免疫生物药物鼻腔给药制剂的药学开发要点。

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

机构信息

Institute of Pharmacy, Sechenov First Moscow State Medical University, Moscow, Russian Federation.

Centre of Epidemiology and Microbiology, The Gamaleya National Centre of Epidemiology and Microbiology, Moscow, Russian Federation.

出版信息

Curr Pharm Biotechnol. 2024;25(11):1394-1405. doi: 10.2174/0113892010260017231002075152.

Abstract

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.

摘要

简介

本文综述了免疫生物药物(IBD)经鼻内原位递药系统的最新进展。由于 COVID-19 大流行,人们对 IBD 经鼻给药的兴趣显著增加。然而,不仅鼻内疫苗传递系统在发展,噬菌体、干扰素等也在发展。能够实现选择性相转变的系统可能是解决黏液纤毛清除引起的经鼻递药问题的现代解决方案。此外,用作原位系统主要赋形剂的智能聚合物也可用作特异性佐剂。

方法

在 2000 年至 2022 年期间,使用“鼻内疫苗”和“鼻内免疫”等关键词,在 PubMed 医学出版物数据库中进行了科学检索,详细分析了 70 多项关于 IBD 经鼻递药的科学研究。

结果与结论

尽管有大量的新研究,但鼻内系统的潜力并未得到实现。基于文献综述的结果,为 IBD 经鼻递药系统的开发创建了一个算法。该综述中描述的此类算法和研究设计组织方法将有助于简化研发过程并将药物推向商业市场,从而提高医疗质量。

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