Suspending agent effects on steroid suspension dissolution profiles

Dissolution profiles and particle-size analyses were determined for two lots of prednisolone acetate. The effects of common suspending agents on dissolution and particle-size distributions of these suspensions also were investigated. Lot-to-lot variation in the prednisolone acetate dissolution rate was observed and was apparently related to the percentage of fine particles within the distribution. Carboxymethylcellulose sodium inhibition of prednisolone acetate dissolution occurred with only one lot of raw material and seemed to be related to aggregation of the fine particles. Hydroxypropyl methylcellulose inhibited both prednisolone acetate lots and was observed with or without small particle aggregation. The dissolution variations observed have important implications in suspension formulation.