Intranasal Ion-Triggered In Situ Delivery System of Virus-like Particles: Development Using the Quality by Design Approach

被引：1
|
作者：
Bakhrushina, Elena O. [1 ]
Mikhel, Iosif B. [1 ]
Kondratieva, Valeriya M. [2 ]
Zubareva, Irina M. [1 ]
Kosenkova, Svetlana I. [1 ]
Belyatskaya, Anastasiya V. [1 ]
Stepanova, Olga I. [1 ]
Krasnyuk Jr, Ivan I. [1 ]
Grebennikova, Tatyana V. [2 ]
Krasnyuk, Ivan I. [1 ]
机构：
[1] Sechenov Univ, IM Sechenov Moscow State Med Univ 1, AP Nelyubin Inst Pharm, Moscow 119048, Russia
[2] Gamaleya Natl Ctr Epidemiol & Microbiol, Dept Epidemiol & Microbiol, Moscow 123098, Russia
来源：
POLYMERS | 2024年 / 16卷 / 05期
关键词：
in situ forming; VLP; intranasal delivery; vaccines; quality by design; ion-triggered polymers; gellan gum; VIVO EVALUATION; SUPPOSITORY; FORMULATION; GEL;
D O I：
10.3390/polym16050685
中图分类号：
O63 [高分子化学（高聚物）];
学科分类号：
070305 ; 080501 ; 081704 ;
摘要：
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.
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页数：16
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