Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials
![Trend in number of publications containing the term “nanocarriers”](https://www.pharmaexcipients.com/wp-content/uploads/2021/03/Trend-in-number-of-publications-containing-the-term-nanocarriers.png)
Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms “surfactant”, “nanomedicine” and “nanocarrier”. Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.
Download the full article here: Surfactants, Nanomedicines and Nanocarriers- A Critical Evaluation on Clinical Trials
or continue reading here: Dri, D.A.; Marianecci, C.; Carafa, M.; Gaucci, E.; Gramaglia, D. Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials. Pharmaceutics 2021, 13, 381. https://doi.org/10.3390/pharmaceutics13030381
Surfactants described in the Investigational Medicinal Product Dossiers (IMPDs)
- Lauroyl polyoxyl-32 glycerides (Gelucire 44/14)
- Mannide monooleate
- Sodium lauryl sulfate
- Polyoxyl 40 hydrogenated castor oil
- Poloxamer 188 (Pluronic F-68)
- Poloxamer 407
- Polysorbate 20 (Tween 20)
- Polysorbate 80 (Tween 80)
- Propylene glycol monocaprylate, type I (Capryol PGMC)