Investigation on the possibility of biowaivers for ibuprofen

Journal of Pharmaceutical Sciences

Volumn 100, Issue 6, 2011, Pages 2343-2349

  Álvarez, Covadonga ^a   Núñez, Ignacio ^a,b   Torrado, Juan J ^a   Gordon, John ^c   Potthast, Henrike ^d   García Arieta, Alfredo ^b  

^a UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^b Division de Farmacologia y Evaluacion Clinica   (Spain)

^c HEALTH CANADA   (Canada)

^d FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES   (Germany)

Author keywords

Absorption; Bioequivalence; Biopharmaceutics classification system (BCS); Dissolution; Permeability; Regulatory science; Solubility

Indexed keywords

IBUPROFEN;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG SOLUBILITY; HUMAN; HUMAN EXPERIMENT; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PH; PHASE 1 CLINICAL TRIAL; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

EID: 79954554225     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22472     Document Type: Article

References (34)

1. Amidon GL, Lennernas H, Shah VP, Crison JR. 1995. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413-420.
2. U.S. Department of Health and Human Services, FDA, CDER, 2000. Guidance for industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System.
3. Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen ML, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VH, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G. 2004. Summary workshop report: Biopharmaceutics classification system - Implementation challenges and extension opportunities. J Pharm Sci 93:1375-1381.
4. Polli JE, Abrahamsson BS, Yu LX, Amidon GL, Baldoni JM, Cook JA, Fackler P, Hartauer K, Johnston G, Krill SL, Lipper RA, Malick WA, Shah VP, Sun D, Winkle HN, Wu Y, Zhang H. 2008. Summary workshop report: Bioequivalence, Biopharmaceutics Classification System, and beyond. AAPS J 10:373-379.
5. Blume HH, Schug BS. 1999. The Biopharmaceutics Classification System (BCS): Class III drugs - Better candidates for BA/BE waiver? Eur J Pharm Sci 9:117-121.
6. Kortejarvi H, Yliperttula M, Dressman JB, Junginger HE, Midha KK, Shah VP, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms: Ranitidine hydrochloride. J Pharm Sci 94:1617-1625.
7. Jantratid E, Prakongpan S, Amidon GL, Dressman JB. 2006. Feasibility of biowaiver extension to Biopharmaceutics Classification System class III drug products: Cimetidine. Clin Pharmacokinet 45:385-399.
8. Committee for Medicinal Products for Human Use (CHMP) 2010. Guideline on the investigation of bioequivalence. London: European Medicines Agency (EMA).
9. Rinaki E, Dokoumetzidis A, Valsami G, Macheras P. 2004. Identification of biowaivers among Class II drugs: Theoretical justification and practical examples. Pharm Res 21:1567-1572.
10. Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, Vogelpoel H, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms: Ibuprofen. J Pharm Sci 94:2121-2131.
11. Lindenberg M, Kopp S, Dressman JB. 2004. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the Biopharmaceutics Classification System. Eur J Pharm Biopharm 58:265-278.
12. World Health Organization. 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. In WHO Technical Report Series 937 ed. Geneva: WHO Press, pp 347-390.
13. Yazdanian M, Briggs K, Jankovsky C, Hawi A. 2004. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharm Res 21:293-299.
14. The United States Pharmacopeia - National Formulary. 2000. Dissolution. USP24 NF19 ed., Rockville, Maryland 2085: The United States Pharmacopeail Covention, Inc., pp 1941-1943.
15. European Pharmacopoeia. 2009. Dissolution test for solid dosage forms. 2010, Supplement 6.6 ed. Strasbourg, France: European Directorate for the Quality of Medicines & Healthcare of the Council of Europe, pp 5091-5100.
16. European Pharmacopoeia. 2001. Buffer solutions. Strasbourg, France: European Directorate for the Quality of Medicines & Healthcare of the Council of Europe, pp 389-393.
17. The United States Pharmacopeia - National Formulary. 2000. Buffer solutions. USP24 NF19 ed., Rockville Maryland 2085: The United States Pharmacopeail Convention, Inc., pp 2231-2232.
18. The United States Pharmacopeia - National Formulary. 2000. Ibuprofen tablets. USP24 NF19 ed. Rockville Maryland 2085: The United States Pharmacopeial Convention, Inc., pp 856-857.
19. European Pharmacopoeia. 2001. Absorption spectrophotometry, ultraviolet and visible. 2002, 4th ed. Strasbourg, France: European Directorate for the Quality of Medicines & Healthcare of the Council of Europ, pp 36-37.
20. max/AUC is an effective metric in investigations of bioequivalence. Pharm Res 12:937-942.
21. Chow SC, Liu JP. 2000. Design and analysis of bioavailability and bioequivalence studies, 2nd ed. New York: Marcel Dekker, Inc.
22. Moore JW, Flanner HH. 1996. Mathematical comparison of dissolution profiles. Pharm Tech 20:64-74.
23. Lobenberg R, Kramer J, Shah VP, Amidon GL, Dressman JB. 2000. Dissolution testing as a prognostic tool for oral drug absorption: Dissolution behavior of glibenclamide. Pharm Res 17:439-444.
24. Committee for Proprietary Medicinal Products. 2001. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. London: EMEA
25. Barends DM. 2007. BCS/BE in the Netherlands and Europe. AAPS Workshop on BE, BCS and Beyond. North Bethesda, Maryland.
26. Schleier P, Prochnau A, Schmidt-Westhausen AM, Peters H, Becker J, Latz T, Jackowski J, Peters EU, Romanos GE, Zahn B, Ludemann J, Maares J, Petersen B. 2007. Ibuprofen sodium dihydrate, an ibuprofen formulation with improved absorption characteristics, provides faster and greater pain relief than ibuprofen acid. Int J Clin Pharmacol Ther 45:89-97.
27. Dewland PM, Reader S, Berry P. 2009. Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen, or ibuprofen acid incorporating poloxamer in healthy volunteers. BMC Clin Pharmacol 9:19-28.
28. Ceppi Monti N, Gazzaniga A, Gianesello V, Stroppolo F, Lodola E. 1992. Activity and pharmacokinetics of a new oral dosage form of soluble ibuprofen. Arzneimittelforschung 42:556-559.
29. Fornasini G, Monti N, Brogin G, Gallina M, Eandi M, Persiani S, Bani M, Della PC, Zara G, Strolin BM. 1997. Preliminary pharmacokinetic study of ibuprofen enantiomers after administration of a new oral formulation (ibuprofen arginine) to healthy male volunteers. Chirality 9:297-302.
30. Desjardins P, Black P, Papageorge M, Norwood T, Shen DD, Norris L, Ardia A. 2002. Ibuprofen arginate provides effective relief from postoperative dental pain with a more rapid onset of action than ibuprofen. Eur J Clin Pharmacol 58:387-394.
31. Black P, Max MB, Desjardins P, Norwood T, Ardia A, Pallotta T. 2002. A randomized, double-blind, placebo-controlled comparison of the analgesic efficacy, onset of action, and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain. Clin Ther 24:1072-1089.
32. Mehlisch DR, Ardia A, Pallotta T. 2002. A controlled comparative study of ibuprofen arginate versus conventional ibuprofen in the treatment of postoperative dental pain. J Clin Pharmacol 42:904-911.
33. Geisslinger G, Dietzel K, Bezler H, Nuernberg B, Brune K. 1989. Therapeutically relevant differences in the pharmacokinetical and pharmaceutical behaviour of ibuprofen lysinate as compared to ibuprofen acid. Int J Clin Pharmacol Ther Toxicol 27:324-328.
34. Cox SR, Brown MA, Squires DJ, Murrill EA, Lednicer D, Knuth DW. 1988. Comparative human study of ibuprofen enantiomer plasma concentrations produced by two commercially available ibuprofen tablets. Biopharm Drug Dispos 9:539-549.