Please use this identifier to cite or link to this item: http://hdl.handle.net/1822/64421

TitleNanopharmaceutics: Part II - Production scales and clinically compliant production methods
Author(s)Souto, Eliana
Silva, Gabriela F.
Dias-Ferreira, João
Zielinska, Aleksandra
Ventura, Fátima
Durazzo, Alessandra
Lucarini, Massimo
Novellino, Ettore
Santini, Antonello
Keywordsnanopharmaceutics
nanonutraceutics
legislation
lipid-based
polymer-based
metal-based
clinical requirements
Issue date4-Mar-2020
PublisherMDPI
JournalNanomaterials
CitationSouto, Eliana; Silva, Gabriela F.; Dias-Ferreira, João; Zielinska, Aleksandra; Ventura, Fátima; Durazzo, Alessandra; Lucarini, Massimo; Novellino, Ettore; Santini, Antonello, Nanopharmaceutics: Part IIProduction Scales and Clinically Compliant Production Methods. Nanomaterials, 10(3), 455, 2020
Abstract(s)Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulationsnanopharmaceuticshave been proposed. These comprise pharmaceutical products at the nanoscale, developed from different types of materials with the purpose to, e.g., overcome solubility problems of poorly water-soluble drugs, the pharmacokinetic and pharmacodynamic profiles of known drugs but also of new biomolecules, to modify the release profile of loaded compounds, or to decrease the risk of toxicity by providing site-specific delivery reducing the systemic distribution and thus adverse side effects. To succeed with the development of a nanopharmaceutical formulation, it is first necessary to analyze the type of drug which is to be encapsulated, select the type matrix to load it (e.g., polymers, lipids, polysaccharides, proteins, metals), followed by the production procedure. Together these elements have to be compatible with the administration route. To be launched onto the market, the selected production method has to be scaled-up, and quality assurance implemented for the product to reach clinical trials, during which in vivo performance is evaluated. Regulatory issues concerning nanopharmaceutics still require expertise for harmonizing legislation and a clear understanding of clinically compliant production methods. The first part of this study addressing Nanopharmaceutics: Part IClinical trials legislation and Good Manufacturing Practices (GMP) of nanotherapeutics in the EU has been published in Pharmaceutics. This second part complements the study with the discussion about the production scales and clinically compliant production methods of nanopharmaceutics.
TypeReview
URIhttp://hdl.handle.net/1822/64421
DOI10.3390/nano10030455
ISSN2079-4991
e-ISSN2079-4991
Publisher versionhttp://www.mdpi.com/journal/nanomaterials
Peer-Reviewedyes
AccessOpen access
Appears in Collections:CEB - Publicações em Revistas/Séries Internacionais / Publications in International Journals/Series

Files in This Item:
File Description SizeFormat 
document_53551_1.pdf480,07 kBAdobe PDFView/Open

Partilhe no FacebookPartilhe no TwitterPartilhe no DeliciousPartilhe no LinkedInPartilhe no DiggAdicionar ao Google BookmarksPartilhe no MySpacePartilhe no Orkut
Exporte no formato BibTex mendeley Exporte no formato Endnote Adicione ao seu ORCID