Sandoz Ag

Lek Pharmaceuticals D.d.

Robert Ziegert-Knepper

Arthur Pichler

Johannes Ludescher

Hubert Sturm

Andreas Hotter

Ulrich Griesser

Verena Adamer

Mairi Haddow

The present invention relates to 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate in crystalline form and to methods for the preparation thereof. In addition the present invention relates to solid pharmaceutical compositions for oral administration comprising an effective amount of the crystalline 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate. Moreover, the present invention relates to the use of crystalline 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate for the preparation of pharmaceutical compositions.

1-[2-(2,4-dimethylphenylsulfanyl) phenyl]piperazine acetate in crystalline form

Provided are a crystalline dihydrate of Rivaroxaban, processes for the preparation thereof, pharmaceutical compositions containing the crystalline dihydrate and processes for preparing and storing the pharmaceutical compositions. Also provided are a crystalline formic acid solvate of Rivaroxaban, processes for the preparation of crystalline Rivaroxaban formic acid solvate and the use of the Rivaroxaban formic acid solvate in the manufacture of the crystalline dihydrate of Rivaroxaban.

Crystalline form of rivaroxaban dihydrate

Growing community of inventors

Kundl, Austria

Robert Ziegert-Knepper