Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations

Current Medical Research and Opinion

Volumn 29, Issue 12, 2013, Pages 1657-1662

  Elshoff, Jan Peer ^a   Timmermann, Lars ^b   Schmid, Miriam ^a   Arth, Christoph ^a   Komenda, Michael ^a   Brunnert, Marcus ^a   Bauer, Lars ^a  

^a UCB PHARMA   (Belgium)

^b UNIVERSITY OF COLOGNE   (Germany)

Author keywords

Adhesion; Bioequivalence; Dopamine receptor agonist; Rotigotine; Transdermal

Indexed keywords

ROTIGOTINE;

ADHESION; APPLICATION SITE REACTION; ARTICLE; BIOEQUIVALENCE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG SAFETY; DRUG STABILITY; DRUG TOLERABILITY; FATIGUE; HEADACHE; HUMAN; HYPERHIDROSIS; MAXIMUM PLASMA CONCENTRATION; NAUSEA; PARKINSON DISEASE; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL (TOPIC); ROOM TEMPERATURE; SCORING SYSTEM; SOMNOLENCE; THERMOSTABILITY; TRANSDERMAL PATCH; TRANSDERMAL PATCH ADHESIVENESS;

ADULT; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DOPAMINE AGONISTS; DOUBLE-BLIND METHOD; HUMANS; MALE; PARKINSON DISEASE; RESTLESS LEGS SYNDROME; TETRAHYDRONAPHTHALENES; THIOPHENES; TRANSDERMAL PATCH;

EID: 84888611828     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2013.841666     Document Type: Article

References (21)

1. Scheller D, Ullmer C, Berkels R, et al. The in vitro receptor profile of rotigotine: a new agent for the treatment of Parkinson's disease. Naunyn Schmiedebergs Arch Pharmacol 2009;379:73-86
2. European Medicines Agency. Neupro: EPAR-Product Information. 2012. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/000626/WC500026397.pdf [Last accessed April 2013]
3. US Prescribing Information. Neupro. 2012. Available at: http://www.ucb.com/-up/ucb-com-products/documents/Neupro%20COL%2004-2012.pdf [Last accessed April 2013]
4. Chaudhuri KR. Crystallisation within transdermal rotigotine patch: is there cause for concern? Expert Opin Drug Deliv 2008;5:1169-71
5. Braun M, Cawello W, Boekens H, et al. Influence of domperidone on pharma-cokinetics, safety and tolerability of the dopamine agonist rotigotine. Br J Clin Pharmacol 2009;67:209-15
6. Cawello W, Braun M, Boekens H. Absorption, disposition, metabolic fate, and elimination of the dopamine agonist rotigotine in man: administration by intravenous infusion or transdermal delivery. Drug Metab Dispos 2009;37: 2055-60
7. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: Skin irritation and sensitization testing of generic transdermal drug products. 1999. Available at: http://www.fda.gov/ohrms/dockets/ 98fr/990236Gd.pdf [Last accessed April 2013]
8. Lehmann EL, D'Abrera HJM. Nonparametrics: Statistical methods based on ranks. New York: Springer, 2006
9. Malik M, Andreas JO, Hnatkova K, et al. Thorough QT/QTc study in patients with advanced Parkinson's disease: cardiac safety of rotigotine. Clin Pharmacol Ther 2008;84:595-603
10. Elshoff JP, Braun M, Andreas JO, et al. Steady-state plasma concentration profile of transdermal rotigotine: an integrated analysis of three, open-label, randomized, phase I multiple dose studies. Clin Ther 2012;34:966-78
11. Whitesides J, Cawello W, Woltering F, et al. Stable plasma levels of rotigotine following transdermal patch removal and new patch application during long-term treatment of patients with advanced Parkinson's disease. Mov Disord 2011;26(S2):S288
12. Whitesides J, Cawello W, Braun M, et al. Stability of rotigotine plasma levels during long-term transdermal application for patients with idiopathic restless legs syndrome. Mov Disord 2011;26(S2):S365 [Abstract]
13. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the investigation of bioequivalence. 2010.
14. Available at: http://www.emea.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/01/WC500070039.pdf [Last accessed April 2013]
15. Davis KL, Edin HM, Allen JK. Prevalence and cost of medication nonadher-ence in Parkinson's disease: evidence from administrative claims data. Mov Disord 2010;25:474-80
16. Grosset KA, Bone I, Grosset DG. Suboptimal medication adherence in Parkinson's disease. Mov Disord 2005;20:1502-7 (Pubitemid 43072661)
17. Grosset KA, Reid JL, Grosset DG. Medicine-taking behavior: implications of suboptimal compliance in Parkinson's disease. Mov Disord 2005;20: 1397-404 (Pubitemid 43072646)
18. Leopold NA, Polansky M, Hurka MR. Drug adherence in Parkinson's disease. Mov Disord 2004;19:513-17
19. Grosset D. Therapy adherence issues in Parkinson's disease. J Neurol Sci 2010;289:115-18
20. Grosset D, Grosset K, Emmerman A, et al. Improved selfreported compliance with transdermal (patch) versus oral medication in Parkinson's disease patients. Eur J Neurol 2006;13(Suppl 2):P1175 [abstract]
21. Schnitzler A, Leffers KW, Hack HJ. High compliance with rotigotine transder-mal patch in the treatment of idiopathic Parkinson's disease. Parkinsonism Relat Disord 2010;16:513-16