Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Dronedarone hydrochloride tablet and preparation method thereof

A dronedarone hydrochloride tablet and a technology for dronedarone hydrochloride are applied to the dronedarone hydrochloride tablet and preparation thereof, and the dronedarone hydrochloride tablet containing surfactant and the field of preparation thereof, which can solve the problem of Easy to stick, poor solubility and other problems, to achieve the effects of convenient operation, improved dissolution, and simple preparation process

Active Publication Date: 2015-07-15
SHANDONG NEWTIME PHARMA
View PDF5 Cites 5 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Dronedarone hydrochloride tablet and preparation method thereof
  • Dronedarone hydrochloride tablet and preparation method thereof
  • Dronedarone hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

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.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to a poloxamer surfactant-containing dronedarone hydrochloride tablet and a preparation method thereof. The tablet contains dronedarone hydrochloride, a molten skeleton material, poloxamer, a disintegrating agent and a lubricant, wherein the molten skeleton material is a medicinal polymer material; the disintegrating agent is one or more of crosslinked povidone, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium and carboxymethyl starch sodium; the lubricant is one or more of magnesium stearate, calcium stearate and colloidal silicon dioxide. The preparation method comprises the following steps: firstly, carrying out melting granulation of poloxamer and the molten skeleton material, carrying out mixing granulation with dronedarone hydrochloride and other proper auxiliary materials, and thus preparing the tablet. The preparation method can effectively overcome the problem of easy sticking during the preparation process of the poloxamer surfactant-containing dronedarone hydrochloride tablet, improves the dronedarone hydrochloride dissolution degree, and is simple and easy to operate and suitable for large 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/38A61K47/34A61K47/32A61P9/06A61K47/10
Inventor 赵志全郝贵周张庆森
Owner SHANDONG NEWTIME PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com