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

Louise Ladebo; Ahmad Y Abuhelwa; David J R Foster; Jens P Kroustrup; Grzegorz J Pacyk; Kenneth T Kongstad; Asbjørn M Drewes; Lona L Christrup; Anne E Olesen

doi:10.1111/bcpt.13634

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

Louise Ladebo, Ahmad Y Abuhelwa, David J R Foster, Jens P Kroustrup, Grzegorz J Pacyk, Kenneth T Kongstad, Asbjørn M Drewes, Lona L Christrup, Anne E Olesen

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Abstract

The 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

Originalsprog	Engelsk
Tidsskrift	Basic & Clinical Pharmacology & Toxicology
Vol/bind	129
Udgave nummer	3
Sider (fra-til)	232-245
ISSN	1742-7835
DOI	https://doi.org/10.1111/bcpt.13634
Status	Udgivet - sep. 2021
Udgivet eksternt	Ja

Dokumenter og links

10.1111/bcpt.13634

Citationsformater

Ladebo, L., Abuhelwa, A. Y., Foster, D. J. R., Kroustrup, J. P., Pacyk, G. J., Kongstad, K. T., Drewes, A. M., Christrup, L. L., & Olesen, A. E. (2021). Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone. Basic & Clinical Pharmacology & Toxicology, 129(3), 232-245. https://doi.org/10.1111/bcpt.13634

@article{37cb7239bec74475b8d8157fd596601f,

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

abstract = "The 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 ",

keywords = "Roux-en-Y gastric bypass, oral controlled-release formulation, oral solution, oxycodone, pharmacokinetic-pharmacodynamic modelling, Gastric Bypass/adverse effects, Oxycodone/pharmacokinetics, Administration, Oral, Humans, Middle Aged, Male, Analgesics, Opioid/pharmacokinetics, Random Allocation, Cross-Over Studies, Delayed-Action Preparations/pharmacokinetics, Aged, 80 and over, Adult, Female, Aged",

author = "Louise Ladebo and Abuhelwa, {Ahmad Y} and Foster, {David J R} and Kroustrup, {Jens P} and Pacyk, {Grzegorz J} and Kongstad, {Kenneth T} and Drewes, {Asbj{\o}rn M} and Christrup, {Lona L} and Olesen, {Anne E}",

year = "2021",

month = sep,

doi = "10.1111/bcpt.13634",

language = "English",

volume = "129",

pages = "232--245",

journal = "Basic & Clinical Pharmacology & Toxicology",

issn = "1742-7835",

publisher = "Wiley",

number = "3",

}

Ladebo, L, Abuhelwa, AY, Foster, DJR, Kroustrup, JP, Pacyk, GJ, Kongstad, KT, Drewes, AM, Christrup, LL & Olesen, AE 2021, 'Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone', Basic & Clinical Pharmacology & Toxicology, bind 129, nr. 3, s. 232-245. https://doi.org/10.1111/bcpt.13634

Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone. / Ladebo, Louise; Abuhelwa, Ahmad Y; Foster, David J R et al.

I: Basic & Clinical Pharmacology & Toxicology, Bind 129, Nr. 3, 09.2021, s. 232-245.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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T1 - Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone

AU - Ladebo, Louise

AU - Abuhelwa, Ahmad Y

AU - Foster, David J R

AU - Kroustrup, Jens P

AU - Pacyk, Grzegorz J

AU - Kongstad, Kenneth T

AU - Drewes, Asbjørn M

AU - Christrup, Lona L

AU - Olesen, Anne E

PY - 2021/9

Y1 - 2021/9

N2 - The 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

AB - The 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

KW - Roux-en-Y gastric bypass

KW - oral controlled-release formulation

KW - oral solution

KW - oxycodone

KW - pharmacokinetic-pharmacodynamic modelling

KW - Gastric Bypass/adverse effects

KW - Oxycodone/pharmacokinetics

KW - Administration, Oral

KW - Humans

KW - Middle Aged

KW - Male

KW - Analgesics, Opioid/pharmacokinetics

KW - Random Allocation

KW - Cross-Over Studies

KW - Delayed-Action Preparations/pharmacokinetics

KW - Aged, 80 and over

KW - Adult

KW - Female

KW - Aged

U2 - 10.1111/bcpt.13634

DO - 10.1111/bcpt.13634

M3 - Journal article

C2 - 34228875

SN - 1742-7835

VL - 129

SP - 232

EP - 245

JO - Basic & Clinical Pharmacology & Toxicology

JF - Basic & Clinical Pharmacology & Toxicology

IS - 3

ER -