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Brivaracetam orally-disintegrating tablets and preparation method thereof

A technology of disintegrating tablet and disintegrating agent, which is applied in the field of brivaracetam orally disintegrating tablet and its preparation, can solve the problems of poor compliance, blockage of trachea, disappearance of muscle tension, etc., and achieves good disintegration performance, easy operation, and easy medication Effect

Inactive Publication Date: 2015-07-29
GUANGDONG SCI FINDER PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, most patients with epileptic seizures present as sudden loss of consciousness and generalized convulsions, or as sudden disturbance of consciousness and loss of muscle tone, or as bilateral rhythmic myoclonic twitches dominated by the head and upper limb muscles, or as Status epilepticus (shown as persistent seizures or recurrent seizures with no recovery of consciousness during intermittent periods), so Buvaracetam is prepared as ordinary tablets or sustained-release tablets that need to be swallowed, and the patient's compliance with taking it is very poor, and may even block trachea, potentially dangerous

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] An orally disintegrating tablet of buvaracetam, which is made of the following components in parts by weight: 23 parts of buvaracetam, 21.6 parts of microcrystalline cellulose, 32 parts of mannitol, 19 parts of lactose, anhydrous citric acid 0.8 parts, 8 parts of cross-linked polyvinylpyrrolidone, 1.5 parts of sucralose, 0.5 parts of menthol, 1.3 parts of micronized silica gel and 0.4 parts of sodium stearyl fumarate. The Buvaracetam orally disintegrating tablet is made by the following steps: weigh each component according to the formula, mix them uniformly, and then adopt the freeze-drying method to obtain the product; the freeze-drying method specifically follows the steps: 1) preparation of the medicinal solution: take Add the prescribed amount of medicine into water to make a medicine solution; 2) Pre-freezing: Prefreeze the medicine solution at -40°C for 12 hours; 3) Sublimation: Under the conditions of a vacuum of 1.05mbar and a partition temperature of 5°C Subli...

Embodiment 2

[0022] An orally disintegrating tablet of Buvaracetam, which is made of the following components in parts by weight: 18 parts of Buvaracetam, 26 parts of microcrystalline cellulose, 20 parts of mannitol, 25 parts of lactose, anhydrous citric acid 0.5 parts, 10 parts of cross-linked polyvinylpyrrolidone, 0.75 parts of sucralose, 1 part of menthol, 0.5 parts of micronized silica gel and 1.5 parts of sodium stearyl fumarate. Its preparation method is with embodiment 1.

Embodiment 3

[0024] An orally disintegrating tablet of buvaracetam, which is made of the following components in parts by weight: 32 parts of buvaracetam, 26 parts of microcrystalline cellulose, 40 parts of mannitol, 10 parts of lactose, anhydrous citric acid 1 part, 2 parts of cross-linked polyvinylpyrrolidone, 2 parts of sucralose, 0.2 part of menthol, 2.5 parts of micronized silica gel and 0.2 part of sodium stearyl fumarate. Its preparation method is with embodiment 1.

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PUM

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Abstract

The invention relates to brivaracetam orally-disintegrating tablets. The brivaracetam orally-disintegrating tablets can be prepared from the following components in parts by weight: 18-32 parts of brivaracetam, 2-10 parts of a disintegrating agent with rapid disintegration property, 30-75 parts of a hydrophilic filling agent, 1.45-4 parts of a flavoring agent and at least one of 0.2-1.5 parts of a lubricating agent and 0.5-2.5 parts of a flow aid. The invention also provides a preparation method of the brivaracetam orally-disintegrating tablets. The brivaracetam orally-disintegrating tablets provided by the invention have good disintegration property and mouth feeling, and the preparation method is simple and easy to operate.

Description

technical field [0001] The invention relates to a buvaracetam preparation, in particular to a buvaracetam orally disintegrating tablet and a preparation method thereof. Background technique [0002] Epilepsy is a long-term chronic brain disease, which is a syndrome of brain dysfunction caused by sudden abnormal excessive discharge of brain cells caused by brain lesions. At present, antiepileptic drugs can be divided into three generations according to their development history. The first generation is traditional classic AEDs, including phenytoin, carbamazepine, and civalate; the second generation is modern AEDs, including phenytoin, carbamazepine, Etiracetam and Gabarpentin, etc.; the third generation is the new AEDs, including Buvaracetam, Calaboza, Retigabine, etc. Among them, buvaracetam, through the high affinity of SV2A and the inhibition of sodium ion channels, significantly improves the antiepileptic activity, has good safety and pharmacokinetic properties, especial...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4015A61K47/38A61K47/40A61P25/08
Inventor 陈亮冯文周
Owner GUANGDONG SCI FINDER PHARMA TECH CO LTD
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