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Claims for Patent: 7,361,650

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Claims for Patent: 7,361,650

Title:.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Abstract: A .gamma.-Crystalline form of ivabradine hydrochloride of formula (I): ##STR00001## characterised by its powder X-ray diffraction data. Medicinal products containing the same which are useful as bradycardics.
Inventor(s): Horvath; Stephane (La Chapelle-Saint-Mesmin, FR), Auguste; Marie-Noelle (Orleans, FR), Damien; Gerard (Meung-sur-Loire, FR)
Assignee: Les Laboratoires Servier (Courbevoie Cedex, FR)
Application Number:11/358,955
Patent Claims: 1. A .gamma.-Crystalline form of ivabradine hydrochloride of formula (I): ##STR00003## exhibiting essentially the following powder X-ray diffraction data, measured using a PANalytical X'Pert Pro diffractometer together with an X'Celerator detector and expressed in terms of ray position (Bragg's angle 2 theta, expressed in degrees), ray height (expressed in counts), ray area (expressed in counts x degrees), ray width at half-height ("FWHM", expressed in degrees) and interplanar distance d (expressed in .ANG.): TABLE-US-00004 Angle Interplanar Ray 2 theta Height Area FWHM distance no. (degrees) (counts) (counts .times. degrees) (degrees) (.ANG.) 1 4.2 1456 144 0.1004 20.762 2 6.9 125 99 0.8029 12.880 3 8.4 182 18 0.1004 10.503 4 10.7 240 32 0.1338 8.249 5 11.3 74 15 0.2007 7.858 6 12.0 644 64 0.1004 7.392 7 12.5 1476 219 0.1506 7.060 8 13.4 2691 400 0.1506 6.612 9 14.5 541 80 0.1506 6.119 10 14.8 104 17 0.1673 5.981 11 15.9 815 67 0.0836 5.559 12 16.3 501 74 0.1506 5.419 13 17.0 1168 154 0.1338 5.210 14 17.9 430 43 0.1004 4.962 15 19.0 667 121 0.184 4.672 16 19.8 527 104 0.2007 4.483 17 20.2 726 144 0.2007 4.392 18 20.5 282 28 0.1004 4.323 19 21.1 2255 260 0.1171 4.208 20 21.4 694 68 0.1004 4.147 21 21.6 744 86 0.1171 4.111 22 22.3 175 35 0.2007 3.987 23 23.5 310 61 0.2007 3.784 24 24.2 1635 270 0.1673 3.683 25 24.5 1335 220 0.1673 3.625 26 24.9 523 95 0.184 3.568 27 25.5 657 130 0.2007 3.485 28 26.0 933 154 0.1673 3.431 29 26.4 1549 230 0.1506 3.380 30 26.8 419 83 0.2007 3.323 31 27.3 350 69 0.2007 3.267 32 28.0 1108 146 0.1338 3.186 33 29.1 144 19 0.1338 3.066.

2. A process for the preparation of the .gamma.-crystalline form of ivabradine hydrochloride of claim 1, wherein a mixture of ivabradine hydrochloride and 2-ethoxyethanol, a mixture of ivabradine hydrochloride, 2-ethoxyethanol and water, or a mixture of ivabradine hydrochloride, ethanol and water is heated until dissolution is complete and is then cooled until crystallisation is complete, and the product thus obtained is collected by filtration.

3. The process of claim 2, wherein the solution of ivabradine hydrochloride is seeded during the cooling step.

4. A solid pharmaceutical composition comprising as active ingredient the .gamma.-crystalline form of ivabradine hydrochloride of claim 1, in combination with one or more pharmaceutically acceptable, inert, non-toxic carriers.

5. A method for treating a condition selected from angina pectoris, myocardial infarct and heart failure, such method comprising administering to a living animal body, including a human, a therapeutically effective amount of a .gamma.-crystalline form of ivabradine hydrochloride of claim 1.
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