2017 AAPS Drug Dissolution for Foreign Particulate Analysis: Overcoming Challenges of MCC in Nasal Sprays

Authors & Contributors

Foreign particulate matter in drug products is a common issue in the pharmaceutical industry that has major impacts on pharmaceutical companies, from both financial and safety aspects. Foreign particulate matter studies are performed for all drug types, both to understand the levels of foreign material present and to submit the product for market release. Typically, these studies are performed by dissolving away drug components, leaving the foreign particulate matter in solution for subsequent filtration and testing. Nasal sprays, however, often utilize the excipient microcrystalline cellulose (MCC) as a filler and stabilizer in the suspension. MCC is exceptionally difficult to dissolve, making foreign particulate matter studies problematic.