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A Streamlined Approach for Nasal Spray Development & Manufacturing
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Nasal sprays are comprised of one or more therapeutically active ingredients that are either dissolved or suspended in solutions in non‐pressurized dispensers. 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. 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.