Novel analytical methods for the characterization of oral wafers.

This study aims at compensating the lack of adequate methods for the characterization of the novel dosage forms buccal wafers by applying recent advanced analytical techniques. Fast-dissolving oral wafers need special methods for assessing their properties in drug development and quality control. For morphologic investigations, scanning electron microscopy (SEM) and near-infrared chemical imaging (NIR-CI) were used. Differences in the distribution of the active pharmaceutical ingredient within wafers can be depicted by NIR-CI. Film thickness was determined by micrometer screw and coating thickness gauge revealing no significant differences between the obtained values. To distinguish between the mechanical properties of different polymers, tensile test was performed. Suitable methods to predict disintegration behaviour are thermomechanical analysis and contact angle measurement. The determination of drug release was carried out by three different methods. Fibre-optic sensor systems allow an online measurement of the drug release profiles and the thorough analysis even within the first seconds of disintegration and drug dissolution.