Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethyl-phenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man

International Journal of Clinical Pharmacology and Therapeutics

Volumn 45, Issue 12, 2007, Pages 662-668

  Tuerck, D ^a   Wang, Y ^a,b   Maboudian, M ^b   Sedek, G ^b   Pommier, F ^c   Appel Dingemanse, Silke ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Exploratory Clinical Development   (United States)

^c NOVARTIS PHARMA K K   (Japan)

Author keywords

D,I MPH; D MPH; Extended release; Pharmacokinetics

Indexed keywords

DEXMETHYLPHENIDATE; METHYLPHENIDATE;

ABNORMAL LABORATORY RESULT; ADULT; AREA UNDER THE CURVE; ARTICLE; BIMODAL DRUG RELEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; EXTENDED DRUG RELEASE; FEMALE; HEART RATE; HUMAN; HUMAN EXPERIMENT; IMMEDIATE DRUG RELEASE; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TABLET FORMULATION;

EID: 37249021434     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP45662     Document Type: Article

References (17)

1. Ballard JE, Boileau RA, Sleator EK, Massey BH, Sprague RL. Cardiovascular responses of hyperactive children to methylphenidate. JAMA. 1976; 236: 2870-2874.
2. Barkley RA. A review of stimulant drug research with hyperactive children. J Child Psychol Psychiatry. 1977; 18: 137-165.
3. Ding YS, Fowler JS, Volkow ND, Logan J, Gatley SJ, Sugano Y. Carbon-11-d-threo-methylphenidate binding to dopamine transporter in baboon brain. J Nucl Med. 1995; 36: 2298-2305.
4. 11C] d-threo- and l-threo-methylphenidate in the human and baboon brain. Psychopharmacology. 1997; 131: 71-78.
5. Greenhill LL. Pharmacologic treatment of attention deficit hyperactivity disorder. Psychiatr Clin North Am. 1992; 15: 1-27.
6. Joyce PR, Nicholls MG, Donald RA. Methylphenidate increases heart rate, blood pressure and plasma epinephrine in normal subjects. Life Sci. 1984; 34: 1707-1711.
7. Kavale K. The efficacy of stimulant drug treatment for hyperactivity: a meta-analysis. J Learn Disabil. 1982; 15: 280-289.
8. Keating GM, Figgitt DP. Dexmethylphenidate. Drugs. 2002; 62: 1899-1904.
9. Markowitz JS, Straughn AB, Patrick KS. Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: focus on methylphenidate formulations. Pharmacotherapy. 2003; 23: 1281-1299.
10. Patrick KS, Caldwell RW, Ferris RM, Breese GR. Pharmacology of the enantiomers of threo-methylphenidate. J Pharmacol Exp Then 1987; 241: 152-158.
11. Patrick KS, Straughn AB, Minhinnett RR, Yeatts SD, Herrin AE, De Vane CL, Malcolm R, Janis GC, Markowitz JS. Influence of ethanol and gender on methylphenidate pharmacokinetics and pharmaco-dynamics. Clin Pharm Ther. 2007; 81: 346-353.
12. Srinivas NR, Hubbard JW, Quinn D, Midha KK. Enantioselective pharmacokinetics and pharmacodynamics of d,l-threo-methylphenidate in children with attention deficit hyperactivity disorder. Clin Pharmacol Ther. 1992; 52: 561-568.
13. Srinivas NR Hubbard JW, Korchinski ED, Midha KK. Enantioselective pharmacokinetics of d,l-threo-methylphenidate in humans. Pharm Res. 1993; 10: 14-21.
14. Sun Z, Murry DJ, Sanghani SP, Davis WI, Kedishvili NY, Zou Q, Hurley TD, Bosron WF. Methylphenidate is stereoselectively hydrolyzed by human carboxylesterase CES1A1. J Pharmacol Exp Ther. 2004; 310: 469-476.
15. Wang Y, Lee L, Somma R, Thompson G, Bakthiar R, Lee J, Rekhi GS, Lau H, Sedek G, Hossain M. In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal-release formulation in healthy volunteers. Biopharm Drug Dispos. 2004; 25: 91-98.
16. Wilens TE, Biederman J. The stimulants. Psychiatry Clin North Am. 1992; 15: 191-222.
17. Wilens TE, Biederman J, Lerner M, Concerta Study Group. Effects of once-daily osmotic-release methylphenidate on blood pressure and heart rate in children with attention-deficit/hyperactivity disorder: results from a one-year follow-up study. J Clin Psychopharmacol. 2004; 24: 36-41.