Dose variation that is associated with approximated one-quarter tablet doses of misoprostol.

Abstract

The purpose of this study was to evaluate dose variation in approximated one-quarter tablet misoprostol fragments. Misoprostol 100 microg tablets were weighed, separated into two lots, and quartered with a razor blade or a pill cutter. Fragments were reweighed, and the misoprostol content was determined by high-performance liquid chromatography mass spectroscopy. Fragment weights varied more when a pill cutter was used (P <.0001). Fewer pill-cutter fragments than razor-cut fragments weighed within 10% of expected (24% vs 65%, P <.0001). Misoprostol content among the fragments that were determined by high-performance liquid chromatography mass spectroscopy was 103% +/- 12% of expected (range, 73%-124%). Tablet fragments that weighed >or=27.5 mg contained misoprostol in excess of 110% of expected in seven of eight fragments, although none from fragments that weighed <or=26.5 mg did. Misoprostol was evenly distributed in all fragments that were assayed. Misoprostol is evenly distributed among tablet fragments. Accurate low-dose misoprostol cervical ripening is possible if the tablet fragments are individually weighed.