Clinical pharmacokinetic comparison of two indometacin containing suppositories with different vehicula.
A single dose each of two brands of indometacin (INN; in some pharmacopoeias called indomethacin) containing suppositories, made with different vehicula , was administered rectally - in a cross over design - to ten healthy volunteers. Product A ( Dolcidium ) was made of a new waxy excipient which emulsifies at body temperature; product B was a leading brand of indometacin containing suppository, made of a hydrophilic polyethyleneglycol basis, which dissolves in body fluid. Plasma indometacin concentrations were measured frequently during a period of 9 h after dosing. Both products showed rather consistent absorption profiles. The maximum plasma indometacin concentration after administration of the product A 50 mg suppository was found after 62 +/- 18 min (mean +/- S.D.), and measured 2.0 +/- 0.5 mg X l-1. After dosing with the reference product those values were 66 +/- 21 min and 1.8 +/- 0.4 mg X l-1, respectively. The area under the plasma indometacin concentration-time curve was found to be 384 +/- 130 mg X l-1 X min for product A 50 mg suppositories and 372 +/- 62 mg X l-1 X min for the reference product. This results in a relative bioavailability of the product A 50 mg suppositories of 1.02, after correction for actual amount of indometacin in each dosage form. None of the above mentioned pharmacokinetic parameters were statistically significantly different (p greater than 0.05), indicating bioequivalence of the two products.
D000328:Adult; D001682:Biological Availability; D005260:Female; D005990:Glycerol; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism*; D007408:Intestinal Absorption; D007700:Kinetics; D008297:Male; D014677:Pharmaceutical Vehicles; D011092:Polyethylene Glycols; D012007:Rectum; D013488:Suppositories; D014885:Waxes
D014677:Pharmaceutical Vehicles; D013488:Suppositories; D014885:Waxes; D011092:Polyethylene Glycols; D005990:Glycerol; D007213:Indomethacin