It is widely recognised that the development of orally inhaled and nasal products (OINDPs) is extremely challenging, thus requiring a rigorous approach to formulation development, analytical testing and CMC support.
However, OINDPs offer significant opportunities for drug development primarily driven by therapeutic advantages over other dosage forms, and new formulation technologies based on nanotechnology.
At Evotec, inhaled drug product development is a major part of the integrated CMC portfolio with dedicated cross-functional teams working together on projects. The team develops inhaled products for new chemical entities (NCEs) and generics for clinical programmes from Phase I to late-stage clinical studies, throughout our cGMP facilities in Italy and the UK. Evotec proposes integrated and stand-alone development plans tailored to each project to increase success and save time.
Our programmes are supported by a dedicated Inhalation Analytics and Material Sciences team using state-of-the-art equipment to characterise and define the drug product's quality attributes. The integrated approach we apply, alongside our scientific expertise, provides robust and reliable development strategies for challenging pharmaceutical inhaled drug product programmes (see graphic for a detailed overview of our integrated capabilities for inhaled drug product development and manufacturing).