Winning Strategies For Oral Dosage Form Development And Manufacturing

By Dave Miller, AustinPx

Oral solid dose (OSD) formulation development must adhere to common considerations, such as project timelines, facilitating CDMO/client transparency and overcoming regulatory challenges. However, development’s difficulty often is compounded by numerous factors such as API supply constraints, challenging physiochemical properties, poor bioavailability, and/or constrained safe handling requirements, to name just a few. Therefore, successful pharmaceutical formulation hinges on front-loaded risk identification and mitigation.

Failure to identify a compound’s red flags — bioavailability, stability, processability, etc. — early in development often manifests as program delays or failures. These setbacks can be avoided through complete molecular characterization, which can de-risk development and accelerate entry into human studies while also increasing the probability of clinical success.

The amount of pre-formulation data necessary to fully understand a molecule and to begin preparing a viable development path can catch sponsor companies off guard. It is not that the requirements are overwhelmingly extensive, expensive, or time-consuming — full molecule characterization is fairly standard — but the importance of data and the criticality of context within that package cannot be overstated. It is both a short- and long-term development map for your OSD formulation.