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

Abstract

Objective: The purpose of this study was to evaluate dose variation in approximated one-quarter tablet misoprostol fragments. Study Design: Misoprostol 100 μg 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. Results: 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 ≥27.5 mg contained misoprostol in excess of 110% of expected in seven of eight fragments, although none from fragments that weighed ≤26.5 mg did. Misoprostol was evenly distributed in all fragments that were assayed. Conclusion: Misoprostol is evenly distributed among tablet fragments. Accurate low-dose misoprostol cervical ripening is possible if the tablet fragments are individually weighed. (Am J Obstet Gynecol 2002;187:615-9.)