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Dronedarone hydrochloride dispersible tablet and preparing method thereof

A technology of dronedarone hydrochloride and dispersible tablets, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2018-05-18
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Arrhythmia often troubles many patients and doctors, especially the clinical application of amiodarone, because it has a good effect on the control of many premature ventricular contractions, atrial fibrillation or atrial flutter, but the long-term The application of it makes its side effects a fly in the ointment, especially it causes liver, lung, thyroid and cornea etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0008] Preparation Process:

[0009] Grind dronedarone hydrochloride through a 200-mesh sieve, then mix it with 22 times the weight of lactose through an 80-mesh sieve for 3 times, add the remaining lactose, microcrystalline cellulose and sodium carboxymethyl starch, pass through an 80-mesh sieve for 3 times and mix evenly. % hydroxypropyl cellulose as binder, granulated with 24 mesh sieve, air-dried at 50 ℃, dried to 1~3% moisture, passed through 24 mesh sieve for granulation, weighed, converted yield, plus Sodium carboxymethyl starch, silicon dioxide, aspartame, mint flavor and magnesium stearate, Φ8 flat punched tablets, tablet weight 300 mg, hardness 20-40N.

Embodiment 2

[0011] Preparation Process:

[0012] Grind dronedarone hydrochloride through a 200-mesh sieve, then mix it with 23 times the weight of mannitol through an 80-mesh sieve for 3 times, add the remaining mannitol, microcrystalline cellulose and sodium carboxymethyl starch, pass through an 80-mesh sieve 3 times and mix well , 2% hydroxypropyl cellulose as binder, granulated with 24 mesh sieve, air-dried at 50 ℃, dried to 1~3% moisture, passed the dried granules through 24 mesh sieve for granulation, weighed, converted yield , plus sodium carboxymethyl starch, silicon dioxide, aspartame, mint essence and magnesium stearate, Φ8 flat punched tablets, tablet weight 300 mg, hardness 20-40 N.

Embodiment 3

[0014] Preparation Process:

[0015] Grind dronedarone hydrochloride through a 200-mesh sieve, then mix it with 33 times the weight of lactose through an 80-mesh sieve for 5 times, add the remaining lactose, microcrystalline cellulose and sodium carboxymethyl starch, pass through an 80-mesh sieve for 3 times and mix evenly. % hydroxypropyl cellulose as binder, granulated with 24 mesh sieve, air-dried at 50 ℃, dried to 1~3% moisture, passed through 24 mesh sieve for granulation, weighed, converted yield, plus Sodium carboxymethyl starch, silicon dioxide, aspartame, mint flavor and magnesium stearate, Φ8 flat punched tablets, tablet weight 300 mg, hardness 20-40N.

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PUM

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Abstract

The invention discloses a preparing method of a dispersible tablet containing a dronedarone hydrochloride and hydrophilic material commixture. The dispersible tablet contains the dronedarone hydrochloride and hydrophilic material commixture and other pharmaceutically-accepted auxiliaries. The dispersible tablet is prepared through wet-method granulating and tabletting and is good in dispersing uniformity; the dissolution speed of a dronedarone hydrochloride solid preparation can be effectively improved, the medicine-taking compliance of a patient and the bioavailability of the medicine are improved, the process is simple, and the method is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a technology for improving the dissolution rate of dronedarone hydrochloride in solid preparations and a method for preparing solid preparation dispersible tablets. Background technique [0002] Dronedarone is a new antiarrhythmic drug developed by Sanofi-Aventis in France, registered in the United States and the European Union, and approved for clinical use in my country in July 2006. Arrhythmia often troubles many patients and doctors, especially the clinical application of amiodarone, because it has a good effect on the control of many premature ventricular contractions, atrial fibrillation or atrial flutter, but the long-term The application of it makes its side effects incur a fly in the ointment, especially it causes liver, lung, thyroid and cornea and so on. The drug has similar electrophysiological effects to amiodarone and is an alternati...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/343A61K47/26A61K47/36A61K47/32A61P9/06
CPCA61K31/343A61K9/0095A61K9/2018A61K9/2027A61K9/2059
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司