Chemical and Pharmaceutical Engineering Institute, Hebei University of Science and Technology, Hebei, China.
J Biomater Sci Polym Ed. 2021 Jun;32(8):994-1008. doi: 10.1080/09205063.2021.1889857. Epub 2021 Mar 9.
In this study, a novel PLGA forming implants (ISFIs) were fabricated and methods for testing the release profiles were also developed. The correlations between release profiles and performances ( correlation, IVIVC) were also studied. PLGA with different molecular weights were selected as the polymeric matrix. Biocompatible -methy1-2-pyrrolidone (NMP) or glyceryl triacetate (GTA) were used as the solvents with the ratios of NMP/GTA from 60/40 (vol/vol) to 20/80 (vol/vol). Eprinomectin (EPR) was chosen as the model therapeutic. release profiles of the EPR-loaded PLGA ISFIs were investigated using various methods (i.e. 'tubule' sample-and-separate and dialysis method). Sprague-Dawley rats were used to study the pharmacokinetics of EPR-loaded PLGA ISFIs. The release data obtained 'tubule' sample-separate method had a good IVIVC (Level A, > 0.99). These results showed that the 'tubule' sample-separate method was capable of discriminating the EPR-loaded ISFIs which were equivalent in formulation composition with manufacturing differences. Meanwhile, this method could be used to predict the performances of ISFIs in the investigated animal model.
在这项研究中,制备了一种新型的 PLGA 成型植入物(ISFI),并开发了测试释放曲线的方法。还研究了释放曲线与性能(相关性、IVIVC)之间的关系。选择不同分子量的 PLGA 作为聚合物基质。使用生物相容性的 N-甲基-2-吡咯烷酮(NMP)或甘油三乙酸酯(GTA)作为溶剂,NMP/GTA 的比例从 60/40(体积/体积)到 20/80(体积/体积)不等。选择依普菌素(EPR)作为模型治疗药物。使用各种方法(即“管”样品分离和透析法)研究了载有 EPR 的 PLGA ISFI 的释放曲线。使用 Sprague-Dawley 大鼠研究了载有 EPR 的 PLGA ISFI 的药代动力学。从“管”样品分离方法获得的释放数据具有良好的 IVIVC(A级,>0.99)。这些结果表明,“管”样品分离方法能够区分在制剂组成和制造差异方面等效的载有 EPR 的 ISFI。同时,该方法可用于预测在研究动物模型中 ISFI 的性能。