Solid Dose Manufacturing
AAIPharma Services' solid dose manufacturing facility is located in Wilmington, North Carolina. The plant specializes in solid oral dosage forms, toxic and potent compounds, and products that are difficult to make. Whether you require clinical or commercial supplies, our Wilmington, NC plant can meet your needs.
We offer:
- A 45,000 sq. ft. cGMP compliant plant in Wilmington North Carolina - FDA and EU inspected and approved
- Clinical and Commercial manufacturing and packaging
- Fully automated powder in capsule manufacturing utilizing Xcelodose® 600S 100% net weight filling technology
- DEA Compliant for Schedule I-V Controlled Substances
- Rated for Level 4 toxic or potent compounds
- Dry blends, roller compaction, wet granulation (low/high shear and spray), film coating, tablet and capsule manufacturing
- Flex suites for novel manufacturing processes
Xcelodose®
AAIPharma utilizes the most advanced precision low-dose capsule filling equipment, the Xcelodose® 600S, to manufacture your preclinical or early phase clinical supplies. With the Xcelodose® 600S, AAIPharma can manufacture batch sizes up to several thousand capsules with fill weights as low as 1.0 mg for neat drug substance, granulations, or blends with 100% dose accountability ensuring each capsule contains an exact amount of drug. Utilizing the Xcelodose® technology, AAIPharma can ship clinical supplies within three months of project kickoff.
Perspectives on Accelerated Early Drug Development (PDF)
The Xcelodose® technology can provide the following benefits to your development program.
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AAIPharma Advantage
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| Decrease development time |
Clinical supplies can be provided in as little as three months in some cases. |
| Decreased API requirement |
Dosing neat API into capsules eliminates the need for much of preformulation, formulation, and analytical development |
| Route of administration |
Xcelodose(R) filled capsules are ideal for oral and inhaled administration |
| Decreased risk of stability issues |
Dosing neat API into capsules removes the potential for excipient interactions and uniformity problems |
| Accurate fill with weights as low as 0.1mg |
Ideal for highly potent compounds |
| Minimize API waste |
Avoids loss of drug found on most alternative equipment |
| Simplify analytical methods development and testing |
Eliminates overlaps and interferences due to excipients. Removes need for blend uniformity method |
| Flexible capsule filling options |
Size 00 to 4 in gelatin or HPMC capsuleshells |
| Dedicated product contact parts |
No need for equipment cleaning verification analytical methods or testing |
| Enhanced QA documentation |
100% fill weights record |
| Software |
21CFR Part 11 compliant |
