Regulatory status quo and prospects for biosurfactants in pharmaceutical applications

Theranostic efficiency of biosurfactants against COVID-19 and similar viruses - A review

“…The guidelines of US Food and Drug Administration (USFDA) emphasized on the rationalization behind the applicability of BSs towards development of dosage forms at a reduced concentration. A guideline for industry was published (for conduction of all vital toxicology studies by using Good Laboratory Practice guidelines and ultramodern protocols) for the conduction of safety evaluation (nonclinical) for new excipients by using International Council of Harmonization (ICH) guidelines S2B, S3A, S3B and S7A [ 136 ]. BSs can preserve the future of nano therapeutics there by helping in reducing regulatory path length of novel, effective, safe and cost-effective nanovaccines and can fulfil the expectations of regulatory bodies, patients, and industries.…”

“…As per regulatory guidelines in pharmaceuticals, BSs should possess safety, pharmacokinetic efficacy, biological and physicochemical compatibility and stability with different components (drug and excipients) to be considered for clinical consideration. Thus, the qualitative BSs must be commended with emerging technologies (cost-effective), with selection of renewable materials followed by innovative techniques for scale-up of bioprocessing as well as characterization [ 132 , 136 ].…”

“…Furthermore, along with the additional bio-based products, the batch-to-batch variability of the structure of BSs could reflect its quality attributes along with the efficacy and safety of the finished product. However, recommending quality by design (QbD) by ICH guidelines (ICH Q8 (R2), ICH Q9, ICH Q10) and risk management through advanced analytical tools such as nuclear magnetic resonance (NMR), chromatographic methods and in-process quality control can leads to adjust the batch to batch variability in scale-up of BSs [ 15 , 136 ].…”

Pharmaceutical prospects of biosurfactants produced from fungal species

“…Potential substitutes to synthesize potent biosurfactants with altered antimicrobial profiles and decreased toxicity against mammalian cells have extended their utility in various sectors of medicine [36]. Moreover, the distinctive molecular features of biosurfactant in synergy with nanotechnology has come up with the development of surfactant-based delivery systems such as micro/Nano-based drug carriers, selfemulsifying drug delivery systems (SEDDS), liposomes, and Niosomes [37]. Since surfactants can have direct effects on biological membranes, they can affect membrane integrity and alter drug transport across the membrane.…”

Extraction, purification and applications of biosurfactants based on microbial-derived glycolipids and lipopeptides: a review

“…Hence, downstream processing forms a significant obstacle in the path of largescale biosurfactant production (Marchant and Banat 2012;Costa et al 2018;Najmi et al 2018). Nevertheless, their demerits play a substantial part in various sectors such as industrial, pharmaceutical (Roy 2017;Ruba et al 2021), and environmental (Pacwa-Płociniczak et al 2011) owing to their structural diversity and unique property. There have been numerous reviews that provide a detailed overview of the utilization of biosurfactants in multiple domains (Nalini et al 2020;Płaza and Achal 2020;Saimmai et al 2020;Sarma and Prasad 2021).…”