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Topiramate composition

A technology of topiramate and composition, applied in the field of medical preparations, can solve the problems of no quality test comparison, large differences in the properties of stabilizers, etc., and achieve the effect of expanding the optional range and improving stability

Pending Publication Date: 2018-08-10
HEFEI COSOURCE PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The properties of these stabilizers are quite different, and there are no rules to follow. What the embodiment adopts is only calcium carbonate, and the test results are only related substances. no test
[0014] Therefore prior art tries to adopt control moisture, control packaging form, preparation process, and add calcium carbonate etc. to promote the stability of topiramate, most of them do not have comprehensive quality test comparison

Method used

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  • Topiramate composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1——alkaline stabilizer comparison

[0046] Preparation

[0047] The main steps of the preparation method of the topiramate composition include:

[0048] (1) Crushing and sieving the raw and auxiliary materials including topiramate, microcrystalline cellulose, lactose, pregelatinized starch, alkaline stabilizer and disintegrant, and mixing them uniformly to obtain a mixed powder.

[0049] (2) Add purified water to the mixed powder and knead to make a soft material, and pass through a 24-mesh sieve to make wet granules.

[0050] (3) The wet granules are dried and sieved through a 24-mesh sieve to obtain dry granules.

[0051] (4) Dry granules, glidants, and lubricants are mixed evenly, and then pressed into tablets and coated.

[0052] Alkaline stabilizer sample prescription and preparation method

[0053] Table 2

[0054] Dosage (per serving)

Prescription 1

Prescription 2

Prescription 3

Prescription 4

Topiramate

100mg ...

Embodiment 2

[0087] Embodiment 2—preferred prescription and reference preparation stability comparison

[0088] Detection method

[0089] Topiramate tablets are easily degraded under high temperature and high humidity conditions to produce sulfate and sulfamate, accompanied by obvious changes in properties. In this example, the stability of the preferred prescription sample and the reference preparation sample is compared with the traits as an index.

[0090] The following prescriptions are for the amount per tablet.

[0091] Preferred prescription sample preparation method

[0092] (1)

[0093] Topiramate 100mg

[0094] Microcrystalline Cellulose 65.7mg

[0095] Lactose 123.4mg

[0096] Sodium citrate 4.3mg

[0097] Pregelatinized starch 15mg

[0098] Sodium starch glycolate 9.6mg

[0099] Preparation method: weigh topiramate, microcrystalline cellulose, lactose, pregelatinized starch, sodium starch glycolate and mix evenly, dissolve sodium citrate with an appropriate amount of p...

Embodiment 3

[0169] Embodiment 3——tablet stability comparison

[0170] Table 13

[0171] Dosage (per serving)

[0172] Preparation method: Recipe 31 weighs topiramate, microcrystalline cellulose, lactose, pregelatinized starch, carboxymethyl starch sodium and mixes them evenly, dissolves sodium citrate with an appropriate amount of purified water, adds to the mixed powder, and kneads to make a soft material , through a 24-mesh sieve to make wet granules, dry at 60°C under normal pressure until the moisture content is ≤2%, after sizing through a 24-mesh sieve, add the prescribed amount of magnesium stearate to press the tablet core, and the hardness is about 90N.

[0173] Prescription 32 Weigh the prescribed amount of topiramate, microcrystalline cellulose, lactose, pregelatinized starch, sodium carboxymethyl starch, and calcium carbonate, mix evenly, and knead the mixed powder with water to make a soft material, pass through a 24-mesh sieve to make wet granules, and keep at 60°C ...

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Abstract

The invention relates to a medical preparation taking a special physical shape as a characteristic and in particular relates to a composition containing topiramate and a preparation method thereof. The topiramate composition provided by the invention is prepared from topiramate and an alkaline stabilizing agent, wherein the pH (Potential of Hydrogen) value of a water solution or suspension solution of the alkaline stabilizing agent is 7.0 to 10; the alkaline stabilizing agent can be dissolved into water or sulfate generated through reaction of the alkaline stabilizing agent and sulfuric acid can be dissolved into the water. By adopting the composition provided by the invention, the stability of the topiramate can be improved and the composition can bear higher water content, so that a selectable range of a packaging material of the composition is expanded; the rigidity of tablets prepared from the composition is also not influenced.

Description

technical field [0001] The present invention relates to medical preparations characterized by a specific physical shape, and also to pharmaceutical preparations containing organic active ingredients for the treatment of cardiovascular diseases. More particularly, it relates to compositions containing topiramate and methods for their preparation. Background technique [0002] Topiramate is a new antiepileptic drug with sulfamate instead of monosaccharide. In the electrophysiological and biochemical studies on neurons cultured in vitro, it was found that there are three mechanisms for the antiepileptic effect of topiramate: 1. Topiramate can block the repeated potential discharge caused by the continuous depolarization of neurons, which is similar to the effect of topiramate after using topiramate. Time is closely related, indicating that topiramate can block sodium channels; 2. Topiramate can increase the frequency of γ-aminobutyric acid (GABA) to activate GABAA receptors, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/02A61K47/12A61K31/7048A61K9/48A61K9/20A61K9/16A61P9/00A61P25/08
CPCA61P9/00A61P25/08A61K9/1611A61K9/1617A61K9/2009A61K9/2013A61K9/485A61K9/4858A61K31/7048
Inventor 张俊孙宏张程开生陈登俊
Owner HEFEI COSOURCE PHARMA CO LTD
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