Industrial perspectives and future of oral drug delivery

Oral drug delivery is the most popular and convenient delivery route, mainly owing to its patient compliance and ease of application. Bioavailability after oral administration depends on the ability of a drug to overcome the harsh gastrointestinal tract microenvironment, metabolic degradation, and limitations caused by the biological barriers of the small intestine before being absorbed to the blood to exert a systemic effect. Hence, the physicochemical properties and the biological interactions of orally administered drugs determine their therapeutic efficacy. Nano-enabled strategies and nanomedicine offer multiple solutions to enhance the bioavailability and the therapeutic activity of drugs, including the modulation of physicochemical and biological properties at the nanoscale, encapsulation for enhanced stability in vivo and the use of nanocarriers for targeted drug delivery. Although there is a large number of nanomedicines already in the market, the translation of many other under development to clinics is retarded due to a lack of standardization for manufacturing and approval procedures of such products with certain complexity, as well as the uncertainties for assessing their quality and safety via traditional methods. Considering the numerous advantages and benefits that nanomedicine offers, there is an urgent need for cost effective and straightforward regulatory mechanisms that can lead to standardized industrial strategies for manufacturing and approval procedures of nanomedicines.