Population in vitro-in vivo correlation model linking gastrointestinal transit time, pH with the in vivo disposition kinetics of itraconazole

Background Sporanox and SUBA-itraconazole are oral capsule formulations of itraconazole with characteristically different pH-dissolution profiles. Oral administration of itraconazole is associated with marked inter-subject and intra‑subject pharmacokinetic variability due, in part, to variability in the drug’s absorption from the GI tract [1]. Objectives The objectives of this work were to : (1) Establish an in vitro-in […]

Population pharmacokinetic modelling of itraconazole and hydroxyl-itraconazole for oral Lozanoc® and Sporanox® capsule formulations in healthy volunteers in fed and fasted state.

Background: Itraconazole is an orally active broad spectrum anti-fungal agent used for treatment of fungal infections. It has a complex absorption kinetics with high between- and within-individual variability in addition to food effects. Hydroxy-itraconazole is the predominant active metabolite. Lozanoc is a novel Mayne Pharma formulation of oral itraconazole with significantly greater bioavailability than the […]