Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and other Drug Device Combination Products.

Biocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDP) and other drug device combination products because finished device components and packaging in these products are often in direct contact with formulation and the patient. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), discusses, in this paper, the current regulatory landscape associated with biocompatibility and how biocompatibility is typically assessed for OINDP, including risk management considerations and navigation of regulatory requirements. The paper also describes current challenges related to alignment of regulatory expectations, particularly for drug device combination products, and proposes some questions and topics for further discussion with regulatory agencies and other stakeholders to help advance alignment. To further illustrate current challenges and industry approaches to meeting biocompatibility requirements, we also present results of an IPAC-RS benchmarking survey and case studies.