Kinetics of generic tacrolimus in heart transplantation: A cautionary note

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.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Brief Communication Source Type: research