Are generic formulations of carvedilol of inferior pharmaceutical quality compared with the branded formulation?

Current Medical Research and Opinion

Volumn 22, Issue 4, 2006, Pages 709-720

  Smith, Julian C ^a   Tarocco, Giorgio ^b   Merazzi, Fabio ^b   Salzmann, Urs ^c  

^a ASTON UNIVERSITY   (United Kingdom)

^b ROCHE MILANO RICERCHE   (Italy)

^c F Hoffmann La Roche   (Switzerland)

Author keywords

Carvedilol; Content; Dissolution; Generics; Purity; Quality; Tablet hardness

Indexed keywords

CARVEDILOL; GENERIC DRUG; TALLITON;

ARTICLE; DRUG FORMULATION; DRUG PURITY; DRUG QUALITY; DRUG SOLUBILITY; EUROPE; TABLET; TABLET HARDNESS;

ADRENERGIC ALPHA-ANTAGONISTS; ADRENERGIC BETA-ANTAGONISTS; CARBAZOLES; DOSAGE FORMS; DRUGS, GENERIC; EUROPE; HUMANS; PROPANOLAMINES; QUALITY CONTROL; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 33646228621     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X96461     Document Type: Article

References (17)

1. Gehr TW, Tenero DM, Boyle DA, et al. The pharmacokinetics of carvedilol and its metabolites after single and multiple dose oral administration in patients with hypertension and renal insufficiency. Eur J Clin Pharmacol 1999;55:269-77
2. McTavish D, Campoli-Richards D, Sorkin EM. Carvedilol: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1993;45:232-58
3. Packer M, Antonopoulos GV, Berlin JA, et al. Comparative effects of carvedilol and metoprolol on left ventricular ejection fraction in heart failure: results of a meta-analysis. Am Heart J 2001;141:899-907
4. Stoschitzky K, Koshucharova G, Zweiker R, et al. Differing beta-blocking effects of carvedilol and metoprolol. Eur J Heart Fail 2001;3:343-9
5. Morgan T. Clinical pharmacokinetics and pharmacodynamics of carvedilol. Clin Pharmacokinet 1994;26:335-46
6. Carlson W, Oberg K. Clinical pharmacology of carvedilol. J Cardiovasc Pharmacol Ther 1999;4:205-18
7. von Mollendorff E, Reiff K, Neugebauer G. Pharmacokinetics and bioavailability of carvedilol, a vasodilating beta-blocker. Eur J Clin Pharmacol 1987;33:511-3
8. Oldham HG, Clarke SE. In vitro identification of the human cytochrome P450 enzymes involved in the metabolism of R(+) and S(-)-carvedilol. Drug Metab Dispos 1997;25:970-7
9. Keating GM, Jarvis B. Carvedilol: a review of its use in chronic heart failure. Drugs 2003;63:1697-741
10. Poole-Wilson PA, Swedberg K, Cleland JG, et al. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet 2003;362:7-13
11. Taylor RB, Shakoor O, Behrens RH, et al. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 2001;357:1933-6
12. European Directorate for the Quality of Medicines. European pharmacopoeia, 5th ed. Strasbourg: 2005 [ISBN 9287152810]
13. Therapeutic Goods Administration, 2003. Note for guidance on the investigation of bioavailability and bioequivalence. Available from www.tga.gov.au/docs/pdf/euguide/ewp/140198entga.pdf/ [last accessed: 11 Dec 2005]
14. Barone JA. Comparative potency and dissolution performance of internationally available piroxicam products. Pharmacoeconomics 1992;1(Suppl. 1):49-52
15. Cuenca E, Zaragoza F. Generic drugs in psychopharmacology: pros and cons. Actas Esp Psiquiatr 1999;27:351-7
16. Hoag SW, Ramachandruni H, Shangraw RF. Failure of prescription prenatal vitamins products to meet USP standards for folic acid dissolution. J Am Pharm Assoc (Wash) 1997;NS37(4):397-400
17. Lambert PA, Conway BR. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin. J Chemother 2003;15:357-68