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Claims for Patent: 7,361,649

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Claims for Patent: 7,361,649

Title:.beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Abstract: A .beta.-Crystalline form of ivabradine 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:11/358,954
Patent Claims: 1. A .beta.-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 Area Interplanar Ray 2 theta Height (counts .times.) FWHM distance no (degrees) (counts) degrees) (degrees) (.ANG.) 1 6.8 130 86 0.6691 13.019 2 9.2 6141 507 0.0836 9.613 3 9.7 882 58 0.0669 9.083 4 10.0 875 72 0.0836 8.837 5 11.9 190 19 0.1004 7.433 6 12.2 500 58 0.1171 7.236 7 13.2 224 30 0.1338 6.694 8 13.8 633 52 0.0836 6.419 9 14.3 466 54 0.1171 6.209 10 14.8 926 76 0.0836 5.977 11 15.0 716 94 0.1338 5.887 12 15.7 531 79 0.1506 5.636 13 16.1 121 16 0.1338 5.502 14 16.9 1354 223 0.1673 5.254 15 18.4 5672 562 0.1004 4.824 16 18.8 1328 131 0.1004 4.716 17 19.7 1617 347 0.2175 4.508 18 20.4 296 34 0.1171 4.341 19 20.7 767 51 0.0669 4.286 20 21.3 1419 211 0.1506 4.178 21 21.6 2458 243 0.1004 4.114 22 22.6 1737 258 0.1506 3.937 23 23.0 1467 73 0.0502 3.865 24 23.7 486 128 0.2676 3.751 25 23.9 504 50 0.1004 3.718 26 25.3 4606 304 0.0669 3.513 27 25.7 791 91 0.1171 3.464 28 26.2 458 91 0.2007 3.406 29 26.6 221 44 0.2007 3.352 30 27.4 706 151 0.2175 3.251 31 27.7 208 27 0.1338 3.215 32 28.1 483 40 0.0836 3.176 33 28.8 242 24 0.1004 3.096 34 29.3 450 74 0.1673 3.049.

2. A process for the preparation of the .beta.-crystalline form of ivabradine hydrochloride of claim 1, wherein a mixture of ivabradine hydrochloride and water or a mixture of ivabradine hydrochloride, isopropanol and water is heated until dissolution is complete and is then progressively cooled until crystallization is complete, and the crystals thereby formed are collected.

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 .beta.-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 .beta.-crystalline form of ivabradine hydrochloride of claim 1.
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