Characterization, Purity Determination and Decomposition Kinetics of Ezetimibe Under Non-Isothermal Conditions / Guilherme A. G. Martins, Fabio S. Murakami, Maximiliano S. Sangoi, Vitor Todeschini, Larissa S. Bernardi, Paulo R. Oliveira
Background: Ezetimibe is a lipid-lowering agent used therapeutically alone or in combination of other drugs. The properties of the solid-state of drugs are critical factors in the pharmaceutical formulation development. Several instrumental techniques can be employed in the analysis of new formulations, but the thermoanalytical techniques, provide a fast and careful evaluation of physicochemical properties of a compound. Objective: To carry out the physicochemical characterization, purity evaluation and non-isothermal kinetic studies of ezetimibe raw material. Methods: A combination of the following different analytical technics was employed: Differential Scanning Calorimetry, Thermogravimetric, Scanning Electron Microscopy, X-ray powder diffraction. Results: The results evidenced the crystalline characteristic of ezetimibe. The sample purity was 99.06 % ± 0.02 and the thermal decomposition followed a zero order kinetic, with activation energy of 96.56 kJ mol–1 and Arrhenius frequency factor of 3,442 x 109 min-1. Conclusion: The characterization of ezetimibe together with the non-isothermal kinetic degradation represents important studies for the pharmaceutical area, since it provides crucial information for the pharmacotechnical/quality control/production areas that should establish the specifications necessary to standardize the requirements of the raw material acquire to ensure the batch-to-batch reproducibility.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
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| Enthalten in: |
Current pharmaceutical analysis - 15(2019), 4, Seite 327- |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Martins, Guilherme A. G.Guilherme A. G. [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Umfang: |
1 Online-Ressource (6 p) |
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| Förderinstitution / Projekttitel: |
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KFL001025104 |
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| 100 | 1 | |a Martins, Guilherme A. G.Guilherme A. G. |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Characterization, Purity Determination and Decomposition Kinetics of Ezetimibe Under Non-Isothermal Conditions |c Guilherme A. G. Martins, Fabio S. Murakami, Maximiliano S. Sangoi, Vitor Todeschini, Larissa S. Bernardi, Paulo R. Oliveira |
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| 520 | |a Background: Ezetimibe is a lipid-lowering agent used therapeutically alone or in combination of other drugs. The properties of the solid-state of drugs are critical factors in the pharmaceutical formulation development. Several instrumental techniques can be employed in the analysis of new formulations, but the thermoanalytical techniques, provide a fast and careful evaluation of physicochemical properties of a compound. Objective: To carry out the physicochemical characterization, purity evaluation and non-isothermal kinetic studies of ezetimibe raw material. Methods: A combination of the following different analytical technics was employed: Differential Scanning Calorimetry, Thermogravimetric, Scanning Electron Microscopy, X-ray powder diffraction. Results: The results evidenced the crystalline characteristic of ezetimibe. The sample purity was 99.06 % ± 0.02 and the thermal decomposition followed a zero order kinetic, with activation energy of 96.56 kJ mol–1 and Arrhenius frequency factor of 3,442 x 109 min-1. Conclusion: The characterization of ezetimibe together with the non-isothermal kinetic degradation represents important studies for the pharmaceutical area, since it provides crucial information for the pharmacotechnical/quality control/production areas that should establish the specifications necessary to standardize the requirements of the raw material acquire to ensure the batch-to-batch reproducibility | ||
| 700 | 1 | |a Murakami, Fabio S. |e verfasserin |4 aut | |
| 700 | 1 | |a Sangoi, Maximiliano S. |e verfasserin |4 aut | |
| 700 | 1 | |a Todeschini, Vitor |e verfasserin |4 aut | |
| 700 | 1 | |a S. Bernardi, Larissa |e verfasserin |4 aut | |
| 700 | 1 | |a R. Oliveira, Paulo |e verfasserin |4 aut | |
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