Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions

Department of Physical Chemistry, “Vinča” Institute of Nuclear Sciences—National Institute of the Republic of Serbia, University of Belgrade, 11 000 Belgrade, Serbia

Author to whom correspondence should be addressed.

Academic Editor: Afzal R. Mohammed

Pharmaceutics 2021, 13(11), 1910; https://doi.org/10.3390/pharmaceutics13111910

Received: 4 October 2021 / Revised: 22 October 2021 / Accepted: 8 November 2021 / Published: 11 November 2021

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Abstract

Ambroxol hydrochloride (AMB), used as a broncho secretolytic and an expectorant drug, is a semi-synthetic derivative of vasicine obtained from the Indian shrub Adhatoda vasica. It is a metabolic product of bromhexine. The paper provides comprehensive and detailed research on ambroxol hydrochloride, gives information on thermal stability, the mechanism of AMB degradation, and data of practical interest for optimization of formulation that contains AMB as an active compound. Investigation on pure AMB and in commercial formulation Flavamed^® tablet (FT), which contains AMB as an active compound, was performed systematically using thermal and spectroscopic methods, along with a sophisticated and practical statistical approach. AMB proved to be a heat-stable and humidity-sensitive drug. For its successful formulation, special attention should be addressed to excipients since it was found that polyvinyl pyrrolidone and Mg stearate affect the thermal stability of AMB. At the same time, lactose monohydrate contributes to faster degradation of AMB and change in decomposition mechanism. It was found that the n-th order kinetic model mechanistically best describes the decomposition process of pure AMB and in Flavamed^® tablets. View Full-Text

Keywords: ambroxol hydrochloride; thermal stability; compatibility; chemometrics

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MDPI and ACS Style

Jelić, D.; Papović, S.; Vraneš, M.; Gadžurić, S.; Berto, S.; Alladio, E.; Gajić, D.; Janković, B. Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions. Pharmaceutics 2021, 13, 1910. https://doi.org/10.3390/pharmaceutics13111910

AMA Style

Jelić D, Papović S, Vraneš M, Gadžurić S, Berto S, Alladio E, Gajić D, Janković B. Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions. Pharmaceutics. 2021; 13(11):1910. https://doi.org/10.3390/pharmaceutics13111910

Chicago/Turabian Style

Jelić, Dijana, Snežana Papović, Milan Vraneš, Slobodan Gadžurić, Silvia Berto, Eugenio Alladio, Dragana Gajić, and Bojan Janković. 2021. "Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions" Pharmaceutics 13, no. 11: 1910. https://doi.org/10.3390/pharmaceutics13111910

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Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions

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