Summary
Both nasal and pulmonary inhalation routes for drug delivery are recognized to be useful as an alternative to oral and parenteral routes. Within nasal drug delivery systems, nasal spray products are promising and capable methods of delivery for both local and systemic disease therapy. Due to the complex nature of nasal spray products, where depending on the specific formulation composition, spray performance for the approval of nasally administered drugs for quality control and assessment of release testing can be complex.
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation proposes an alternative spray testing approach for finished combination product testing. Acceptance testing for spray pattern, droplet size distribution (DSD) and delivered dose (% of label claim) on incoming pump (actuator) lots can be used for the release testing of the finished drug product with proper justification [1]. This approach was utilized in the RezenopyTM NDA filing to leverage release of finished nasal spray drug product using incoming actuator results. Media comparison studies using USP Purified Water (USP-PW), placebo formulation, and finished product were conducted for spray testing including spray pattern, DSD, and delivered dose. Along with media comparison study, statistical analysis showed that spray characteristics of USP-PW and drug product are equivalent. The study concluded that the finished combination product RezenopyTM can be released using incoming actuator data based on FDA approval.