Fexofenadine crystal form and processes for its preparation thereof
OwnerShlomit Wizel, Ilan Kor-Sadeinventors
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Abstract
Provided is a crystalline form of fexofenadine free base and processes for its preparation.
Claims30
A crystalline form of fexofenadine free base characterized by a powder X-ray diffraction pattern with peaks at 11.9, 17.6, 18.2, 18.6, and 19.4±0.2 degrees two theta.
A process for preparing crystalline fexofenadine HCl salt comprising acidifying a basic aqueous solution of fexofenadine free base containing a mixture of water and an organic solvent to precipitate the crystalline form, and converting the crystal to the HCl salt.
A process for preparing crystalline fexofenadine HCl salt comprising the steps of preparing a solution of fexofenadine keto acid in a water miscible organic solvent in the presence of a base and water;
- adding a reducing agent to the solution to reduce the keto-acid;
- acidifying reaction mixture obtained from the reduction to precipitate fexofenadine free base, recovering the crystalline form of fexofenadine free base and converting it HCl salt.
Dependencies are inferred from the claim text.