Doughy Mass
Causes: Remedies
- Too much water (often seen on scaleup): Add granulating water slowly; mix well after each addition.
- Overmixing during the granulation step: Reduce water or mixing time.
- Wrong binder: Change Binder
- Component of the mix (e.g., active drug or excipient): If possible, use alcohol/water or alcohol as granulating fluid - select appropriate binder; use Avicel PH-101, which gives 1. less sticky or doughy mass which is easier to screen, and 2. allows a wider range of solvent volume.
Moisture Sensitive Drugs
Causes: Remedies
- Instability with water:
- If possible, use ethyl alcohol or isopropyl alcohol (if latter, determine acceptable residual solvent by GC or another appropriate method) as granulating fluids, methylcellulose, and PVP as binders.
- Try slugging or roller compaction as dry granulation methods
ALSO READ: Manufacturing Defects of Tablets
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