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Dronedarone hydrochloride orally disintegrating tablet and preparing method thereof

A technology for dronedarone hydrochloride and orally disintegrating tablets is applied in the field of orally disintegrating tablets containing dronedarone hydrochloride and the field of preparation thereof, and achieves the effects of good promotion prospects, short disintegration time and less toxic and side effects

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

[0026] Ingredient Name Weight Percentage (%) Dronedarone Hydrochloride 10% Mannitol 50% Lactose 30% Sodium Carboxymethyl Starch 10% Povidone 3% Aspartame 1% Micronized Silica Gel 1% Magnesium Stearate 1%

[0027] Preparation:

[0028] (1) Micronize dronedarone hydrochloride, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0029] (2) After sieving and mixing dronedarone hydrochloride, mannitol, lactose, carboxymethyl starch sodium with a prescribed amount of 5%, and aspartame, add an aqueous solution of povidone with a concentration of 20% of the prescribed amount, preparation of soft materials;

[0030] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0031] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of sodium carboxymethyl starch to the dry granules obtained in (3), and mix wel...

Embodiment 2

[0034] Ingredient Name Weight Percentage (%) Dronedarone Hydrochloride 12% Mannitol 45% Lactose 25% Croscarmellose Sodium 10% Hydroxypropyl Cellulose 2% Aspartame 2% Magnesium Stearate 1%

[0035] Preparation:

[0036] (1) Micronize dronedarone hydrochloride, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0037] (2) After sieving and mixing dronedarone hydrochloride, mannitol, lactose, 5% croscarmellose sodium and aspartame in the prescription amount, add hydroxypropyl alcohol with a prescription amount of 25% Cellulose ethanol aqueous solution to prepare soft materials;

[0038] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0039] (4) Add magnesium stearate and the remaining amount of croscarmellose sodium to the dry granules obtained in (3), and mix well;

[0040] (5) Determining the content of intermedia...

Embodiment 3

[0042] Ingredient Name Weight Ratio (%) Dronedarone Hydrochloride 15% Mannitol 40% Xylitol 31% Crospovidone 6% Hydroxypropyl Cellulose 4% Aspartame 2% Lemon Flavor 1% Micronized Silica Gel 1 % Magnesium Stearate 1%

[0043] Preparation:

[0044] (1) Micronize dronedarone hydrochloride, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0045] (2) After sieving and mixing dronedarone hydrochloride, mannitol, xylitol, crospovidone with a prescribed amount of 3%, aspartame, and lemon essence, add hydroxy Propyl cellulose ethanol aqueous solution to prepare soft materials;

[0046] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0047] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of crospovidone to the dry granules obtained in (3), and mix well;

[0048] (5) Determining the content of...

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Abstract

The invention discloses a dronedarone hydrochloride orally disintegrating tablet and a preparing method thereof. The orally disintegrating tablet is a pharmaceutical composition containing dronedaronehydrochloride, a filling agent, a disintegrating agent, a wetting agent, an adhesive, a corrigent and a lubricant. The wet-method granulating and tabletting method is adopted in the preparing method.The dronedarone hydrochloride orally disintegrating tablet is simple in preparing process, low in cost, convenient to take, rapid in effect and high in bioavailability, and the medicine-taking compliance of a patient can be improved due to the dosage form.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing dronedarone hydrochloride and a preparation method thereof. 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 alternative to the latter because it does not contain iodine. Therefore, it will not cause adv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/26A61K47/36A61K47/38A61K47/32A61P9/06
CPCA61K31/343A61K9/0056A61K9/2018A61K9/2027A61K9/2054A61K9/2059
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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