Comparison of in vitro, in vivo, and in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver

Introduction: The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process. This work aims to compare in vitro, silico, vivo data establish if previously published prednisone tablet formulations candidates.
 Method: To achieve this goal, permeation studies were conducted on Caco-2 cells. A previous bioequivalence study between test reference drug product was applied an silico evaluation using Gastroplus® assess of two other proposed formulations.
 Results: apparent permeability coefficient presented a value 3.69 x 10-5 cm/s 180 minutes. shows that tested equivalent. simulations successfully predicted pharmacokinetics since they validated with study. Both exhibit same plasma concentration vs. time profiles.
 Conclusions: Through results, it is possible infer may be bioequivalent concerning product. result helpful requesting. Toward reduce costs use human beings studies, approach could essential way pharmaceutical industry.