The client needed formulation development of an oral dosage form from scratch. They required one month of stability data on a lead formulation prototype in order to submit their IND on a very aggressive timeline and GMP clinical trial material within four months of the start of formulation development.
Partnering with Alcami
Alcami used a Gerteis Mini-Pactor® roller compactor to develop a capsule formulation and critical processing parameters at the target dosage in record time. The team communicated via weekly meetings and worked with the client to align on protocols and next steps with parallel activities wherever possible so that the project progressed with minimal “dead time.” Additionally, analytical testing in support of prototype development and stability was expedited to meet the target timeline.
Challenges and Solutions
In addition to the inherent challenges of developing a new formulation from scratch, the team was tasked: with evaluating the API for its physical characteristics; developing prototypes to determine a suitable formulation; manufacture a prototype batch for stability and method development; manufacture an engineering batch to determine critical processing parameters; complete method qualifications; manufacture and package a GMP clinical package; and prepare for distribution to the clinic. This product had a very high drug load and complicated methodology (two actives requiring two assays: one UV and one ICP-MS; non-HPLC backend for dissolution). Even with these unique development requirements, the project remained on track.
Where Are They Now?
The client successfully filed their IND by the target date, and Alcami is progressing the project by working toward the manufacture of GMP material to support a Phase I trial.