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Novel ivabradine hydrochloride crystal form C and preparation method thereof

A technology of ivabradine hydrochloride and its crystal form, which is applied in the field of ivabradine hydrochloride new crystal form C and its preparation, can solve problems such as uneconomical, high and difficult to remove, product quality and safety impact, and achieve preparation The method is simple in process, good in product stability, and easy to control the effect of operation

Active Publication Date: 2013-04-03
江苏宇田医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the preparation method of the above-mentioned crystal form, it involves large energy-consuming operations such as freeze-drying and distillation, which is neither economical nor operable and has application prospects for industrial scale-up.
Moreover, some methods involve acetonitrile, toluene, isopropanol and other solvents with high toxicity and high boiling point that are difficult to remove, which have a certain impact on the quality and safety of the finished product.

Method used

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  • Novel ivabradine hydrochloride crystal form C and preparation method thereof
  • Novel ivabradine hydrochloride crystal form C and preparation method thereof
  • Novel ivabradine hydrochloride crystal form C and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] In a 50 mL reaction bottle, add 2.0 g ivabradine hydrochloride and 2.0 mL absolute ethanol, heat to 40°C, after the solid dissolves, add 20.0 mL ethyl acetate, cool to 0±5°C and stir for crystallization for 30 min , filtered, and the filter cake was dried under reduced pressure to obtain the product.

[0022] like Figure 1-2 Shown is the new crystal form C of ivabradine hydrochloride prepared by the method described in Example 1, wherein: Cu-Ka radiation is used, and according to the detection parameters shown in Table 3, it is obtained by 2θ angle and interplanar spacing (d ) value represents the X-ray powder diffraction pattern, the specific characteristic peak parameters are shown in Table 2; DSC measurement has a characteristic melting absorption peak with a peak value of 195 °C.

[0023] The characteristic peak parameter of the powder diffraction pattern of the new crystal form C of table 2 ivabradine hydrochloride of the present invention

[0024] Numb...

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Abstract

The invention belongs to the field of pharmaceutical chemicals, and relates to a novel ivabradine hydrochloride crystal form C and a preparation method of the novel ivabradine hydrochloride crystal form C. The preparation method comprises the following steps in sequence: heating ivabradine hydrochloride and ethanol to obtain a settled solution; adding ethyl acetate; stirring and devitrifying in a cooling condition; filtering; and collecting the product which is the ivabradine hydrochloride crystal form C. The novel ivabradine hydrochloride crystal form C provided by the invention is different from all publicized crystal forms in a crystal morphology, and has the advantages of being clear and reproducible in outline, relatively high in process stability, simple and convenient in operation, and relatively high in product stability.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and in particular relates to a new crystal form C of ivabradine hydrochloride and a preparation method thereof. Background technique [0002] The chemical name of Ivabradine is 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4-2-0]oct-1,3,5-triene-7 -yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one hydrochloride, is The first selective and specific cardiac pacing current inhibitor developed by the French company Servier, the product was approved by the European Medicines Evaluation Agency (EMEA) in August 2005 and launched in 27 countries in Europe for the treatment of concomitant Chronic stable angina with normal sinus rhythm, contraindication or intolerance to β-blockers. [0003] European patent EP0534859 proposes the preparation and therapeutic use of ivabradine and its pharmaceutically acceptable acid addition salts, more particularly the hydrochloride. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D223/16
Inventor 陈言德洪承杰刘德龙朱万里
Owner 江苏宇田医药有限公司
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