Current Opinion on Pharmaceutical Development and Regulatory Perspective on Characterization Parenteral Delivery Systems.

摘要

Over the last decade, numerous new molecular entities (NME, small molecules and biologics) have been formulated under the umbrella of nanomedicine drug delivery technologies. Some of them were submitted through the New Drug Application (NDA) [1], the Biological Legal Application (BLA) [2] while others under the 505b2 [3] pathway. In order to enhance product life cycle management, numerous of these NMEs have been reformulated with the help of nanotechnologies and filed at different regulatory agencies under the 505b2 (for the FDA) and hybrid (EMA) submissions. Nevertheless, the 505B2/hybrid pathways have not only allowed, from a regulatory perspective, to narrow down the time of submission but also from a more scientific standpoint, afforded the generation of “already marketed drug product” presenting a better safety and compliance doubled with a higher efficacy profile. (Bobo., et al.) [4] have reported the number of “51 FDA-approved nanomedicines” showing the growing interest of drug formulated with the help of nanotechnology. The authors illustrate that some nanomedicines have been filed and approved 60 years ago (1957: high molecular weight Iron Dextran) and more recently, such as ADYNOVATE (Baxalta), a polymer-protein conjugate (PEGylated factor VIII) where PEG was added to the formulation in order to stabilize the factor VIII protein, enhancing its in vivo half-life.