Ensuring a Streamlined Approach for Nasal Spray Product Development & Manufacturing


Nasal sprays are comprised of one or more therapeutically active ingredients that are either dissolved or suspended in solutions in non‐pressurized dispensers. The most common use is for allergy‐related symptoms, such as allergic rhinitis. Nasal sprays can be unit dose, bi‐dose or multi‐dose devices. The 2002 U.S. Food and Drug Administration guidance on “Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products ‐ Chemistry, Manufacturing, and Controls Documentation” describes several tests for characterizing nasal spray drug products. The regulatory guidance may have some differences in, or additions to, testing requirements in Europe, Canada or other countries compared to that in the United States.

Because the efficacy of the drug product depends on the ability of the spray device to deliver reproducible plumes and uniform dose content, some aspects of nasal spray development are unique such as formulation, container closure system, plume characterization, manufacturing and stability testing. Therefore, these aspects need to be carefully considered during the development program.

This white paper aims to provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products.