Manufacturing and Bioprocessing
2019 PharmSci 360
Amorphous solid dispersion (ASD) formulation is a dispersion of amorphous active ingredients in an inert carrier or matrix. Although ASD is a promising strategy for enhancing drug solubility, it has not been recognized to its full potential due to a lack of understanding as to how solid state stability is affected by manufacturing conditions such as method of preparation, formulation parameters (choice of excipients, drug-polymer ratio), processing conditions, and in part due to a lack of characterization techniques available to study drug-polymer miscibility and intermolecular interactions in the solid state. In this presentation I would discuss two case studies. In the first, effect of two manufacturing methods, viz. anti-solvent precipitation and solvent evaporation on ASD performance would be presented. In the second study, the effect of two equipment variables (two fluid vs three fluid nozzle) for preparing stable spray dried ASDs would be evaluated.