| Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study. | |
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MedLine Citation:
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PMID: 18759645 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To evaluate the pharmacokinetic properties of the methylphenidate transdermal system (MTS) in pediatric patients diagnosed with ADHD (attention-deficit/hyperactivity disorder) in a laboratory school setting. METHOD: A phase II, randomized, double-blind, placebo-controlled, laboratory classroom study was conducted with prior dose optimization. Children (aged 6-12 years) with ADHD were titrated over 5 weeks to an optimal clinical MTS dose (10, 15, 20, or 30 mg/9 h). Participants were randomized to 1 week of either MTS or corresponding placebo, followed by crossover to the alternate treatment. Laboratory school evaluations, including pharmacokinetic blood sampling, occurred at the end of each treatment. RESULTS: MTS delivered d- and l-MPH (methylphenidate) into the systemic circulation throughout the 9-hour wear time, and plasma concentrations declined rapidly after patch removal. Over the time-course of clinical effectiveness (2-12 h), mean plasma concentrations of d-MPH at the most frequently titrated doses (15 and 20 mg/9 h) ranged from 4.97 to 28.3 ng/mL. Systemic exposure increased approximately dose proportionately. Plasma concentrations of the l-MPH were approximately one-half to two-thirds those for d-MPH. CONCLUSIONS: Plasma concentrations of the much less active l-MPH were consistently lower than those of d-MPH. The clinical relevance of the MTS pharmacokinetic profile is discussed. |
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Authors:
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David Pierce; Catherine M Dixon; Sharon B Wigal; James J McGough |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of child and adolescent psychopharmacology Volume: 18 ISSN: 1557-8992 ISO Abbreviation: J Child Adolesc Psychopharmacol Publication Date: 2008 Aug |
Date Detail:
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Created Date: 2008-09-01 Completed Date: 2008-10-27 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9105358 Medline TA: J Child Adolesc Psychopharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 355-64 Citation Subset: IM |
Affiliation:
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Shire Pharmaceutical Development Ltd, Basingstoke, United Kingdom. dpierce@shire.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Cutaneous Attention Deficit Disorder with Hyperactivity / drug therapy* Central Nervous System Stimulants / administration & dosage, pharmacokinetics*, therapeutic use Child Cross-Over Studies Dose-Response Relationship, Drug Double-Blind Method Female Humans Male Methylphenidate / administration & dosage, pharmacokinetics*, therapeutic use Stereoisomerism Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Central Nervous System Stimulants; 113-45-1/Methylphenidate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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