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New crystalline form of hydrochloric acid Ivabradine and preparation method thereof

A technology of ivabradine hydrochloride and crystal form, applied in the direction of organic chemistry, etc., can solve problems not detailed

Inactive Publication Date: 2010-07-07
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this reference does not detail the conditions for obtaining in a reproducible manner a form of ivabradine exhibiting those characteristics

Method used

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  • New crystalline form of hydrochloric acid Ivabradine and preparation method thereof
  • New crystalline form of hydrochloric acid Ivabradine and preparation method thereof
  • New crystalline form of hydrochloric acid Ivabradine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: Ivabradine hydrochloride in W-crystalline form

[0015] 1.0 g of ivabradine hydrochloride was added to 30 mL of acetone and 2 mL of methanol for dissolution under reflux, and the filtrate was allowed to stand for crystallization. Then pump and filter, and wash the filter cake with a small amount of acetone. The filter cake was vacuum dried at 85°C to constant weight. A 0.85 g sample of crystal form W was obtained. The melting point is 196.5-197.7°C.

[0016] The powder X-ray diffraction pattern is shown in Figure (1).

[0017]

[0018]

Embodiment 2

[0019] Embodiment 2: pharmaceutical composition

[0020] For the preparation of 1000 tablets, wherein each tablet contains 5 mg of ivabradine base, the compound 5.39g of the following prescription example 1, lactose 60.0g, microcrystalline cellulose 20.0g, magnesium stearate 1.0 g, 13.61 g of starch, prepared by a conventional tablet preparation process.

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PUM

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Abstract

The invention discloses a new crystalline form of hydrochloric acid Ivabradine and a preparation method thereof. A mixture of the hydrochloric acid Ivabradine, methanol and acetone is heated to be completely dissolved, natural stewing is carried out for complete crystallization, and products are collected through filtration so as to obtain the new crystalline form of the hydrochloric acid Ivabradine.

Description

technical field [0001] The invention relates to a new crystal form of ivabradine hydrochloride and a preparation method thereof. Background technique [0002] Ivabradine and its addition salts with pharmaceutically acceptable acids, more particularly its hydrochloride, possess extremely valuable pharmacological and therapeutic properties, especially bradycardic properties, making these compounds For the treatment or prophylaxis of various clinical conditions of myocardial ischemia such as angina pectoris, myocardial infarction and related arrhythmias, as well as various pathological conditions involving arrhythmias, especially supraventricular arrhythmias and heart failure. [0003] The preparation and therapeutic use of ivabradine and its pharmaceutically acceptable acid addition salts, more particularly its hydrochloride, have been described in European patent specification EP 0534859. [0004] In view of the pharmaceutical value of this compound, it is of utmost importan...

Claims

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Application Information

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IPC IPC(8): C07D223/16
Inventor 王春霞卢文张志强
Owner BEIJING D VENTUREPHARM TECH DEV
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