In vitro bioequivalence approach for a locally acting gastrointestinal drug: Lanthanum carbonate

Molecular Pharmaceutics

Volumn 10, Issue 2, 2013, Pages 544-550

  Yang, Yongsheng ^a   Shah, Rakhi B ^a   Yu, Lawrence X ^a   Khan, Mansoor A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

bioavailability; bioequivalence; dissolution; lanthanum carbonate; locally acting GI drugs; phosphate binding

Indexed keywords

LANTHANUM CARBONATE; PLACEBO;

AREA UNDER THE CURVE; ARTICLE; BINDING AFFINITY; BIOEQUIVALENCE; CLINICAL TRIAL (TOPIC); DRUG BINDING; DRUG SOLUBILITY; IN VITRO STUDY; MAXIMUM PLASMA CONCENTRATION; PH; PRIORITY JOURNAL; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TABLET HARDNESS;

GASTROINTESTINAL AGENTS; HUMANS; KINETICS; LANTHANUM; THERAPEUTIC EQUIVALENCY;

EID: 84873386688     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/mp300517p     Document Type: Article

References (24)

1. Chen, M. L.; Shah, V.; Patnaik, R.; Adams, W.; Hussain, A.; Conner, D.; Mehta, M.; Malinowski, H.; Lazor, J.; Huang, S. M.; Hare, D.; Lesko, L.; Sporn, D.; Williams, R. Bioavailability and bioequivalence: an FDA regulatory overview Pharm. Res. 2001, 18, 1645-1650 (Pubitemid 34020417)
2. 21CFR 320.1. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c= ecfr&sid=a2c8242fba4332eaa1b90947931245a3&rgn=div5&view= text&node=21:5.0.1.1.7&idno=21#21:5.0.1.1.7.1.1.1H (accessed January 16, 2012).
3. 21CFR 320.24. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c= ecfr&sid=d9163a7669065f57fd10dc270a4af519&rgn=div8&view= text&node=21:5.0.1.1.7.2.1.4&idno=21 (accessed January 16, 2012).
4. Lionberger, R. A. FDA critical path initiatives: opportunities for generic drug development AAPS J. 2008, 10, 103-109
5. Committee for Proprietary Medicinal Products: Note for guidance on the investigation of bioavailability and bioequivalence. http://www.ema.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003519.pdf (accessed March 16, 2012)
6. FDA Draft Guidance on Lanthanum Carbonate. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM270541.pdf (accessed May 8, 2011).
7. FDA Draft Guidance on Sevelamer Carbonate. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm089620.pdf (accessed April 8, 2012).
8. FDA Draft Guidance on Cholestyramine. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM273910.pdf (accessed April 8, 2012).
9. FDA Draft Guidance on Colesevelam Hydrochloride. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm083337.pdf (accessed April 8, 2012).
10. Haidar, S. H.; Davit, B.; Chen, M. L.; Conner, D.; Lee, L.; Li, Q. H.; Lionberger, R.; Makhlouf, F.; Patel, D.; Schuirmann, D. J.; Yu, L. X. Bioequivalence approaches for highly variable drugs and drug products Pharm. Res. 2008, 25, 237-241
11. Holford, N. H.; Sheiner, L. B. Understanding of the dose response relationship: clinical application of pharmacokinetic pharmacodynamic models Clin. Pharmacokinet. 1981, 6, 429-453 (Pubitemid 12213270)
12. Gillespia, W. R. Bioaquivalance assessment based on pharmacodynamic response-bioequivalence on the dose scale: rationale, theory and methods. Presentation to a joint session of the Advisory Committee for Pharmaceutical Science and Pulmonary-Allergy Drugs Advisory Comittee, Gaithersburg, Maryland, October 16, 1996, Transcript, pp 40-52.
13. FDA Guidance for Industry. E 10 Choice of Control Group and Related Issues in Clinical Trials. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM073139.pdf (accessed April 12, 2012).
14. Polli, J. E. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalenc eof immediate-release solid oral dosage forms AAPS J. 2008, 10, 289-299
15. FDA Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf (accessed April 12, 2012)
16. Behets, G. J.; Verberckmoes, S. C.; Haese, P. C.; De Broe, M. E. Lanthanum carbonate: a new phosphate binder Curr. Opin. Nephrol. Hypertens. 2004, 13, 403-409 (Pubitemid 38901619)
17. Pai, A. B.; Conner, T. A.; McQuade, C. R. Therapeutic use of the phosphate binder lanthanum carbonate Expert Opin. Drug Metab. 2009, 5, 71-81
18. Pennick, M.; Dennis, K.; Damment, S. J. Absolute bioavailability and disposition of lanthanum in healthy human subjects administered lanthanum carbonate J. Clin. Pharmacokinet. 2006, 46, 738-746 (Pubitemid 43882797)
19. Damment, S. J.; Pennick, M. Clinical Pharmacokinetics of the Phosphate Binder Lanthanum Carbonate J. Clin. Pharmacokinet. 2008, 47, 553-563
20. Product monograph: Fosrenol (Lanthanum carbonate hydrate) February 2010. http://www.shirecanada.com/en/shire-canada/Fosrenol-M-100203-En.pdf (accessed March 8, 2011).
21. Samy, R.; Faustino, P. J.; Adams, W.; Yu, L. X.; Khan, M. A.; Yang, Y. Development and validation of an ion chromatography method for the determination of phosphate-binding of lanthanum carbonate J. Pharm. Biomed. Anal. 2010, 51, 1108-1112
22. Autissier, V.; Dammen, S. J.; Henderson, R. A. Relative in vitro efficacy of the phosphate binders lanthanum carbonate and sevelamer hydrochloride J. Pharm. Sci. 2007, 96, 2818-2287
23. Sheikh, M. S.; Maguire, J. A.; Emmett, M.; Santa Ana, C. A.; Nicar, M. J.; Schiller, L. R.; Fordtran, J. S. Reduction of dietary phosphorus absorption by phosphorus binders. A theoretical, in vitro, and in vivo study J. Clin. Invest. 1989, 83, 66-73 (Pubitemid 19048406)
24. Gessner, P. K.; Hasan, M. M. Freundlich and Langmuir isotherms as models for the adsorption of toxicants on activated charcoal J. Pharm. Sci. 1987, 76, 319-327 (Pubitemid 17118163)