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In vitro dissolution testing strategies for nanoparticulate drug delivery systems: recent developments and challenges

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Abstract

Nanoparticulate systems have emerged as prevalent drug delivery systems over the past few decades. These delivery systems (such as liposomes, emulsions, nanocrystals, and polymeric nanocarriers) have been extensively used to improve bioavailability, prolong pharmacological effects, achieve targeted drug delivery, as well as reduce side effects. Considering that any unanticipated change in product performance of such systems may result in toxicity and/or change in vivo efficacy, it is essential to develop suitable in vitro dissolution/release testing methods to ensure product quality and performance, and to assist in product development. The present review provides an overview of the current in vitro dissolution/release testing methods such as dialysis, sample and separate, as well as continuous flow methods. Challenges and future directions in the development of standardized and biorelevant in vitro dissolution/release testing methods for novel nanoparticulate systems are discussed.

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Acknowledgments

The authors would like to thank the US Army Medical Research (#W81XWH-07-1-0688 and #W81XWH-09-1-0711) and the National Institutes of Health Grant (#R43 EB011886-01) for financial support.

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  1. Department of Pharmaceutical Sciences, University of Connecticut, 69 North Eagleville Road U 3092, Storrs, CT, 06269, USA

    Jie Shen & Diane J. Burgess

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  1. Jie Shen
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Correspondence to Diane J. Burgess.

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Shen, J., Burgess, D.J. In vitro dissolution testing strategies for nanoparticulate drug delivery systems: recent developments and challenges. Drug Deliv. and Transl. Res. 3, 409–415 (2013). https://doi.org/10.1007/s13346-013-0129-z

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