Advanced formulations for intranasal delivery of biologics.

INTRODUCTION: The global biologics market has been ever increasing over the last decades and is predicted to top Euro 350 by 2020. Facing this scenario, the parenteral route of biologics administration as hitherto standard route is inconvenient for the future. Among the alternatives, the intranasal delivery of therapeutic biologicals seems to be most promising but researchers are still facing challenges as indicated by the scarce number of successfully marketed peptide drugs. AREAS COVERED: This review article is a compilation of current research focusing on achievements in the field of auxiliary agents for biologics delivery. First, the key benefits of the nose as most promising alternative route of drug administration are highlighted. Then, the potential of the different auxiliary agents in preclinical research is in detail discussed. Moreover, the most used permeation enhancing agents, mucolytic agents, mucoadhesive agents, in situ gelling agents and enzyme inhibiting agents in the formulation of nasal drug delivery systems are described. Thus, the overall purpose of this review is to highlight recent achievements in nasal delivery of biologics and to encourage researchers to work in the direction of needle-free nasal administration of biologics. EXPERT OPINION: The nasal epithelium is a promising route for biologics administration, which is reflected in a number of well-established products on the market treating chronic diseases as well as a large number of clinical trials currently in progress. The nasal route of drug administration might be a chance to improve therapy of biologics however break-through advances, especially for very complex molecules, such as antibodies, are still needed.