Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Kinetic Investigation of Oxidative Thermal Decomposition of Levonorgestrel

Version 1 : Received: 28 August 2023 / Approved: 29 August 2023 / Online: 30 August 2023 (04:01:50 CEST)

A peer-reviewed article of this Preprint also exists.

Ridichie, A.; Ledeţi, A.; Peter, F.; Ledeţi, I.; Muntean, C.; Rădulescu, M. Kinetic Investigation of the Oxidative Thermal Decomposition of Levonorgestrel. Processes 2023, 11, 3210, doi:10.3390/pr11113210. Ridichie, A.; Ledeţi, A.; Peter, F.; Ledeţi, I.; Muntean, C.; Rădulescu, M. Kinetic Investigation of the Oxidative Thermal Decomposition of Levonorgestrel. Processes 2023, 11, 3210, doi:10.3390/pr11113210.

Abstract

In this study, we have focused on studying the heterogenous degradation kinetics of regarding the decomposition of emergency contraceptive agent levonorgestrel (LNG), which is a second-generation synthetic progestogen that is the active component of the racemic mixture of norgestrel. The degradation processes of the active pharmaceutical ingredient (API) were compared with the ones obtained from model system containing the API along with the excipients that are found in a commercialized pharmaceutical formulation in a mass ratio of 1:1 (LNGMIX), in order to observe if the excipients have a stabilizing or destabilizing effect for the degradation of this progestogen. To achieve this, the following investigational methods were used: FTIR (Fourier transform infrared) spectroscopy and thermal analysis (TG/DTG/DSC analysis). For the kinetic analysis the data obtained from two main decomposition processes observed on the DTG curves were used and processed with a preliminary method, namely ASTM E698 and two isoconversional methods: Friedman and Flynn-Wall-Ozawa. The isoconversional study revealed that the decomposition mechanism of both LNG and LNGMIX are complex, and the excipients have a stabilizing effect over decomposition of API in tablet.

Keywords

levonorgestrel; thermal analysis; kinetic study; decomposition; isoconversional methods

Subject

Chemistry and Materials Science, Analytical Chemistry

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