Wilmington, NC: AAIPharma announces that it has acquired the Xcelodose® 600S system; the most advanced and accurate capsule filling equipment available to the pharmaceutical industry. With the Xcelodose® 600S, manufacturing clinical trial materials has become faster and more precise, and will enhance AAIPharma Services' capability to rapidly supply preclinical and early phase clinical GMP supplies.
The Xcelodose® 600S can accommodate batch sizes up to several thousand capsules in sizes from 00 to size 4 with a variety of fills including neat drug substance, granulations, and blends.
This technology provides the following benefits to pharma and biotech companies looking to initiate drug development programs:
* Decreased development time with clinical supplies available in less than three months.
* Reduced active ingredient requirements through dosing into capsules reducing waste.
* Reduced cleaning requirements through the use of dedicated product contact parts
* Xcelodose® filled capsules are ideal for oral and inhaled administration, with flexible filling options from size 00 to 4 in gelatin or HPMC capsule shells
* 100% of the batch fill weights are recorded.
* Lower potential for stability issues by eliminating the possibility of excipient interactions and uniformity problems.
* Ideal for highly potent compounds, with accurate fill with weights as low as 0.10 mg.
* Xcelodose® is 21CFR Part 11 compliant.
AAIPharma Services plans to place the unit in its FDA and EU approved solid dose manufacturing facility in Wilmington, NC inside a specially designed containment system which will allow for enhanced operator safety. The unit is expected to be installed and validated (ready for use) in June 2009.
About AAIPharma
AAIPharma Inc. is an international pharmaceutical services provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. AAIPharma Services' offerings include: analytical services, product development services, drug delivery technologies, contract manufacturing (solids and parenterals) and clinical packaging and distribution services.
For more information on the Company, please visit AAIPharma's website at www.aaipharma.com.
Contact: Barry Johnson: Barry.Johnson@aaipharma.com
