EFFECT OF MOISTURE ON THE PHYSICAL AND DISSOLUTION PROPERTIES OF IBUPROFEN TABLETS: A NARRATIVE REVIEW

Ibuprofen is poorly water soluble, and its tablets are sensitive to storage humidity, making them a useful model for studying moisture related instability. This narrative review examines how moisture affects the physical and dissolution properties of ibuprofen tablets: how water is taken up, how it changes hardness, disintegration and dissolution, and how coating and packaging influence these outcomes, along with key analytical and regulatory considerations. Moisture is not simply harmful. Small amounts (up to ~2.5%) can strengthen tablets by improving particle bonding, whereas levels above ~3.5% tend to weaken them, and storage at ≥75% relative humidity usually causes measurable hardness loss. The main effects occur through hygroscopic excipients such as microcrystalline cellulose, starch and disintegrants, which absorb water, soften the tablet matrix and slow disintegration, often reducing drug release. Coating and packaging strongly modulate these effects. In the studies reviewed, some sugar coated tablets lost dissolution performance under humid conditions, while film coated tablets did not, and appropriate packaging offered additional protection. Thus, controlling moisture uptake is as much a formulation and packaging challenge as a stability one. Key gaps remain, including real time imaging of moisture within tablets, models that distinguish temporary softening from permanent damage, understanding moisture behavior in amorphous dispersions, and developing in line monitoring for continuous manufacturing.