PMID- 27228207
OWN - NLM
STAT- MEDLINE
DCOM- 20180104
LR  - 20181113
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 26
IP  - 6
DP  - 2016 Aug
TI  - A Single-Dose, Single-Period Pharmacokinetic Assessment of an Extended-Release 
      Orally Disintegrating Tablet of Methylphenidate in Children and Adolescents with 
      Attention-Deficit/Hyperactivity Disorder.
PG  - 505-12
LID - 10.1089/cap.2015.0261 [doi]
AB  - OBJECTIVE: To determine the pharmacokinetic (PK) profile of a proprietary 
      formulation of methylphenidate (MPH) in children and adolescents with 
      attention-deficit/hyperactivity disorder (ADHD) in a phase 1 study. 
      Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) 
      combine two technologies in a single-tablet formulation-an extended-release 
      profile that was designed for once-daily dosing in an ODT that does not require 
      water or chewing for ingestion. METHODS: This was a single-dose, open-label, 
      single-period, single-treatment study, in which 32 children with ADHD who were 
      receiving MPH in doses of 40 or 60 mg before beginning the study each received a 
      60-mg dose (2 x 30 mg) of MPH XR-ODT. The following plasma PK parameters of MPH 
      were determined for participants grouped by age (6-7, 8-9, 10-12, and 13-17 years 
      old): maximum concentration (Cmax), time to maximum concentration (Tmax), 
      elimination half-life (T(1/2)), area under the curve from 0 hours to infinity 
      (AUCinf), oral clearance (CL/F), and volume of distribution in the terminal phase 
      (Vz/F). Safety and tolerability were also assessed. RESULTS: A total of 32 
      participants received the study drug. For all participants, plasma 
      concentration-time profiles of MPH exhibited a broad peak after administration of 
      MPH XR-ODT through  approximately 8 hours, indicating extended release from the formulation, 
      followed by an apparent first-order elimination phase. As age increased, MPH 
      exposure decreased and mean estimates of CL/F increased; however, 
      weight-normalized CL/F values were comparable across age groups. Similarly, mean 
      estimates of Vz/F increased with age, but weight-normalization decreased 
      differences across age groups, with the exception of the youngest age group, 
      which had higher values. All adverse events (AEs) were mild. CONCLUSION: This 
      XR-ODT formulation of MPH demonstrated weight-normalized clearance rates that 
      were consistent across all age groups, a PK profile consistent with once-daily 
      dosing, and an AE profile consistent with this class of medication in children 
      and adolescents with ADHD.
FAU - Childress, Ann
AU  - Childress A
AD  - 1 Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.
FAU - Newcorn, Jeffrey
AU  - Newcorn J
AD  - 2 Department of Psychiatry, Icahn School of Medicine at Mount Sinai , New York 
      City, New York.
FAU - Stark, Jeffrey G
AU  - Stark JG
AD  - 3 Worldwide Clinical Trials , Austin, Texas.
FAU - McMahen, Russ
AU  - McMahen R
AD  - 4 Neos Therapeutics, Inc. , Grand Prairie, Texas.
FAU - Tengler, Mark
AU  - Tengler M
AD  - 4 Neos Therapeutics, Inc. , Grand Prairie, Texas.
FAU - Sikes, Carolyn
AU  - Sikes C
AD  - 4 Neos Therapeutics, Inc. , Grand Prairie, Texas.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160526
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Tablets)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Age Factors
MH  - Area Under Curve
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Child
MH  - Delayed-Action Preparations
MH  - Female
MH  - Half-Life
MH  - Humans
MH  - Male
MH  - Methylphenidate/*administration & dosage/adverse effects/pharmacokinetics
MH  - Tablets
MH  - Tissue Distribution
PMC - PMC4991613
EDAT- 2016/05/27 06:00
MHDA- 2018/01/05 06:00
PMCR- 2016/08/01
CRDT- 2016/05/27 06:00
PHST- 2016/05/27 06:00 [entrez]
PHST- 2016/05/27 06:00 [pubmed]
PHST- 2018/01/05 06:00 [medline]
PHST- 2016/08/01 00:00 [pmc-release]
AID - 10.1089/cap.2015.0261 [pii]
AID - 10.1089/cap.2015.0261 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2016 Aug;26(6):505-12. doi: 
      10.1089/cap.2015.0261. Epub 2016 May 26.