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Solid medicine composition containing dronedarone

A technology of dronedarone and a composition, applied in the field of oral solid pharmaceutical compositions, can solve the problems of complex process, large dosage, difficulty in mass production and the like

Active Publication Date: 2013-06-05
BEIJING HONGWAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the amount of amphiphilic lipid surfactant and phospholipid needs to be large to meet the solubility requirements, and organic solvents and heating and dissolving are required to change the original crystal form of dronedarone in the process. Therefore, the process is complicated and difficult Mass production on general industrial production lines

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Dronedarone hydrochloride tablet.

[0027] Dronedarone hydrochloride tablets were prepared according to the following formula.

[0028] Element Dosage (mg) Percentage (%) Dronedarone Hydrochloride 426 71.0 lactose monohydrate 30 5.0 pregelatinized starch 30 5.0 microcrystalline cellulose 20 3.3 hypromellose 30 5.0 Glycerol 50 8.3 Crospovidone 10 1.7 Magnesium stearate 4 0.7 ———— 600 100

[0029] The process method is as follows:

[0030] After sieving each solid material respectively, mix 426g dronedarone hydrochloride, 30g lactose monohydrate, 20g microcrystalline cellulose, 30g pregelatinized starch, 30g hypromellose and 10g crospovidone Uniform; wet the mixture with glycerol aqueous solution, granulate with a 16-mesh sieve, dry at a temperature of 50°C, and arrange and sieve with a 18-mesh sieve. After mixing 4 g of magnesium stearate with the granules, the tablets are finally ...

Embodiment 2

[0032] The dronedarone hydrochloride tablet with the same formulation as in Example 1 was prepared by the following process.

[0033] After sieving each solid material respectively, 426g dronedarone hydrochloride, 30g lactose monohydrate, 20g microcrystalline cellulose, 30g pregelatinized starch, 50g glycerol and 10g crospovidone were mixed uniformly; The mixture is moistened with an aqueous solution of hydroxypropylmethylcellulose, granulated with a 16-mesh sieve, dried at a temperature of 50°C, and sieved with a 18-mesh sieve. After mixing 4 g of magnesium stearate with the granules, the tablets are finally compressed with a tablet weight of 600 mg per tablet.

[0034] This granulation process can also be carried out in equipment with a fluidized bed.

Embodiment 3

[0036] After sieving each solid material respectively, mix 426g dronedarone hydrochloride, 30g lactose monohydrate, 20g microcrystalline cellulose, 30g pregelatinized starch, 30g hypromellose and 10g crospovidone Uniform; wet the mixture with glycerol aqueous solution, granulate with a 16-mesh sieve, dry at a temperature of 50°C, and arrange and sieve with a 18-mesh sieve. After mixing 4 g of magnesium stearate with the granules, the tablets are finally compressed with a tablet weight of 600 mg per tablet.

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PUM

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Abstract

The invention relates to a solid medicine composition containing dronedarone. The solid medicine composition containing dronedarone is characterized by containing the dronedarone for resisting arrhythmia or pharmacal acceptable salt serving as one active ingredient, and pharmacal acceptable polyhydroxy-alcohol. The solid medicine composition can be combined with one or more drug excipient.

Description

technical field [0001] The present invention relates to a novel oral solid pharmaceutical composition, which contains dronedarone or a pharmaceutically acceptable salt as an active ingredient. Background technique [0002] Dronedarone hydrochloride is a drug for the treatment of arrhythmia first developed by Sanofi-Synthelabo. This product is a benzofuran derivative without iodine. The lipid is low, so the curative effect of amiodarone is maintained, and there is no extracardiac adverse reaction of amiodarone, and the half-life is 1-2 days, which is more convenient for adjusting the dosage of the drug. [0003] The solubility of dronedarone hydrochloride in aqueous media is very low, especially its solubility is pH-dependent at room temperature, and the solubility is the largest in the range of pH 3 to 5, about 1-2 mg / ml, and about 6-7 at pH The solubility at pH 7 is very low, and the solubility at pH 7 is only 10ug / ml. [0004] Because of the dissolution characteristics o...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K9/20A61K9/48A61K31/343A61K47/10A61P9/06
Inventor 不公告发明人
Owner BEIJING HONGWAN PHARMA TECH
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