Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation

The stability of active pharmaceutical ingredients (APIs) and the corresponding pharmaceutical formulations are nowadays of great importance in pharmaceutical research and technology. The quality of an API or of finished pharmaceutical products (FPPs) is time dependent under the influence of several...

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Bibliographic Details
Published in:Processes 2023-06, Vol.11 (6), p.1738
Main Authors: Baul, Bianca, Ledeţi, Adriana, Cîrcioban, Denisa, Ridichie, Amalia, Vlase, Titus, Vlase, Gabriela, Peter, Francisc, Ledeţi, Ionuţ
Format: Article
Language:English
Subjects:
Air temperature
Antihypertensive drugs
Antihypertensives
Decomposition
Degradation
Excipients
Formulations
Fourier transforms
Hypertension
Infrared analysis
Infrared spectroscopy
Investigations
Kinetics
Methods
Nervous system
Packaging materials
Pharmaceuticals
Phase transitions
Thermal stability
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Summary:The stability of active pharmaceutical ingredients (APIs) and the corresponding pharmaceutical formulations are nowadays of great importance in pharmaceutical research and technology. The quality of an API or of finished pharmaceutical products (FPPs) is time dependent under the influence of several parameters, such as light and air exposure, temperature, and humidity. Additionally, the stability profile of an API is influenced by the formulation composition, due to the presence of excipients or by the characteristic of the packaging materials. In this sense, the main objective of this study was to analyze the degradation kinetics of the antihypertensive drug moxonidine as a pure ingredient (MOX) and in two different solid mixtures, one corresponding to a pharmaceutical formulation (MOXTAB) and the other to an enriched pharmaceutical formulation in MOX (MOXMIX). As investigation techniques, FTIR (Fourier transform infrared) spectroscopy and TG/DTG/HF analysis were employed, while the thermoanalytical data were processed according to the ASTM E698 kinetic method and the isoconversional methods of Flynn–Wall–Ozawa (FWO) and Friedman (FR). The kinetic methods revealed that the excipients have a stabilizing effect on MOX (in terms of Ea values), but the decomposition mechanism of the samples is complex, according to the results suggested by the analysis of Ea vs. α values.
ISSN:2227-9717
2227-9717
DOI:10.3390/pr11061738