Gemifloxacin mesylate (GFM): dissolution test based on in vivo data

References

• Blondeau J, Tillotson G. Gemifloxacin for the management of community-acquired respiratory tract infections. Antibiotiques 2007;9:173–80
   Google Scholar
• FDA. Food and Drug Administration. 2008. Prescribing Information. Available from: http://www.acessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf [last accessed 9 May 2011]
   Google Scholar
• Grossman R, Rotschafer J, Tan J. Antimicrobial treatment of lower respiratory tract infections in the hospital setting. Am J Med 2005;118:29S–38S
   PubMed Web of Science ®Google Scholar
• Johnson DM, Jones RN, Erwin ME. The quality control study group. Anti-streptococcal activity of SB-265805 (LB20304), a novel fluoronaphthyidone, compared with five other compounds, including quality control guidelines. Diagn Microbiol Infect Dis 1999;33:87–91
   PubMed Web of Science ®Google Scholar
• Krishna MV, Sankar DG. Utility of α and π-Acceptors for the spectrophotometric determination of gemifloxacin mesylate in pharmaceutical formulations. E J Chem 2008;5:493–8
   Web of Science ®Google Scholar
• Krishna MV, Sankar DG. Spectrophotometric determination of gemifloxacin mesylate in pharmaceutical formulations through ion-pair complex formation. E J Chem 2008;5:515–20
   Web of Science ®Google Scholar
• Paim CS, Führ F, Miron DS, et al. Stability-indicating LC assay and determination of system suitability limits with a robustness test of gemifloxacin mesylate in tablets. Curr Anal Chem 2010;6:269–76
   Web of Science ®Google Scholar
• Ranjane PN, Gandhi SV, Kadukar SS, Bothara KG. Stability indicating RP-LC method for the determination of gemifloxacin mesylate. Chromatographia 2010;71:1113–17
   Web of Science ®Google Scholar
• Tavares VF, Patto DCS, Singh AK, et al. Quantitative determination of gemifloxacin mesylate in tablets by capillary zone electrophoresis and high performance liquid chromatography. Lat Am J Pharm 2011;30:746–52
   Web of Science ®Google Scholar
• Paim CS, Führ F, Barth AB, et al. Gemifloxacin mesylate (GFM) stability evaluation applying a validated bioassay method and in vitro cytotoxic study. Talanta 2011;83:1774–9
   PubMed Web of Science ®Google Scholar
• FDA. Food and Drug Administration. Dissolution methods. 2011. Available from: http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults_Dissolutions.cfm [last accessed 19 April 2011]
   Google Scholar
• USP 34. The United States Pharmacopoeia. 34th ed. Rockville (MD): United States Pharmacopoeia Convention; 2011
   Google Scholar
• Al-Hadiya BMH, Khady AA, Mostafa GAE. Validated liquid chromatographic-fluorescence method for the quantitation of gemifloxacin in human plasma. Talanta 2010;83:110–16
   PubMed Web of Science ®Google Scholar
• Landersdorfer CB, Kirkpatrick CMJ, Kinzig M, et al. Competitive inhibition of renal tubular secretion of gemifloxacin by probenecid. Antimicrob Agents Chemother 2009;53:3902–7
   PubMed Web of Science ®Google Scholar
• Berrozpe JD, Lanao JM, Delfina JMP. Biofarmacia y Farmacocinética. Madrid: Editorial Sintesis; 1997
   Google Scholar
• Cardot J-M, Beyssac E. In vitro/in vivo correlations. In: Swarbrick J, Boylan JC, eds. Encyclopedia of pharmaceutical technology. 3rd ed. Vol. 1. New York: Informa Healthcare; 2006:1062–72
   Google Scholar
• Shargel L, Yu ABC. Applied biopharmaceutical and pharmacokinetics. 5th ed. New York: Appleton & Lange; 2005
   Google Scholar
• Schliecker G, Schmidt C, Fuchs S, et al. In vitro and in vivo correlation of buserelin release from biodegradable implants using statistical moment analysis. J Control Release 2004;94:25–37
   PubMed Web of Science ®Google Scholar
• FDA. Food and Drug Administration. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro–in vivo correlations. Rockville (MD): Food and Drug Administration; 1997
   Google Scholar
• FDA. Food and Drug Administration. Guidance for industry. Dissolution testing of immediate release solid oral dosage forms. Rockville (MD): US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research; 1997
   Google Scholar
• Space JS, Opio AM, Nickerson B, et al. Validation of a dissolution method with HPLC analysis for lasofoxifene tartrare low dose tablets. J Pharm Biomed Anal 2007;44:1064–71
   PubMed Web of Science ®Google Scholar
• Tzanavaras PD, Verdoukas A, Balloma T. Optimization and validation of a dissolution test for famotidine tablets using flow injection analysis. J Pharm Biomed Anal 2006;41:437–41
   PubMed Web of Science ®Google Scholar
• Singhvi G, Shah A, Yadav N, Saha R. Prediction of in vivo plasma concentration–time profile from in vitro release data of designed formulations of milnacipran using numerical convolution method. Drug Dev Ind Pharm [Online] 2013. Oct 28. Available from: http://informahealthcare.com/doi/full/10.3109/03639045.2013.850706?prevSearch=allfield%253A%2528correlation%2529&searchHistoryKey [last acessed 10 Jan 2014]
   Google Scholar
• Yaro P, He X, Liu W, et al. In vitro–in vivo correlations for three different commercial immediate-release indapamide tablets. Drug Dev Ind Pharm [Online] 2013 Oct 8. Available from: http://informahealthcare.com/doi/full/10.3109/03639045.2013.842577?prevSearch=allfield%253A%2528correlation%2529&searchHistoryKey [last acessed 10 Jan 2014]
   Google Scholar
• Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413–20
   PubMed Web of Science ®Google Scholar
• Dressman JB, Reppas C. In vitro–in vivo correlations for lipophilic, poorly water-soluble drugs. Eur J Pharm Sci 2000;11:S73–80
   PubMed Web of Science ®Google Scholar
• Apparaju SK, Nallani SC. Pharmacokinetics: basics of drug absorption from a biopharmaceutical perspective. In: Chilukuri D, Sunkara G, Young D, eds. Pharmaceutical product development: in vitro–in vivo correlation. New York: Informa Healthcare USA Inc., Churchill Livingstone; 2007:71–105
   Google Scholar
• Takka S, Sakr A, Goldberg A. Development and validation of an in vitro–in vivo correlation for buspirone hydrochloride extended release tablets. J Control Release 2003;88:147–57
   PubMed Web of Science ®Google Scholar
• Shabir G. Validation of high-performance liquid chromatography methods for pharmaceutical analysis. J Chromatogr A 2003;987:57–66
   PubMed Web of Science ®Google Scholar