
Inventor 尹莉吴菁
Owner HUZHOU LLISSY BIOLOGY TECH
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