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• W2019830605 abstract "Single-dose administration of once-daily hydromorphone ER (OROS® hydromorphone) produces monophasic delivery of hydromorphone from 2-18 hours after administration, yielding dose-proportional pharmacokinetics and sustained plasma concentrations for more than 24 hours. The traditional pharmacokinetic parameters were reported previously. Compared with IR hydromorphone, once-daily hydromorphone ER significantly delays time to achieve maximum plasma concentration by approximately 12-14 hours. In an experimental acute-dose pain model, a statistically significant linear relationship was demonstrated between hydromorphone plasma concentration and percent increase in pain tolerance, resulting in a longer time that tolerance remained above 50% of peak tolerance with the once-daily ER formulation versus the IR formulation. The current analysis was conducted using data from a previously published single-dose pharmacokinetic study of once-daily hydromorphone ER in comparison with IR hydromorphone in 30 healthy volunteers. Under fasting conditions, subjects received once-daily hydromorphone ER 16 mg and IR hydromorphone 4 mg every 6 hours for 24 hours in a crossover design with 7-14 days between treatments. Once-daily hydromorphone ER remained above 50%Cmax for 21.6 ± 6.7 h compared with 5.9 ± 4.1 h for IR hydromorphone across the 24-hour dosing period. These data demonstrate that once-daily hydromorphone ER concentrations remain elevated above 50%Cmax for most of the 24-hour dosing period and for an extended period of time compared with IR hydromorphone regimen administered at the same total daily dose. Further studies are needed to assess the relationship of the time to reach 50% Cmax and the time that plasma concentration remains above 50%Cmax to onset and duration of analgesic effect. Editorial and writing support were provided by Synchrony Medical LLC, funded by Covidien. Single-dose administration of once-daily hydromorphone ER (OROS® hydromorphone) produces monophasic delivery of hydromorphone from 2-18 hours after administration, yielding dose-proportional pharmacokinetics and sustained plasma concentrations for more than 24 hours. The traditional pharmacokinetic parameters were reported previously. Compared with IR hydromorphone, once-daily hydromorphone ER significantly delays time to achieve maximum plasma concentration by approximately 12-14 hours. In an experimental acute-dose pain model, a statistically significant linear relationship was demonstrated between hydromorphone plasma concentration and percent increase in pain tolerance, resulting in a longer time that tolerance remained above 50% of peak tolerance with the once-daily ER formulation versus the IR formulation. The current analysis was conducted using data from a previously published single-dose pharmacokinetic study of once-daily hydromorphone ER in comparison with IR hydromorphone in 30 healthy volunteers. Under fasting conditions, subjects received once-daily hydromorphone ER 16 mg and IR hydromorphone 4 mg every 6 hours for 24 hours in a crossover design with 7-14 days between treatments. Once-daily hydromorphone ER remained above 50%Cmax for 21.6 ± 6.7 h compared with 5.9 ± 4.1 h for IR hydromorphone across the 24-hour dosing period. These data demonstrate that once-daily hydromorphone ER concentrations remain elevated above 50%Cmax for most of the 24-hour dosing period and for an extended period of time compared with IR hydromorphone regimen administered at the same total daily dose. Further studies are needed to assess the relationship of the time to reach 50% Cmax and the time that plasma concentration remains above 50%Cmax to onset and duration of analgesic effect. Editorial and writing support were provided by Synchrony Medical LLC, funded by Covidien." @default.
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• W2019830605 date "2011-04-01" @default.
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• W2019830605 title "Characterization of the pharmacokinetic profile of single-dose once-daily hydromorphone ER (OROS hydromorphone) versus IR hydromorphone administered over 24 hours in healthy volunteers" @default.
• W2019830605 doi "https://doi.org/10.1016/j.jpain.2011.02.241" @default.
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