Preparation, Characterization of Hydrates and Anhydrous Forms of Anti migraine Drug-Frovatriptan Succinate

摘要

Frovatriptan succinate (FS) is administrated in monohydrate form. A new dihydrate form of FS is crystallized using acetone and water solvent combination. Interestingly, FS can be crystallized as monohydrate and dihydrate using acetone and water solvent combination. The process conditions are studied and optimized w.r.t. temperature of crystallization and % concentration of water, to get the desired hydrate. The result showed that the concentration of water is deciding factor for the formation of monohydrate and dihydrate of FS. Two different anhydrous forms were produced from two hydrates, by solvent mediated and solid-state transformation techniques. Effect of relative humidity on the anhydrous forms is also investigated. On exposure to humidity both the anhydrous forms are found to be unstable and convert to their corresponding hydrated form. Two hydrated forms and the two anhydrous forms obtained are characterized using X-Ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA) and Fourier Transform Infra-red (FTIR).