Mathematical Models of Dissolution

Tablet dissolution testing where the drug release is observed as a function of time is an essential part of tablet formulation studies. These tests provide information about the dissolution mechanism and ensure the reproducibility of drug release, which is important for tablet quality assurance. However, the dissolution tests are time-consuming and thus optimal planning of experiment and sophisticated methods for its results evaluation would be needed. Identification of the parameters of specific dissolution models is crucial problem in dissolution studies. Aim of this thesis is to find the optimal time for observation of the empirical dissolution data if the parametric form of the dissolution profile is assumed to be known and the parameters should be estimated. Our approach is based on stochastic properties of the dissolution process and the Fisher information concept. Furthermore, basic models of dissolution and their stochastic modifications, including a new model based on the theory of stochastic differential equations, are presented. Parameters of studied models are estimated via maximum likelihood method.