Nanopharmaceutics: part I-Clinical trials legislation and good manufacturing practices (GMP) of nanotherapeutics in the EU
Open accessAbstract
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.
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Continuous manufacturing approaches like microfluidic assembly offer promising pathways to enhance reproducibility and scalability, yet demand considerable investment and process optimization.
“Continuous manufacturing approaches like microfluidic assembly offer promising pathways to enhance reproducibility and scalability, yet demand considerable investment and process optimization [217].”
From From design to Deployment: The innovative role of nanomicelles in targeted ophthalmic therapeutics (2025) · cites this paper as [217]
The Introduction describes scale-up as challenging, and the Conclusions say a reproducible, scalable production method must be developed and validated. Those passages support the general need for reproducibility and scalability, but they do not identify continuous manufacturing or microfluidic assembly as a promising approach, or discuss the investment such approaches require. No page numbers were available in our copy. (LLM, conf=0.82)
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- Authors
- Souto, E. B., Silva, G. F., Dias-Ferreira, J., Zielinska, A., Ventura, F., Durazzo, A., Lucarini, M., Novellino, E., & Santini, A.
- Affiliations
- University of Coimbra (PT)
- Department of Pharmaceutical Technology, Faculty of Pharmacy (FFUC), University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal
- University of Lisbon (PT)
- Consiglio per la ricerca in agricoltura e l’analisi dell’economia agraria (IT)
- University of Naples Federico II (IT)
- Corresponding author
- Souto, Eliana B.
- Santini, Antonello
- ORCID
- Venue
- Pharmaceutics
- Publisher
- MDPI AG
- Published
- 2020-02-11
- Volume
- 12
- Issue
- 2
- Pages
- 146
- ISSN
- 1999-4923 (ISSN-L)
- PMC
- PMC7076491
- OpenAlex
- W3005713586
- Cited by
- 144
- References
- 61
- Citations by year
- 2026: 28 · 2025: 30 · 2024: 9 · 2023: 19 · 2022: 25 · 2021: 15 · 2020: 17 · 2019: 1
- FWCI
- 1.27
- Type
- journal article
- Language
- en
- Open access
- gold
- dx.doi.org
- Licence
- Locations
- Pharmaceutics (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, cc-by)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, cc-by-nc-nd)
- Funders
- Fundação para a Ciência e a Tecnologia (UIDB/04469/2020, COMPETE, PT2020, M-ERA-NET-0004/2015-PAIRED, UIDB/04469)
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Engineering › Biomedical Engineering › Nanotechnology research and applications
- Keywords
- nanotherapeutics, regulatory legislation, good manufacturing practices, clinical trials, European Union regulation, liposomal drug delivery, block copolymer micelles, scale-up production
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