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J. Control. Release, Nov 19 2024, 377 S0168-3659(24)00766-1 | https://doi.org/10.1016/j.jconrel.2024.11.021
In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide)
Yan Wang a, Andrew Otte b, Haesun Park c, Kinam Park b,d
aFood and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, Silver Spring, MD 20993, USA
bPurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA
cAkina, Inc, West Lafayette, IN 47906, USA
dPurdue University, Department of Industrial and Molecular Pharmaceutics, West Lafayette, IN 47907, USA
Corresponding author: Kinam Park
aFood and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, Silver Spring, MD 20993, USA
bPurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA
cAkina, Inc, West Lafayette, IN 47906, USA
dPurdue University, Department of Industrial and Molecular Pharmaceutics, West Lafayette, IN 47907, USA
Corresponding author: Kinam Park
Abstract
In vitro-in vivo correlation (IVIVC), linking in vitro drug release to in vivo drug release or in vivo drug absorption, has been explored chiefly for oral extended-release dosage forms. Currently, there are no official guidelines on IVIVC development for non-oral drug delivery systems. Recently, many long-acting injectable (LAI) formulations based on poly(lactide-co-glycolide) (PLGA) have been developed to deliver various drugs, ranging from small molecules to peptides and proteins, for up to 6 months. The circumstances involved in the LAI formulations are drastically different from those in oral formulations, which generally deliver drugs for a maximum of 24 h. This article examines 37 IVIVC studies of PLGA microparticle formulations available in the literature. Understanding and establishing an IVIVC of LAI formulations requires more than merely plotting the percentage in vitro drug release against the percentage in vivo absorption. In vivo drug absorption (or release) should be measured to provide a complete pharmacokinetic profile when feasible. Accelerated in vitro release methods need to be respective of the real-time measurements by sharing the same release mechanism. Obtaining meaningful IVIVCs with predictive capability will be highly useful for future regulatory actions and for developing generic and new formulations.
논문정보
- Research article
- 2024년 11월 (BRIC 등록일 2025-01-22)
- 국외 연구진
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