Shilpa Medicare Limited

Vinod Kumar Singh

Vimal Kumar Shrawat

Prashant Purohit

Akshay Kant Chaturvedi

Rafiuddin Dr

Akshaykant Chaturvedi

Nagnnath Kokare

Rafiuddin

Veereshappa

The present invention provides process for preparation of Crystalline Erlotinib HCl (I) Form-SE characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2&#x3b8;&#xb0; peaks selected from the XRPD peak set of 5.60, 10.00, 11.40, 13.00, 13.50, 15.20, 18.40, 20.65, 21.86, 23.5, 31.80, 32.13, 32.80, 34.40&#xb1;0.20 2&#x3b8;&#xb0;, DSC isotherm comprising the endothermic peaks ranging between 213 to 217&#xb0; C. (Peak &#x2212;1) and 225 to 235&#xb0; C. (Peak &#x2212;2) and IR absorption characteristic peaks at approximately 3278 cm, 1948 cm, 1871 cm, 1632 cm, 1164 cm, 1024 cm, 940 cmand 742 cmuseful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.

Crystalline erlotinib hydrochloride process

The present invention provides a non-solvated amorphous form of (2&#x3b1;,5&#x3b2;,7&#x3b2;,10&#x3b2;,13&#x3b1;)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I), and process for preparation thereof. The present application also provides a non-solvated amorphous form of (2&#x3b1;,5&#x3b2;,7&#x3b2;,10&#x3b2;,13&#x3b1;)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I) having an XRPD pattern as per FIG., and IR spectrum as per FIG.and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.

Process for preparing amorphous cabazitaxel

The present invention relates to crystalline 2-Chloro-N-(4-chloro-3-pyridin-2-ylphenyl)-4-methylsulfonylbenzamide (I) designated as Form-SV and process for preparation thereof.  The invention further relates to pharmaceutical compositions comprising crystalline Form-SV or non-crystalline form of (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide, useful in the treatment of cancer.

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The present invention provides crystalline polymorphic forms of Fingolimod HCl (I) and processes for preparation thereof. The application provides processes for preparation of crystalline polymorphic forms-&#x3b1;, &#x3b2; and &#x3bc; substantially free from process related impurities. The crystalline polymorphic forms of Fingolimod HCl (I) obtained by the processes according to the present invention having an XRDP pattern as per FIGS.and, which are useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment or prevention of autoimmune related disorder including multiple sclerosis.

Fingolimod polymorphs and their processes

The present invention provides process for preparation of crystalline Bortezomib (Ia) as its monohydrate which is designated as crystalline Form-SB and characterized by having water content ranging between 3.5-6.0% w/w; X-ray powder diffraction pattern comprising characteristic 2&#x3b8;&#xb0; peaks selected from the XRPD peak set of 5.6, 7.5, 9.8, 10.2, 11.3, 15.1, 18.0, 20.5, 21.5 and 23.6&#xb1;0.20 2&#x3b8;&#xb0;, wherein peaks at 9.8 and 11.39&#xb1;0.20 2&#x3b8;&#xb0; are un-split and 100% intensity peak is present at 5.6&#xb1;0.20 2&#x3b8;&#xb0;, DSC isotherm comprising the endothermic peaks ranging between 45 to 60&#xb0; C. (Peak-1) and 175 to 185&#xb0; C. (Peak-2) and IR absorption characteristic peaks approximately at 3387 cm, 3304 cm, 2953 cm, 2927 cm, 2868 cm, 1627 cm, 1455 cm, 1400 cm, 1201 cm, 1150 cm, 1020 cm, 747 cmand 702 cmand Raman absorption spectra having characteristic peaks approximately at 3066 cm, 1583 cm, 1528 cm, 1281 cm, 1213 cm, 1035 cm, 1022 cmand 1004 cm. The invention also provides the use of said crystalline Form-SB as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer.

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Raichur, India

Vinod Kumar Singh