In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study
Само за регистроване кориснике
2014
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
In vitro - in vivo correlations (IVIVC) are generally accepted as a valuable tool in modified release formulation development aimed at (i) quantifying the in vivo drug delivery profile and formulation related effects on absorption; (ii) establishing clinically relevant dissolution specifications and (iii) supporting the biowaiver claims. The aim of the present study was to develop relevant IVIVC models based on mechanistic gastrointestinal simulation (GIS) and artificial neural network (ANN) analysis and to evaluate their applicability and usefulness in biopharmaceutical drug characterisation. Nifedipine osmotic release tablets were selected as model drug product on the basis of their robustness, dissolution limited drug absorption and the availability of relevant literature data. Although the osmotic release tablets have been designed to be robust against the influence of physiological conditions in the gastrointestinal tract, notable differences in nifedipine dissolution kinetics wer...e observed depending on the in vitro experimental conditions employed. The results obtained indicate that both GIS and ANN model developed were sensitive to input kinetics represented by the in vitro profiles obtained under various experimental conditions. Different in silico approaches may be successfully employed in the in vitro - in silico - in vivo model development. However, the results obtained may differ and relevant outcomes are sensitive to the methodology employed.
Кључне речи:
Gastrointestinal simulation / Artificial neural network / Dissolution / In vitro - in vivo correlation / NifedipineИзвор:
European Journal of Pharmaceutical Sciences, 2014, 62, 212-218Издавач:
- Elsevier Science BV, Amsterdam
Финансирање / пројекти:
- Развој производа и технологија које обезбеђују жељено ослобађање лековитих супстанци из чврстих фармацеутских облика (RS-MESTD-Technological Development (TD or TR)-34007)
DOI: 10.1016/j.ejps.2014.05.030
ISSN: 0928-0987
PubMed: 24911992
WoS: 000340301500025
Scopus: 2-s2.0-84903300210
Институција/група
PharmacyTY - JOUR AU - Ilić, Marija AU - Đuriš, Jelena AU - Kovacević, Ivan AU - Ibrić, Svetlana AU - Parojčić, Jelena PY - 2014 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2076 AB - In vitro - in vivo correlations (IVIVC) are generally accepted as a valuable tool in modified release formulation development aimed at (i) quantifying the in vivo drug delivery profile and formulation related effects on absorption; (ii) establishing clinically relevant dissolution specifications and (iii) supporting the biowaiver claims. The aim of the present study was to develop relevant IVIVC models based on mechanistic gastrointestinal simulation (GIS) and artificial neural network (ANN) analysis and to evaluate their applicability and usefulness in biopharmaceutical drug characterisation. Nifedipine osmotic release tablets were selected as model drug product on the basis of their robustness, dissolution limited drug absorption and the availability of relevant literature data. Although the osmotic release tablets have been designed to be robust against the influence of physiological conditions in the gastrointestinal tract, notable differences in nifedipine dissolution kinetics were observed depending on the in vitro experimental conditions employed. The results obtained indicate that both GIS and ANN model developed were sensitive to input kinetics represented by the in vitro profiles obtained under various experimental conditions. Different in silico approaches may be successfully employed in the in vitro - in silico - in vivo model development. However, the results obtained may differ and relevant outcomes are sensitive to the methodology employed. PB - Elsevier Science BV, Amsterdam T2 - European Journal of Pharmaceutical Sciences T1 - In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study VL - 62 SP - 212 EP - 218 DO - 10.1016/j.ejps.2014.05.030 ER -
@article{ author = "Ilić, Marija and Đuriš, Jelena and Kovacević, Ivan and Ibrić, Svetlana and Parojčić, Jelena", year = "2014", abstract = "In vitro - in vivo correlations (IVIVC) are generally accepted as a valuable tool in modified release formulation development aimed at (i) quantifying the in vivo drug delivery profile and formulation related effects on absorption; (ii) establishing clinically relevant dissolution specifications and (iii) supporting the biowaiver claims. The aim of the present study was to develop relevant IVIVC models based on mechanistic gastrointestinal simulation (GIS) and artificial neural network (ANN) analysis and to evaluate their applicability and usefulness in biopharmaceutical drug characterisation. Nifedipine osmotic release tablets were selected as model drug product on the basis of their robustness, dissolution limited drug absorption and the availability of relevant literature data. Although the osmotic release tablets have been designed to be robust against the influence of physiological conditions in the gastrointestinal tract, notable differences in nifedipine dissolution kinetics were observed depending on the in vitro experimental conditions employed. The results obtained indicate that both GIS and ANN model developed were sensitive to input kinetics represented by the in vitro profiles obtained under various experimental conditions. Different in silico approaches may be successfully employed in the in vitro - in silico - in vivo model development. However, the results obtained may differ and relevant outcomes are sensitive to the methodology employed.", publisher = "Elsevier Science BV, Amsterdam", journal = "European Journal of Pharmaceutical Sciences", title = "In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study", volume = "62", pages = "212-218", doi = "10.1016/j.ejps.2014.05.030" }
Ilić, M., Đuriš, J., Kovacević, I., Ibrić, S.,& Parojčić, J.. (2014). In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study. in European Journal of Pharmaceutical Sciences Elsevier Science BV, Amsterdam., 62, 212-218. https://doi.org/10.1016/j.ejps.2014.05.030
Ilić M, Đuriš J, Kovacević I, Ibrić S, Parojčić J. In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study. in European Journal of Pharmaceutical Sciences. 2014;62:212-218. doi:10.1016/j.ejps.2014.05.030 .
Ilić, Marija, Đuriš, Jelena, Kovacević, Ivan, Ibrić, Svetlana, Parojčić, Jelena, "In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study" in European Journal of Pharmaceutical Sciences, 62 (2014):212-218, https://doi.org/10.1016/j.ejps.2014.05.030 . .