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 (tx%), assay time (tx min), dissolution efficacy
(ED), difference factor (f1), similarity factor (f2) and Rescigno index (xi1 and xi2)
can be used to characterize drug dissolution/release profiles.