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Process development to overcome drug substance agglomeration and restore dissolution performance
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DOI：10.1016/j.xphs.2026.104368.png)
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Abstract
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• Drug-substance agglomerates remained in the process blend and compacted into dense, low-porosity domains, causing slow and incomplete dissolution. • Targeted shear deagglomeration (shear premix or fine-screen co-milling) improved micro-distribution and restored rapid dissolution. • Particle-size and wettability adjustments alone were ineffective because agglomerate integrity limited accessible surface area after compaction. • SEM/µCT diagnostics and a shear-mixing step enabled scalable, pH-robust dissolution without changing the clinical formulation.
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