In- vitro dissolution testing of oral thin films: a comparison between USP 1, USP 2 apparatuses and a new millifluidic flow-through device

Thin strips of polymeric films have been recently proposed as a promising drug delivery alternative for non-compliant patients (geriatric, children, bedridden) and different therapeutic classes (e.g. vaccines, peptides and nanoparticles).In this work, a new millifluidic continuous flow-through device is proposed for dissolution studies of oral dissolving strips. The millifluidic device is covered by patent. The flow-through device mimics mouth physiological conditions thanks to the laminar tangential solvent flow, flow rates order of 1 mL/min and low hold-up volume (1 cm3). Pilot dissolution tests have been performed on commercially available melatonin strips with different initial drug loadings and thicknesses. Dissolution profiles obtained with the flow-through device are compared with those obtained using the official USP XXXVII basket (USP 1) and paddle (USP 2) apparatuses.