纳米药物已成为有希望的治疗方法，用于靶向传递药物，并且作为传统癌症治疗的有益替代，因为相比健康组织，它们可以在肿瘤部位提供更高浓度的化疗药物，从而提高药物疗效并降低全身毒性。长效注射剂越来越成为制药研究的焦点，因为它们可以减少用药频率并提高患者的生活质量。由于不同配方设计方法的独特性和范围，以及药物释放机制的复杂性可能导致固有的变异性，因此开发用于修饰释放纳米药物的体外释放（IVR）方法具有挑战性。与口服产品相比，对于给药产品的溶解或释放方法的监管指导相对有限。本文详细介绍了对一种聚合物纳米颗粒进行的广泛体外释放方法开发工作，以制定释放介质组成和选择合适的仪器和采样技术，以将释放的药物与制剂分离开来。目的是开发一种适当稳健的分析方法，生成临床相关的体外释放数据。版权所有©2023。Elsevier B.V.出版。

Nanomedicines have emerged as a promising approach for targeted therapeutic delivery and specifically as a beneficial alternative to conventional cancer therapies as they can deliver higher concentrations of chemotherapeutic agents at the tumour site compared to healthy tissue, thus providing improved drug efficacy and lower systemic toxicity. Long acting injectables are increasingly becoming the focus of pharmaceutical research, as they can reduce dosing frequency and improve the life quality of patients. Development of an in vitro release (IVR) method for modified release nanomedicines is challenging because of the uniqueness and range of different formulation design approaches, as well as the complex nature of drug release mechanisms which may result in inherent variability. Regulatory guidance on the development of dissolution or release methods for parenteral products is limited relative to oral products. This article details the extensive in vitro release method development work conducted on a polymeric nanoparticle to develop the release media composition and selection of suitable apparatus and sampling technique to separate the released drug from the formulation. The aim was to develop a suitably robust analytical method that generated clinically relevant in vitro release data.Copyright © 2023. Published by Elsevier B.V.