MTOSoftgels: Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies

By Lisa Z Crandall

Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. Traditionally, all supplies are manufactured up front, either as separate capsule strengths or multiples of a low strength capsule. When multiple capsules are used, there is a risk for excipient-related gastrointestinal side effects that cloud study results. Analytical stability studies must be lengthy to encompass the scheduled time for all dosing, although dose escalation trials are usually halted before the higher doses are reached. Large batch sizes use massive amounts of expensive bulk drug.

An alternate approach is to manufacture just-in-time using made-to-order softgel capsules (MTOSoftgels): hand filled and cohort specific. This strategy confers great cost savings, not only on bulk drug and manufacturing, but on shorter analytical stability study lengths. Since formulations can be flexible, there is no need to dose multiple low strength capsules at the highest dose cohorts, lowering the chance of excipient-related gastrointestinal side effects.