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

Autor: Il'Giovine ZJ; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio., Williams JB; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio., Mason RP; Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Elucida Research LLC, Beverly, Massachusetts., Sherratt SCR; Elucida Research LLC, Beverly, Massachusetts; Department of Molecular, Cellular, and Biomedical Sciences, University of New Hampshire, Durham, New Hampshire., Hsich EM; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio., Lever H; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio., Mehra MR; Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts., Starling RC; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: starlir@ccf.org.
Jazyk: angličtina
Zdroj: The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation [J Heart Lung Transplant] 2021 Jul; Vol. 40 (7), pp. 569-572. Date of Electronic Publication: 2021 Apr 24.
DOI: 10.1016/j.healun.2021.03.009
Abstrakt: 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 (IC 50 ) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant.
(Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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