Bedaquiline medicinal preparation

A technology of bedaquiline pharmacy and bedaquiline, which is applied in the direction of antibacterial drugs, pill delivery, pharmaceutical formulations, etc., can solve the problems of poor dissolution effect of bedaquiline, and achieve increased bioavailability and high dissolution rate , good dissolution effect

Active Publication Date: 2020-11-06
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention provides a kind of bedaquiline pharmaceutical preparation, aims at overcoming the problem that bedaquiline dissolution effect is poor

Method used

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  • Bedaquiline medicinal preparation
  • Bedaquiline medicinal preparation
  • Bedaquiline medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]

[0023] Preparation:

[0024] (1) Preparation of bedaquiline solid composition:

[0025] (i) fumaric acid and hypromellose were added to 220mL of ethanol aqueous solution containing 80% ethanol and dissolved to make a mixed solution;

[0026] (ii) In the bedaquiline fumarate of 38 μm in the particle diameter d0.9 placed in the fluidized bed, spray the above-mentioned mixed solution, granulate, dry, and granulate to obtain the bedaquiline solid composition , wherein, the weight ratio of particles with a particle size smaller than 150 μm in the solid composition is 60% (w / w).

[0027] (2) Preparation of bedaquiline preparation:

[0028] The bedaquiline pharmaceutical preparation is obtained by mixing the above-mentioned bedaquiline solid composition with lactose, sodium carboxymethyl starch and magnesium stearate and pressing into tablets.

Embodiment 2

[0030]

[0031] Preparation:

[0032] (1) Preparation of bedaquiline solid composition:

[0033] (i) adding sorbic acid and sodium carboxymethyl cellulose to 240 mL of aqueous ethanol containing 50% ethanol and dissolving it into a mixed solution;

[0034] (ii) In the bedaquiline fumarate of 50 μm in the particle diameter d0.9 placed in the fluidized bed, spray the above mixed solution, granulate, dry, and granulate to obtain the bedaquiline solid composition , wherein, the weight ratio of particles with a particle size smaller than 150 μm in the solid composition is 63.6% (w / w).

[0035] (2) Preparation of bedaquiline preparation:

[0036] The bedaquiline pharmaceutical preparation is obtained by mixing the above-mentioned bedaquiline solid composition with microcrystalline cellulose, lactose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and magnesium stearate, and pressing into tablets.

Embodiment 3

[0038]

[0039]

[0040] Preparation:

[0041] (1) Preparation of bedaquiline solid composition:

[0042] (i) adding malic acid and hydroxypropyl cellulose to 250 mL of ethanol aqueous solution containing 70% ethanol and dissolving to make a mixed solution;

[0043] (ii) In the bedaquiline fumarate of 46 μm in the particle diameter d0.9 placed in the fluidized bed, spray the above mixed solution, granulate, dry, and granulate to obtain the bedaquiline solid composition , wherein, the weight ratio of particles with a particle size smaller than 150 μm in the solid composition is 68.9% (w / w).

[0044] (2) Preparation of bedaquiline preparation:

[0045] The above-mentioned bedaquiline solid composition is mixed with microcrystalline cellulose, lactose, crospovidone, croscarmellose sodium and sodium stearyl fumarate to obtain the bedaquiline drug preparation.

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Abstract

The invention provides a bedaquiline medicinal preparation which comprises a bedaquiline solid composition and accessories. The bedaquiline solid composition comprises bedaquiline or pharmaceuticallyacceptable salt thereof, an acidifier and an adhesive. The bedaquiline medicinal preparation prepared by the invention aims to solve a problem of poor dissolving effect of the bedaquiline and has a good dissolution rate; quality of the obtained product meets standards and requirements; and the bedaquiline medicinal preparation is suitable for industrial large-scale production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation for treating pulmonary tuberculosis, specifically bedaquiline pharmaceutical preparation, and a preparation method of the pharmaceutical preparation. Background technique [0002] Bedaquiline Fumarate (Bedaquiline Fumarate) is a new type of drug for the treatment of multidrug-resistant tuberculosis developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. In December 2012, FDA approved bedaquiline fumarate tablets to be launched in the United States. At present, the drug has been marketed in many countries around the world, including the United States, Europe, and Japan. In November 2016, the National Medical Products Administration (NMPA) approved the import and marketing of bedaquiline fumarate tablets in my country. The drug is a diarylquinoline anti-mycobacterial drug. It is suitable for the treatment of adults (≥18 years old) with multidrug-resistant tuberculosis (MDR-TB), and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K47/38A61K47/32A61K9/16A61K9/20A61K31/47A61P31/06
CPCA61K47/12A61K47/38A61K47/32A61K9/1617A61K9/1652A61K9/1682A61K9/2013A61K9/2054A61K9/2027A61K9/2095A61K31/47A61P31/06
Inventor 陈海建刘营营高健龙郑雪静耿玉先产运霞
Owner BEIJING WINSUNNY PHARMA CO LTD
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