TY  - JOUR
AU  - Jelić, Dijana
AU  - Papović, Snežana
AU  - Vraneš, Milan
AU  - Gadžurić, Slobodan
AU  - Berto, Silvia
AU  - Alladio, Eugenio
AU  - Gajić, Dragana
AU  - Janković, Bojan Ž.
PY  - 2021
UR  - https://vinar.vin.bg.ac.rs/handle/123456789/10048
AB  - 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.
T2  - Pharmaceutics
T1  - Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
VL  - 13
IS  - 11
SP  - 1910
DO  - 10.3390/pharmaceutics13111910
ER  - 

@article{
author = "Jelić, Dijana and Papović, Snežana and Vraneš, Milan and Gadžurić, Slobodan and Berto, Silvia and Alladio, Eugenio and Gajić, Dragana and Janković, Bojan Ž.",
year = "2021",
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.",
journal = "Pharmaceutics",
title = "Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions",
volume = "13",
number = "11",
pages = "1910",
doi = "10.3390/pharmaceutics13111910"
}

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

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

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