A dronedarone hydrochloride composition

A technology of dronedarone hydrochloride and dronedarone hydrochloride tablets, applied in the field of medicine, can solve problems such as occurrence of splits, fragments, influence on drug safety and effective use, etc., and achieve the effect of convenient transportation and storage

Active Publication Date: 2019-09-13
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] It was found in actual work that dronedarone hydrochloride tablets with a tablet weight of 600mg or less had cracks in the fr...

Method used

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  • A dronedarone hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Dronedarone Hydrochloride 400g, Sodium Lauryl Sulfate 2g, Lactose 90g, Hypromellose 16.8g, Crospovidone 10g, Silicon Dioxide 6.48g, Magnesium Stearate 6.48g , prepare 1000 tablets as follows.

[0025] (1) Co-micronize dronedarone hydrochloride and sodium lauryl sulfate with a jet mill, the particle size D90 after micronization is 5um, and set aside.

[0026] (2) Weigh the prescribed amount of hypromellose and add it into the prescribed amount of purified water to prepare a 7% aqueous solution of hypromellose (W / W), stir and dissolve until evenly mixed, and set aside.

[0027] (3) Weigh the co-micronized material and other auxiliary materials prepared in the first step according to the specification ratio, put them into the one-step granulator, turn on the fan and heat to make the material evenly heated in the fluidized state, turn on the spray button, and spray into the viscous Mixture, adjust the liquid inlet speed, atomization pressure, inlet air temperatu...

Embodiment 2

[0030] Example 2: 400 g of dronedarone hydrochloride, 5 g of polyethylene glycol 4000, 120 g of lactose, 16.8 g of hydroxypropylmethylcellulose, 10 g of crospovidone, 6.41 g of silicon dioxide, and 6.41 g of magnesium stearate. According to Example 1, dronedarone hydrochloride and polyethylene glycol 4000 were co-micronized, and the particle size D90 after micronization was 10 um. The preparation method prepared 1000 tablets.

Embodiment 3

[0031] Example 3, Dronedarone Hydrochloride 400g, Sodium Lauryl Sulfate 3g, Lactose 100g, Crospovidone 10g, Hypromellose 16.8g, Silicon Dioxide 6.4g, Magnesium Stearate 6.4g According to the preparation method of Example 1, dronedarone hydrochloride and sodium lauryl sulfate were micronized, and the particle size D90 after micronization was 8um, and 1000 tablets were prepared.

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Abstract

The invention relates to a solid preparation composition containing a benzofurane derivative and a preparation method thereof and belongs to the technical field of medicines. The technical scheme is that a dronedarone hydrochloride composition is characterized in that dronedarone hydrochloride and a surfactant undergo co-micronization to D90 5-10[mu]m. Through a co-micronization technology of dronedarone hydrochloride and the surfactant, a rational formula and a preparation method, a stable tablet is obtained. The tablet which is moderate in weight and convenient to transport and store is provided clinically.

Description

technical field [0001] The invention relates to a solid preparation composition containing benzofuran derivatives and a new preparation process thereof, belonging to the technical field of medicine. Background technique [0002] Dronedarone, the chemical name is 2-n-butyl-3-[4-(3-di-n-butyl-aminopropoxy)benzoyl]-5-methylsulfabenzofuran, Molecular formula is C 31 h 44 N 2 o 5 S, the molecular weight is 556.765. [0003] Dronedarone hydrochloride is the first drug developed by Sanofi-Synthelabo to treat arrhythmia. It is similar in structure to amiodarone, but does not contain iodine, has increased methylsulfonyl group, has weak lipophilicity, reduces its iodine-derived organ toxicity, shortens half-life, and reduces the tissue accumulation of drugs. [0004] The active ingredient content of dronedarone hydrochloride tablets is 400 mg, which belongs to large-scale drugs. In order to facilitate swallowing, it is generally necessary to control the weight of the tablet, th...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/343A61K47/10A61K47/20A61J3/06A61P9/06
Inventor 张丽丽蔡亚辉邹元华
Owner DISHA PHARMA GRP
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