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PHARMACOKINETICS AND PHARMACODYNAMICS

Pharmacokinetics and Pharmacodynamics of Once-Daily Controlled-Release Oxybutynin and Immediate-Release Oxybutynin

Joseph L. Reiz, BSc, Paulette Salem, HonBSc and Andrew C. Darke, PhD

From Purdue Pharma (Canada), Department of Scientific Affairs, Pickering, Ontario, Canada.

Oxybutynin is used to treat patients with urinary urgency, frequency, and urge incontinence. In this 2-way, multiple-dose, crossover study, the pharmacokinetics and pharmacodynamics of once-daily controlled-release oxybutynin were compared with immediate-release oxybutynin. Eighteen healthy male volunteers received one 15-mg controlled-release oxybutynin tablet once daily for 5 days or one 5-mg immediate-release oxybutynin tablet every 8 hours for 5 days. The washout period between treatments was ≥7 days. The mean steady-state AUC for oxybutynin following controlled-release oxybutynin treatment was higher (73.0 ng·h/mL) than following immediate-release oxybutynin treatment (53.6 ng·h/mL) (P = .0001). The mean Cmax was lower for controlled-release oxybutynin (5.7 ng/mL) than for immediate-release oxybutynin (7.5 ng/mL) (P = .0051), with a smaller fluctuation in oxybutynin plasma concentration for controlled-release oxybutynin (135.6%) than for immediate-release oxybutynin (319.3%) (P = .0001). Mean stimulated saliva output was greater for controlled-release oxybutynin, and mean dry mouth severity was less than immediate-release oxybutynin.

Key Words: urinary incontinence • oxybutynin • anticholinergic • pharmacology • controlled release

Address for reprints: Address for correspondence: Joseph L. Reiz, 575 Granite Court, Pickering, Ontario, Canada, L1W 3W8; e-mail: Joseph.Reiz{at}purdue.ca.


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