Process for the preparation of crystalline forms of sunitinib malate
AssigneeGenerics [UK] Limited
InventorsAbhay Gaitonde, Vinayak Gore, Bharati Choudhari, Mahesh Hublikar, Prakash Bansode, Sunanda Phadtare
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Abstract
The present invention, relates to novel processes for the preparation of sunitinib malate formula (I), pharmaceutical compositions comprising said polymorph and the use of the said pharmaceutical compositions in the treatment of various forms of cancer.
Claims37
-80. (canceled)
A method for the preparation of sunitinib malate form I, comprising the steps of:
- mixing sunitinib with one or more solvents;
- adding malic acid to the mixture from step (i);
- and
- isolating a resultant solid from the mixture formed in step (ii).
A method for the preparation of sunitinib malate form I, comprising the steps of:
- mixing malic acid with one or more solvents;
- adding sunitinib to the mixture from step (i);
- and
- isolating a resultant solid from the mixture formed in step (ii).
A method for the preparation of sunitinib malate form I, comprising the steps of:
- dissolving sunitinib in a solvent system at elevated temperature wherein said solvent system comprises one or more solvents chosen from the group comprising acetone, methanol and ethyl acetate;
- adding malic acid to the solution from step (i);
- stirring the solution for a defined period of time;
- and
- isolating the resultant solid sunitinib malate form I from the mixture formed in step (iii).
A method for the preparation of sunitinib malate form I, comprising the steps of:
- slurrying sunitinib in a solvent system wherein said solvent system comprises one or more solvents chosen from the group comprising acetone, methanol and ethyl acetate;
- adding malic acid to the slurry from step (i);
- stirring the slurry for a defined period of time;
- and
- isolating the resultant solid sunitinib malate form I.
Dependencies are inferred from the claim text.