2017 DDL Dual Automated Approach for Sizing and Characterizing Budesonide In Suspension

Budesonide is a corticosteroid that is commonly administered by means of a nebulizer to help prevent symptoms of asthma, when regularly inhaled. The suspension contains the ingredients micronized budesonide (API), citric acid, edetate disodium dehydrate, polysorbate 80, sodium chloride, sodium citrate and water for injection; however, all excipients in the suspension are in liquid form. The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of the drug product. Therefore, gaining an understanding of API particle size distribution (PSD) is becoming of greater importance to regulatory agencies.