Scale-up of spray dried amorphous solid dispersions

With an increasing number of relatively insoluble drugs in development today, there is a need to develop and use platform technologies capable of addressing solubility issues. Among the different alternatives, the use of stabilised amorphous solid dispersions is becoming increasingly popular, with pharmaceutical spray drying being one of the key technologies used in their preparation. In spray dried dispersions (SDD), the active pharmaceutical ingredient (API) is molecularly dispersed in a polymeric matrix. The polymer is used to stabilise the amorphous, metastable form of the drug and sustain supersaturation of the API in solution/biological fluids, thereby increasing bioavailability.