A dronedarone hydrochloride tablet and preparation method thereof
A technology of dronedarone hydrochloride tablet and dronedarone hydrochloride, applied in the field of dronedarone hydrochloride tablet and its preparation, surfactant-containing dronedarone hydrochloride tablet and its preparation, can solve the problem of Easy to stick, poor solubility and other problems, to achieve the effect of convenient operation, improved dissolution rate, and simple preparation process
Active Publication Date: 2021-01-29
SHANDONG NEWTIME PHARMA
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- Description
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- Application Information
AI Technical Summary
Problems solved by technology
[0009] In order to solve the problems of its poor solubility and easy sticking in the production process, the inventors have carried out a large number of experiments, and unexpectedly found that the melted skeleton material and poloxamer were melted and granulated by hot-melt extrusion technology, and then combined with After the drug is mixed, it is granulated and compressed, which can not only improve the solubility of the drug, but also solve the problem of easy sticking and punching during the production process of the preparation
Method used
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Embodiment 1
[0030]
[0031] Preparation Process:
[0032] Copovidone and poloxamer are granulated using a hot-melt extruder, then mixed with dronedarone hydrochloride and cross-linked povidone evenly, and an appropriate amount of pure water is added to granulate, and the dried granules are added to the prescription amount of stearin Magnesium acid, mixed evenly, and compressed into tablets.
Embodiment 2
[0034]
[0035] Preparation Process:
[0036] Granulate acrylic resin E and poloxamer using a hot-melt extruder, then mix them evenly with dronedarone hydrochloride and cross-linked povidone, add an appropriate amount of pure water, granulate, and add the prescribed amount of stearin to the dried granules Magnesium acid, mixed evenly, and compressed into tablets.
Embodiment 3
[0038]
[0039] Preparation Process:
[0040] Granulate acrylic resin E and poloxamer using a hot-melt extruder, then mix them evenly with dronedarone hydrochloride and cross-linked povidone, add an appropriate amount of pure water, granulate, and add the prescribed amount of stearin to the dried granules Magnesium acid, mixed evenly, and compressed into tablets.
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The invention relates to a dronedarone hydrochloride tablet containing a poloxamer surfactant and a preparation method thereof. The tablet comprises dronedarone hydrochloride, melting matrix material, poloxamer, disintegrant, lubricant; wherein, the melting matrix material is a pharmaceutically acceptable polymer material; the disintegrating agent is crospovidone, One or more of low-substituted hydroxypropyl cellulose, croscarmellose sodium, and sodium carboxymethyl starch; the lubricant is one or more of magnesium stearate, calcium stearate, and micropowder silica gel Several kinds. The preparation method comprises the following steps: first melting and granulating the poloxamer and molten skeleton material, and then mixing and granulating with dronedarone hydrochloride and other suitable auxiliary materials to form tablets. The technical solution of the present invention effectively overcomes the problem of easy sticking and punching during the preparation of dronedarone hydrochloride tablets containing poloxamer surfactants, improves the dissolution rate of dronedarone hydrochloride, and is simple and easy to operate , suitable for mass production.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a dronedarone hydrochloride tablet and a preparation method thereof, more specifically, to a surfactant-containing dronedarone hydrochloride tablet and a preparation method thereof. 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...
Claims
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IPC IPC(8): A61K9/20A61K31/343A61K47/38A61K47/10A61K47/32A61P9/06
Inventor 赵志全郝贵周张庆森
Owner SHANDONG NEWTIME PHARMA