Pharm Res (2018) 35: 140 https://doi.org/10.1007/s11095-017-2325-x RESEARCH PAPER Polymorphic Transformation of Indomethacin during Hot Melt Extrusion Granulation: Process and Dissolution Control 1 1 1 2 3 Ting Xu & Kajalajit Nahar & Rutesh Dave & Simon Bates & Kenneth Morris Received: 6 October 2017 /Accepted: 3 December 2017 /Published online: 10 May 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2017 Conclusions By determining the conditions that either pre- ABSTRACT Purpose To study and elucidate the effect of the intensity and vent or facilitate process induced transformations of IMC duration of processing stresses on the possible solid-state polymorphs during melt granulation, a design space was de- changes during a hot melt extrusion granulation process. veloped to control the polymorph present in the resulting Methods Blends of α-indomethacin and PEG 3350 (w/w 4:1) granules. This represents the conditions necessary to balance were granulated using various screw sizes/designs on the melt the thermodynamic relationships between the polymorphs of extruder under different temperature regimes. Differential the IMC system and the kinetics of the possible transforma- Scanning Calorimetry and X-ray Powder Diffraction were tions as a function of the processing stresses. employed for characterization. The dissolution behavior of . . the
Pharmaceutical Research – Springer Journals
Published: May 10, 2018
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