Effects of application to two different skin sites on the pharmacokinetics of transdermal methylphenidate in pediatric patients with attention-deficit/ hyperactivity disorder

Journal of Child and Adolescent Psychopharmacology

Volumn 19, Issue 3, 2009, Pages 227-232

  González, Mario A ^a   Campbell, Dawn ^b   Rubin, Jonathan ^c  

^a P'Kinetics International Inc   (United States)

^b DAC Associates Consulting   (United States)

^c SHIRE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHYLPHENIDATE;

ACCIDENTAL INJURY; AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; CALCULATION; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG WITHDRAWAL; ERYTHEMA; HIP; HUMAN; JAW MOVEMENT; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OPEN STUDY; PAIN; RANDOMIZED CONTROLLED TRIAL; RASH; SCAPULA; SIDE EFFECT; SKIN; TIME TO MAXIMUM PLASMA CONCENTRATION; VIRAL UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, CUTANEOUS; AREA UNDER CURVE; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; BIOLOGICAL AVAILABILITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CROSS-OVER STUDIES; FEMALE; HIP; HUMANS; MALE; METHYLPHENIDATE; SCAPULA; SKIN ABSORPTION;

EID: 67650862794     PISSN: 10445463     EISSN: None     Source Type: Journal    
DOI: 10.1089/cap.2008.0081     Document Type: Article

References (19)

1. Berti JJ, Lipsky JJ: Transcutaneous drug delivery: A practicalreview. Mayo Clin Proc 70:581-586, 1995.
2. Biederman J, Lopez FA, Boellner SW, Chandler MC: A randomized, double-blind, placebo controlled, parallel group study of SLI381 (Adderall XR) in children with attentiondeficit hyperactivity disorder. Pediatrics 110:258-266, 2002.
3. Connor D, Steingard R: New formulations of stimulants for attention deficit hyperactivity disorder: Therapeutic potential.CNS Drugs 18:1011-1030, 2004.
4. Daytrana [package insert]: Wayne (Pennsylvania): Shire DevelopmentInc., 2007.
5. FDA Guidance for Industry: Statistical approaches to establishing bioequivalence, 2001. Accessed at http://www.fda.gov/cder/guidance/3616fnl.pdf/.
6. Findling RL, Bukstein OG, Melmed RD, Lo'pez FA, Sallee FR, Arnold LE, Pratt RD: A randomized, double-blind, placebocontrolled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry 69:149-159, 2008.
7. Greenhill LL, Pliszka S, Dulcan MK, Bernet W, Arnold V, Beitchman J, Benson RS, Bukstein O, Kinlan J, McClellan J, Rue D, Shaw JA, Stock S, American Academy of Child and Adolescent Psychiatry: Practice parameter for the use of stimulant medications in the treatment of children, adolescents and adults. AACAP Official Action. J Am Acad ChildAdolesc Psychiatry 41(Suppl 2):26S-49S, 2002.
8. Heal DJ, Pierce DM: Methylphenidate and its isomers: Their role in the treatment of attention-deficit hyperactivity disorder using a transdermal delivery system. CNS Drugs 20:713-738, 2006.
9. IMS national prescription data, 2005-2007.
10. Lopez F, Silva R, Pestreich L, Muniz R: Comparative efficacy of two once daily methylphenidate formulations (Ritalin LA and Concerta) and placebo in children with attention deficit hyperactivity disorder across the school day. Paediatr Drugs5:545-555, 2003.
11. McGough JJ, Wigal S, Abikoff H, Turnbow JM, Posner K, Moon E: A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal systemin children with ADHD. J Attention Disord 9:476-485, 2006.
12. Noonan PK, Gonza'lez MA: Pharmacokinetics and the variability of percutaneous absorption. J Toxicol-Cutaneous and OcularToxicol 8:511-516, 1989.
13. Olfson M: New options in the pharmacological management of attention deficit hyperactivity disorder. Am J Managed Care10(Suppl 4):S117-S124, 2004.
14. Pelham W, Burrows-Maclean L, Gnagy EM, Fabiano GA, Coles EK, Tresco KE, Chacko A, Wymbs BT, Wienke AL, Walker KS, Hoffman MT: Transdermal methylphenidate, behavioral, and combined treatment for children with ADHD. Exp Clin Psychopharmacol13:111-126, 2005.
15. Pelham WE, Gnagy EM, Burrows-Maclean L, Williams A, Fabiano GA, Morrisey SM, Chronis AM, Forehand GL, Nguyen CA, Hoffman MT, Lock TM, Fielbelkorn K, Coles EK, Panahon CJ, Steiner RL, Meichenbaum DL, Onyango AN, Morse GD: Once-a-day Concerta methylphenidate versus threetimes- daily methylphenidate in laboratory and natural settings.Pediatrics 107:E105, 2001.
16. Schuirmann, DJ: A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
17. Silva R, Muniz R, Pestreich LK, Brams M, Childress A, Lopez FA: Efficacy of two long-acting methylphenidate formulations in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol15:637-654, 2005.
18. Swanson J, Gupta S, Lam A, et al.: Development of a new oncea- day formulation of methylphenidate for the treatment of attention-deficit/ hyperactivity disorder: Proof-of-concept and proof-of-product studies. Arch Gen Psychiatry 60:204-211, 2003.
19. Swanson JM, Wigal SB, Wigal T, Sonuga-Barke E, Greenhill LL, Biederman J, Kollins S, Nguyen AS, DeCory HH, Hirshe Dirksen SJ, Hatch SJ, COMACS Study Group: A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the COMACS Study). Pediatrics 113:e206-216, 2004.