Solid-state characterization of two polymorphs of aspartame hemihydrate

Journal of Pharmaceutical Sciences
S S LeungD J Grant

Abstract

From the known crystal structure of aspartame hemihydrate, designated form 1, the theoretical powder X-ray diffraction (PXRD) pattern was calculated. This PXRD pattern differs significantly from that of the commercially available aspartame hemihydrate, which is therefore a different polymorph, designated form II. Form II transforms to form I during ball-milling or on heating for 30 min at 160 degrees C in the presence of steam. The two polymorphs were compared by PXRD, differential scanning calorimetry, thermogravimetric analysis, Karl Fischer titrimetry, Fourier transform infrared (FTIR) absorption spectroscopy, 13C solid-state nuclear magnetic resonance (SSNMR) spectroscopy, scanning electron microscopy, particle size analysis, and measurements of true density and intrinsic dissolution rate. Comparison of the 13C SSNMR and FTIR spectra of the two polymorphs suggests that the crystal structure of form II is less symmetric, with the side chains located in multiple environments. Although both hemihydrate polymorphs on heating in the absence of moisture dehydrate to a crystalline anhydrate, form I does so at a lower temperature, suggesting weaker interactions of water with aspartame molecules. At higher temperatures the anhydrate...Continue Reading

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Citations

Apr 28, 2001·Advanced Drug Delivery Reviews·S R VippaguntaD J Grant
Nov 17, 1999·Journal of Pharmaceutical Sciences·T Hamaura, J M Newton
Apr 21, 1998·Journal of Pharmaceutical Sciences·S S LeungD J Grant
Apr 25, 2007·Journal of Pharmaceutical Sciences·Joseph F KrzyzaniakNina Ni
Aug 12, 2009·Journal of Pharmaceutical Sciences·Anna Cecilia JørgensenJukka Rantanen
Feb 2, 2008·Journal of Pharmaceutical Sciences·Suman A LuthraMarcel Utz
Jul 13, 2002·Journal of Pharmaceutical Sciences·Zedong DongDavid J W Grant
Jun 25, 2010·Journal of Pharmaceutical Sciences·Vishal KoradiaJukka Rantanen
Apr 26, 2014·Critical Reviews in Food Science and Nutrition·Shan-Yang Lin, Chih-Cheng Lin
Feb 24, 2006·The Analyst·Robin K Harris
Jul 6, 2000·Analytical Chemistry·D Dollimore, P Phang
Sep 12, 2020·Crystal Growth & Design·Doris E BraunUlrich J Griesser

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