The proposed study examined the characterization and
stability of solid-state amorphous imatinib
mesylate (IM) after 15 months under controlled relative
humidity (60 ± 5%) and temperature (25 ±
2°C) conditions. The most common methods of
amorphization include rapid precipitation from
solution, quench-cooling, spray-drying, freeze-drying,
and hot melt extrusion. After 2 weeks, and 1, 3,
6, and 15 months, the samples were characterized using
differential scanning calorimetry (DSC),
thermogravimetric analysis (TGA), X-ray powder
diffractometry (XRPD), attenuated total reflectanceFourier transform infrared
spectroscopy (ATR-FTIR) and scanning electron microscopy (SEM). Additionally, the amorphous form of imatinib mesylate was
obtained via supercooling of the melt in a DSC
apparatus, and aged at various temperatures (3, 15, 25 and 30°C) and time
periods (1–16 h). Glass transition and enthalpy
relaxation were used to calculate molecular-relaxation-time parameters. The Kohlrausch–Williams–Watts (KWW) equation was applied to
fit the experimental enthalpyrelaxation data. The mean
molecular-relaxation-time constant () increased with decreasing ageing temperature. The results showed a high stability of amorphous
imatinib mesylate adequate to enable its use in
solid dosage form.
Author
(s) Details
Bożena Karolewicz
Department of Drug Form Technology, Wroclaw Medical University, Borowska
211 A, 50-556 Wroclaw, Poland.
Agata Górniak
Laboratory of Elemental Analysis and Structural Research, Wroclaw Medical
University, Borowska 211 A, 50-556 Wroclaw, Poland.
Dominik M. Marciniak
Department of Drug Form Technology, Wroclaw Medical University, Borowska
211 A, 50-556 Wroclaw, Poland.
Igor Mucha
Department of Analytical Chemistry, Wroclaw Medical University, Borowska
211 A, 50-556 Wroclaw, Poland
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