Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate

Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate

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 reflectance
Fourier 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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