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Vigabatrin chewable tablet and preparation method thereof

A technology of vigabatrin and chewable tablets, which is applied in the field of preparation of vigabatrin chewable tablets, can solve the problems of inconvenient taking of vigabatrin oral preparations, and achieve poor drug compliance, good compliance, simple and reliable process The effect of the operation

Inactive Publication Date: 2018-05-11
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In view of this, the present invention provides a chewable tablet of vigabatrin to improve the inconvenience of taking vigabatrin oral preparations

Method used

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  • Vigabatrin chewable tablet and preparation method thereof
  • Vigabatrin chewable tablet and preparation method thereof
  • Vigabatrin chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Table 2

[0049] Element

Dosage for 1000 tablets (g)

mass percentage

Vigabatrin 160101

250

60％

Mannitol

110

26.4％

Aspartose

25

6％

Menthol

4

0.9％

iron dioxide

3

0.7％

hypromellose

12

2.8％

Sodium carboxymethyl starch

10

2.4％

Magnesium stearate

3

0.7％

[0050] Preparation Process

[0051] (1) Pass the auxiliary material through an 80-mesh sieve, and set aside;

[0052] (2) Weigh hypromellose, add 95% ethanol solution, stir and dissolve, and prepare 5% hypromellose solution as a binder.

[0053] (3) According to the mass percentage content of each component in the tablet in Table 2, take vigabatrin, mannitol, aspartose, menthol, iron dioxide, sodium starch glycolate and place in In the wet mixing granulator, mix for a few minutes until uniform, then add the prepared binder hydroxypropyl cellulose solution, cut and stir to make a soft material.

[0...

Embodiment 2

[0058] table 3

[0059] Element

Dosage for 1000 tablets (g)

weight percentage

Vigabatrin 160102

250

58.7％

Xylitol

70

16.4％

starch

30

7.0％

sodium saccharin

25

5.9％

Lemon Spice

6

1.4％

iron dioxide

3

0.7％

Low-substituted hydroxypropyl cellulose

16

3.8％

Polyvinylpyrrolidone

20

4.7％

silica

6

1.4％

[0060] Preparation Process

[0061] (1) Pass the auxiliary material through an 80-mesh sieve, and set aside;

[0062] (2) Weigh polyvinylpyrrolidone, add 95% ethanol solution, stir to dissolve, and prepare 8% adhesive solution.

[0063] (3) According to the mass percentage content of each component in the tablet in Table 3, weigh vigabatrin raw materials, xylitol, starch, sodium saccharin, lemon flavor, low-substituted hydroxypropyl cellulose and dioxide The iron is placed in a wet mixing granulator, mixed for a few minutes until uniform, then the p...

Embodiment 3

[0068] Table 4

[0069] Element

Dosage for 1000 tablets (g)

weight percentage

Vigabatrin 160103

100

40％

microcrystalline cellulose

100

40％

Cyclamate

15

6％

Taro Spice

4

1.6％

iron dioxide

2

0.8％

Hydroxypropyl Cellulose

14

5.6％

Crospovidone

10

4％

Magnesium stearate

5

2％

[0070] Preparation Process

[0071] (1) Pass the auxiliary material through an 80-mesh sieve, and set aside;

[0072] (2) Weigh hydroxypropyl cellulose, add 95% ethanol solution, stir and dissolve, and prepare 5% binder solution

[0073] (3) According to the mass percentage content of each component in the tablet in Table 4, weigh vigabatrin raw material, microcrystalline cellulose, cyclamate, taro flavor, iron dioxide and place it in wet mixing granulation In the machine, mix for a few minutes until uniform, then add an appropriate amount of 4% hypromellose solution binder, cut and sti...

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Abstract

The invention relates to the vigabatrin drug field, in particular to a vigabatrin chewable tablet and a preparation method thereof. The method includes: subjecting a prescription dosage of active ingredient and a pharmaceutically acceptable carrier to wet granulation, and conducting drying and size stabilization so as to obtain vigabatrin particles, and then performing tabletting to obtain the vigabatrin chewable tablet. The chewable tablet can be taken slowly by mouth chewing or sucking, has good taste, can be taken whenever and wherever possible without water, the drug can be taken conveniently, and the drug compliance is improved. At the same time, compared with oral particles, the vigabatrin chewable tablet has the characteristics of good stability and convenient production, transportation and carrying.

Description

technical field [0001] The invention relates to the field of vigabatrin medicines, in particular to a preparation method of vigabatrin chewable tablets. Background technique [0002] Vigabatrin, the chemical name is 4-amino-5-hexenoic acid. This product is an inhibitor of GABA aminotransferase. It is highly selective and inhibits this enzyme, thereby increasing the concentration of GABA in the brain and producing antiepileptic drugs. The role of; especially effective for drug-resistant partial-onset epilepsy. It is mainly used to prevent and treat petit mal seizures, and is the drug of choice; it is more effective for typical and compound petit mal seizures. Good curative effect can often be obtained by using this product when other drugs are ineffective. It is especially suitable for children with nodular epilepsy and myoclonic epilepsy. [0003] [0004] The vigabatrin tablets developed by Merrell Dow Pharmaceutical Company, which irreversibly inhibit GABA aminotrans...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/197A61P25/10
CPCA61K9/2095A61K9/0056A61K9/2059A61K9/2077A61K31/197
Inventor 梁静阁冯小路郭婷婷杨波郭亚兵
Owner WUHAN WUYAO SCI & TECH
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