Alternate Routes of Administration

Patients, caregivers, payers, drug developers, and the continually evolving standard of care all play a critical role in shaping the drug product and formulation requirements to better meet unmet medical needs of patients. A significant area of growth in recent years has been in the non-oral route of administration (alternate route and injectable route of administration, RoA). The use of drug products for alternate route of administration or the use of drug-device combination products offers an opportunity to enable a product in situations where there are significant oral challenges, such as extensive gastrointestinal metabolism, low oral bioavailability, suboptimal oral PK, local gastrointestinal toxicity, or other adverse reactions. Additionally, drug-device combination products (both injectable and non-injectable for alternate route products) present an opportunity to consider an enhanced product that improves patient compliance and increases treatment options to manage diseases.