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

Autor: Stults CLM; C & M Technical Consulting, LLC, San Mateo, CA., Lanning CL; Merck & Co., Inc., West Point, PA., Nagao LM; Faegre Drinker Biddle & Reath, LLP, Washington DC; and lee.nagao@faegredrinker.com., Conners J; Sumitomo Pharma America, Marlborough, MA.
Jazyk: angličtina
Zdroj: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2024 Feb 20; Vol. 78 (1), pp. 125-139. Date of Electronic Publication: 2024 Feb 20.
DOI: 10.5731/pdajpst.2023.012852
Abstrakt: Biocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDPs) 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 article, the current regulatory landscape associated with biocompatibility and how biocompatibility is typically assessed for OINDPs, including risk management considerations and navigation of regulatory requirements. The article 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.
(© PDA, Inc. 2024.)
Databáze: MEDLINE