FreeThink scientists have led the adoption of a “tiered” approach to formulation development, with an emphasis on stability. Traditional excipient compatibility studies often have a poor correlation with final product stability and require a significant investment of time and resources. Instead, at FreeThink we employ a tiered approach enabled by our Accelerated Stability Assessment Program software, ASAPprime®.
In this process, we select two-to-three first-tier formulations and prepare dosages of these formulations. At FreeThink’s laboratories, we can prepare standard formulations for tablets, capsules, liquids and other dosage forms. These dosages are studied using ASAPprime®, and then evaluated to see if one or more of the formulations is acceptable for stability. If deemed acceptable, the formulations can be developed rapidly and then manufactured in most cases, since they are based on standard excipient blends with a history of successful manufacturing. For tablets and capsules, these formulations generally include diluents, binders, disintegrants and lubricants.
If none of the formulations reach the desired stability targets, a second-tier study is initiated. These formulations may include such stabilizers as antioxidants and pH modifiers. In the end, a final formulation is generally achieved in less than four months.