Preparation and in vitro/in vivo evaluation of esomeprazole magnesium-modified release pellets

References

• Alhnan MA, Basit AW. (2011). Engineering polymer blend microparticles: an investigation into the influence of polymer blend distribution and interaction. Eur J Pharm Sci 42:30–6
   PubMed Web of Science ®Google Scholar
• Amighi K, Moes A. (1995). Evaluation of thermal and film forming properties of acrylic aqueous polymer dispersion blends: application to the formulation of sustained-release film coated theophylline pellets. Drug Dev Ind Pharm 21: 2355–69
   Web of Science ®Google Scholar
• Andersson T, Hassan-Alin M, Hasselgren G, et al. (2001). Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole. Clin Pharmacokinet 40:411–26
   PubMed Web of Science ®Google Scholar
• Bhattacharjya S, Wurster DE. (2008). Investigation of the drug release and surface morphological properties of film-coated pellets, and physical, thermal and mechanical properties of free films as a function of various curing conditions. AAPS PharmSciTech 9:449–57
   PubMed Web of Science ®Google Scholar
• Biswas BK, Islam MS, Begum F, et al. (2008). In vitro release kinetic study of esomeprazole magnesium from methocel K15M and methocel K100 LVCR matrix tablets. Dhaka Univ J Pharm Sci 7:39–45
   Google Scholar
• Blandizzi C, Tuccori M, Colucci R, et al. (2008). Clinical efficacy of esomeprazole in the prevention and healing of gastrointestinal toxicity associated with NSAIDs in elderly patients. Drugs Aging 25:197–208
   PubMed Web of Science ®Google Scholar
• Chan FK, Ching JY, Hung LC, et al. (2005). Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med 352: 238–44
   PubMed Web of Science ®Google Scholar
• Colucci R, Fornai M, Antonioli L, et al. (2009). Characterization of mechanisms underlying the effects of esomeprazole on the impairment of gastric ulcer healing with addition of NSAID treatment. Digest Liver Dis 41:395–405
   Web of Science ®Google Scholar
• Food and Drug Administration. (1997). Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. : Food and Drug Administration
   Google Scholar
• Galmiche J, Bruley Des Varannes S, Ducrotte P, et al. (2004). Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther 19:655–62
   PubMed Web of Science ®Google Scholar
• Gaynor C, Dunne A, Davis J. (2008). A comparison of the prediction accuracy of two IVIVC modelling techniques. J Pharm Sci 97:3422–32
   PubMed Web of Science ®Google Scholar
• Goldstein J, Hochberg M, Fort J, et al. (2010). Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 32: 401–13
   PubMed Web of Science ®Google Scholar
• Graham D, Abudayyeh S, El-Zimaity H, et al. (2006). Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther 24:845–50
   PubMed Web of Science ®Google Scholar
• Guthmann C, Lipp R, Wagner T, et al. (2007). Development of a Multiple Unit Pellet Formulation for a Weakly Basic Drug. Drug Dev Ind Pharm 33:341–9
   PubMed Web of Science ®Google Scholar
• Heckötter UM, Larsson A, Sriamornsak P, et al. (2011). Effect of annealing time and addition of lactose on release of a model substance from Eudragit® RS coated pellets produced by a fluidized bed coater. Chem Eng Res Des 89:697–705
   Web of Science ®Google Scholar
• Jambhekar SS, Breen PJ, Rojanasakul Y. (1987). Influence of formulation and other factors on the release of chlorpheniramine mateate from polymer coated beads. Drug Dev Int Pharm 13:2789–810
   Web of Science ®Google Scholar
• Joshi M. (2013). Role of Eudragit in targeted drug delivery. Int J Curr Pharm Res 5:58–62
   Google Scholar
• Kabir AKL, Jesmeen T, Talukder MMU, et al. (2009). In vitro release kinetics study of different brands of esomeprazole sustained release tablets available in Bangladesh. S J Pharm Sci 2:27–31
   Google Scholar
• Karim S, Baie SH, Hay YK, et al. (2013). Stability study of paracetamol and omeprazole pellets formulated through sieving-spheronisation. Lat Am J Pharm 32:431–6
   Web of Science ®Google Scholar
• Kim MS, Kim JS, You YH, et al. (2007). Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology. Int J Pharm 341:97–104
   PubMed Web of Science ®Google Scholar
• Lecomte F, Siepmann J, Walther M, et al. (2003). Blends of enteric and GIT-insoluble polymers used for film coating: physicochemical characterization and drug release patterns. J Control Release 89:457–71
   PubMed Web of Science ®Google Scholar
• Madden FN, Godfrey KR, Chappell MJ, et al. (1996). A comparison of six deconvolution techniques. J Pharmacokinet Biophys 24:283–99
   PubMedGoogle Scholar
• Miehlke S, Schneider-Brachert W, Bästlein E, et al. (2003). Esomeprazole-based one-week triple therapy with clarithromycin and metronidazole is effective in eradicating Helicobacter pylori in the absence of antimicrobial resistance. Aliment Pharmacol Ther 18:799–804
   PubMed Web of Science ®Google Scholar
• Muschert S, Siepmann F, Leclercq B, et al. (2009). Prediction of drug release from ethylcellulose coated pellets. J Control Release 135:71–9
   PubMed Web of Science ®Google Scholar
• Nollenberger K, Albers J. (2013). Poly (meth) acrylate-based coatings. Int J Pharm 457:461–9
   PubMed Web of Science ®Google Scholar
• Pastoris O, Verri M, Boschi F, et al. (2008). Effects of esomeprazole on glutathione levels and mitochondrial oxidative phosphorylation in the gastric mucosa of rats treated with indomethacin. Naunyn-Schmiedeberg's Arch Pharmacol 378:421–9
   Google Scholar
• Qiao M, Luo Y, Zhang L, et al. (2010). Sustained release coating of tablets with Eudragit® RS/RL using a novel electrostatic dry powder coating process. Int J Pharm 399:37–43
   PubMed Web of Science ®Google Scholar
• Samir AlKhatib H, Sakr A. (2003). Optimization of methacrylic acid ester copolymers blends as controlled release coatings using response surface methodology. Pharm Dev Technol 8:87–96
   PubMed Web of Science ®Google Scholar
• Schultz P, Kleinebudde P. (1997). A new multiparticulate delayed release system: part I: dissolution properties and release mechanism. J Control Release 47:181–9
   Web of Science ®Google Scholar
• Sean CS, Paul B. (2002). Martindale: the complete drug reference. : Pharmaceutical Press, 219–599
   Google Scholar
• Timmermans J, Amighi K, Puigdevall J, et al. (1998). Peroral sustained-release film-coated pellets as a means to overcome physicochemical and biological drug-related problems. II. Bioavailability and tolerance assessment in dogs. Drug Dev Ind Pharm 24:517–25
   PubMed Web of Science ®Google Scholar
• Wesseling M, Kuppler F, Bodmeier R. (1999). Tackiness of acrylic and cellulosic polymer films used in the coating of solid dosage forms. Eur J Pharm Biopharm 47:73–8
   PubMed Web of Science ®Google Scholar
• Zhang Y, Huo MR, Zhou JP, et al. (2010). PKSolver: an add-in program for pharmacokinetic and pharmacodynamic data analysis in Microsoft Excel. Comput Methods Programs Biomed 99:306–14
   PubMed Web of Science ®Google Scholar