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. 2024 Mar 2;16(5):685.
doi: 10.3390/polym16050685.

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

Elena O Bakhrushina  1 , Iosif B Mikhel  1 , Valeriya M Kondratieva  2 , Irina M Zubareva  1 , Svetlana I Kosenkova  1 , Anastasiya V Belyatskaya  1 , Olga I Stepanova  1 , Ivan I Krasnyuk Jr  1 , Tatyana V Grebennikova  2 , Ivan I Krasnyuk  1
Affiliations

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

Elena O Bakhrushina et al. Polymers (Basel). .

Abstract

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.

Keywords: VLP; gellan gum; in situ forming; intranasal delivery; ion-triggered polymers; quality by design; vaccines.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Gellan gum chemical structure (PubChem).
Figure 2
Figure 2
Hydroxypropyl methylcellulose chemical structure (PubChem).
Figure 3
Figure 3
Poloxamer 124 chemical structure (PubChem).
Figure 4
Figure 4
QbD methodology description.
Figure 5
Figure 5
Ishikawa chart.
See this image and copyright information in PMC

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