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

Dronedarone hydrochloride tablet and preparation method thereof

A technology of dronedarone hydrochloride tablets and dronedarone hydrochloride, which is applied in the fields of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as complex processes, and achieve simple preparation process and increased safety Sexuality and easy operation

Active Publication Date: 2014-02-12
SHANDONG NEWTIME PHARMA
View PDF9 Cites 5 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using solvent precipitation technology, the drug is deposited on the surface of the inert carrier to increase the surface area, thereby increasing the dissolution rate, but the process is more complicated

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

[0026]

[0027] Preparation Process:

[0028] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix them with microcrystalline cellulose and crospovidone evenly, add half the amount of calcium stearate, and dry process Granules, the remaining amount of calcium stearate is added to the granules, mixed and compressed into tablets.

Embodiment 2

[0030]

[0031] Preparation Process:

[0032] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix with lactose and crospovidone evenly, add half the amount of magnesium stearate, dry granulate, granulate Add the remaining amount of magnesium stearate to the mixture, mix and compress into tablets.

Embodiment 3

[0034]

[0035]

[0036] Preparation Process:

[0037] Add dronedarone hydrochloride and hydroxypropyl methylcellulose into a ball mill to pulverize until the particle size is less than 1 μm, then mix them with microcrystalline cellulose and sodium carboxymethyl starch, add pure water to granulate, dry, and granulate Add magnesium stearate, mix and compress 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

PropertyMeasurementUnit
particle diameteraaaaaaaaaa
Login to View More

Abstract

The invention belongs to the field of pharmaceutical preparations, and specifically relates to a surfactant-free dronedarone hydrochloride tablet. The dronedarone hydrochloride tablet comprises the following components in parts by weight: 400 parts of dronedarone hydrochloride, 100-1200 parts of hydroxypropyl methyl cellulose, 20-640 parts of disintegrating agent, 7-10 parts of lubricant, and zero surfactant. The technical scheme of the dronedarone hydrochloride tablet is characterized in that no surfactant is added, so that the safety is improved, and the problems of low melting point and easy sticking of the surfactant in the production process of the preparation are also avoided; and simultaneously, the dissolution rate of dronedarone hydrochloride is obviously improved. In the preparation process, the dronedarone hydrochloride and hydroxypropyl methyl cellulose are together ground until the particle size thereof is not greater than 1 micron, and then the obtained powder is formed into tablets with other suitable accessories; the process is quite simple, convenient to operate and suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a dronedarone hydrochloride tablet, more specifically, to a dronedarone hydrochloride tablet without a surfactant. 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 solubility is only 10 μg / ml at pH=7. [0004] Because of its diss...

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): A61K9/20A61K31/343A61K47/38A61P9/06
Inventor 赵志全郝贵周程战立
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