Nanopharmaceutics: Part II-Production Scales and Clinically Compliant Production Methods

• Tipo: Outra Publicação em Revista Científica Internacional
• Data: 2020

Autores

Souto, EB (Autor) Outra; Silva, GF (Autor) Outra; Dias Ferreira, J (Autor) Outra; Zielinska, A (Autor) Outra; Ventura, F (Autor) Outra; Durazzo, A (Autor) Outra; Lucarini, M (Autor) Outra; Novellino, E (Autor) Outra; Santini, A (Autor) Outra

Revista

Título: Nanomaterials

Vol. 10

Página Final: 455

ISSN: 2079-4991

Editora: MDPI

Indexação

ISI Web of Knowledge - 40 Citações

Scopus - 49 Citações

Classificação Científica

CORDIS: Ciências da Saúde

Outras Informações

ID Authenticus: P-00R-T9B

DOI: 10.3390/nano10030455

Abstract (EN): Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulations-nanopharmaceutics-have 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 I-Clinical 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.

Idioma: Inglês

Tipo (Avaliação Docente): Científica

Nº de páginas: 16