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. 2021 Mar 13;13(3):381.
doi: 10.3390/pharmaceutics13030381.

Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials

Diego Alejandro Dri  1   2 , Carlotta Marianecci  2 , Maria Carafa  2 , Elisa Gaucci  1 , Donatella Gramaglia  1
Affiliations

Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials

Diego Alejandro Dri et al. Pharmaceutics. .

Abstract

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.

Keywords: clinical trials; nanocarriers; nanomedicines; regulatory; surfactants.

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Conflict of interest statement

Authors declare no conflict of interest. Conflict of interest declaration of authors 1 in accordance with the Conflict of Interest Regulations approved by the AIFA Board of Directors (25.03.2015) and published on the Official Journal of 15.05.2015 according to EMA policy /626261/2014 on the handling of the conflicts of interest for scientific committee members and experts.

Figures

Figure 1
Figure 1
Trend in number of publications containing the term “nanocarriers” (histogram), and in number of publications containing the term “nanocarriers + clinical trials”, in the last 5 years (searching criteria: article title, abstract, keywords). Source: www.scopus.com (accessed on 6 February 2021).
Figure 2
Figure 2
Percentage of instances for different surfactants found in the composition of the investigational medicinal products (IMPs).
Figure 3
Figure 3
Categories of nanomedicines identified in the IMPDs and number of instances.
See this image and copyright information in PMC

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