Dasatinib anhydrate containing oral formulation improves variability and bioavailability in humans.

ABSTRACT: Dasatinib monohydrate indicated for the treatment of chronic myeloid leukemia displays pH-dependent solubility. The aim of reported development program of novel dasatinib anhydrate containing formulation was to demonstrate improved absorption and lower pharmacokinetic variability compared to dasatinib monohydrate. In a bioavailability study comparing formulations containing 110.6 mg and 140 mg of dasatinib as anhydrate and monohydrate, respectively, both C_max and AUC of dasatinib were within standard 80.00-125.00% range, while the intra- and inter-subject variability for AUC_0-inf after the test product was approximately 3-fold and 1.5-fold less than after the reference, respectively.In a drug-drug interaction study, omeprazole 40 mg reduced the mean AUC_0-inf

SUBMITTER: Hofmann J 

PROVIDER: S-EPMC10681895 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature