Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions
Аутори
Jelić, DijanaPapović, Snežana
Vraneš, Milan
Gadžurić, Slobodan
Berto, Silvia
Alladio, Eugenio
Gajić, Dragana
Janković, Bojan Ž.
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
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.
Кључне речи:
ambroxol hydrochloride / chemometrics / compatibility / thermal stabilityИзвор:
Pharmaceutics, 2021, 13, 11, 1910-Финансирање / пројекти:
- COST [CA18202]
DOI: 10.3390/pharmaceutics13111910
ISSN: 1999-4923
PubMed: 34834325
WoS: 000729132600001
Scopus: 2-s2.0-85119618016
Колекције
Институција/група
VinčaTY - 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 . .