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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

Authorized Users Only
2014
Authors
Ilić, Marija
Đuriš, Jelena
Kovacević, Ivan
Ibrić, Svetlana
Parojčić, Jelena
Article (Published version)
Metadata
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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 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.

Keywords:
Gastrointestinal simulation / Artificial neural network / Dissolution / In vitro - in vivo correlation / Nifedipine
Source:
European Journal of Pharmaceutical Sciences, 2014, 62, 212-218
Publisher:
  • Elsevier Science BV, Amsterdam
Funding / projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.1016/j.ejps.2014.05.030

ISSN: 0928-0987

PubMed: 24911992

WoS: 000340301500025

Scopus: 2-s2.0-84903300210
[ Google Scholar ]
22
19
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2076
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - 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 . .

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