Combined Methodologies for Determining In Vitro Bioavailability of Drugs and Prediction of In Vivo Bioequivalence From Pharmaceutical Oral Formulations.

ABSTRACT: With the aim of developing an in vitro model for the bioavailability (BA) prediction of drugs, we focused on the study of levonorgestrel (LVN) released by 1.5 mg generic and brand-name tablets. The developed method consisted in combining a standard dissolution test with an optimized parallel artificial membrane permeability assay (PAMPA) to gain insights into both drug release and gastrointestinal absorption. Interestingly, the obtained results revealed that the tablet standard dissolution test, combined with an optimized PAMPA, highlighted a significant decrease in the release (15 ± 0.01 μg min^-1 vs 30 ± 0.01 μg min^-1) and absorption (19 ± 7 × 10^-6 ± 7 cm/s Pe vs 41 ± 15 × 10^-6 cm/s Pe) profiles of a generic LVN tablet when compared to th

SUBMITTER: De Simone A 

PROVIDER: S-EPMC8597939 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature