{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T05:17:17Z","timestamp":1777353437490,"version":"3.51.4"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,5,25]],"date-time":"2017-05-25T00:00:00Z","timestamp":1495670400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Neos Therapeutics, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Extended\u2010release methylphenidate is a first\u2010line treatment for attention\u2010deficit\/hyperactivity disorder. A methylphenidate extended\u2010release orally disintegrating tablet (MPH XR\u2010ODT) has recently been developed. Here we report an open\u2010label, randomized, 2\u2010period, 2\u2010treatment crossover study to determine the effect of food on the bioavailability of a single 60\u2010mg dose of MPH XR\u2010ODT in healthy adults. Blood samples were collected predose through 36 hours postdose. Maximum plasma concentration (C<jats:sub>max<\/jats:sub>), time to maximum plasma concentration (T<jats:sub>max<\/jats:sub>), terminal elimination half\u2010life (T<jats:sub>1\/2<\/jats:sub>), overall systemic exposure (AUC<jats:sub>last<\/jats:sub> and AUC<jats:sub>inf<\/jats:sub>), and partial areas under the concentration curve (AUC<jats:sub>0\u20133<\/jats:sub>, AUC<jats:sub>3\u20137<\/jats:sub>, and AUC<jats:sub>7\u201312<\/jats:sub>) were calculated. In total, 48 participants completed the study. For total methylphenidate from MPH XR\u2010ODT, the lower limit of the 90% confidence interval (CI) around the geometric mean ratio (GMR, fed\/fasted) for C<jats:sub>max<\/jats:sub> was below 80%, indicating a slightly decreased rate of absorption with food, whereas the 90%CIs around the GMRs of AUC<jats:sub>last<\/jats:sub> and AUC<jats:sub>inf<\/jats:sub> were within the 80%\u2013125% limits, suggesting no food effect on exposure. The most common adverse events (AEs) were palpitations and decreased appetite. No serious, unusual, or unexpected AEs were reported. Thus, food had no substantial effect on overall bioavailability of MPH XR\u2010ODT, which may be an important factor for some patients.<\/jats:p>","DOI":"10.1002\/cpdd.361","type":"journal-article","created":{"date-parts":[[2017,5,25]],"date-time":"2017-05-25T17:26:32Z","timestamp":1495733192000},"page":"160-167","source":"Crossref","is-referenced-by-count":5,"title":["Fed and Fasted Administration of a Novel Extended\u2010Release Methylphenidate Orally Disintegrating Tablet Formulation for the Treatment of ADHD"],"prefix":"10.1002","volume":"7","author":[{"given":"Richard H.","family":"Weisler","sequence":"first","affiliation":[{"name":"Duke University Medical Center  Durham NC USA"},{"name":"University of North Carolina at Chapel Hill  Raleigh NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey G.","family":"Stark","sequence":"additional","affiliation":[{"name":"Worldwide Clinical Trials  Austin TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn","family":"Sikes","sequence":"additional","affiliation":[{"name":"Neos Therapeutics, Inc.  Grand Prairie TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,5,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2011-2654"},{"issue":"7","key":"e_1_2_8_3_1","first-page":"456","article-title":"Diagnosis and management of ADHD in children","volume":"90","author":"Felt BT","year":"2014","journal-title":"Am Fam Physician"},{"key":"e_1_2_8_4_1","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1186\/1471-244X-13-237","article-title":"Long\u2010acting methylphenidate formulations in the treatment of attention\u2010deficit\/hyperactivity disorder: a systematic review of head\u2010to\u2010head studies","volume":"13","author":"Coghill D","year":"2013","journal-title":"BMC Psychiatry"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-9-72"},{"key":"e_1_2_8_6_1","unstructured":"Kaiser Permanente National Guideline Summary for Child\/Adolescent Attention\u2010Deficit\/Hyperactivity Disorder.https:\/\/providers.kaiserpermanente.org\/info_assets\/cpp_oh\/oh_adhd_national_guideline_summary_03_22_1012.pdf. Accessed July 8 2015."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/pch\/14.9.593"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00787-009-0056-1"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1586\/14737167.2013.841544"},{"issue":"4","key":"e_1_2_8_10_1","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1002\/pnp.289","article-title":"Pharmacological treatments for ADHD","volume":"17","author":"Caroline P.","year":"2013","journal-title":"Prog Neurol Psychiatry"},{"key":"e_1_2_8_11_1","unstructured":"ChildressA.Patients\u2019 with ADHD and Healthcare Professionals\u2019 Perspectives on Available ADHD Formulations Swallowing Tablets and Capsules and Treatment Adherence.Abstract: The American Professional Society of ADHD and Related Disorders 2016 Annual Meeting. 2016."},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1586\/ern.13.31"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12402-013-0106-x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.2165\/00023210-200418140-00005"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2015.0261"},{"issue":"1","key":"e_1_2_8_16_1","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1089\/cap.2016.0002","article-title":"Efficacy, safety, and tolerability of an extended\u2010release orally disintegrating methylphenidate tablet in children 6\u201312 years of age with attention\u2010deficit\/hyperactivity disorder in the laboratory classroom setting","volume":"27","author":"Childress AC","year":"2017","journal-title":"J Child Adolesc Psychopharmacol"},{"issue":"4","key":"e_1_2_8_17_1","first-page":"35","article-title":"Orally disintegrating tablets: formulation, preparation techniques and evaluation","volume":"1","author":"Nagar P","year":"2011","journal-title":"J Appl Pharm Sci"},{"issue":"3","key":"e_1_2_8_18_1","doi-asserted-by":"crossref","first-page":"189","DOI":"10.2174\/1872211309666150529150342","article-title":"Fast dissolving\/disintegrating dosage forms: growth from immediate release to sustained release and traditional medicines","volume":"9","author":"Saharan VA","year":"2015","journal-title":"Recent Pat Drug Deliv Formul"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1185\/030079902125000840"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2014.0160"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.12659\/MSM.890495"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.comppsych.2013.09.015"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"},{"key":"e_1_2_8_24_1","unstructured":"International Conference on Harmonisation. 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