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Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone

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dc.contributor.authorLadebo, L.
dc.contributor.authorAbuhelwa, A.Y.
dc.contributor.authorFoster, D.J.R.
dc.contributor.authorKroustrup, J.P.
dc.contributor.authorPacyk, G.J.
dc.contributor.authorKongstad, K.T.
dc.contributor.authorDrewes, A.M.
dc.contributor.authorChristrup, L.L.
dc.contributor.authorOlesen, A.E.
dc.date.issued2021
dc.description.abstractThe physiological changes following Roux-en-Y gastric bypass (RYGB) surgery may impact drug release from mechanistically different controlled-release tablets, making generic substitution inappropriate. This study aimed to characterise the pharmacokinetic-pharmacodynamic relationships of oxycodone from a lipid-based and water-swellable controlled-release tablet in RYGB patients. Twenty RYGB patients received 10-mg oral solution oxycodone or 20-mg controlled-release (water-swellable or lipid-based) oxycodone in a three-way, randomised, semiblinded and cross-over study. Blood sampling and pupillary recordings were conducted over a 24-h period. A previously established pharmacokinetic-pharmacodynamic model of these three formulations in healthy volunteers was used in the analysis as a reference model. No differences in absorption kinetics were seen between controlled-release formulations in patients. However, the absorption lag time was 11.5 min in patients vs 14 min in healthy volunteers for controlled-release tablets (P < 0.001). Furthermore, oral bioavailability was 14.4% higher in patients compared to healthy volunteers regardless of formulation type (P < 0.001). Oxycodone pharmacodynamics were not significantly affected by formulation or patient status. However, baseline pupil diameter was inversely correlated with age (P < 0.001) and plasma concentrations of oxycodone at half-maximum effect were 31% lower in males compared to females (P < 0.05). Generic substitution of monophasic lipid-based and water-swellable controlled-release oxycodone tablets may be considered safe in RYGB patients.
dc.identifier.citationBasic and Clinical Pharmacology and Toxicology, 2021; 129(3):232-245
dc.identifier.doi10.1111/bcpt.13634
dc.identifier.issn1742-7835
dc.identifier.issn1742-7843
dc.identifier.orcidFoster, D.J.R. [0000-0002-7345-4084]
dc.identifier.urihttps://hdl.handle.net/11541.2/148124
dc.language.isoen
dc.publisherWILEY
dc.rightsCopyright 2021 Nordic Association for the Publication of BCPT
dc.source.urihttps://doi.org/10.1111/bcpt.13634
dc.subjectHumans
dc.subjectOxycodone
dc.subjectAnalgesics, Opioid
dc.subjectDelayed-Action Preparations
dc.subjectGastric Bypass
dc.subjectAdministration, Oral
dc.subjectCross-Over Studies
dc.subjectRandom Allocation
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.titleEffect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone
dc.typeJournal article
pubs.publication-statusPublished
ror.mmsid9916543219101831

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