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Omega-crystal form, preparation method and medicine composite of ivabradine hydrochloride

A technology of hydrochloride and crystal form, applied in the field of ω-crystal form of ivabradine hydrochloride, its preparation and pharmaceutical composition, capable of solving problems not specifically described in detail

Inactive Publication Date: 2010-08-18
成都威克药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The method for the synthesis of ivabradine and its hydrochloride is described in the patent specification EP0534859, but the conditions for obtaining in a reproducible manner the formation of ivabradine exhibiting those characteristics are not specifically detailed in the document

Method used

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  • Omega-crystal form, preparation method and medicine composite of ivabradine hydrochloride
  • Omega-crystal form, preparation method and medicine composite of ivabradine hydrochloride
  • Omega-crystal form, preparation method and medicine composite of ivabradine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: the omega-crystal form of ivabradine hydrochloride

[0020] 20 grams of ivabradine hydrochloride obtained according to the method described in European patent specification EP0534859 was added to 30 ml of purified water, heated while stirring until completely dissolved. It is then cooled and freeze-dried. According to XRD it was shown that the ω-crystal form was generated.

Embodiment 2

[0021] Embodiment 2: pharmaceutical composition

[0022] Recipe for the preparation of 1000 tablets each containing 7.5 mg of febuxostat:

[0023] Compound 8.085g of Example 1

[0024] Cornstarch 30g

[0025] Mannitol 85g

[0026] PVP 11.5g

[0027] Magnesium Stearate 0.8g.

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PUM

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Abstract

The invention discloses a new crystal form omega-crystal form of ivabradine hydrochloride and preparation method thereof. The mixture of the ivabradine hydrochloride and water is heated and dissolved completely and then is frozen and dried to obtain delta-crystal form crystal. The crystal form has stable temperature and humidity, does not contain any organic solvent and moisture and is applicable to preparation technical process and a long period of storage. The medicine composite taking the crystal form composite as active ingredient can be used to treat or prevent angina, myocardial infarction and relative arhythmicity.

Description

technical field [0001] The present invention relates to omega-crystal form of ivabradine hydrochloride, its preparation method and pharmaceutical composition with the compound as active ingredient. Background technique [0002] The chemical name of ivabradine is 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]oct-1,3,5-trien-7-yl]- Methyl}(methyl)-amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-phenylacryrazine-2-one, Ivar The general formula (I) of Bradine hydrochloride (Ivabradine hydrochloride) is: [0003] [0004] Ivabradine hydrochloride has extremely valuable pharmacological and therapeutic properties, especially bradycardic properties, which make the compound useful in the treatment or prevention of various clinical conditions of myocardial ischemia such as angina pectoris, myocardial infarction and Associated arrhythmias, and various case conditions involving arrhythmias, especially supraventricular arrhythmias and heart failure. [0005] The preparation and thera...

Claims

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Application Information

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IPC IPC(8): C07D223/16A61K31/55A61P9/10A61P9/06A61P9/04
Inventor 王德祥吴松福李主全
Owner 成都威克药业有限责任公司