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The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

Authors :
Cvijić Sandra
Ignjatović Jelisaveta
Parojčić Jelena
Ibrić Svetlana
Source :
Arhiv za farmaciju, Vol 71, Iss 4, Pp 318-335 (2021)
Publication Year :
2021
Publisher :
Pharmaceutical Association of Serbia, Belgrade, Serbia, 2021.

Abstract

Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a particularly useful tool in formulation development. PBPK/PBBM facilitated strategies have been increasingly evaluated over the past few years, as demonstrated by several reports from the pharmaceutical industry, and a number of research and review papers on this subject. Also, the leading regulatory authorities have recently issued guidance on the use of PBPK modeling in formulation design. In silico PBPK models can comprise different dosing routes (oral, intraoral, parenteral, inhalation, ocular, dermal etc.), although the majority of published examples refer to modeling of oral drugs performance. In order to facilitate the use of PBPK modeling tools, a couple of companies have launched commercially available software such as GastroPlus™, Simcyp™ PBPK Simulator and PK-Sim®. This paper highlights various application fields of PBPK/PBBM modeling, along with the basic principles, advantages and limitations of this approach, and provides relevant examples to demonstrate the practical utility of modeling & simulation tools in different stages of formulation development.

Details

Language :
Serbian
ISSN :
00041963 and 22178767
Volume :
71
Issue :
4
Database :
Directory of Open Access Journals
Journal :
Arhiv za farmaciju
Publication Type :
Academic Journal
Accession number :
edsdoj.821d7df8afc493597f1f37cce3ff794
Document Type :
article
Full Text :
https://doi.org/10.5937/arhfarm71-32479