FM-CAPS® Clinical Trial Capsules
FM-CAPS® is a flexible dosage form that addresses today’s complex formulation issues to accelerate your drug development process. FM-CAPS® enable fast, efficient color selection using a reformulation approach, allowing you to leverage earlier-stage clinical stability studies to support your final dosage form format. This innovative method removes wasted motion in clinical trials, resulting in shorter timelines and reduced costs. Traditional capsule development and testing is conducted in standard clear capsules. If any change is made to the API formulation, including additives used in the coloration of the final market ready product, the entire development process starts over and the new formulation must be resubmitted to the regulatory agency with the additional color dyes. FM-CAPS® contain the primary range dyes and additives, making it much easier to achieve the desired coloration by removing unneeded dyes and retaining only those necessary to producing the desired market color.
Generic and alternative namesClinical Trial Capsules
Claims / benefits / efficacyUp to 9 months faster to market Reduced regulatory interaction Reduced number of required stability studies Seamless transition from clinical to market capsules Quick color matching & logo designs
Applicationdrugs during the development process