Nanotechnology and the Pace of Regulation
Does nanotechnology hold the future of drug delivery? From the number of early research studies connecting drug delivery methods with nano-scale science, it would be tough to argue that it doesn’t. FDA recognized this when it formed its Nanotechnology Task Force in 2006 and Nanotechnology Interest Group in 2007. Although no new announcements have been released from the groups since last year, the research and development arena has been busy.
In April, FDA approved an investigational new drug application with a Phase 1 trial go-ahead for a nano-enabled cancer drug (Calandro Pharmaceuticals). The biopharmaceutical company developed a cyclodextrin-based polymer system to delver its “Cyclosert” nanoparticles that are between 30 and 60 nm in diameter. What is most interesting is that the particles are hydrophilic and have a neutral surface charge, which means they are not recognized as foreign particles and therefore avoid being taken up by macrophages.
Another nano-scale system could potentially deliver drugs in tiny bags. Rice University scientists developed a new gold-tipped “nanobaton” system comprising nanometer-sized metal and carbon stick-shaped particles that spontaneously assemble to form spherical sacs, trapping oil droplets in water. Magnetic fields and ultraviolet light is used to turn the bags inside out, thereby releasing their contents.
In time, I suspect the wheels of regulation and oversight will catch up to the pace of research and development. In the interim, a vew into innovative potential delivery systmes is exciting enough.