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. After 2 weeks, and 1, 3, 6, and 15 months, the samples were c...
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| Format: | Article |
| Language: | English |
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MDPI AG
2019-07-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/11/7/304 |
| _version_ | 1811301626075414528 |
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| author | Bożena Karolewicz Agata Górniak Dominik M. Marciniak Igor Mucha |
| author_facet | Bożena Karolewicz Agata Górniak Dominik M. Marciniak Igor Mucha |
| author_sort | Bożena Karolewicz |
| collection | DOAJ |
| description | 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 (<i>τ</i>) increased with decreasing ageing temperature. The results showed a high stability of amorphous imatinib mesylate adequate to enable its use in solid dosage form. |
| first_indexed | 2024-04-13T07:12:15Z |
| format | Article |
| id | doaj.art-3c1146e86389445a97607687e47fa088 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-13T07:12:15Z |
| publishDate | 2019-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-3c1146e86389445a97607687e47fa0882022-12-22T02:56:50ZengMDPI AGPharmaceutics1999-49232019-07-0111730410.3390/pharmaceutics11070304pharmaceutics11070304Molecular Mobility and Stability Studies of Amorphous Imatinib MesylateBożena Karolewicz0Agata Górniak1Dominik M. Marciniak2Igor Mucha3Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, PolandLaboratory of Elemental Analysis and Structural Research, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, PolandDepartment of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, PolandDepartment of Analytical Chemistry, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, PolandThe 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 (<i>τ</i>) increased with decreasing ageing temperature. The results showed a high stability of amorphous imatinib mesylate adequate to enable its use in solid dosage form.https://www.mdpi.com/1999-4923/11/7/304imatinib mesylateamorphous formstabilitymolecular mobilitythermal analysismean relaxation-time constant |
| spellingShingle | Bożena Karolewicz Agata Górniak Dominik M. Marciniak Igor Mucha Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate Pharmaceutics imatinib mesylate amorphous form stability molecular mobility thermal analysis mean relaxation-time constant |
| title | Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate |
| title_full | Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate |
| title_fullStr | Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate |
| title_full_unstemmed | Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate |
| title_short | Molecular Mobility and Stability Studies of Amorphous Imatinib Mesylate |
| title_sort | molecular mobility and stability studies of amorphous imatinib mesylate |
| topic | imatinib mesylate amorphous form stability molecular mobility thermal analysis mean relaxation-time constant |
| url | https://www.mdpi.com/1999-4923/11/7/304 |
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