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

Ambroxol hydrochloride (AMB), used as a broncho secretolytic and an expectorant drug, is a semi-synthetic derivative of vasicine obtained from the Indian shrub <i>Adhatoda vasica</i>. It is a metabolic product of bromhexine. The paper provides comprehensive and detailed research on ambro...

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Autores principales:	Dijana Jelić, Snežana Papović, Milan Vraneš, Slobodan Gadžurić, Silvia Berto, Eugenio Alladio, Dragana Gajić, Bojan Janković
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	ambroxol hydrochloride thermal stability compatibility chemometrics Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/10eac5a1340e4635b4d90511d6dce553
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spelling	oai:doaj.org-article:10eac5a1340e4635b4d90511d6dce5532021-11-25T18:41:43ZThermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions10.3390/pharmaceutics131119101999-4923https://doaj.org/article/10eac5a1340e4635b4d90511d6dce5532021-11-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1910https://doaj.org/toc/1999-4923Ambroxol hydrochloride (AMB), used as a broncho secretolytic and an expectorant drug, is a semi-synthetic derivative of vasicine obtained from the Indian shrub <i>Adhatoda vasica</i>. 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<sup>®</sup> 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<sup>®</sup> tablets.Dijana JelićSnežana PapovićMilan VranešSlobodan GadžurićSilvia BertoEugenio AlladioDragana GajićBojan JankovićMDPI AGarticleambroxol hydrochloridethermal stabilitycompatibilitychemometricsPharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1910, p 1910 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	ambroxol hydrochloride thermal stability compatibility chemometrics Pharmacy and materia medica RS1-441
spellingShingle	ambroxol hydrochloride thermal stability compatibility chemometrics Pharmacy and materia medica RS1-441 Dijana Jelić Snežana Papović Milan Vraneš Slobodan Gadžurić Silvia Berto Eugenio Alladio Dragana Gajić Bojan Janković Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
description	Ambroxol hydrochloride (AMB), used as a broncho secretolytic and an expectorant drug, is a semi-synthetic derivative of vasicine obtained from the Indian shrub <i>Adhatoda vasica</i>. 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<sup>®</sup> 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<sup>®</sup> tablets.
format	article
author	Dijana Jelić Snežana Papović Milan Vraneš Slobodan Gadžurić Silvia Berto Eugenio Alladio Dragana Gajić Bojan Janković
author_facet	Dijana Jelić Snežana Papović Milan Vraneš Slobodan Gadžurić Silvia Berto Eugenio Alladio Dragana Gajić Bojan Janković
author_sort	Dijana Jelić
title	Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
title_short	Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
title_full	Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
title_fullStr	Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
title_full_unstemmed	Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
title_sort	thermo-analytical and compatibility study with mechanistic explanation of degradation kinetics of ambroxol hydrochloride tablets under non-isothermal conditions
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/10eac5a1340e4635b4d90511d6dce553
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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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