Dose variation that is associated with approximated one-quarter tablet doses of misoprostol.
OBJECTIVE
The purpose of this study was to evaluate dose variation in approximated one-quarter tablet misoprostol fragments.


METHODS
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.


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 >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.


CONCLUSIONS
Misoprostol is evenly distributed among tablet fragments. Accurate low-dose misoprostol cervical ripening is possible if the tablet fragments are individually weighed.
Williams
Mark C
MC
Department of Obstetrics and Gynecology, University of South Florida, Tampa, USA. mwilliam@hsc.usf.edu
Tsibris
John C M
JC
Davis
George
G
Baiano
John
J
O'brien
William F
WF
D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage* / Q000032:analysis; D010120:Oxytocics / Q000008:administration & dosage*; D011247:Pregnancy; D013607:Tablets
D010120:Oxytocics; D013607:Tablets; D016595:Misoprostol