Converting from a Spray-Dried Dispersion to a KinetiSol Formulation in <5 Months

A Phase 2 oral drug candidate faced limited bioavailability, high pill burden and complex manufacturing with its spray-dried dispersion formulation. AustinPx transitioned the product to KinetiSol™ in less than five months, producing prototypes within four weeks and completing clinical formulation development, scale-up and CTM manufacturing in four additional months. The reformulation delivered a fivefold increase in AUC in animal testing and a threefold improvement in human bioavailability. It also reduced pill burden and manufacturing time while eliminating organic solvents, nitrogen and roller compaction. These results supported advancement toward Phase 3 and strengthened the asset’s clinical performance, manufacturing scalability, and commercial potential.

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