Prediction of drug dissolution from Toremifene 80 mg tablets by NIR spectroscopy.

The aim of our study was to justify substitution of dissolution analysis for NIR measurement of Toremifene 80 mg tablets. We studied implementation of a NIRS method by integrating the method development to discrimination power of the dissolution method. Hence, we analyzed 20 DoE tablet batches and studied which of the critical formulation factors affecting dissolution were statistically significant.

Use of conventional surfactant media as surrogates for FaSSIF in simulating in vivo dissolution of BCS class II drugs.

The usefulness of selected conventional surfactant media to enhance dissolution of BCS class II drugs similarly to fasted state simulated intestinal fluid (FaSSIF) and to predict the absorption of drugs in vivo was evaluated. Dissolution behavior of danazol (Danol), spironolactone (Spiridon) and N74 (phase I compound) was compared between FaSSIF, containing physiological levels of sodium taurocholate (STC) and lecithin, and dissolution media containing various concentrations of anionic surfactant, sodium lauryl sulfate (SLS) or non-ionic surfactant, polysorbate (Tween) 80. Although these media differed largely in their solubilization ability, micelle size, diffusivity and surface tension, similar dissolution enhancing levels were achieved between FaSSIF and drug-specific concentrations of conventional surfactants.