Process of making crystalline aripiprazole
AssigneeSynthon BV
InventorsGerrit Ettema, Raymond Westheim, Faysal Kalmoua
Life of this patent
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Abstract
Crystalline aripiprazole Form B can be formed by crystallizing from a solvent selected from 1-propanol, 2-propanol, 1-butanol, ethyl acetate, acetonitrile or a combination thereof.
Claims22
A process, which comprises:
- crystallizing aripiprazole Form B from a solution of aripiprazole dissolved in a solvent selected from the group consisting of 1-propanol, 2-propanol, 1-butanol, ethyl acetate, acetonitrile, and mixtures thereof.
The process according to 1, wherein the solvent has a water content of less than 1%.
A process for making aripiprazole Form B, which comprises:
- providing a solution which contains aripiprazole dissolved in a solvent selected from the group consisting of 1-propanol, 2-propanol, 1-butanol, ethyl acetate, acetonitrile, and combinations thereof;
- crystallizing said aripiprazole from said solution to form aripiprazole crystals;
- and
- recovering the crystals from the solvent to obtain isolated crystalline aripiprazole Form B.
A population of crystalline aripiprazole Form B particles, wherein at least 95% of said particles have a particle size of less than 200 microns and less than 20% of said particles have a particle size of 10 microns and less, and wherein said population is substantially non-hygroscopic.
Dependencies are inferred from the claim text.