The pharmacokinetics of a new sustained-release form of diclofenac sodium in humans.
In the present study, two sustained release diclofenac preparations were administered every 12 hours over 4 days to ten human volunteers. Diurnal profiles were recorded on the 1st and 4th days, from which pharmacokinetic parameters were calculated: particular attention was given to cumulation. One, a newly developed sustained release formulation, had a MRT of 5.5 hours, and showed surprisingly small variation coefficients [AUC ss (72-84 hrs) +/- 26%; Cmax ss (72-84 hrs) +/- 19%] after 7 administered doses; accordingly, the maximum concentrations were within a very narrow time window [tmax ss (72-84 hrs) range: 1.5-2.5 hours after administration]. Due to the selected release profiles with this formulation, there was no danger of cumulation in spite of administration every 12 hours [AUC 0-12 hrs, mean value = 1555 ng/ml x h; AUC ss 72-84 hrs, mean value = 1750 ng/ml x h].
Pharm-Analyt Labor Gmbh, Traiskirchen, Austria.
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D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male
D003692:Delayed-Action Preparations; D004008:Diclofenac