Overcoming challenges with coprecipitation of amorphous solid dispersions, an accessible manufacturing method

Wombwell Claire – Team leader, Veranova; Paul Lewis – Scientist, Veranova

Introduction:

Coprecipitation is used in manufacture of marketed ASDs, but not as widely as spray drying or hot melt extrusion¹.  However there are circumstances that inhibit use of spray drying and HME, including limited solubility in solvents suitable for spray drying and thermolabile API. Coprecipitation can also be limited by solvent/antisolvent availability but uses traditional reaction vessels which are well understood and modelled, making it easily accessible and scalable. It is important to gain an understanding of the technique and how to improve manufacture, through control of the critical process parameters, to overcome common issues faced, including slow filtration and solvent entrapment.