Abstract
The pharmacokinetic profiles of 2 once-daily microgranulated sustained release (SR) morphine sulfate 60mg capsule formulations, differing only in coating excipients (A and B; Ethypharm QD®), were compared with the pharmacokinetic profile of a 60mg capsule containing SR morphine sulfate microgranules (C; M-Eslon®) intended for twice-daily administration. A single dose was given to 12 healthy male volunteers after overnight fasting. Blood samples were drawn over the 48 hours following administration, and a validated high performance liquid chromatography method was used to analyse plasma morphine and morphine-6-glucuronide (M6G) concentrations. Area under the plasma concentration-time curve values for A, B and C were 132, 137 and 145 µg·h/L for morphine, and 1322, 1434 and 1324 µg·h/L for M6G, showing bioequivalence for the extent of absorption. However, the respective peak plasma concentrations were 5.3, 4.9 and 11.7 µg/L for morphine and 36.9, 38.3 and 97.2 µg/L for M6G, showing a higher plasma concentration (because of a higher rate of release) for capsule C and providing evidence for the more extended release of morphine from capsules A and B. On the basis of these results, it can be concluded that these once-daily microgranulated SR morphine 60mg capsules are a promising alternative to twice-daily treatment.
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