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

When a client needed to manufacture softgel capsule clinical supplies in a low cost, highly dose flexible manner, they turned to Velesco Pharmaceutical Services for MTOSoftgels.

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.