Methylphenidate bioavailability in adults when an extended-release multiparticulate formulation is administered sprinkled on food or as an intact capsule

Journal of the American Academy of Child and Adolescent Psychiatry
H S PentikisSimon Hatch

Abstract

To determine the single-dose bioavailability of 20-mg Metadate CD (methylphenidate HCI, USP) Extended-Release Capsules sprinkled onto 1 level tablespoon (15 mL) of applesauce relative to an intact capsule under fasted conditions in healthy adults. This was a single-center, open-label, single-dose, randomized, two-way crossover study with a 6-day washout period between doses, in healthy male and female subjects (N= 26), aged 21-40 years. Plasma concentration-time data for methylphenidate were used to calculate the pharmacokinetic parameters for each treatment. The pharmacokinetic profile for Metadate CD exhibited biphasic release characteristics with a sharp initial slope and a second rising portion. For Cmax (maximum observed concentration), AUC(0-infinity) (area under the plasma concentration curve from time 0 to infinity) and AUC(0-infinity) (area under the plasma concentration curve from time 0 to the last measurable time point), the geometric least squares mean ratios and 90% confidence intervals were within the 80% to 125% confidence interval for bioequivalence. Adverse events were similar to those reported for methylphenidate. The bioavailability of methylphenidate was not altered when Metadate CD capsules were administer...Continue Reading

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Citations

Aug 6, 2005·The Psychiatric Quarterly·Feng LiuRaul R Silva
Apr 9, 2009·Expert Opinion on Pharmacotherapy·Robert JanknegtLuuk J Kalverdijk
Apr 25, 2013·Expert Opinion on Drug Metabolism & Toxicology·Rafael Maldonado
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Dec 19, 2002·Current Medical Research and Opinion·S J Hirshey DirksenS J Hatch
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May 31, 2017·Journal of Child and Adolescent Psychopharmacology·Sharon B WigalDonna Palumbo
Aug 22, 2003·Journal of the American Academy of Nurse Practitioners·Peter J Piliero, Joseph P Colagreco
Oct 5, 2019·Expert Opinion on Drug Metabolism & Toxicology·Ann C ChildressF Randy Sallee
Nov 30, 2004·Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie·Kathrin SeveckeGerd Lehmkuhl
Feb 20, 2017·Journal of Pharmacokinetics and Pharmacodynamics·Liang LiHao Zhu
Apr 18, 2019·Journal of the Endocrine Society·Eleni DanielMadhu Davies

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