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Review

Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU

1
Department of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal
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CEB - Centre of Biological Engineering, University of Minho, Campus de Gualtar 4710-057 Braga, Portugal
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Department of Biochemistry and Human Biology, Faculty of Pharmacy, University of Lisbon, 1649-003 Lisbon, Portugal
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CREA-Research Centre for Food and Nutrition, Via Ardeatina 546, 00178 Rome, Italy
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Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Napoli, Italy
*
Authors to whom correspondence should be addressed.
Pharmaceutics 2020, 12(2), 146; https://doi.org/10.3390/pharmaceutics12020146
Received: 19 September 2019 / Revised: 20 January 2020 / Accepted: 7 February 2020 / Published: 11 February 2020
(This article belongs to the Special Issue Nanosystems as Drug Delivery Carrier: From Nature to the Medication)
The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the “Holy Grail” of medicine—nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here. View Full-Text
Keywords: nanopharmaceutics; legislation; clinical trials; quality; safety; GMP nanopharmaceutics; legislation; clinical trials; quality; safety; GMP
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MDPI and ACS Style

Souto, E.B.; Silva, G.F.; Dias-Ferreira, J.; Zielinska, A.; Ventura, F.; Durazzo, A.; Lucarini, M.; Novellino, E.; Santini, A. Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU. Pharmaceutics 2020, 12, 146. https://doi.org/10.3390/pharmaceutics12020146

AMA Style

Souto EB, Silva GF, Dias-Ferreira J, Zielinska A, Ventura F, Durazzo A, Lucarini M, Novellino E, Santini A. Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU. Pharmaceutics. 2020; 12(2):146. https://doi.org/10.3390/pharmaceutics12020146

Chicago/Turabian Style

Souto, Eliana B., Gabriela F. Silva, João Dias-Ferreira, Aleksandra Zielinska, Fátima Ventura, Alessandra Durazzo, Massimo Lucarini, Ettore Novellino, and Antonello Santini. 2020. "Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU" Pharmaceutics 12, no. 2: 146. https://doi.org/10.3390/pharmaceutics12020146

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