FM-CAPS® Clinical Trial Capsules
As part of our commitment to delivering unparalleled quality across preclinical, clinical and commercial supply, we developed FM-CAPS®, 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.
Reducing Time to Market
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.
Available in size 5-000
Manufactured with Pharmaceutical Grade Bovine Gelatin
Guaranteed disintegration within 15 minutes
Moisture content is kept between 13% and 16%
Visual quality is based on the ANSI/ASQ-Z1.4 Single Sampling Plan
Five-year shelf life
- Up 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
Your Capsule. Your Way.
FM-CAPS® are available in a full range of sizes, and can be customized with diverse coloration, imprinting and finishing options to reflect the unique characteristics of your brand.
Connect with an Encapsulation Expert
Learn how CapsCanada’s FM-CAPS® can accelerate your development efforts to bring your products to market faster.
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