Regulatory status quo and prospects for biosurfactants in pharmaceutical applications

Ruba Ismail; Zain Baaity; Ildikó Csóka

doi:10.1016/j.drudis.2021.03.029

Regulatory status quo and prospects for biosurfactants in pharmaceutical applications

Drug Discov Today. 2021 Aug;26(8):1929-1935. doi: 10.1016/j.drudis.2021.03.029. Epub 2021 Apr 5.

Authors

Ruba Ismail¹, Zain Baaity², Ildikó Csóka³

Affiliations

¹ Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös Str. 6, H-6720 Szeged, Hungary; Department of Applied and Environmental Chemistry, Institute of Chemistry, Faculty of Science and Informatics, University of Szeged, Rerrich Bela Sq.1., H-6720 Szeged, Hungary. Electronic address: ruba.ismail@szte.hu.
² Department of Medical Microbiology and Immunobiology, Faculty of Medicine, University of Szeged, 10 Dóm Square, H-6720 Szeged, Hungary.
³ Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös Str. 6, H-6720 Szeged, Hungary.

PMID: 33831583
DOI: 10.1016/j.drudis.2021.03.029

Abstract

The concept of going 'green' and 'cold' has led to utilizing renewable resources for the synthesis of microbial biosurfactants that are both patient and eco-friendly. In this review, we shed light on the potential and regulatory aspects of biosurfactants in pharmaceutical applications and how they can significantly contribute to novel concepts for the Coronavirus 2019 (COVID-19) vaccine and future treatment. We emphasize that more specific guidelines should be formulated to regulate the approval of biosurfactants for human use. It is also crucial to implement a risk-based approach from the early research and development (R&D) phase in addition to establishing more robust standardized techniques and assays to evaluate the characteristics of biosurfactants.

Keywords: COVID-19; EMA; FDA; Microbial biosurfactants; Nanoformulations.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Antiviral Agents / pharmacology*
COVID-19 Drug Treatment*
COVID-19 Vaccines / pharmacology*
COVID-19* / prevention & control
Drug Discovery* / methods
Drug Discovery* / trends
Drug and Narcotic Control / organization & administration
Ecological and Environmental Phenomena
Humans
Nanostructures
Pharmaceutical Preparations / classification
SARS-CoV-2* / drug effects
SARS-CoV-2* / physiology
Surface-Active Agents / pharmacology*

Substances

Antiviral Agents
COVID-19 Vaccines
Pharmaceutical Preparations
Surface-Active Agents