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

Bianca Baul; Adriana Ledeţi; Denisa Cîrcioban; Amalia Ridichie; Titus Vlase; Gabriela Vlase; Francisc Peter; Ionuţ Ledeţi

LAPSE

Living Archive for Process Systems Engineering

LAPSE:2023.36282

Published Article

LAPSE:2023.36282

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

Bianca Baul, Adriana Ledeţi, Denisa Cîrcioban, Amalia Ridichie, Titus Vlase, Gabriela Vlase, Francisc Peter, Ionuţ Ledeţi

July 7, 2023

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.

Record ID

LAPSE:2023.36282

Keywords

drug degradation, isoconversional methods, kinetic study, moxonidine, thermal stability

Subject

Materials

Suggested Citation

Baul B, Ledeţi A, Cîrcioban D, Ridichie A, Vlase T, Vlase G, Peter F, Ledeţi I. Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation. (2023). LAPSE:2023.36282

Author Affiliations

Baul B: Faculty of Industrial Chemistry and Environmental Engineering, University Politehnica Timisoara, 2 Victoriei Square, 300006 Timisoara, Romania
Ledeţi A: Advanced Instrumental Screening Center, Faculty of Pharmacy, Victor Babeş University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania [ORCID]
Cîrcioban D: Advanced Instrumental Screening Center, Faculty of Pharmacy, Victor Babeş University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania [ORCID]
Ridichie A: Faculty of Industrial Chemistry and Environmental Engineering, University Politehnica Timisoara, 2 Victoriei Square, 300006 Timisoara, Romania; Advanced Instrumental Screening Center, Faculty of Pharmacy, Victor Babeş University of Medicine and Pharmacy,
Vlase T: Research Centre for Thermal Analysis in Environmental Problems, West University of Timisoara, Pestalozzi Street 16, 300115 Timisoara, Romania [ORCID]
Vlase G: Research Centre for Thermal Analysis in Environmental Problems, West University of Timisoara, Pestalozzi Street 16, 300115 Timisoara, Romania
Peter F: Faculty of Industrial Chemistry and Environmental Engineering, University Politehnica Timisoara, 2 Victoriei Square, 300006 Timisoara, Romania; Research Institute for Renewable Energy, University Politehnica Timisoara, 138 Gavril Musicescu, 300501 Timisoa [ORCID]
Ledeţi I: Faculty of Industrial Chemistry and Environmental Engineering, University Politehnica Timisoara, 2 Victoriei Square, 300006 Timisoara, Romania; Advanced Instrumental Screening Center, Faculty of Pharmacy, Victor Babeş University of Medicine and Pharmacy, [ORCID]

Journal Name

Processes

Volume

11

Issue

6

First Page

1738

Year

2023

Publication Date

2023-06-07