Coprecipitated Amorphous Dispersions as Drug Substance: Opportunities and Challenges
Neil A. Strotman, Luke Schenck
Abstract
The toolbox of methods for generating amorphous solid dispersions, which are often critical to achieving high kinetic solubility and bioavailability of drug molecules, continues to grow with coprecipitated amorphous dispersions (cPAD) recently emerging as a promising option. While compositionally, materials prepared via cPAD bear similarities to those prepared by hot-melt extrusion or spray-drying, the method of preparation is more consistent with Drug Substance (DS: the Active Pharmaceutical Ingredient) operations, as compared to Drug Product (DP: finished dosage form, e.g., tablet, capsule) operations. Preparing cPAD as DS presents significant advantages from a speed to clinic, flexibility, and cost perspective without risking material critical quality attributes or patient safety. In fact, preliminary efforts indicate the potential for improved amorphous solid dispersion property control during the precipitation event, and beneficial bulk powder properties supporting downstream processing. Initial investigations suggest that cPAD can be viewed as a specific type of coprocessed API (DS), although this will be a subject of future regulatory decisions.