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Non-surfactant dronedarone hydrochloride tablet

A surfactant, nedarone tablet technology, applied in the directions of pill delivery, cardiovascular system diseases, drug combination, etc., can solve the problems of low bioavailability and low dissolution rate, so as to improve the dissolution rate and increase the safety. , to avoid the effect of low melting point

Inactive Publication Date: 2018-05-18
GUANGDONG YIMING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because of its dissolution characteristics, the solubility of dronedarone hydrochloride gradually decreases during the process of gradually increasing pH from the stomach to the intestinal tract, and it cannot be dissolved from solid preparations or The dissolution rate is very low, resulting in low bioavailability of dronedarone hydrochloride in gastrointestinal administration, so it is necessary to find a way to improve the dissolution rate of dronedarone hydrochloride to improve its bioavailability

Method used

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Embodiment Construction

[0013] In order to make the technical means, creative features, goals and effects achieved by the present invention easy to understand, the present invention will be further described below in conjunction with specific embodiments.

[0014] The invention provides a technical solution: a surfactant-free dronedarone hydrochloride tablet, which is composed of the following raw materials: dronedarone hydrochloride, citric acid, magnesium stearate, and hydroxypropyl methylcellulose , Low-substituted hydroxypropyl cellulose, croscarmellose sodium and sodium carboxymethyl starch.

[0015] Use dried potato powder, starch meal and starch-containing agricultural and sideline products as raw materials, prepare medium, cook under normal pressure, cool to inoculation temperature, add seed koji, put it into koji plate for fermentation, and then use calcium carbonate to neutralize and sulfuric acid Extract the fermented liquid through the process of solution to obtain the citric acid in the ...

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PUM

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Abstract

The invention provides a non-surfactant dronedarone hydrochloride tablet. The tablet is prepared from dronedarone hydrochloride, citric acid, magnesium stearate, hydroxypropylmethyl cellulose, low-substituted hydroxypropyl cellulose, croscarmellose sodium and sodium carboxymethyl starch. Compared with the prior art, the tablet has the following advantages that no surfactant is added, both the safety is improved and the problems of a low melting point and easy sticking of the surfactant during production of a preparation are avoided, the dissolution degree of dronedarone hydrochloride in tap water is significantly increased, and the in-vivo environment is better simulated.

Description

technical field [0001] The invention relates to a surfactant-free dronedarone hydrochloride tablet, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of dronedarone hydrochloride is 2-n-butyl-3-[4-(3-di-n-butyl-aminopropoxy)benzoyl]-5-methylsulfabenzofuran 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 dissolution characteristics, the solubility of dronedarone hydrochloride gradually dec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/12A61K47/38A61K47/36A61P9/06
CPCA61K9/2059A61K9/2013A61K9/2054A61K9/2095A61K31/343A61K47/12A61K47/36A61K47/38
Inventor 李易春
Owner GUANGDONG YIMING PHARMA
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