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
References
Mar 1, 1992·Journal of the American Academy of Child and Adolescent Psychiatry·P A FitzpatrickA D Borgstedt
Sep 1, 1989·Journal of the American Academy of Child and Adolescent Psychiatry·B BirmaherB Maminski
Jan 1, 1982·Journal of the American Academy of Child Psychiatry·C T GualtieriG R Breese
Oct 1, 1981·Journal of Medicinal Chemistry·K S PatrickG R Breese
May 1, 1995·The American Journal of Psychiatry·R R Pleak
Oct 1, 1996·Journal of Developmental and Behavioral Pediatrics : JDBP·A R Miller
May 5, 1999·JAMA : the Journal of the American Medical Association·P R Breggin
Oct 20, 2000·Biopharmaceutics & Drug Disposition·N B ModiS K Gupta
Mar 5, 2002·Pediatrics·Laurence L GreenhillUNKNOWN ADHD Study Group
Citations
Aug 6, 2005·The Psychiatric Quarterly·Feng LiuRaul R Silva
Sep 1, 2004·Journal of Psychiatric Practice·Russell A Barkley
Oct 4, 2011·Annals of General Psychiatry·Inyang Takon
Dec 5, 2009·CNS Drugs·Marit D Moen, Susan J Keam
Apr 9, 2009·Expert Opinion on Pharmacotherapy·Robert JanknegtLuuk J Kalverdijk
Apr 25, 2013·Expert Opinion on Drug Metabolism & Toxicology·Rafael Maldonado
Nov 22, 2005·Expert Opinion on Drug Delivery·Kennerly S PatrickJohn S Markowitz
Dec 19, 2002·Current Medical Research and Opinion·S J Hirshey DirksenS J Hatch
Dec 4, 2008·Human Psychopharmacology·Kennerly S PatrickMario A González
Oct 11, 2016·PloS One·Xiaoxia YangJeffrey Fisher
May 31, 2017·Journal of Child and Adolescent Psychopharmacology·Sharon B WigalDonna Palumbo
Sep 16, 2003·Biopharmaceutics & Drug Disposition·Lucy LeeMohammad Hossain
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
Dec 7, 2019·Journal of Child and Adolescent Psychopharmacology·Steven Caras, Terrilyn Sharpe
Dec 9, 2004·CNS Drugs·Daniel F Connor, Ronald J Steingard
Nov 30, 2004·Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie·Kathrin SeveckeGerd Lehmkuhl
Sep 24, 2016·Therapeutic Drug Monitoring·James ErmerPatrick T Martin
Feb 20, 2017·Journal of Pharmacokinetics and Pharmacodynamics·Liang LiHao Zhu
Nov 5, 2003·Pharmacotherapy·John S MarkowitzKennerly S Patrick
Sep 10, 2011·Postgraduate Medicine·Ann C ChildressSally A Berry
Mar 27, 2019·Drugs in R&D·Yi WangBrigitte Robertson
Jan 1, 2015·Children·Hannah K Batchelor
Apr 18, 2019·Journal of the Endocrine Society·Eleni DanielMadhu Davies
Oct 16, 2021·European Journal of Drug Metabolism and Pharmacokinetics·Zhao WangAzmi Nasser
Nov 3, 2007·Pediatrics·L Eugene ArnoldYaser Ramadan