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A dronedarone hydrochloride tablet and preparation method thereof

A technology of dronedarone hydrochloride tablet and dronedarone hydrochloride, which is applied in the directions of pill delivery, cardiovascular system diseases, drug combination, etc., can solve problems such as complicated process, achieve simple preparation process, increase safety and operation handy effect

Active Publication Date: 2016-09-07
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using solvent precipitation technology, the drug is deposited on the surface of the inert carrier to increase the surface area, thereby increasing the dissolution rate, but the process is more complicated

Method used

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  • A dronedarone hydrochloride tablet and preparation method thereof
  • A dronedarone hydrochloride tablet and preparation method thereof
  • A dronedarone hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation Process:

[0028] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix them with microcrystalline cellulose and crospovidone evenly, add half the amount of calcium stearate, and dry process Granules, the remaining amount of calcium stearate is added to the granules, mixed and compressed into tablets.

Embodiment 2

[0030]

[0031] Preparation Process:

[0032] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix with lactose and crospovidone evenly, add half the amount of magnesium stearate, dry granulate, granulate Add the remaining amount of magnesium stearate to the mixture, mix and compress into tablets.

Embodiment 3

[0034]

[0035]

[0036] Preparation Process:

[0037] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix them with microcrystalline cellulose and sodium carboxymethyl starch, add pure water to granulate, dry, and granulate Add magnesium stearate, mix and compress into tablets.

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Abstract

The invention belongs to the field of pharmaceutical preparations, in particular to a surfactant-free dronedarone hydrochloride tablet. Contains the following components by mass: 400 parts of dronedarone hydrochloride, 100-1200 parts of hydroxypropyl methylcellulose, 20-640 parts of disintegrant, 7-10 parts of lubricant, excluding Surfactant. The technical scheme of the present invention does not add any surfactant, which not only increases the safety, but also avoids the problem of low melting point of the surfactant and easy sticking during the production process of the preparation, and at the same time significantly improves the dissolution rate of dronedarone hydrochloride . During the preparation process, dronedarone hydrochloride and hydroxypropyl methylcellulose are pulverized together until the particle size is not greater than 1 μm, and then made into tablets with other suitable auxiliary materials. The process is relatively simple, the operation is convenient, and it is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a dronedarone hydrochloride tablet, more specifically, to a dronedarone hydrochloride tablet without a surfactant. Background technique [0002] Dronedarone hydrochloride (dronedarone hydrochloride), the chemical name is 2-n-butyl-3-[4-(3-di-n-butyl-aminopropoxy)benzoyl]-5-methylsulfabenzoyl Furan hydrochloride, CAS: 141625-93-6, is a newly developed drug for the treatment of arrhythmia by Sanofi-Aventis. In 2009, it was approved by the US FDA and Europe for the treatment of paroxysmal or persistent atrial fibrillation. [0003] Dronedarone hydrochloride has very low solubility in aqueous media, especially its solubility is pH-dependent at room temperature, and has a maximum solubility in the range of pH 3 to 5, which is about 1-2mg / ml, and at pH about 6 The solubility becomes very low at pH=7, and the solubility is only 10 μg / ml at pH=7. [0004] Because of its diss...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/38A61P9/06
Inventor 赵志全郝贵周程战立
Owner SHANDONG NEWTIME PHARMA
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