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ABSTRACT: Topiramate [2,3:4,5-bis-O-(1-methylethylidene) β-D-fructo-pyranose sulfamate] was found to form a new polymorphic form in the presence of polyethylene glycol 8000 (PEG). Comparative study of the solid state interactions of PEG and structural topiramate analogue lacking sulfamate group (Diacetone D-fructose) indicated that the sulfamate moiety was essential for the formation of the new polymorph. The drug-polymer interactions were investigated using differential s canning calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR) and hot stage microscopy. The new polymorphic form was characterized using variable temperature powder X-ray diffraction (VTPXRD) and solid state Nuclear Magnetic Resonance (ssNMR). The new polymorph was found to form only in the presence of PEG at specific weight ratios.
International journal of pharmaceutics 03/2011; 411(1-2):86-91. · 2.96 Impact Factor