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Bosentan tablet composition

A composition and technology for tablets, applied in the field of bosentan compositions, can solve the problems of loose tablets, drug quality risks, and related substances, etc. Effects of Dissolution Requirements

Inactive Publication Date: 2019-03-19
WEIHAI YUNRUI INFORMATION TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this patent solves the problem of improving dissolution without crushing, the stability test found that during long-term storage, the tablet becomes loose and the related substances become higher, which poses a certain risk to the quality of the drug

Method used

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  • Bosentan tablet composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1. Bosentan 62.5g, anhydrous lactose 78g, calcium hydrogen phosphate 8g, mannitol 10g, sodium lauryl sulfate 0.1g, micropowder silica gel 12g, microcrystalline cellulose 20g, croscarmellose Sodium 1.5g, magnesium stearate 0.8g. Prepare 1000 tablets according to the preparation method described in the technical scheme of this specification.

Embodiment 2

[0018] Example 2. Bosentan 62.5g, anhydrous lactose 48g, calcium hydrogen phosphate 16g, mannitol 20g, sodium lauryl sulfate 0.8g, micropowder silica gel 8g, microcrystalline cellulose 32g, croscarmellose Sodium 1.5-4g, magnesium stearate 0.8-1.6g. Prepare 1000 tablets according to the preparation method described in the technical scheme of this specification.

Embodiment 3

[0019] Example 3. Bosentan 62.5g, anhydrous lactose 67g, calcium hydrogen phosphate 12g, mannitol 15g, sodium lauryl sulfate 0.7g, micropowder silica gel 11g, microcrystalline cellulose 28g, croscarmellose Sodium 2.5g, magnesium stearate 1.3g. Prepare 1000 tablets according to the preparation method described in the technical scheme of this specification.

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Abstract

The invention relates to bosentan tablet composition and belongs to the technical field of pharmacy. The bosentan tablet composition is composed of, by weight per 1000 tablets, 62.5 g of bosentan, 48-78 g of lactose anhydrous, 8-16 g of calcium bicarbonate, 10-20 g of mannitol, 0.1-0.8 g of lauryl sodium sulfate, 8-12 g of superfine silica powder, 20-32 g of microcrystalline cellulose, 1.5-4 g ofcrossarmellose sodium and 0.8-1.6 g of magnesium stearate. The bosentan tablet composition can meet the requirements on dissolution rate and meanwhile solve the problems of tablet loosening and related substance content increasing during storage.

Description

technical field [0001] The invention relates to a bosentan composition and belongs to the technical field of pharmacy. Background technique [0002] Pulmonary arterial hypertension (PAH) is a rare disease that is very unfamiliar to the general public but extremely malignant. About 15 to 25 people in every million people will suffer from this disease. It can occur in any age and gender, usually more than 70% of the patients are young, and the incidence rate of women is about 2 times higher than that of men. The onset of the disease is insidious and the development is relatively slow. The patient's earliest symptoms are usually shortness of breath, fatigue, and palpitations during physical activity. As the disease progresses, patients may even experience chest pain, cough, hemoptysis, and syncope. If the correct diagnosis and targeted treatment cannot be obtained in time, most patients will die within 2 to 3 years or even less. Therefore, PAH is called "malignant tumor in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/02A61K47/26A61K31/506A61P11/00A61P9/12
CPCA61K9/2009A61K9/2018A61K31/506A61P9/12A61P11/00
Inventor 孙学胜
Owner WEIHAI YUNRUI INFORMATION TECH CO LTD
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