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news.UK-based Almac, a contract development and manufacturing company, has added Xcelodose 600S precision powder micro-dosing system, to its product development capabilities. The company said that this move was in response to the client requirements for preclinical and early phase clinical GMP supply.
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As claimed, the Xcelodose system can help reduce processing time and API usage in simple formulations of API or powder-in-capsule, when compared to traditional methods.
Manufactured by Capsugel, the system is a precision powder micro-doser and automated encapsulator that can fill formulations or API directly into capsules with a high level of accuracy.
The Xcelodose system can dispense amounts as low as 100 micrograms and up to 100 milligrams and beyond, into capsules from size 0 to 4. Additionally, the unit minimizes overall development time by simplifying analytical and stability protocols.
Almac will install the Xcelodose system in its product development facility in Craigavon, UK. The unit will be installed and validated, and be ready for use from March 2010.
John McQuaid, technical development manager of Almac, said: “Whilst Almac has always offered API in capsule shells, we now see examples of some clients maintaining this approach through to phase 2 studies in an attempt to compress their overall development timelines, requiring significant quantities of capsules for which an automated solution is best.”
Complementing Almac’s existing containment capabilities for processing compounds with an OEL ranging from 0.03 – 10µg / m3 / 8hrs TWA, the Xcelodose 600S system will include an Xcelohood system to offer containment when filling capsules with API of high or unknown toxicity.
David Edwards, director of pharmaceutical technology at Capsugel, said: “We are delighted to be working with Almac in this area. We see this as yet another recognition by pharmaceutical companies that the use of the Xcelodose system and ‘API in a capsule’ dosage forms are valuable tools for speeding up the process of early stage pharmaceutical development in both Phase 1 and Phase 2 studies.”