Purpose

The bio-enabling technological approach of an amorphous solid dispersion (ASD) via spray drying was utilized in the development of a solid oral dosage form of Compound G. Following preliminary feasibility studies and in an attempt to optimise the spray drying process for future scale-up, a Design of Experiments was constructed using a 24 full-factorial design. The process parameters of air temperature, nozzle size, nozzle pressure and solution feed-rate were investigated for their impact on the selected response factors of drug related impurities, residual acetone, particle size distribution and process yield.

_{a Aptuit, An Evotec Company, Verona}

_{b Grünenthal GmbH, Aachen}