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Chronic-Pain Patients on Immediate-Release Tramadol Can Be Readily Switched to Once-Daily Extended-Release Formulation: Presented at ACCP By Maria Bishop BOSTON, MA -- September 19, 2006 -- Patients receiving various dosing regimens of the analgesic tramadol hydrochloride (HCl) immediate-release (IR) for moderate to moderately severe chronic pain can be readily switched to once-daily tramadol extended-release (ER), according to researchers speaking here at the American College of Clinical Pharmacology 35th Annual Meeting (ACCP). Bindu P. Murthy, PharmD, Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, New Jersey, led a team of investigators in determining that patients taking tramadol IR (dosed at a lower amount every 6 hours) can be readily switched to the same equivalent daily dose across the full range of available strengths of tramadol ER (100 mg, 200 mg, and 300 mg). The team used data from 2,248 plasma samples from 61 healthy men and women under fasting conditions (based on modeling data pooled from three phase I studies). The total clearance of drug after extravascular administration (CL/F) and apparent volume of distribution after extravascular administration (Vd/F) were the same for both ER and IR formulations, with simultaneous fit of pharmacokinetic data from both treatments. A strong correlation (0.67) was observed between CL/F and Vd/F. Monte Carlo simulations also resulted in similar plasma tramadol concentrations for tramadol ER 200 mg once daily and tramadol IR 50 mg every 6 hours. Similar results were obtained for the Monte Carlo simulation that compared total doses of 100 mg or 300 mg between the 2 formulations. Dr. Murthy's team undertook this study to determine how best to transition patients from tramadol IR to ER with optimal reduction of breakthrough pain and withdrawal symptoms. They recommended that patients taking intermediate tramadol IR doses be transitioned to the next lower 100-mg tramadol ER increment (e.g., for a total daily dose of 225 to 275 mg tramadol IR, a 200-mg ER dose is suggested). Tramadol is an analgesic agent with a mode of action that resembles that of narcotics, but with less potential for abuse and addiction. [Presentation title: Dose Conversion of Immediate- to Extended-Release Tramadol Using a Population Pharmacokinetic Approach. Abstract 124] E-mail this page to a friend or colleague! To print, use this version