Whitepapers

WHITE PAPER - How Advanced Containment Technology Is Reshaping High-Potency API Micronization

Harry Wade, Technical Associate, and Rosie Bird, EHS Lead, Catalent Dartford, review how for many high-potency APIs, micronization is not a downstream convenience but a critical performance step. Particle size distribution directly influences dissolution behavior, bioavailability, blend uniformity, and dose accuracy, particularly when therapeutic doses are measured in micrograms.

WHITE PAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers

There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.