In Vivo Dissolution Rates: An Error Analysis

Abstract

The uncertainty associated with the determination of in vivo dissolution rates was determined by Monte Carlo simulation. Error was imposed upon sets of artificially generated data that simulated plasma drug levels after tablet and solution dosage from ingestion. Deconvolutions were performed on the data sets to determine how error in the plasma levels propagated into the in vivo dissolution determinations. Two approaches were taken in the performance of the deconvolution step of the simulation. In the first, a model was explicitly assumed for dissolution. In the second, deconvolution was accomplished by a mass balance approach in which no explicit model for dissolution was assumed.