Processes for preparing cinacalcet hydrochloride crystal Form I
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsRevital Lifshitz-Liron, Sharon Avhar-Maydan
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Abstract
The invention provides processes for the preparation of cinacalcet hydrochloride crystalline Form I.
Claims29
A process for preparing a crystalline form of Cinacalcet hydrochloride, wherein the crystalline form of Cinacalcet hydrochloride is characterized by powder XRD peaks at about 13.9, 19.0, 21.3, 25.5±0.2° 2θ, the process comprising:
- a. providing a solution of Cinacalcet base in a solvent in which Cinacalcet hydrochloride has a low solubility;
- b. acidifying the solution with hydrochloric acid to obtain a reaction mixture;
- c. maintaining the reaction mixture to obtain a precipitate;
- and
- d. recovering precipitated Cinacalcet hydrochloride crystal form I.
A process for preparing a crystalline form of Cinacalcet hydrochloride, wherein the Cinacalcet hydrochloride is characterized by powder XRD peaks at about 13.9, 19.0, 21.3, 25.5±0.2° 2θ, the process comprising:
- a. providing a slurry of amorphous Cinacalcet hydrochloride, characterized by an XRD diffractogram, substantially as depicted in FIG. 4, in a solvent selected from the group consisting of water, MTBE, and C5-C8 alkanes;
- b. maintaining the slurry at a temperature of from about room temperature to reflux temperature for about 2 to 30 hours;
- and
- c. recovering Cinacalcet hydrochloride crystal Form I.
A process for preparing Cinacalcet hydrochloride crystalline form I comprising:
- a. providing a solution of Cinacalcet hydrochloride in a solvent selected from a C3-6 ketone, C1-C5 straight or branched alcohol, and mixtures thereof;
- b. combining the solution with an antisolvent;
- c. maintaining the solution to obtain a precipitate;
- and
- d. recovering Cinacalcet hydrochloride crystal form I.
Dependencies are inferred from the claim text.