Liquid-Liquid Phase Separation (LLPS), also known as oiling out or phase demixing, is often encountered during the development of an Active Pharmaceutical Ingredient (API). This phenomenon is characterized by the formation of a dispersed phase (solute rich droplets) and a continuous phase (solute lean) from an initial single liquid phase. Liquid-Liquid Phase Separation (LLPS) can have signficant effects on crystal purity and scale-up.
This presentation describes a strategy employed to design and develop robust, scalable crystallization processes that avoids Liquid-Liquid Phase Separation (LLPS) or oiling out.
Experimental and modeling approaches are presented for an intermediate and a final Active Pharmaceutical Ingredient (API) exhibiting Liquid-Liquid Phase Separation (LLPS). This webinar focuses specifically on examples where Liquid-Liquid Phase Separation (LLPS) occurs in a ternary system (solute/solvent/anti-solvent). The solvent and anti-solvent are fully miscible in the P,T phase diagram but the presence of the solute forces a spinodal decomposition that inhibits/delays the formation of crystals. A thermodynamic and kinetic development is proposed to explain why:
Dr. Moussa Bourkerche
Senior Consultant Engineer, Eli Lilly
As a Senior Consultant Engineer at Eli Lilly, Moussa Boukerche is responsible for the design and development of crystallization processes in API manufacturing. Prior to Eli Lilly, Moussa worked in the field of industrial crystallization for several companies, including SANOFI (France), Pfizer (UK), and Aughinish Alumina (Ireland).