Arti Bagada the choice is dependent on whether you want to utilize a nasal drug product for local or systemic delivery/ action, as well as the drug product profile. To support a regulatory filing for a new nasal spray drug product, the latest characterization and test data guidelines recommended by the US Food and Drug Administration (USFDA) and European Medicines Agencies (EMA) should be followed.

Besides preliminary characterization (sterility testing, aerodynamic particle size distribution, spray pattern, plume geometry, extractables/leachables, priming/repriming, tail-off profiling, dose proportionality, effect of dosing orientation, spray content uniformity, and ICH guided stability testing), other cutting edge characterization techniques should include Deposition Studies in Nasal Casts and Computational Fluid Dynamic Simulation Models.

Preclinical considerations should be guided by ICH M3 (R2) and ICH S9. Follow USFDA guidelines for pharmacokinetic, pharmacodynamic, or clinical endpoint studies when conducting bioequivalence studies (FDA Docket Number: FDA-2013-D-1464). Check applications covered in Section 505(b)(2) issued by the Center for Drug Evaluation and Research as well.

Regulatory requirements and global interpretations of qualitative and quantitative homogeneity, as required for New Drug Applications, may differ across countries. Therefore, quality control during the manufacturing, as well as in vitro analytical and in vivo characterization, must be robust enough to enable INDD system reproducibility and performance. Adopt USFDA and Inhalation CMC Guidance for the regulatory landscape of nasal spray drug products.