Whether its selecting the dosage form, optimal drug loading, or compatible excipients, drug formulation can be a lengthy process. Optimizing these formulation choices is key for developing a drug product that can be used for phase III clinical trials, batch release testing, and ultimate market release. Ensuring therapeutic efficacy through drug bioavailability, stability, and release performance are a few of the essential areas to satisfy during formulation development.
Microstructure properties including particle size, porosity, phase dispersion, and crystallinity are all key to optimizing these efficacy parameters. Unfortunately, the final microstructure of a drug product can be a black box, with little known about the arrangement of internal ingredients. It can thus be difficult to understand the effects of different formulations and processes on drug release, slowing down the formulation decision cycle. To fully understand these properties, 3D techniques with high sensitivity and resolution are required.