The Manufacture of Low-Dose Oral Solid Dosage Form to Support Early Clinical Studies Using an Automated Micro-Filing System

摘要

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.