Research progress on nanomedicines release testing methods

SUN Jiabei; PENG Bo; LIN Xiaoyang; WU Yun; HUANG Haiwei

doi:10.13506/j.cnki.jpr.2025.12.012

Abstract：Objective To summarize the commonly used detection methods for in vitro drug release studies of nanomedicine delivery systems.Methods This review summarized the commonly used in vitro drug release testing methods for nanodrug delivery systems,and the underlying principles,experimental setups,and key advantages and disadvantages of each method are described and compared,with a focus on comparing their respective advantages,disadvantages,and applicability.Results The sample-and-separation method allows for direct measurement of drug release,with relatively simple equipment requirements,but it involves tedious sampling procedures and carries a risk of drug loss or leakage.The continuous flow method offers more convenient sampling and higher levels of automation and standardization,but the technique is relatively complex and costly.The dialysis membrane method is simple in both setup and sampling,yet it is limited by the potential barrier effect of the dialysis membrane on drug diffusion and may not be suitable for drugs that bind to the membrane.Emerging methods,such as real-time monitoring techniques,show promise but may be applicable only to certain types of drugs or formulations.Each method presents distinct strengths and weaknesses in terms of accuracy,reproducibility,practicality,and suitability for different nanopharmaceutical systems.Conclusion There is currently no one-size-fits-all in vitro drug release method for nanopharmaceuticals,and the choice of method should be carefully tailored based on the properties of the drug,the delivery system,and the intended application.Looking ahead,the development of in vitro drug release assays that better correlate with in vivo release behavior represents a crucial direction for future research.Establishing standardized protocols,improving method robustness,and integrating advanced technologies will enhance the reliability of in vitro testing and support the rational design,quality control,and clinical translation of nanopharmaceuticals.