Capsugel, global leader of innovative dosage forms and capsule filling equipment for the pharmaceutical and dietary supplement industries.
Xcelodose® Precision Powder Micro-dosing System: enables pharmaceutical companies to dose active pharmaceutical ingredient alone into capsules and other compact containers.
To take Intellectual Property (IP) as already developed through Proof of Principle testing, and create a solution for high precision powder micro-dosing of active pharmaceutical ingredients into capsules, and other solid dose containment systems. The system had to provide full traceability and to be capable of validation by pharmaceutical companies and/or their contractors. It required re-design for manufacturability of the overall machine.
We worked closely with the client to understand the various market opportunities for such a system. It was clear that one solution would not meet all needs and that there needed to be a semi-automatic solution, capable of accepting a wide variety of containers, as well as a system accepting a more limited range of capsules but capable of running at high speeds. Design studies enabled clear specifications to be developed ensuring, where possible, common features, parts and controls.
The semi-automatic Xcelodose® 120 system capable of accepting a wide variety of containers including vials, syringes and blisters; and the fully automatic Xcelodose® 600 system for use with capsule sizes 00 – 4, and capable of automatically filling capsules with prescribed weights as low as 100mcg and with precision levels of ~ 2% RSD at speeds of up to 600 capsules per hour with the amount of powder in every container being recorded to comply with 21 CFR part 11 requirements.
Our client had an industry standard offering in automated capsule filling for preparation of early stage clinical trial supplies. Our long term relationship has led to the development of series two systems (Xcelodose® 120S and Xcelodose® 600S systems) which both offer increased functionality.
In addition further developments to the range include the Xcelolab™ powder dispenser which has been specifically designed for laboratory use; the Relative Humidity Control Unit and Xcelohood™ containment system. For further information on these products visit www.xcelodose.com.