@article{Caccavo2023,

title = {Impact of drug release in USP II and in-vitro stomach on pharmacokinetic: The case study of immediate-release carbamazepine tablets},

author = {Diego Caccavo and Marco Iannone and Anna Angela Barba and Gaetano Lamberti},

url = {https://www.sciencedirect.com/science/article/pii/S0009250922009563},

doi = {10.1016/j.ces.2022.118371},

year  = {2023},

date = {2023-03-05},

journal = {Chemical Engineering Science},

volume = {267},

abstract = {The in-vitro reproduction of the real physiological conditions that occur along the gastrointestinal (GI) tract would be the optimum for the dissolution and release testing of pharmaceutical formulations for oral intake. In this study a method for the automated reproduction of the real pH conditions that occurs in the gastric cavity and a device that mimics the same forces exerted by the internal walls of the stomach are presented. Commercial immediate-release carbamazepine tablets were tested in conventional (USP II) and unconventional apparatuses. The gastric pH and the fluid dynamic conditions are factors to be carefully considered since they both affect the drug release profiles. Finally, a PBPK model was used to predict the evolution of plasma drug concentrations knowing the experimental in-vitro GI release behavior. It was found that, for immediate-release carbamazepine tablet, the gastric drug release does not have a major impact on the plasmatic drug concentration.},

keywords = {Drug Delivery Systems, Mathematical modeling, Pharmacokinetics},

pubstate = {published},

tppubtype = {article}

}

@article{Cascone2016,

title = {Gastrointestinal behavior and ADME phenomena: I. In vitro simulation},

author = {Sara Cascone and Gaetano Lamberti and Francesco Marra and Giuseppe Titomanlio and Matteo d'Amore and Anna Angela Barba},

url = {https://www.sciencedirect.com/science/article/pii/S1773224716302659

},

doi = {10.1016/j.jddst.2016.08.002},

issn = {1773-2247},

year  = {2016},

date = {2016-10-01},

journal = {Journal of Drug Delivery Science and Technology},

volume = {35},

pages = {272-283},

abstract = {The most common administration route for pharmaceuticals is the oral one. A drug orally administered has to undergo several processes in order to carry out its therapeutic potential. The pharmaceutical has to dissolve and to release the API (Active Pharmaceutical Ingredient) in the desired location along the GI (Gastro Intestinal) tract, to pass through the intestinal wall, to overcome the liver (first-pass metabolism), and finally to reach the plasma, where it has to be stable during its travel toward the target organ/tissue. The key roles in this complex framework are played by the design (such as matrices, reservoirs, enteric systems) and the testing of the pharmaceuticals.



This review is focused on the state of the art in the pharmaceutical testing methods, carried out by the simulation of what happens once the pharmaceutical has been administered, investigating the in vitro approach. In the first section, the generalities of the dissolution and the ADME (Adsorption, Distribution, Metabolism and Excretion) phenomena are investigated. In the second section, the in vitro apparatuses are described, with a special focus on the role of food in their design and behavior. Some case histories of application for each approach are also discussed.},

keywords = {Biodistribution, In vitro, Pharmacokinetics},

pubstate = {published},

tppubtype = {article}

}

@article{Lamberti2016,

title = {Gastrointestinal behavior and ADME phenomena: II. in silico simulation},

author = {Gaetano Lamberti and Sara Cascone and Francesco Marra and Giuseppe Titomanlio and Matteo D'Amore and Anna Angela Barba},

url = {http://www.sciencedirect.com/science/article/pii/S1773224716302118},

doi = {10.1016/j.jddst.2016.06.014},

issn = {1773-2247},

year  = {2016},

date = {2016-07-04},

journal = {Journal of Drug Delivery Science and Technology},

volume = {35},

pages = {165-171},

abstract = {The main goal of the pharmacokinetic modeling is the prediction of the drug concentration in the blood, tissues, and organs. The approaches to the modeling of physiological phenomena can be different on the basis of the details used to describe the Adsorption, Distribution, Metabolism, and Excretion (ADME) phenomena.



This review is focused on the state of the art in the pharmacokinetic modeling, on the different approaches used to describe the drug fate once it is administered. In particular, the early and the recent developments in the pharmacokinetic and in the gastrointestinal behavior modeling are discussed, together with some case histories of their applications.},

keywords = {In silico, Pharmacokinetics},

pubstate = {published},

tppubtype = {article}

}

@article{Abbiati2015a,

title = {A PSE approach to patient-individualized physiologically-based pharmacokinetic modeling},

author = { Roberto Andrea Abbiati and Gaetano Lamberti and Anna Angela Barba and Mario Grassi and Davide Manca},

url = {http://www.sciencedirect.com/science/article/pii/B9780444635785500104},

doi = {10.1016/B978-0-444-63578-5.50010-4},

issn = {15707946},

year  = {2015},

date = {2015-01-01},

journal = {12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering},

volume = {37},

pages = {77--84},

publisher = {Elsevier},

series = {Computer Aided Chemical Engineering},

abstract = {Pharmacokinetic modeling allows predicting the drug concentration reached in the blood as a consequence of a specific administration. When such models are based on mammalian anatomy and physiology it is possible to theoretically evaluate the drug concentration in every organ and tissue of the body. This is the case of the so-called physiologically based pharmacokinetic (PBPK) models. This paper proposes and validates a procedure to deploy PBPK models based on a simplified, although highly consistent with human anatomy and physiology, approach. The article aims at reducing the pharmacokinetic variations among subjects due to inter-individual variability, by applying a strategy to individualize some model parameters. The simulation results are validated respect to experimental data on remifentanil.},

keywords = {Complexity reduction, In silico, Lumping, Personalization, Pharmacokinetics, Physiologically-Based modeling, Remifentanil},

pubstate = {published},

tppubtype = {article}

}

@article{del2014physiologically,

title = {A physiologically oriented mathematical model for the description of in vivo drug release and absorption},

author = {Renzo {Del Cont} and Michela Abrami and Dritan Hasa and Beatrice Perissutti and Dario Voinovich and Anna Angela Barba and Gaetano Lamberti and Gabriele Grassi and Italo Colombo and Davide Manca and Mario Grassi},

url = {http://pub.iapchem.org/ojs/index.php/admet/article/view/34},

doi = {10.5599/admet.2.2.34},

issn = {1848-7718},

year  = {2014},

date = {2014-07-01},

journal = {ADMET \& DMPK},

volume = {2},

number = {2},

pages = {80--97},

abstract = {This paper focuses on a physiologically-oriented mathematical model aimed at studying the in vivo drug release, absorption, distribution, metabolism and elimination (ADME). To this purpose, the model accounts for drug delivery from an ensemble of non-eroding poly-disperse polymeric particles and the subsequent ADME processes. The model outcomes are studied with reference to three widely used drugs: theophylline, temazepam and nimesulide. One of the most important results of this study is the quantitative evaluation of the interplay between the release kinetics and the subsequent ADME processes. Indeed, it is usually assumed that in vivo drug release coincides with in vitro so that the effect exerted by the ADME processes is neglected. In addition, the proposed model may be an important tool for the design of delivery systems since, through proper changes, it could also account for different oral delivery systems.},

keywords = {In silico, Pharmacokinetics},

pubstate = {published},

tppubtype = {article}

}