Presentations
Formulation Strategies for Enabling “Undevelopable” Compounds
Many modern drug candidates fall outside traditional guidelines like Lipinski’s Rule of Five, making them difficult to formulate with conventional technologies. This poster, presented by Dave Miller at DDC (2025) and the PECK Symposium (2025), highlights how KinetiSol™ was used to formulate a poorly soluble compound with multiple developability challenges—including high dose, poor solubility, and low permeability.
KinetiSol processing outperformed solvent-based and bulk micro-precipitation methods in both in vitro and in vivo studies, delivering higher bioavailability, better control of particle morphology, and superior pharmacokinetics. These results reinforce the value of KinetiSol as a go-to technology for enabling challenging compounds and redefining what’s possible in drug development.
Redefining Drug-Like Properties with Kinetisol
Christopher Lipinski’s Rule of Five (Ro5) has been used for nearly three decades to evaluate whether a compound possesses the chemical and physical properties to potentially be an orally active drug in humans. But have modern molecules and technologies rendered Lipinski’s guidelines irrelevant?
The KinetiSol process accommodates high-temperature melters without issue and solvent solubility is irrelevant to the process. Compared to other technologies, KinetiSol formulations typically result in superior bioavailability, smoother planning and execution of manufacturing, and a significantly reduced environmental impact.