In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material attribute (CMA) that directly affects:
- Dissolution and bioavailability (especially for BCS Class II/IV drugs)
- Content uniformity and blend homogeneity
- Flow and compressibility during manufacturing
- Tablet hardness, stability, and even patient safety
A robust risk assessment of PSD using tools like FMEA and QbD principles helps identify and control these risks early in development.
- Setting the right PSD specifications (e.g., D10/D50/D90)
- Linking PSD to CQAs and biopharmaceutic performance
- Aligning with regulatory expectations (ICH Q8/Q11, ANDA filings)
In the world of generics, controlling PSD is not just good science—it is essential for therapeutic equivalence and regulatory success.
Related Topics:
| Partition Coefficient | Dissociation Constants | Buffer Capacity |
| Bioavailability | Biotechnology | Bioinformatics |
Resource Person: Vijay Agrawal