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Pharmacokinetics and Pharmacodynamics Modeling and Simulation Systems to Support the Development and Regulation of Liposomal Drugs

1,2, 2, 3 and 2,4,*
1
Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, China
2
Division of Pharmacotherapy and Experimental Therapeutics, School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA
3
Department of Biomedical Engineering, University at Buffalo, The State University of New York, 332 Bonner Hall, Buffalo, NY 14260, USA
4
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(3), 110; https://doi.org/10.3390/pharmaceutics11030110
Received: 30 January 2019 / Revised: 25 February 2019 / Accepted: 28 February 2019 / Published: 7 March 2019
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Abstract

Liposomal formulations have been developed to improve the therapeutic index of encapsulated drugs by altering the balance of on- and off-targeted distribution. The improved therapeutic efficacy of liposomal drugs is primarily attributed to enhanced distribution at the sites of action. The targeted distribution of liposomal drugs depends not only on the physicochemical properties of the liposomes, but also on multiple components of the biological system. Pharmacokinetic–pharmacodynamic (PK–PD) modeling has recently emerged as a useful tool with which to assess the impact of formulation- and system-specific factors on the targeted disposition and therapeutic efficacy of liposomal drugs. The use of PK–PD modeling to facilitate the development and regulatory reviews of generic versions of liposomal drugs recently drew the attention of the U.S. Food and Drug Administration. The present review summarizes the physiological factors that affect the targeted delivery of liposomal drugs, challenges that influence the development and regulation of liposomal drugs, and the application of PK–PD modeling and simulation systems to address these challenges. View Full-Text
Keywords: pharmacokinetic–pharmacodynamics; modeling and simulation; PBPK model; liposomal drugs; EPR effect; regulatory review pharmacokinetic–pharmacodynamics; modeling and simulation; PBPK model; liposomal drugs; EPR effect; regulatory review
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He, H.; Yuan, D.; Wu, Y.; Cao, Y. Pharmacokinetics and Pharmacodynamics Modeling and Simulation Systems to Support the Development and Regulation of Liposomal Drugs. Pharmaceutics 2019, 11, 110.

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