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In vitro-in vivo-in silico approach in biopharmaceutical characterization of ibuprofen IR and SR tablets

Authorized Users Only
2015
Authors
Beloica, Sofija
Cvijić, Sandra
Bogataj, Marija
Parojčić, Jelena
Article (Published version)
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Abstract
Within the last decades, physiologically based pharmacokinetic models have emerged into a biopharmaceutical toolkit that has been proven useful in understanding how physicochemical, formulation and physiological factors affect oral drug absorption. The purpose of this study was to develop a drug specific physiologically based pharmacokinetic model that will allow mechanistic interpretation of oral absorption from dosage forms exhibiting different in vitro and different in vivo performance (i.e. immediate release and sustained release tablets) and identification of bioperformance dissolution testing. Ibuprofen was chosen to be used for the "proof of concept" considering it is well characterised and the necessary physicochemical, biopharmaceutical and pharmacokinetic properties for model development could be found in the literature. Gastrointestinal simulation technology implemented in Simcyp (R) was successful in estimating ibuprofen oral absorption. The developed model exhibited good g...eneralisation ability for the dosage forms studied. The obtained results indicate that the model was sensitive to input kinetics represented by the in vitro drug release profiles obtained under various dissolution conditions. According to the obtained results, reciprocating cylinder apparatus with biorepresentative change in media pH might be considered as bioperformance dissolution in the case of the two ibuprofen SR products studied. These results further justify the use of integrated in vitro-in vivo-in silico approach in estimating bioperformance of oral solid dosage forms.

Keywords:
Bioperformance dissolution / Gastrointestinal simulation / In vitro-in vivo-in silica approach / Ibuprofen
Source:
European Journal of Pharmaceutical Sciences, 2015, 75, 151-159
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.1016/j.ejps.2015.03.027

ISSN: 0928-0987

PubMed: 25861718

WoS: 000356552500016

Scopus: 2-s2.0-84929706296
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2464
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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