Process Simplification Series No. 6: Direct Compression to Replace Roller Compaction via API Flowability Improvement

Oral solid dosage forms, mainly in the forms of tablets and capsules, still dominate the drug product market for their convenience to patients, not only for administration, but also safe and easy to compliance. In manufacturing of oral solid dosage forms, the flowability of active pharmaceutical ingredient (API), excipients used to formulate the API, and formulations play an important role, and should be assessed in the drug product development stage. Even in the simplest processing route, the final blends containing the drug substance and excipients should present appropriate flowability in order to be compressed into tablets or filled into capsule shells. Poor flowability can cause segregation and stratification, and bad feeding which will consequently result in some manufacturing issues such as weight variation and bad content uniformity.