文献类型：期刊文献

英文题名：A New Method for Evaluating Actual Drug Release Kinetics of Nanoparticles inside Dialysis Devices via Numerical Deconvolution

作者：Zhou, Yousheng[1];He, Chunsheng[2];Chen, Kuan[2];Ni, Jieren[3];Cai, Yu[4];Guo, Xiaodi[5];Wu, Xiao Yu[2]

机构：[1]AP CAD Inc, Toronto, ON M2N 3X2, Canada;[2]Univ Toronto, Adv Pharmaceut & Drug Delivery Lab, Leslie Dan Fac Pharm, 144 Coll St, Toronto, ON M5S 2S2, Canada;[3]East China Univ Sci & Technol, Sch Informat Sci & Engn, Shanghai 200237, Peoples R China;[4]Jinan Univ, Sch Pharm, Guangzhou 510632, Guangdong, Peoples R China;[5]Prinston Pharmaceut Inc, Cranbury, NJ 08512 USA

年份：2016

卷号：243

起止页码：11

外文期刊名：JOURNAL OF CONTROLLED RELEASE

收录：;EI(收录号：20164102895308);WOS:【SCI-EXPANDED(收录号:WOS:000392290000002)】；

基金：This work was partially supported by a Discovery grant and equipment grants to X.Y. Wu from the Natural Science and Engineering Research Council Canada (grant No. RGPIN 1511 and No. EQPEQ 1511). Technical assistance from R. Zhang in the diagram of Fig. 1A is also acknowledged.

语种：英文

外文关键词：Nanoparticles; drug release kinetics; numerical deconvolution; dialysis experiments; actual release profiles inside the dialysis device

摘要：Nanoparticle formulations have found increasing applications in modern therapies. To achieve desired treatment efficacy and safety profiles, drug release kinetics of nanoparticles must be controlled tightly. However, actual drug release kinetics of nanoparticles cannot be readily measured due to technique difficulties, although various methods have been attempted. Among existing experimental approaches, dialysis method is the most widely applied one due to its simplicity and avoidance of separating released drug from the nanoparticles. Yet this method only measures the released drug in the medium outside a dialysis device (the receiver), instead of actual drug release from the nanoparticles inside the dialysis device (the donor). Thus we proposed a new method using numerical deconvolution to evaluate actual drug release kinetics of nanoparticles inside the donor based on experimental release profiles of nanoparticles and free drug solution in the receptor determined by existing dialysis tests. Two computer programs were developed based on two different numerical methods, namely least square criteria with prescribed Weibull function or orthogonal polynomials as input function. The former was used for all analyses in this work while the latter for verifying the reliability of the predictions. Experimental data of drug release from various nanoparticle formulations obtained from different dialysis settings and membrane pore sizes were used to substantiate this approach. The results demonstrated that this method is applicable to a broad range of nanoparticle and microparticle formulations requiring no additional experiments. It is independent of particle formulations, drug release mechanisms, and testing conditions. This new method may also be used, in combination with existing dialysis devices, to develop a standardized method for quality control, in vitro-in vivo correlation, and for development of nanoparticles and other types of dispersion formulations. (C) 2016 Elsevier B.V. All rights reserved.