Kinetics of generic tacrolimus in heart transplantation: A cautionary note.

ABSTRACT: Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC₅₀) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (1

SUBMITTER: Il'Giovine ZJ 

PROVIDER: S-EPMC10257977 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature