Melt Extruded Drug Formulations for Individual Dosing by the Solid Dosage Pen

This work focuses on the development, the manufacturing, and the characterisation of melt-extruded rods for the application by the Solid Dosage Pen ¿ a device which permits individual dosing by cutting slices of pre-defined heights from these rods.

Tailored dissolution kinetics of the model drug carbamazepine were achieved with immediate, biphasic, and sustained release characteristics. Dose-dependent dissolution behaviour of sustained release formulations was minimised by applying a wax-coating via co-extrusion technologies and completely overcome by the embedding of coated micropellets into rods. The mechanical properties of the rods were systematically investigated by the evaluation of the maximum cutting force, the tensile strength, and the E-modulus.

To conclude, innovative production processes, new analytic methods and novel formulations were established for peroral solid dosage forms for the SDP. The melt-extruded formulations allowed for individual dosing by the SDP and could therefore provide a new platform in personalised medicine as well as in paediatrics and geriatrics.