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Topiramate pharmaceutical composition

A composition and a technology for topiramate, which are applied in the field of topiramate pharmaceutical compositions and their preparation, can solve the problems that tablets are prone to splitting, the operation process is cumbersome, the preparation method is cumbersome and the like, and the quality and safety are guaranteed, and the process is simple and convenient. Effects of storage and transportation

Active Publication Date: 2015-11-04
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to improve the stability of the topiramate preparation and prevent the degradation of the topiramate active ingredient, WO01 / 89445 discloses a topiramate blister pack without a desiccant, which includes a disc-shaped sheet for placing a pre-dried topiramate chamber and a sealing The cover plate of the disk-shaped flakes, most of the topiramate tablets currently on the market are packed in the described blister packs, but these packs are relatively expensive and the operation process is loaded down with trivial details; CN1726011 discloses a dual or multi-phase tablet containing topiramate and its preparation method, one phase of the tablet contains topiramate, and the other phase contains a hygroscopic gum material selected from alginate, gum arabic or xanthan gum. The preparation method of this tablet is cumbersome, easy to separate, and has low dissolution rate; WO2006 / 097946 discloses a topiramate tablet containing 5%-35% topiramate and 25%-70% spray-dried mannitol granules in a weight ratio. The tablet is prepared by a direct compression method, and the tablet prepared by this method is prone to splitting, poor content uniformity

Method used

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  • Topiramate pharmaceutical composition
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  • Topiramate pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Topiramate 20mg

[0035] Pregelatinized Starch 42mg

[0036] Sodium carboxymethyl starch 1.2mg

[0037]Preparation method: Weigh topiramate, pregelatinized starch, and sodium carboxymethyl starch in the prescribed amount, pulverize them separately, sieve, and mix evenly to prepare a mixed powder, use a dry granulator to make the mixed powder into large pieces, pulverize, and collect 250 μm Granules between -550μm and drug-containing granules are prepared, and the rest of the materials continue to dry granulate until the proportion of collected particles between 250μm and 550μm exceeds 75%, and they are compressed into tablets or loaded into capsules.

Embodiment 2

[0039] Topiramate 28mg

[0040] Pregelatinized Starch 56mg

[0041] Low-substituted hydroxypropyl cellulose 2.7mg

[0042] Prepare according to the method in Example 1.

Embodiment 3

[0044] Topiramate 30mg

[0045] Pregelatinized starch 60mg

[0046] Sodium carboxymethyl starch 2.0mg

[0047] Low-substituted hydroxypropyl cellulose 1.0mg

[0048] Prepared according to the method in Example 1.

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Abstract

The invention relates to a pharmaceutical composition of topiramate. Pregelatinized starch is added to the composition to increase the stability of the active ingredient of topiramate, thereby ensuring the quality and safety of the composition; the pregelatinized starch also plays a role in the composition. The role of the dry binder ensures the hardness and friability of the composition, reduces the amount of auxiliary materials, and saves costs; the invention also relates to a preparation method for the topiramate composition, which includes a dry granulation process, and the method is simple in process , After granulation, the finished product has a uniform particle size, which is convenient for storage and transportation, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a topiramate pharmaceutical composition and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Epilepsy is a neurological disease, usually brain dysfunction caused by sudden abnormal excessive discharge of brain cells caused by brain lesions. It is estimated that the incidence of epilepsy in different populations around the world is about 0.3% to 0.5%, and the prevalence is about With 5 to 10 people in every 1000 people, epilepsy seriously threatens people's health and affects people's daily life. [0003] Topiramate, a new type of antiepileptic drug that replaces monosaccharides with sulfamic acid esters, was developed by Johnson & Johnson in the United States and was launched in the UK under the trade name Topamax in 1995. In the electrophysiological and biochemical studies on neurons cultured in vitro, it was found that there are three mechanisms for the antiep...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/7048A61K47/38A61K47/36A61P25/08
Inventor 马跃中梅喆胡晓虎耿玉先
Owner BEIJING WINSUNNY PHARMA CO LTD
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