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Preparation method of dronedarone hydrochloride tablets

A technology of dronedarone hydrochloride tablets and dronedarone hydrochloride, which is applied in the field of medicine and can solve problems such as low melting point of poloxamers and easy sticking, etc.

Inactive Publication Date: 2016-03-23
QINGDAO HISER MEDICAL CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, poloxamer has a low melting point and is prone to sticking and punching during tablet compression. The patent does not propose an effective solution to the problem of sticking and punching

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Poloxamer 42.6g

[0031] KollicoatIR127.8g

[0032] Ethanol 1000g

[0033] Dronedarone hydrochloride 426g (contains dronedarone 400g)

[0034] Lactose 100g

[0035] Crospovidone 20g

[0036] Appropriate amount of 50% ethanol solution

[0037] Magnesium stearate 6g

[0038] Preparation Process

[0039] (1) Poloxamer and KollicoatIR were dissolved in ethanol, dried at 40°C to remove ethanol, and sieved to obtain the KollicoatIR-coated poloxamer mixture (1).

[0040] (2) Dronedarone hydrochloride, lactose, and crospovidone were all passed through a 100-mesh sieve, mixed uniformly, an appropriate amount of 50% ethanol solution was added, granulated, and dried at 50°C to obtain the mixture (2).

[0041] (3) Prescription amount Weigh the mixture (1) and (2), add magnesium stearate, mix, and compress into tablets to obtain.

Embodiment 2

[0043] Poloxamer 127.8g

[0044] KollicoatIR127.8g

[0045] Ethanol 2000g

[0046] Dronedarone hydrochloride 426g (contains dronedarone 400g)

[0047] Lactose 100g

[0048] Microcrystalline cellulose 80g

[0049] Crospovidone 20g

[0050] Appropriate amount of 50% ethanol solution

[0051] Magnesium stearate 6g

[0052] Preparation Process

[0053] (1) Poloxamer and KollicoatIR were dissolved in ethanol, dried at 40°C to remove ethanol, and sieved to obtain the KollicoatIR-coated poloxamer mixture (1).

[0054] (2) Dronedarone hydrochloride, lactose, microcrystalline cellulose, and crospovidone were all passed through a 100-mesh sieve, mixed evenly, an appropriate amount of 50% ethanol solution was added, granulated, and dried at 50°C to obtain the mixture (2).

[0055](3) Prescription amount Weigh the mixture (1) and (2), add magnesium stearate, mix, and compress into tablets to obtain.

Embodiment 3

[0057] Poloxamer 85.2g

[0058] KollicoatIR170.4g

[0059] Ethanol 1500g

[0060] Dronedarone hydrochloride 426g (contains dronedarone 400g)

[0061] Mannitol 100g

[0062] Croscarmellose Sodium 25g

[0063] Appropriate amount of 40% ethanol solution

[0064] Magnesium stearate 6g

[0065] Preparation Process

[0066] (1) Poloxamer and KollicoatIR were dissolved in ethanol, dried at 40°C to remove ethanol, and sieved to obtain the KollicoatIR-coated poloxamer mixture (1).

[0067] (2) Dronedarone hydrochloride, mannitol, and croscarmellose sodium were all passed through a 100-mesh sieve, mixed evenly, an appropriate amount of 40% ethanol solution was added, granulated, and dried at 50°C to obtain the mixture (2).

[0068] (3) Prescription amount Weigh the mixture (1) and (2), add magnesium stearate, mix, and compress into tablets to obtain.

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PUM

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Abstract

The invention discloses a preparation method of dronedarone hydrochloride tablets. The preparation method includes the steps that firstly, poloxamer and Kollicoat IR are dissolved in ethanol, ethanol is removed through drying, screening is performed, and a poloxamer mixture (1) wrapped by Kollicoat IR is obtained; secondly, dronedarone hydrochloride, a disintegrating agent and a filling agent are evenly mixed, granulation is performed, drying is performed, and a mixture (2) is obtained; thirdly, the mixture (1) and the mixture (2) are evenly mixed, a proper amount of magnesium stearate is added, and the dronedarone hydrochloride tablets are obtained through mixing and tabletting.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of dronedarone hydrochloride tablets. Background technique [0002] Dronedarone hydrochloride (Dronedarone) is an analogue of amiodarone, the chemical name is N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]phenyl]-5-benzene And furyl]-methanesulfonamide hydrochloride. It is a class III antiarrhythmic new drug, which has blocking effects on calcium, potassium, and sodium channels, and has anti-adrenergic effects. Dronedarone is similar to amiodarone in chemical structure, but does not contain iodine, and its lipophilicity is weaker than that of amiodarone. After taking it, phospholipids will not be deposited in the lungs, so the adverse reactions outside the cardiovascular system are less than that of amiodarone. , clinically well tolerated. Dronedarone is currently the only antiarrhythmic drug that has been shown to significantly reduce the morbidi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/34A61K31/343A61P9/06
Inventor 仵妍张华高世芳孙勇杨春燕
Owner QINGDAO HISER MEDICAL CENT
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