Abstract
Automated powder dispensing systems enable supplying early clinical studies using drug-in-capsule approach, which is material sparing and requires a minimum amount of resources. However, the inability of accurately filling the capsule with a small amount, e.g., several micrograms, of drug limits the use of these systems for potent drugs. We demonstrate that formulated powder blends can be used to successfully fill capsules containing 5 μg to 5 mg of drug with adequate content uniformity. Effective formulation and process strategies that enable this approach are presented with examples.
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Acknowledgment
Mike Kennedy, Dominick Daurio, Rick Chiu, Xuemei Wang, Lan Li, Shukun Wang, and Lu Xi are acknowledged for the partial data contributions to this research.
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Bi, M., Sun, C.C., Alvarez, F. et al. The Manufacture of Low-Dose Oral Solid Dosage Form to Support Early Clinical Studies Using an Automated Micro-Filing System. AAPS PharmSciTech 12, 88–95 (2011). https://doi.org/10.1208/s12249-010-9549-y
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DOI: https://doi.org/10.1208/s12249-010-9549-y