News

For simple formulations of API or powder-in-capsule, the Xcelodose® system can significantly reduce processing time and API usage resulting in cost savings when compared to hand filling options

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times,” said John McQuaid, Technical Development Manager.

McQuaid added:, “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, Capsugel’s Director of Pharmaceutical Technology commented: “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.”

The Xcelodose® system, manufactured by Capsugel, is a precision powder micro-doser and automated encapsulator that has the ability to 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 00 to 4. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit minimizes overall development time by simplifying analytical and stability protocols.

Almac will install the Xcelodose® system in its state-of-the-art product development facility in Craigavon, UK. The unit will be installed and validated, ready for use from March 2010. 

- ENDS –

For further information contact:

Sue Peffer
Marketing & Commercial Executive
Capsugel
T: +44 1304 644791
E : sue.peffer@pfizer.com

About Almac Group:
Almac is a financially stable, privately owned organisation with over 30 years experience. It provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation and analytical development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture and packaging.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”.  US operations are based in Pennsylvania, North Carolina and California.  Construction of the company’s new $120m North American Headquarters in PA started in July 2008 and will be completed in 2010.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com.

About Capsugel:
Capsugel, a division of Pfizer Inc. with over 2,800 colleagues and ten facilities around the world, is a global leader in innovative dosage forms and solutions for the healthcare industry.  Offering a comprehensive array of products and services, from hard gelatin, softgel, and vegetarian capsules, to innovative R&D equipment and liquid formulations as part of its Licaps® Drug Delivery System, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production.  For more information about Capsugel, visit www.capsugel.com.

Xcelodose® and Xcelohood™ are trademarks of Capsugel.