Innovative Strategies for Broadening the Formulators Toolbox

Topical gel formulation enables delivery of therapeutics and active compounds not amenable to formulation as traditional biphasic creams. Gel formulations are often manufactured under ambient conditions and can contain non-aqueous solvents to mitigate potential for API (active pharmaceutical ingredient) degradation via thermally or hydrolytically labile actives. Driving innovation within the field of gel formulation and characterization promotes a deeper process and product understanding, ultimately delivering a more robust product to the patient. Given the trend of poor solubility of small molecule therapeutics, solvent systems with low or no water are increasingly demanded to boost solubility. This presentation will touch upon two case studies that showcase advancement in gel product development for poorly water-soluble APIs: 1) Solvation monitoring in non-aqueous gels, and 2) Critical material attribute identification of neutralizers in low water content gels.