Nanomedicines - Tiny particles and big challenges.

Nanomedicines - Tiny particles and big challenges.
Adv Drug Deliv Rev. 2019 Jun 18;:
Authors: Marques MRC, Choo Q, Ashtikar M, Rocha TC, Bremer-Hoffmann S, Wacker MG
Abstract
After decades of research, nanotechnology has been used in a broad array of biomedical products including medical devices, drug products, drug substances, and pharmaceutical-grade excipients. But like many great achievements in science, there is a fine balance between the risks and opportunities of this new technology. Some materials and surface structures in the nanosize range can exert unexpected toxicities and merit a more detailed safety assessment. Regulatory agencies such as the United States Food and Drug Administration or the European Medicines Agency have started dealing with the potential risks posed by nanomaterials. Considering that a thorough characterization is one of the key aspects of controlling such risks this review presents the regulatory background of nanosafety assessment and provides some practical advice on how to characterize nanomaterials and drug formulations. Further, the challenges of how to maintain and monitor pharmaceutical quality through a highly complex production processes will be discussed.
PMID: 31226397 [PubMed - as supplied by publisher]

Source: Advanced Drug Delivery Reviews - June 17, 2019 Category: Drugs & Pharmacology Authors: Marques MRC, Choo Q, Ashtikar M, Rocha TC, Bremer-Hoffmann S, Wacker MG Tags: Adv Drug Deliv Rev Source Type: research