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Published on: June 3, 2022
Regulatory status quo and prospects for biosurfactants in pharmaceutical applications
Ruba Ismail1, Zain Baaity2, Ildikó Csóka3
1Institute 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.
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.
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