Main Aspects of Pharmaceutical Development of Immunobiological Drugs for Intranasal Administration.

Introduction: The review presents the latest developments in the area of intranasal in situ delivery systems of immunobiological drugs (IBDs). Interest in intranasal administration for IBDs has increased significantly due to the COVID-19 pandemic. However, not only intranasal delivery of vaccines is developing, but also bacteriophages, interferons, etc. systems that make a selective phase transition can be a modern solution to intranasal delivery problems caused by mucociliary clearance. In addition, smart-polymers used as the main excipients in in situ systems can be used as specific adjuvants.

Methods: A scientific search was conducted on the PubMed database of medical publications for the period from 2000 to 2022, using the keywords "intranasal vaccine"; "intranasal immunization". There were analyzed in detail more than 70 scientific studies on intranasal delivery of IBDs.

Results And Conclusions: Despite the large number of new studies, the potential of possibilities of intranasal systems is not being realized. Based on the results of the literature review an algorithm was created for the development of systems for intranasal delivery of IBDs. Such algorithms and the methods of study design organization described in the review will help to facilitate the R&D process and bring the drug to commercial market, which will help to improve the quality of medical care.