Dissolution performance related to particle size distribution for cohpiercially available prednisolone acetate suspensions

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Abstract
Dissolution performance for three commercially available parenteral prednisolone acetate suspensions was analyzed using a diffusion based model. Physicochemical properties of the drug and particle size characteristics of the formulation were included in the model as important determinants of dissolution performance. The model describes the dissolution profile for each formulation with a single characteristic value, the dissolution rate constant. For Products I and II with similar particle size characteristics, the model sufficiently describes the dissolution profile for each formulation but does not provide conclusive evidence about reasons for differences in dissolution performance between the two products. For Product III, the model sufficiently describes the dissolution profile and adequately includes the effect of a bimodal distribution of larger drug particles. This approach to the analysis of dissolution data for suspension formulations is suggested as being useful during the formulation process to provide for predetermined dissolution characteristics, as an evaluative tool in quality assurance, assurance, and for correlating in-vivo and in-vitro product performance.