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Delta,-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

A technology of ivabradine hydrochloride and crystallization, which is applied in the directions of drug combination, organic chemistry method, active ingredient of heterocyclic compounds, etc., can solve the problems of unspecified acquisition and the like

Inactive Publication Date: 2007-04-18
SERVIER LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this document does not describe the conditions for obtaining ivabradine in a form that exhibits the above-mentioned characteristics in a reproducible manner

Method used

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  • Delta,-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
  • Delta,-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1: Ivabradine hydrochloride in delta-crystalline form

[0034] 160ml of acetonitrile was preheated to 70°C, then 2g of ivabradine hydrochloride obtained by the method described in the patent specification EP0534859 was added part by part, while stirring until completely dissolved. The solution was then kept at ambient temperature for 2 days. Crystals were vacuum filtered and spread on crystallization trays.

[0035] The water content of the obtained product was determined by coulometric method to be 2.8%.

[0036] Powder X-ray Diffraction Pattern:

[0037] The powder X-ray diffraction pattern (diffraction angles) of the delta-form of ivabradine hydrochloride is given in the table below with highlighted lines:

[0038]

[0039] 4

Embodiment 2

[0040] Embodiment 2: pharmaceutical composition

[0041] Formulation for the preparation of 1000 tablets each containing 5 mg ivabradine base:

[0042] Compound of Example 1 ................................. 5.39g

[0043] corn starch................................................ .20g

[0044] Anhydrous colloidal silica...................................0.2g

[0045] Mannitol................................................ 63.91g

[0046] PvP................................................................ .....10g

[0047] Magnesium stearate.............................................. ..0.5g

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Abstract

The invention relates to the d crystalline form of ivabradine hydrochloride having general formula (I), which is characterised by its X-ray diffraction pattern on powder. The invention is suitable for medicaments.

Description

technical field [0001] The present invention relates to ivabradine hydrochloride (ivabradine) of formula (I) in delta-crystalline form, a process for its preparation and pharmaceutical compositions comprising it. [0002] Background technique [0003] Ivabradine and its addition salts with pharmaceutically acceptable acids, especially its hydrochloride, have very valuable pharmacological and therapeutic properties, especially bradycardic properties, which make These compounds are useful in the treatment or prophylaxis of various clinical conditions of myocardial ischemia, such as angina pectoris, myocardial infarction and related cardiac rhythm disturbances, and also in various pathologies involving cardiac rhythm disturbances, especially supraventricular cardiac rhythm disturbances, and heart failure. [0004] European patent specification EP 0 534 859 already describes the preparation and therapeutic use of ivabradine and its addition salts with pharmaceutically accept...

Claims

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Application Information

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IPC IPC(8): C07D223/16A61K31/55A61P9/10A61P9/06A61P9/04
CPCC07D223/16A61P9/00A61P9/04A61P9/06A61P9/10A61K31/55C07B2200/13
Inventor S·霍瓦特M-N·奥古斯特G·达米安
Owner SERVIER LAB
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