Abstract
Several scientific areas have benefited significantly from the introduction of nanotechnology and the respective evolution. This is especially noteworthy in the development of new drug substances and products. This review focuses on the introduction of nanomedicines in the pharmaceutical market, and all the controversy associated to basic concepts related to these nanosystems, and the numerous methodologies applied for enhanced knowledge. Due to the properties conferred by the nanoscale, the challenges for nanotechnology implementation, specifically in the pharmaceutical development of new drug products and respective regulatory issues are critically discussed, mainly focused on the European Union context. Finally, issues pertaining to the current applications and future developments are presented.
Highlights
Over the last years, nanotechnology has been introduced in our daily routine
The use of nanotechnology in the development of new medicines is part of our research and in the European Union (EU) it has been recognized as a Key Enabling Technology, capable of providing new and innovative medical solution to address unmet medical needs (Bleeker et al, 2013; Ossa, 2014; Tinkle et al, 2014; Pita et al, 2016)
Evaluation Methods The evaluation of possible toxic effects of the nanomaterials can be ascribed to the presence of well-known molecular responses in the cell
Summary
Nanotechnology has been introduced in our daily routine. This revolutionary technology has been applied in multiple fields through an integrated approach. An increasing number of applications and products containing nanomaterials or at least with nano-based claims have become available. Some efforts have been made in order to find a consensual definition due to the fact that nanomaterials possess novel physicochemical properties, different from those of their conventional bulk chemical equivalents, due to their small size. These properties greatly increase a set of opportunities in the drug development; some concerns about safety issues have emerged. The physicochemical properties of the nanoformulation which can lead to the alteration of the pharmacokinetics, namely the absorption, distribution, elimination, and metabolism, the potential for more cross biological barriers, toxic properties and their persistence in the environment and human body are some examples of the concerns over the application of the nanomaterials (Bleeker et al, 2013; Tinkle et al, 2014)
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