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Hydrochloric acid dronedarone medicinal compositions for oral use and method for preparing the same

A technology of dronedarone hydrochloride and dronedarone, which is applied in the field of pharmaceutical compositions of salts, can solve the problems of complex manufacturing process and poor stability, and achieves the effect of solving the problem of dissolution rate

Inactive Publication Date: 2008-04-02
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method for improving the solubility of dronedarone hydrochloride has a complicated manufacturing process and may have poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] (1) The dronedarone hydrochloride is pulverized by a fluidized bed air flow to obtain micronized dronedarone hydrochloride with an average particle size of less than 15 nm;

[0042] (2) Sodium lauryl sulfate and polyvinylpyrrolidone k30 are completely dissolved in water, and then the micronized dronedarone hydrochloride obtained in (1) is suspended therein to obtain a suspension;

[0043] (3) Suspending the lactose in a fluidized bed granulator, spraying the suspension obtained in (2) into the lactose for granulation to obtain granules;

[0044] (4) Add microcrystalline cellulose PH101 and magnesium stearate to the granules obtained in step (3), and further compress them into tablets.

Embodiment 2

[0047] (1) Crushing dronedarone hydrochloride with a fluidized bed air flow to obtain micronized dronedarone hydrochloride with an average particle size greater than 15 μm and less than 50 μm;

[0048] (2) Sodium lauryl sulfate and polyvinylpyrrolidone k30 are completely dissolved in water, and then the micronized dronedarone hydrochloride obtained in (1) is suspended therein to obtain a suspension;

[0049] (3) Suspending the lactose in a fluidized bed granulator, spraying the suspension obtained in (2) into the lactose for granulation to obtain granules;

[0050](4) Add microcrystalline cellulose PH101 and magnesium stearate to the granules obtained in step (3), and further compress them into tablets.

Embodiment 3

[0053] (1) The dronedarone hydrochloride is pulverized by a fluidized bed air flow to obtain micronized dronedarone hydrochloride with an average particle size of less than 15 nm;

[0054] (2) Dissolving polyvinylpyrrolidone k30 completely in water, and then suspending the micronized dronedarone hydrochloride obtained in (1) to obtain a suspension;

[0055] (3) Suspending the lactose in a fluidized bed granulator, spraying the suspension obtained in (2) into the lactose for granulation to obtain granules;

[0056] (4) Add microcrystalline cellulose PH101 and magnesium stearate to the granules obtained in step (3), and further compress them into tablets.

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Abstract

The invention provides a solid drug combination, consisting of micronized hydrochlorid Dronedarone, surfactant and hydrophilic polymer which is used as cosolvent. The invention is mainly used to cure arrhythmia.

Description

technical field [0001] The present invention relates to a novel solid pharmaceutical composition, especially a pharmaceutical composition containing dronedarone or a pharmaceutically acceptable salt. Background technique [0002] The chemical name of Dronedarone is 2-n-butyl-3-[4-(3-di-n-butyl-aminopropoxy)benzoyl]-5-methylsulfabenzofuran, molecular formula for C 31 h 44 N 2 o 5 S, the molecular weight is 556.765. [0003] Dronedarone hydrochloride is a newly developed drug for treating arrhythmia by Sanofi-Synthelabo. This product is a benzofuran derivative without iodine. Its structure and characteristics are similar to those of amiodarone, but dronedarone does not contain iodine and has low lipophilicity, so it maintains the curative effect of amiodarone without amine Iodone has extracardiac adverse reactions, and the half-life is 1 to 2 days, which makes it easier to adjust the drug dose. [0004] Dronedarone hydrochloride has very low solubility in aqueous media,...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/343A61K47/38A61K47/34A61P9/06A61K47/10A61K47/32A61K47/42
Inventor 莫良侃
Owner BEIJING VENTUREPHARM BIOTECH
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