Bakhrushina Elena O, Mikhel Iosif B, Kondratieva Valeriya M, Zubareva Irina M, Kosenkova Svetlana I, Belyatskaya Anastasiya V, Stepanova Olga I, Krasnyuk Ivan I, Grebennikova Tatyana V, Krasnyuk Ivan I
A.P. Nelyubin Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow 119048, Russia.
Departament of Epidemiology and Microbiology, The Gamaleya National Centre of Epidemiology and Microbiology, Moscow 123098, Russia.
Polymers (Basel). 2024 Mar 2;16(5):685. doi: 10.3390/polym16050685.
The rapid growth in the prevalence of infectious diseases requires timely action from drug developers. In recent years, the COVID-19 pandemic has demonstrated the unpreparedness of the population for such emergencies. The introduction of modern methods of Design of Experiments (DoE) is required to accelerate the process of drug development and bring a drug to market. The main objective of this study was to develop an ion-triggered in situ system for intranasal delivery of VLP using a Quality by Design approach. Based on a literature review and initial studies, the key QTPP, CQA, CPP, and CMA were identified to develop a novel delivery system for virus-like particles. As a result of the studies on the quality attributes of the developed delivery system, an ion-triggered in situ gel meeting all the specified parameters was obtained using the Quality by Design method.
传染病患病率的迅速增长要求药物研发人员及时采取行动。近年来，新冠疫情表明民众对这类突发事件毫无准备。需要引入现代实验设计（DoE）方法来加速药物研发进程并将药物推向市场。本研究的主要目的是采用质量源于设计的方法开发一种用于鼻内递送病毒样颗粒（VLP）的离子触发原位系统。基于文献综述和初步研究，确定了关键的质量目标产品概况（QTPP）、关键质量属性（CQA）、关键工艺参数（CPP）和关键物料属性（CMA），以开发一种新型的病毒样颗粒递送系统。通过对所开发递送系统的质量属性进行研究，采用质量源于设计的方法获得了一种符合所有指定参数的离子触发原位凝胶。
