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Topiramate sustained-release oral suspension and preparation method thereof

A slow-release suspension and topiramate technology, which is applied in liquid transportation, pharmaceutical formulations, dispersion liquid transportation, etc., can solve the problems of complex preparation process and achieve the effects of simple process, improved drug compliance and low cost

Inactive Publication Date: 2016-11-16
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process is more complicated

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

500.0

[0023] Preparation Process:

[0024] (1) Preparation of topiramate ion exchange resin composite particles: Add the prescribed amount of polysulfonylstyrene sodium ion resin into a mixer equipped with deionized water at a speed of 500 rpm, gradually add topiramate under stirring, and continue stirring for 3 hours until After the ion exchange is balanced, let it stand, filter, discard the filtrate to collect the filtrate, and dry it in a blast drying oven at 50°C. After drying, the composite particles pass through a 10-40 mesh sieve to obtain the topiramate ion exchange resin composite particles;

[0025] (2) Preparation of slow-release microparticles: Add the prescribed amount of composite microparticles, polyacrylic acid resin coating material, and propylene glycol into 50% ethanol solution under stirring to make the concentration 30%, 500rpm, and continue stirring for 1h until the dispersion is uniform. Spray drying, spray drying air inlet temperature 100 ~ 110 ...

Embodiment 2

500.0

[0029] Preparation Process:

[0030] (1) Preparation of topiramate ion exchange resin composite particles: Add the prescribed amount of polysulfonylstyrene sodium ion resin into a mixer equipped with deionized water at a speed of 500 rpm, gradually add topiramate under stirring, and continue stirring for 3 hours until After the ion exchange is balanced, let it stand, filter, discard the filtrate to collect the filtrate, and dry it in a blast drying oven at 50°C. After drying, the composite particles pass through a 10-40 mesh sieve to obtain the topiramate ion exchange resin composite particles;

[0031] (2) Preparation of slow-release microparticles: Add the prescribed amount of composite microparticles, polyacrylic acid resin coating material, and propylene glycol into 50% ethanol solution under stirring to make the concentration 30%, 500rpm, and continue stirring for 1h until the dispersion is uniform. Spray drying, spray drying air inlet temperature 100 ~ 110 ...

Embodiment 3

[0034] Raw materials

[0035] Preparation Process:

[0036] (1) Preparation of topiramate ion exchange resin composite particles: Add the prescribed amount of polysulfonylstyrene sodium ion resin into a mixer equipped with deionized water at a speed of 500 rpm, gradually add topiramate under stirring, and continue stirring for 3 hours until After the ion exchange is balanced, let it stand, filter, discard the filtrate to collect the filtrate, and dry it in a blast drying oven at 50°C. After drying, the composite particles pass through a 10-40 mesh sieve to obtain the topiramate ion exchange resin composite particles;

[0037] (2) Preparation of slow-release microparticles: Add the prescribed amount of composite microparticles, polyacrylic acid resin coating material, and propylene glycol into 50% ethanol solution under stirring to make the concentration 30%, 500rpm, and continue stirring for 1h until the dispersion is uniform. Spray drying, spray drying air inlet tem...

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Abstract

The invention discloses a sustained-release oral suspension containing topiramate and a preparation method of the oral suspension. The preparation (the oral suspension) consists of such ingredients as topiramate, ion exchange resin, a coating material, a suspension aid, a plasticizer, a preservative, a flavoring agent and the like. The preparation process comprises steps of preparing a drug-resin complex, and mixing the drug-resin complex with other additives, so that the sustained-release suspension is prepared. The topiramate sustained-release preparation provided by the invention, by virtue of an ion exchange technology, can mask bad taste of the topiramate; and meanwhile, the preparation, which is in the form of liquid, can be conveniently taken by patients having difficulty in swallowing, so that patients' compliance is significantly improved. The topiramate sustained-release preparation provided by the invention, after being taken, is stable in blood concentration which falls in between the peak concentration and the valley concentration of a quick-release preparation; and the sustained-release preparation can be used for effectively controlling the attack of epilepsy, and the occurrence rate of side and adverse reactions can be reduced.

Description

technical field [0001] The invention relates to a pharmaceutical preparation for treating epilepsy and a preparation method thereof, which belongs to medicine for neurosurgery diseases, and in particular to a topiramate sustained-release suspension and a preparation method thereof. Background technique [0002] Topiramate is a new broad-spectrum antiepileptic drug with multiple antiepileptic mechanisms and is effective for all kinds of epileptic seizures, especially for primary and secondary generalized tonic-clonic seizures and simple or complex partial seizures. It is also effective for myoclonus and infantile spasms. However, its therapeutic window is very narrow, and the fluctuation of blood drug concentration will cause many side effects. Therefore, in order to improve patient compliance and clinical administration needs, it is generally made into a sustained-release preparation. [0003] The chemical name of topiramate is 2,3:4,5-bis-O-(1-methylethylene)-β-D-fructopyr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/7048A61K9/50A61K47/32A61K47/38A61P25/08
CPCA61K9/0002A61K9/0095A61K9/5026A61K9/5042A61K31/7048A61K47/32
Inventor 刘冲马莉
Owner BEIJING VENTUREPHARM BIOTECH
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