Elastomers have been used in OINDPs for more than 50 years. Constituting an integral part of OINDP container closure systems (CCSs) and/or delivery devices (DDs), they are important to the safety and performance of drug products. The quality of elastomeric components and their construction is essential for ensuring that a CCS/DD functions according to its intended use in the drug product and is not detrimental to a particular product’s quality, safety or efficacy.
Elastomers in orally inhaled and nasal drug products, Part I: Elastomer selection and qualification
A rationalized, risk-based approach to elastomer selection and qualification is critical for OINDP quality and safety. This is the first of a two-part series of articles on elastomers to be published by Inhalation.