Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®

BMC Pharmacology and Toxicology

Volumn 14, Issue , 2013, Pages

  Gasser, Urs E ^a   Fischer, Anton ^b   Timmermans, Jan P ^b   Arnet, Isabelle ^c  

^a ClinResearch Ltd   (Switzerland)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c UNIVERSITY OF BASEL   (Switzerland)

Author keywords

Benserazide hydrochloride; Generics; Levodopa; Parkinson's Disease; Pharmaceutical quality

Indexed keywords

BENSERAZIDE; BENSERAZIDE PLUS LEVODOPA; LEVODOPA; BENSERAZIDE, LEVODOPA DRUG COMBINATION; DOPAMINE RECEPTOR STIMULATING AGENT; DRUG COMBINATION; GENERIC DRUG; MICROCAPSULE; TABLET;

ARTICLE; COLOR; DRUG CAPSULE; DRUG QUALITY; DRUG SOLUBILITY; MASS; POWDER; SHELF LIFE; TABLET; CHEMISTRY; CLINICAL PRACTICE; COMPARATIVE STUDY; DRUG COMBINATION; HUMAN; MICROCAPSULE; PARKINSON DISEASE; POSTMARKETING SURVEILLANCE; PROCEDURES; QUALITY CONTROL; STANDARDS; STATISTICS AND NUMERICAL DATA; THERAPEUTIC EQUIVALENCE;

BENSERAZIDE; CAPSULES; COLOR; DOPAMINE AGENTS; DRUG COMBINATIONS; DRUGS, GENERIC; HUMANS; LEVODOPA; PARKINSON DISEASE; PHYSICIAN'S PRACTICE PATTERNS; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 84880600701     PISSN: 20506511     EISSN: None     Source Type: Journal    
DOI: 10.1186/2050-6511-14-24     Document Type: Article

References (25)

1. Schapira AHV, Olanow CE. Principles of treatment in Parkinson's disease 2005, Philadelphia, PA: Elsevier Health Sciences, eds.
2. Fahn S, Sulzer D. Neurodegeneration and neuroprotection in Parkinson disease. NeuroRx 2004, 1:139-154. 10.1602/neurorx.1.1.139, 534919, 15717014.
3. Sulzer D. Multiple hit hypotheses for dopamine neuron loss in Parkinson's disease. Trends Neurosci 2007, 30(5):244-250. 10.1016/j.tins.2007.03.009, 17418429.
4. Yahr MD, Duvoisin RC, Schear MJ, Barrett RE, Hoehn MM. Treatment of Parkinsonism with levodopa. Arch Neurol 1969, 4:343-354.
5. Hauser RA, Zesiewicz TA. Advances in the pharmacologic management of early Parkinson disease. Neurologist 2007, 13(3):126-132. 10.1097/01.nrl.0000256433.15481.eb, 17495756.
6. Jankovic J, Stacy M. Medical management of levodopa-associated motor complications in patients with Parkinson's disease. CNS Drugs 2007, 21(8):677-692. 10.2165/00023210-200721080-00005, 17630819.
7. Esposito E, Cuzzocrea S. New therapeutic strategy for Parkinson's and Alzheimer's disease. Curr Med Chem 2010, 17(25):2764-2774. 10.2174/092986710791859324, 20586718.
8. Contin M, Martinelli P. Pharmacokinetics of levodopa. J Neurol 2010, 257(Suppl 2):S253-S261.
9. Swiss Summary of product characteristics of Madopar®/ Prolopa®. http://www.swissmedicinfo.ch>Madopar.
10. Martindale - the Extra Pharmacopoeia 1993, London: The Pharmaceutical Press, Reynolds JEF, 30.
11. EU/1/98/071/001-006 - Type II Variation EMEA/H/C/00154/II/0045 Widening of dissolution specification Q-value at shelf-life from 75% to 65%. 2007, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf, EU/1/98/071/001-006 - Type II Variation EMEA/H/C/00154/II/0045.
12. Duh MS, Cahill KE, Paradis PE, Cremieux PY, Greenberg PE. The economic implications of generic substitution of antiepileptic drugs: a review of recent evidence. Expert Opin Pharmacother 2009, 10(14):2317e28.
13. Berg MJ, Gross RA, Haskins LS, Zingaro WM, Tomaszewski KJ. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav 2008, 13(4):693e9.
14. Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia 2007, 8(3):464-469.
15. Go C, Rosales RL, Schmidt P, Lyons KE, Pahwa R, Okun MS. A generic versus branded pharmacotherapy in Parkinson's disease: Does it matter? A review. Parkinsonism Relat Disords 2011, 17:308-312.
16. Ferner RE, Lenney W, Marriott JF. Controversy over generic substitution. BMJ 2010, 340:c2548. 10.1136/bmj.c2548, 20516014.
17. Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 2003, 25(6):1578-1592. 10.1016/S0149-2918(03)80157-1, 12860486.
18. National Parkinson Foundation Lessons from the 2011 Sinemet shortage- The National Parkinson Foundation's Helpline speaks. 2012, Available from: http://www.parkinson.org [March 15, 2013] http://www.parkinson.org/NationalParkinsonFoundation/files/ae/aea8377b-cf22-46d0-bdc6-3922290efb60pdf, National Parkinson Foundation.
19. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003, 5(11):2875e90.
20. et al. US Food and Drug Administration Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products - general consideration. [July 18, 2010]. 2010, Available from: http://www.fda.gov/cder/guidance/4964dft.pdf, US Food and Drug Administration.
21. Pahwa R, Marjama J, McGuire D, Lyons K, Zwiebel F, Silverstein P. Pharmacokinetic comparison of Sinemet and Atamet (generic carbidopa/levodopa): a single-dose study. Mov Disord 1996, 11:427-430. 10.1002/mds.870110412, 8813223.
22. Chaná P, Fierro A, Reyes-Parada M, Sáez-Briones P. Pharmacokinetic comparison of Sinemet and Grifoparkin (levodopa/carbidopa 250/25 mg) in Parkinson s disease: a single dose study [Article in Spanish]. Rev Med Chil 2003, 131:623-631.
23. Fernandez N, Garcia JJ, Diez MJ, Sahagun AM, Gonzalez A, Diez R, et al. Effects of slowed gastrointestinal motility on levodopa pharmacokinetics. Auton Neurosci 2010, 156(1-2):67e72.
24. Sims-McCallum RP. Adverse reaction caused by excipients in mercaptopurine tablets. Ann Pharmacother 2007, 41(9):1548.
25. Hebron BS, Hebron HJ. Aspirin sensitivity: acetylsalicylate or excipients. Intern Med 2009, 39(8):546-549.