A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 46, Issue 9, 2008, Pages 466-476

  Haessler, F ^a   Tracik, F ^b   Dietrich, H ^c   Stammer, H ^d   Klatt, Jan ^b  

^a ROSTOCK UNIVERSITY MEDICAL CENTER   (Germany)

^b Novartis Pharma GmbH   (Germany)

^c MEDA Manufacturing GmbH   (Germany)

^d Pharmalog Inst F Klin Forsch G   (Germany)

Author keywords

Bioequivalence; Food effect; Medikinet ; Methylphenidate; Pharmaco kinetics; Retard; Ritalin LA

Indexed keywords

MEDIKINET; METHYLPHENIDATE; UNCLASSIFIED DRUG;

ADULT; AGITATION; AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; ATTENTION DISTURBANCE; BIOEQUIVALENCE; BLURRED VISION; CLINICAL TRIAL; COLD; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG RELEASE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TOLERANCE; EYE DISEASE; FATIGUE; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; HEART DISEASE; HEART PALPITATION; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; HYPERHIDROSIS; HYPERVIGILANCE; INSOMNIA; IRRITABILITY; MALE; MAXIMUM PLASMA CONCENTRATION; MEAL; MEAN RESIDENCE TIME; MENTAL DISEASE; MOOD DISORDER; NAUSEA; NERVOUSNESS; NEUROLOGIC DISEASE; NORMAL HUMAN; PARESTHESIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SOFT TISSUE DISEASE; TACHYCARDIA; TIME TO MAXIMUM PLASMA CONCENTRATION; VASCULAR DISEASE; VOLUNTEER; XEROSTOMIA;

EID: 52149084789     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP46466     Document Type: Article

References (23)

1. Banaschewski T et al. Long acting medications for the hyperkinetic disorders - A systematic review and European treatment guideline. Eur Child Adolesc Psychiatry. 2006; 15: 476-495.
2. Barkley RA. A review of stimulant drug research with hyperactive children. J Child Psychol Psychiatry. 1977; 18: 137-165.
3. Doepfner M et al. Comparative efficacy of once-a-day extended-release methylphenidate, two-times-daily immediate-release methylphenidate, and placebo in a laboratory school setting. Eur Child Adolsc Psychiatry. 2004; 13 (Suppl 1): I93-101.
4. Elan Pharmaceuticals. Technology Focus 2007. Available for download under http://www.elan.com/Images/ Elan_Technology_07v1_tcm3-17145.pdf (last accessed on January 4th 2008).
5. Fischer R et al. Bioequivalence of a methylphenidate hydrochloride extended-release preparation: comparison of an intact capsule and an opened capsule sprinkled on applesauce. Int J Clin Pharmacol Ther. 2006; 44: 135-141.
6. Food and Drug Administration. Guidance for Industry, Statistical Approaches to Establish Bioequivalence. US department of Health and Human services, Food and Drug Administration, Center for evaluating Drug Evaluation and Research; 2001.
7. Goldfield GS et al. Methylphenidate reduces energy intake and dietary fat intake in adults: a mechanism of reduced reinforcing value of food. Am J Clin Nutr. 2007; 86: 308-315.
8. Greenhill LL, Osman BB. Sections 3, 6 and 7. In: Greenhill LL, Osman BB (eds) Ritalin®: Theory and patient management. New York: MaryAnn Liebert Publishers; 1991. pp. 35-257.
9. Hauschke D et al. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther and Toxicol. 1990; 28: 72-78.
10. Lee L et al. Bioavailability of modified-release Methylphenidate: Influence of high-fat breakfast when administered intact and when capsule content sprinkled on applesauce. Biopharm Drug Dispos. 2003; 24: 233-243.
11. Lyseng-Williamson KA, Keating GM. Extended-Release Methylphenidate (Ritalin LA®). Drugs. 2002; 65: 2251-2259.
12. Markowitz JS et al. Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults. Clin Pharmacokinet. 2003; 42: 393-401.
13. Medice Arzneimittel, Pütter GmbH & Co. KG. Medikinet® retard 10mg/20 mg. Zusammenfassung der Merkmale des Arzneimittels (Product information 2006).
14. Novartis Pharmaceuticals Corp. Ritalin LA® Product Monograph. East Hanover (NJ): Novartis Phamaceuticals Corp.; 2002.
15. Patrick KS et al. The absorption of sustained-release methylphenidate formulation compared to an immediate release formulation. Biopharm Drug Dispos. 1989; 10: 165-171.
16. Pelham et al. Once-a-Day Concerta Methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics. 2001; 107: E105.
17. Perel JM et al. Correlates of pharmacokinetics and attentional measures in methylphenidate treated children. Clin Pharmacol Ther. 1991; 49: 160-161.
18. Semenchuk MR. Avinza Elan. Curr Opin Invest Drugs. 2002; 3: 1369-1372.
19. Spencer T et al. Pharmacotherapy of attention-deficit hyperactivity disorder across the life-cycle. J Amer Acad Child Adolesc Psychiatry. 1996; 35: 409-432.
20. Spencer T et al. Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2007; 61: 1380-1387.
21. Swanson J et al. Acute tolerance to methylphenidate in the treatment of attention deficit hyperactivity disorder in children. Clin Pharmacol Ther. 1999; 66: 295-305.
22. Wilens TE, Biederman J. The stimulants. Psychiatr Clin North Am. 1992; 15: 191-222.
23. Wolraich et al. Treatment of attention deficit hyperactivity disorder in children and adolescents - safety considerations. Drug Safety. 2007; 30: 17-26.