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 flowthrough 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. [ABSTRACT FROM AUTHOR]