Is one paracetamol suppository of 1000 mg bioequivalent with two suppositories of 500 mg.
A common belief is that one tablet or suppository containing, e.g. 100 mg of a drug can be substituted, without any changes in the therapeutic effect, with two units of the same brand containing 50 mg of the drug. In the present study a single dose of paracetamol was administered to healthy volunteers as (a) two tablets of 500 mg, (b) two suppositories of 500 mg, and (c) one suppository of 1000 mg. There were statistically significant differences in all bioavailability parameters (t(max), C(max) and AUC) between the three treatments. The relative bioavailability of the 500 mg suppositories was 77% and that of the 1000 mg suppositories 66%. The absorption rate from suppositories was markedly lower than from the tablets. Especially low absorption rate was obtained with the suppository of 1000 mg. The two strengths, although having the same trade name, were not therefore bioequivalent.
Närvänen
T
T
Department of Pharmacy, University of Helsinki, Finland.
Halsas
M
M
Smal
J
J
Marvola
M
M
D000082:Acetaminophen / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D013488:Suppositories / Q000008:administration & dosage / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D018712:Analgesics, Non-Narcotic; D013488:Suppositories; D000082:Acetaminophen