Modeling and comparison of dissolution profiles

Abstract

Over recent years, drug release/dissolution from solid pharmaceutical dosage forms has been the subject of intense and profitable scientific developments. Whenever a new solid dosage form is developed or produced, it is necessary to ensure that drug dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays, on drug dissolution studies. The quantitative analysis of the values obtained in dissolution/release tests is easier when mathematical formulas that express the dissolution results as a function of some of the dosage forms characteristics are used. In some cases, these mathematic models are derived from the theoretical analysis of the occurring process. In most of the cases the theoretical concept does not exist and some empirical equations have proved to be more appropriate. Drug dissolution from solid dosage forms has been described by kinetic models in which the dissolved amount of drug ( Q) is a function of the test time, t or Q= f( t). Some analytical definitions of the Q( t) function are commonly used, such as zero order, first order, Hixson–Crowell, Weibull, Higuchi, Baker–Lonsdale, Korsmeyer–Peppas and Hopfenberg models. Other release parameters, such as dissolution time ( t x% ), assay time ( t x min ), dissolution efficacy (ED), difference factor ( f 1), similarity factor ( f 2) and Rescigno index ( ξ 1 and ξ 2) can be used to characterize drug dissolution/release profiles.