Crystalline forms of cabazitaxel and process for preparation thereof

A crystalline Form-2 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at about 3.9477, 6.9328, 7.8516, 10.1685, 10.7552, 11.6174, 12.1755, 12.8255, 13.5716, 14.0264, 15.1085, 17.2533 and 18.1414±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 3;
• melting endotherms of 68.5, 114.59 and 174° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 5.88 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-3 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 4.2517, 6.9143, 7.5307, 8.5018, 8.6671, 10.0963, 11.016, 11.7729, 12.2981, 12.655, 13.2716, 13.3755, 13.8385, 14.3319, 15.1075 and 15.5934 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 5;
• a melting endotherm of 71.59° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 1.44 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-4 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 6.9147, 7.9157, 10.1788, 10.7274, 12.2545, 13.9828, 15.1051, 17.2041, 18.1419, 19.7907, 21.5114, 23.1898, 24.6259, 25.3476 and 35.589 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 7;
• melting endotherms of 45.35 and 124.92° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 4.82 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-5 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.4653, 7.9088, 8.632, 10.0056, 10.1441, 12.6034, 12.8787, 13.3288, 13.7267, 14.0979, 14.7919, 14.9815, 15.8132, 16.6686, 17.0039, 17.4065, 17.565, 17.9825, 18.8633, 19.4114, 20.0775, 20.3849, 20.8302, 21.5334, 21.9088, 22.3894, 22.8016, 23.8831, 24.4216, 25.3046, 26.0013, 26.5986, 27.1112, 27.6563, 28.1144, 28.4627, 29.3176, 29.9773, 30.3352, 30.7862, 31.6162, 32.0435, 32.7366, 34.0162, 34.4257, 35.2812, 35.6799, 36.3708, 37.2971, 37.9603 and 39.4846. degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 9;
• melting endotherms of 56.29 and 145.27° C. as measured by differential scanning calorimetry and
• a weight loss of about 0.97 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-6 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.5382, 7.8933, 8.5705, 9.0313, 9.9955, 12.53567, 12.7543, 13.1642, 13.8096, 14.1239, 14.9894, 15.1341, 15.5073, 15.8243, 15.9533, 16.6157, 16.8378, 17.3433, 17.8146, 18.7843, 19.6295, 20.0721, 20.272, 20.6837, 21.6467, 22.0733, 22.4547, 22.8002, 23.352, 23.8517, 24.4177, 25.2362, 25.9305, 26.3936, 26.9242, 27.4422, 27.8523, 28.2344, 28.8554, 30.1018, 30.9761, 31.3884, 32.409, 33.0368, 34.1981, 34.9906, 36.1324, 36.5453, 37.1655, 37.8404 and 38.3193 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 11;
• a melting endotherm of 157.26° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 4.0 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-7 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at about 5.1654, 6.0558, 7.5462, 7.7852, 8.8713, 9.5395, 10.1166, 10.3287, 10.3287, 10.7561, 11.3142, 11.6744, 11.7668, 12.0871, 12.5438, 12.7839, 13.0253, 13.3688, 14.147, 14.4314, 15.2768, 15.4254, 15.7276, 16.0658, 16.7552, 17.1127, 17.633, 18.0978, 18.5174, 18.9323, 19.6057, 20.309, 21.0129, 21.3404, 21.8444, 22.3403, 22.7858, 23.4707, 24.0622, 24.479, 25.1489, 25.6754, 26.632, 27.1126, 27.884, 28.8493, 30.3359, 30.7151, 31.6619, 32.6055, 33.4331, 35.9047, 36.7957, 37.5168 and 38.4523 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 13;
• a melting endotherm of 162° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 1.902 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-8 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.4653, 7.9088, 8.632, 10.0056, 10.1441, 12.6034, 12.8787, 13.3288, 13.7267, 14.0979, 14.7919, 14.9815, 15.8132, 16.6686, 17.0039, 17.4065, 17.565, 17.9825, 18.8633, 19.4114, 20.0775, 20.3849, 20.8302, 21.5334, 21.9088, 22.3894, 22.8016, 23.8831, 24.4216, 25.3046, 26.0013, 26.5986, 27.1112, 27.6563, 28.1144, 28.4627, 29.3176, 29.9773, 30.3352, 30.7862, 31.6162, 32.0435, 32.7366, 34.0162, 34.4257, 35.2812, 35.6799, 36.3708, 37.2971, 37.9603 and 39.4846 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 15;
• by a melting endotherms of 151.84 and 159.08° C. as measured by differential scanning calorimetry;
• and
• by a weight loss of about 7.126 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-9 of Cabazitaxel characterized by:

• an X-ray powder diffraction (XRD) pattern having peaks at about 7.4888, 7.8964, 14.9996, 15.8372, 18.1238, 19.4223, 20.0681, 22.578, 23.88, 27.0807 and 34.2049 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 17;
• by a melting endotherm 156.51° C. as measured by differential scanning calorimetry;
• and
• by a weight loss of about 3.31 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-10 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.3698, 7.667, 8.8401, 10.0932, 10.1915, 12.1842, 12.5108, 12.6905, 13.2027, 13.4312, 14.3957, 14.7872, 15.2618, 15.6302, 16.206, 16.8942, 17.6122, 17.9955, 18.4562, 18.6846, 19.3745, 19.7227, 20.2884, 20.9802, 21.1714, 21.6056, 21.779, 22.268, 22.595, 23.1582, 23.3974, 23.7276, 24.5077, 25.003, 25.3184, 25.7709, 26.1442, 26.286, 26.7247, 26.9795, 27.7495, 28.3621, 28.6729, 28.8427, 30.0072, 30.2711, 30.6479, 30.9287, 31.3812, 33.572, 34.6909, 35.3171, 35.8341, 36.2362, 36.6585, 37.3182, 39.0095 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 19;
• a melting endotherm of 163.24° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 1.39 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-11 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.3745, 7.6642, 8.8442, 10.0941, 12.1815, 12.5115, 12.6887, 13.1938, 13.4343, 14.4048, 14.7832, 15.2664, 15.6318, 16.1844, 16.8979, 17.6182, 17.9285, 17.9944, 18.4383, 18.6827, 19.3607, 19.69, 20.2846, 20.9841, 21.1786, 21.2743, 21.5948, 21.7825, 22.0077, 22.2638, 22.5902, 23.1399, 23.4095, 23.6935, 24.511, 25.0016, 25.2019, 25.779, 26.2666, 26.9532, 27.728, 28.2877, 28.6692, 30.0142, 30.6341, 30.9294, 31.3636, 33.5386, 34.0535, 34.6503, 35.7594, 36.2287, 36.6173, 37.5314 and 39.0013 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 21;
• a melting endotherm of 162.26° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 1.91 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-12 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.2416, 7.3725, 7.7374, 8.0736, 8.9401, 9.8027, 10.3081, 11.0522, 12.5684, 12.9213, 13.2282, 13.5547, 14.2406, 14.4855, 14.8101, 15.105, 15.2813, 15.6609, 16.3001, 17.1182, 17.5246, 17.7526, 18.4631, 18.7094, 19.4528, 19.7879, 20.4143, 21.2813, 21.9409, 22.362, 22.5558, 22.9703, 23.7148, 24.2623, 25.328, 25.7613, 26.126, 27.2233, 27.8554, 29.3835, 30.3838, 30.884, 31.483, 32.2384, 33.7493, 36.45, 37.8297 and 39.072. degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 23;
• a melting endotherm of 150.47° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 4.03 w/w, as measured by a Thermo gravimetric analysis (TGA).

A crystalline Form-13 of Cabazitaxel characterized by at least one of:

• an X-ray powder diffraction (XRD) pattern having peaks at 7.6407, 8.2470, 8.9083, 9.6908, 10.2052, 10.8975, 11.7467, 12.5726, 13.1374, 13.6142, 14.5568, 14.7306, 15.1414, 15.3346, 15.8172, 15.9783, 16.1685, 16.5428, 17.0081, 17.4437, 17.7617, 18.3039, 18.6969, 19.2043, 19.3552, 19.8813, 20.5800, 21.1902, 21.6304, 21.8210, 22.6461, 23.0075, 23.3798, 23.6649, 24.227, 24.6723, 24.8109, 25.2951, 25.7631, 26.3656, 26.7471, 27.009, 27.2631, 27.4812, 28.0822, 28.9015, 29.2351, 29.4124, 29.9002 and 30.3023 degrees two theta ±0.2 degrees two-theta;
• an X-ray powder diffraction (XRD) pattern as depicted in FIG. 25;
• a melting endotherm of 119.57° C. as measured by differential scanning calorimetry;
• and
• a weight loss of about 3.058 w/w, as measured by a Thermo gravimetric analysis (TGA).