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1. WO2011095835 - HIGHLY PURE IMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

Publication Number WO/2011/095835
Publication Date 11.08.2011
International Application No. PCT/IB2010/003418
International Filing Date 22.12.2010
IPC
C07D 401/04 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
DHETEROCYCLIC COMPOUNDS
401Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
02containing two hetero rings
04directly linked by a ring-member-to-ring- member bond
A61K 31/506 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
506not condensed and containing further heterocyclic rings
A61P 35/02 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
CPC
A61P 35/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
C07D 401/04
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
DHETEROCYCLIC COMPOUNDS
401Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
02containing two hetero rings
04directly linked by a ring-member-to-ring-member bond
Applicants
  • ACTAVIS GROUP PTC EHF [IS]/[IS] (AllExceptUS)
  • KHUNT, Mayur, Devjibhai [IN]/[IN] (UsOnly)
  • PATIL, Nilesh, Sudhir [IN]/[IN] (UsOnly)
  • PAGIRE, Haushabhau, Shivaji [IN]/[IN] (UsOnly)
  • PRADHAN, Nitin, Sharadchandra [IN]/[IN] (UsOnly)
Inventors
  • KHUNT, Mayur, Devjibhai
  • PATIL, Nilesh, Sudhir
  • PAGIRE, Haushabhau, Shivaji
  • PRADHAN, Nitin, Sharadchandra
Priority Data
251/CHE/201002.02.2010IN
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) HIGHLY PURE IMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
(FR) IMATINIB DE GRANDE PURETÉ OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI
Abstract
(EN) Provided herein are impurities of imatinib, N-acetylpiperazine, N-acetylamino, N- chloromethylamino, formamide, 4-methylbenzamide and '2.24 RRt' impurities, and processes for the preparation and isolation thereof. Provided further herein is a highly pure imatinib or a pharmaceutically acceptable salt thereof substantially free of at least one, or two, or more, of the N-acetylpiperazine, N-acetylamino, N-chloromethylamino, formamide, 4-methylbenzamide, and '2.24 RRt' impurities, processes for the preparation, and pharmaceutical compositions comprising highly pure imatinib or a pharmaceutically acceptable salt thereof substantially free of impurities. Disclosed also herein is a process for preparing substantially pure α-form of imatinib mesylate.
(FR) La présente invention concerne des impuretés d'imatinib, des impuretés N-acétylpipérazine, N-acétylamino, N- chlorométhylamino, formamide, 4-méthylbenzamide et '2.24 RRt', ainsi que leurs procédés de préparation et de leur isolement. L'invention concerne également un imatinib de grande pureté ou un sel pharmaceutiquement acceptable de celui-ci sensiblement exempt d'un, ou de deux, ou de plusieurs parmi des impuretés N-acétylpipérazine, N-acétylamino, N- chlorométhylamino, formamide, 4-méthylbenzamide et '2.24 RRt', leurs procédés de préparation, et des compositions pharmaceutiques comportant de l'imatinib de grande pureté ou un sel pharmaceutiquement acceptable de celui-ci sensiblement exempts d'impuretés. L'invention concerne en outre un procédé pour la préparation d'une forme alpha pure de mésylate d'imatinib.
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