Pharmaceutical Technology
Pharmaceutical Technology in NIPER JEE covers unit operations, granulation and compression, powder flow, drying, scale-up, QbD, and process validation.
Core rules and concepts
- Size reduction: hammer mill for coarse milling, ball mill for fine milling, fluid-energy mill for micronization; heat-sensitive drugs need cooling.
- Powder flow: angle of repose <30° indicates excellent flow; Carr’s index = [(tapped − bulk)/tapped] × 100; Hausner ratio = tapped/bulk. Carr’s 12–16% and Hausner 1.12–1.18 indicate good flow.
- Granulation: wet granulation uses binder and liquid; dry granulation uses slugging or roller compaction; direct compression needs good flow and compressibility.
- Drying: tray drying is slow; fluid-bed drying is faster; spray drying produces spherical particles.
- Tablet compression: hardness, friability, disintegration, and dissolution are interlinked. Over-lubrication with magnesium stearate slows dissolution.
- QbD links critical material attributes and process parameters to critical quality attributes; PAT enables real-time control.
Worked example
A powder has bulk density 0.40 g/mL and tapped density 0.50 g/mL. Carr’s index = (0.50 − 0.40)/0.50 × 100 = 20%. Hausner ratio = 0.50/0.40 = 1.25. This indicates fair flow, not excellent; a direct-compression formulation may need a glidant or granulation.
Traps that cost marks
- Putting bulk density in the denominator of Carr’s index; the denominator is tapped density.
- Confusing true density with bulk density.
- Assuming higher hardness always improves tablets; excessive hardness can delay disintegration.
- Treating process validation as a single batch check; it is a documented, lifecycle approach.