Case Studies
Converting from a Spray-Dried Dispersion to a KinetiSol Formulation in <5 Months
A Phase 2 oral drug candidate formulated as a spray-dried dispersion faced limitations in bioavailability, pill burden, and solvent-intensive manufacturing. In less than five months, AustinPx converted the program to a KinetiSol™ formulation, achieving a 5x increase in AUC, reducing manufacturing time by 67%, and eliminating organic solvents and secondary processing steps. The result was improved in vivo performance, lower cost of goods, and a scalable path forward to Phase 3.
Data-Driven Development of Clofazimine: A High-Drug Load Pediatric Mini-Tablet
The development of clofazimine pediatric mini-tablets demonstrates a data-driven approach to pharmaceutical development. By leveraging predictive tools and iterative design, AustinPx transformed a formulation-challenged compound into a scalable, patient-friendly product suitable for clinical trials.
Using KinetiSolTM Technology to Improve an Abandoned Prostate Cancer Medication
In 2019, there were approximately 175,000 new cases of prostate cancer, contributing to 10% of male cancer-related fatalities. Galeterone, a novel prostate cancer candidate treatment, was discontinued after a Phase III clinical trial due to lack of efficacy. This Case Study explores how KinetiSol outperforms Spray Dried ASD and helped bring Galeterone to market.