| Autor: |
Karolewicz B; Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland., Górniak A; Laboratory of Elemental Analysis and Structural Research, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland., Marciniak DM; Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland., Mucha I; Department of Analytical Chemistry, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland. igor.mucha@umed.wroc.pl. |
| Jazyk: |
angličtina |
| Zdroj: |
Pharmaceutics [Pharmaceutics] 2019 Jul 01; Vol. 11 (7). Date of Electronic Publication: 2019 Jul 01. |
| DOI: |
10.3390/pharmaceutics11070304 |
| Abstrakt: |
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. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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