Nose-to-brain drug delivery: Regulatory aspects, clinical trials, patents, and future perspectives

With the recent advancements in development of complex formulations as well as complex active pharmaceutical ingredient, the route of administration is playing an important role. With nasal route having multiple advantages and unique passage to brain, it has attracted attention of formulation scientists to explore it for not only conventional drug delivery platform but also complex molecules like proteins and peptides including vaccines. Although lot of research is going on for delivery of nucleic acids for brain-related diseases via nasal route, not many formulations have been commercialized. There have been modifications in regulatory guidelines as well as commercial approach with the development of medical devices for nasal delivery. The present chapter deals in detail with the possible opportunities with this route of administration. A separate section based on regulatory guidelines for intranasal products has been included to give insight for commercialization aspects. Various patents and clinical trials on intranasal delivery systems, devices, and formulations have been summarized. The chapter also discusses the role of nanotechnology and recent advancement in nanomedicine for intranasal products along with medical devices used in intranasal formulations.