Abstract

Compressed suppositories in indomethacin were formulated employing PEG 4000 as base with a view to minimize the gastric irritation of the drug upon oral administration. Preliminary pharmacodynamic experiments displayed comparable antiinflammatory activity and reduced ulcerogenic potential of the drug upon rectal administration. The influence of disintegrants (primogel and potato starch) on the in vitro release of drug was studied employing USPXX basket and dialysis methods. Based on the in vitro drug release studies from dialysis method, fast release suppositories containing 5% primogel and 10% potato starch were further evaluated for pharmacokinetic performance in healthy human volunteers. The study indicated that disintegrants did not influence either the rate or the extent of absorption of indomethacin compared to plain suppositories. It was concluded that in vitro drug release by dialysis method could not simulate the in vivo conditions.