API In Capsule vs. The Lost Art Of Formulation Development

For pharmaceutical companies racing to bring products to market, using API-in-capsule (neat dosing) can appear to be an appealing shortcut to obtain crucial Phase I clinical trial data before undergoing the expense and time of full formulation development. This approach is often utilized to meet aggressive Phase 1 study timelines and manage limited financial resources.

However, this short route defers, but does not eliminate, the need for later-stage formulation work. Decisions based on neat API in capsule may negatively affect downstream development, potentially increasing both the total development time and costs later on. Furthermore, a drug substance's physical characteristics may limit its suitability for neat dosing due to capsule-filling challenges.

It is critical for development teams to carefully weigh the downstream implications of using neat drug substance for early studies against the benefits of a fully formulated product.