Formulation and Quality – Chemical
2019 PharmSci 360
In academic medical centers, clinical investigators may plan human testing of test new combinations of medications or new dietary supplements, animal testing of novel molecules. Although every pharmacist knows how to mix a pharmaceutical powder and fill a capsule, in many cases this is not ideal. In order to ensure the most accurate results of clinical (or pre-clinical) trials, dissolution of novel drug products should be determined according to the new USP-NF General Chapter 1236 Solubility Measurements using biorelevant dissolution media, for better predictions of in vivo performance. Even more critically, enteric coating may be needed for certain novel formulations including lipid-based, intestinal-targeted, or nanoparticle-driven strategies. This talk will present tips and tricks to show you how to make small batches of solid- or liquid-filled capsules (gelatin or “vegetarian”) suitable for dissolution testing or small trials, perform band sealing, and provide enteric coatings without the need for highly expensive equipment.