Novel mathematical model for predicting the dissolution profile of spherical particles under non-sink conditions

Abstract

A mechanistic mathematical model was designed to predict dissolution patterns under non-sink conditions. Sulfamethoxazole was used as a model drug, and its physico-chemical properties such as solubility, density, and intrinsic dissolution rate constant etc., were investigated in order to apply these experimental values to the proposed model. Dissolution tests were employed as a way of validating the mathematical model, and it was found that the predictions given by the model were surprisingly accurate for all particle sizes. In addition, a simulation focused on forecasting the fraction of the drug that was dissolved at a certain time point when various initial particle diameters were used was also particularly valuable. Therefore, these results demonstrated that the model enables dissolution profiles to be analyzed under non-sink conditions. © 2010 Pharmaceutical Society of Japan.