Differences in the In Vitro and In Vivo Pharmacokinetic Profiles of Once-Daily Modified-Release Methylphenidate Formulations in Canada: Examination of Current Bioequivalence Criteria

Clinical Therapeutics

Volumn 34, Issue 5, 2012, Pages 1170-1181

  Shram, Megan J ^a,b   Quinn, Anne Marie ^c   Chen, Nancy ^a   Faulknor, Janice ^a   Luong, Doanh ^c   Sellers, Edward M ^a,b,d,e   Endrenyi, Laszlo ^b  

^a SYNEOS HEALTH   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c Janssen Inc   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e DL Global Partners Inc   (Canada)

Author keywords

Bioequivalence; Complex modified release formulation; In vitro dissolution; Methylphenidate; Partial area under the concentration time curve; Pharmacokinetics

Indexed keywords

35308907A; 35312313A; 9KG994; FGG; METHYLPHENIDATE; OBG411; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ADULT; AGITATION; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BACKACHE; BIOEQUIVALENCE; CANADA; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CONTUSION; CRITERION VARIABLE; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MARKETING; DRUG RELEASE; DRUG SAFETY; DRUG SCREENING; DRUG SOLUBILITY; DYSPEPSIA; EUPHORIA; FEMALE; HEADACHE; HUMAN; HYPERHIDROSIS; IN VITRO STUDY; IN VIVO STUDY; INSOMNIA; LIMB DISEASE; LOGORRHEA; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCULOSKELETAL CHEST PAIN; NAUSEA AND VOMITING; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SIDE EFFECT; SINGLE DRUG DOSE; SUNBURN; SUSTAINED DRUG RELEASE; TABLET; THIRST; TOOTH PAIN;

ADULT; AREA UNDER CURVE; CANADA; CENTRAL NERVOUS SYSTEM STIMULANTS; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MALE; METHYLPHENIDATE; OSMOTIC PRESSURE; SOLUBILITY; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 84860718857     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.02.010     Document Type: Article

References (26)

1. Swanson J.M., Wigal S.B., Wigal T., et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics 2004, 113(3 Pt 1):e206-e216.
2. Banaschewski T., Coghill D., Santosh P., et al. Long-acting medications for the hyperkinetic disorders: a systematic review and European treatment guideline. Eur Child Adolesc Psychiatry 2006, 15:476-495.
3. Parasrampuria D.A., Schoedel K.A., Schuller R., et al. Assessment of pharmacokinetics and pharmacodynamic effects related to abuse potential of a unique oral osmotic-controlled extended-release methylphenidate formulation in humans. J Clin Pharmacol 2007, 47:1476-1488.
4. Parasrampuria D.A., Schoedel K.A., Schuller R., et al. Do formulation differences alter abuse liability of methylphenidate?. A placebo-controlled, randomized, double-blind, crossover study in recreational drug users. J Clin Psychopharmacol 2007, 27:459-467.
5. Swanson J., Gupta S., Lam A., et al. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies. Arch Gen Psychiatry 2003, 60:204-211.
6. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral Dosage Formulations Used for Systemic Effects 1992, Health Canada, Health Canada, Ottawa, ON, Canada.
7. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence studies. Part B: Oral Modified Release Formulations 1996, Health Canada, Health Canada, Ottawa, ON, Canada.
8. Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug products: General Considerations 2003, 5. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD.
9. Endrenyi L., Tothfalusi L. Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products?. J Pharm Pharmaceut Sci 2010, 13:107-113.
10. Rouleau B., Lavoie L., Leblanc J., et al. Reporting of adverse drug reactions by community pharmacists: a qualitative study in Quebec. Drug Inf J 2011, 45:627-639.
11. Anschütz M., Wonnemann M., Schug B., et al. Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration. Int J Clin Pharmacol Ther 2010, 48:158-170.
12. Use of partial AUC: case studies and BE approaches US Food and Drug Administration, Accessed February 27, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM209320.pdf.
13. Gonzalez M.A., Pentikis H.S., Anderl N., et al. Methylphenidate bioavailability from two extended-release formulations. Int J Clin Pharmacol Ther 2002, 40:175-184.
14. Haessler F., Tracik F., Dietrich H., et al. A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers. Int J Clin Pharmacol Ther 2008, 46:466-476.
15. Schütz H., Fischer R., Grossmann M., et al. Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers. Int J Clin Pharmacol Ther 2009, 47:761-769.
16. Methylphenidate Extended-Release Tablets [monograph USP32-NF-24] 2003, US Pharmacopeia-National Formulary, Rockville, MD.
17. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system US Food and Drug Administration, Center for Drug Evaluation and Research, Accessed October 26, 2011. http://www.fda.gov/downloads/Drugs/%20GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf.
18. Declaration of Helsinki, 6th rev World Medical Association, Accessed April 13, 2009. http://www%20wma%20net/en/30publications/10policies/b3/17c%20pdf.
19. Background information for the FDA Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. Topic 2: Use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications (ANDAs) for products with complex pharmacokinetic profiles US Food and Drug Administration, Center for Drug Evaluation and Research, Accessed April 13, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM207955.pdf.
20. Summary minutes of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology meeting, April 13, 2010 US Food and Drug Administration, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, Accessed October 26, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM210930.pdf.
21. Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products: general considerations 2003, 8-9. US Food and Drug Administration, Center for Drug Evaluation and Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD.
22. Srinivas N.R., Hubbard J.W., Korchinski E.D., Midha K.K. Enantioselective pharmacokinetics of dl-threo-methylphenidate in humans. Pharm Res 1993, 10:14-21.
23. Kimko H.C., Cross J.T., Abernethy D.R. Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokinet 1999, 37:457-470.
24. 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 Drugs 2003, 5:545-555.
25. Spencer T.J., Biederman J., Ciccone P.E., et al. PET study examining pharmacokinetics, detection and likeability, and dopamine transporter receptor occupancy of short- and long-acting oral methylphenidate. Am J Psychiatry 2006, 163:387-395.
26. Draft Guidance on Zolpidem US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD, Accessed March 6, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175029.pdf.