Document Detail


Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study.
MedLine Citation:
PMID:  18759645     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
David Pierce; Catherine M Dixon; Sharon B Wigal; James J McGough
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of child and adolescent psychopharmacology     Volume:  18     ISSN:  1557-8992     ISO Abbreviation:  J Child Adolesc Psychopharmacol     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-09-01     Completed Date:  2008-10-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9105358     Medline TA:  J Child Adolesc Psychopharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  355-64     Citation Subset:  IM    
Affiliation:
Shire Pharmaceutical Development Ltd, Basingstoke, United Kingdom. dpierce@shire.com
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MeSH Terms
Descriptor/Qualifier:
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:
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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