05.08.09
AAIPharma has acquired the Xcelodose 600S capsule filling system, enhancing the company’s preclinical and early phase clinical GMP supply capabilities. 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.
Some of the benefits this technology provides include: 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; and lower potential for stability issues by eliminating the possibility of excipient interactions and uniformity problems.
The company plans to install the unit in its solid dose manufacturing facility in Wilmington, NC within a specially designed containment system that will allow for enhanced operator safety. The unit is expected to be available and validated by June 2009. Xcelodose is 21CFR Part 11 compliant.
Some of the benefits this technology provides include: 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; and lower potential for stability issues by eliminating the possibility of excipient interactions and uniformity problems.
The company plans to install the unit in its solid dose manufacturing facility in Wilmington, NC within a specially designed containment system that will allow for enhanced operator safety. The unit is expected to be available and validated by June 2009. Xcelodose is 21CFR Part 11 compliant.