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Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate

1
Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland
2
Laboratory of Elemental Analysis and Structural Research, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland
3
Department of Analytical Chemistry, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(7), 304; https://doi.org/10.3390/pharmaceutics11070304
Received: 8 May 2019 / Revised: 20 June 2019 / Accepted: 20 June 2019 / Published: 1 July 2019
(This article belongs to the Special Issue Drug Stability and Stabilization Techniques)
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Abstract

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. 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 enthalpy-relaxation data. The mean molecular-relaxation-time constant (τ) increased with decreasing ageing temperature. The results showed a high stability of amorphous imatinib mesylate adequate to enable its use in solid dosage form. View Full-Text
Keywords: imatinib mesylate; amorphous form; stability; molecular mobility; thermal analysis; mean relaxation-time constant imatinib mesylate; amorphous form; stability; molecular mobility; thermal analysis; mean relaxation-time constant
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Karolewicz, B.; Górniak, A.; Marciniak, D.M.; Mucha, I. Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate. Pharmaceutics 2019, 11, 304.

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