Spray Drying for Generation of a Ternary Amorphous System of Celecoxib, PVP, and Meglumine

Abstract

Generation of amorphous forms of a poorly soluble drug by solid dispersion techniques has been a subject of intensive research for decades. Apart from the stability of the dispersions, development of a suitable production technology is a major challenge to the successful commercialization of these products. Coprocessing of celecoxib (CEL), poly(vinyl pyrrolidone), and meglumine by spray drying resulted in an amorphous drug product that provided enhanced solubility and stability to an otherwise poorly soluble crystalline form of CEL. The spray-drying process parameters were optimized to provide an amorphous product with required characteristics. The product was stable for 3 months under the accelerated stability storage conditions. This technique can serve as a suitable means for generating a ready-to-formulate amorphous drug-additive(s) composite that can be directly filled into hard gelatin capsules.