Relative variability in bioavailability of oral controlled-release formulations of oxycodone and morphine.
A retrospective analysis compared the coefficients of variation associated with the maximum plasma concentration (Cmax) and the extent of absorption (area under the curve [AUC] from 0 hour to the last observation) for oral, controlled-release tablet formulations of oxycodone (OxyContin) and morphine (MS Contin). Data from fasting, male subjects aged 18 to 45 years were taken from five controlled-release oxycodone (N = 82) and seven controlled-release morphine (N = 101) single-dose, bioequivalence studies. The coefficients of variation of Cmax and AUC were approximately 33% less for controlled-release oxycodone than for controlled-release morphine (P =.005). The variation from the minimum to maximum value was two to three times less for controlled-release oxycodone than for controlled-release morphine. Among healthy male subjects, the absorption of oxycodone from oral controlled-release oxycodone was significantly more consistent than the absorption of morphine from oral controlled-release morphine in terms of both maximum absorption and extent of absorption.
Colucci
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RD
Purdue Pharma L.P., Stamford, CT 06901-3431, USA. dr.robert.colucci@pharma.com
Swanton
R E
RE
Thomas
G B
GB
Kaiko
R F
RF
D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000097:blood / Q000493:pharmacokinetics*; D010098:Oxycodone / Q000097:blood / Q000493:pharmacokinetics*; D012016:Reference Values; D012189:Retrospective Studies; D013810:Therapeutic Equivalency
D003692:Delayed-Action Preparations; D009020:Morphine; D010098:Oxycodone