Novel naproxen/esomeprazole magnesium compound pellets based on acid-independent mechanism: in vitro and in vivo evaluation

References

• Somasundaram S, Hayllar H, Rafi S, et al. Review: the biochemical basis of non-steroidal anti-inflammatory drug-induced damage to the gastrointestinal tract: a review and a hypothesis. Scand J Gastroenterol 1995;30:289–99.
   PubMed Web of Science ®Google Scholar
• Roberts DN, Miner PB. Safety aspects and rational use of a naproxen + esomeprazole combination in the treatment of rheumatoid disease. Drug Healthcare Patient Saf 2011;3:1–8
   PubMedGoogle Scholar
• Wallace JL, McKnight W, Reuter BK, et al. NSAID-induced gastric damage in rats: requirement for inhibition of both cyclooxygenase 1 and 2. Gastroenterology 2000;119:706–14.
   PubMed Web of Science ®Google Scholar
• Warner TD, Giuliano F, Vojnovic I, et al. Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 1999;96:7563–8.
   PubMed Web of Science ®Google Scholar
• Lichtenberger LM. The hydrophobic barrier properties of gastrointestinal mucus. Annu Rev Physiol 1995;57:565–83.
   PubMed Web of Science ®Google Scholar
• Goddard PJ, Hills BA, Lichtenberger LM. Does aspirin damage canine gastric mucosa by reducing its surface hydrophobicity? Am J Physiol-Gastr L 1987;252:G421–30.
   PubMed Web of Science ®Google Scholar
• Somasundaram S, Rafi S, Hayllar J, et al. Mitochondrial damage: a possible mechanism of the topical phase of NSAID induced injury to the rat intestine. phase NSAID injury the intestine. Gut 1997;41:344–53.
   PubMed Web of Science ®Google Scholar
• Hiraishi H, Shimada T, Terano A. Involvement of oxidative stress in the pathogenesis of NSAID-induced gastric mucosal damage. J Gastroenterol 2000;35:567–9.
   PubMed Web of Science ®Google Scholar
• Blandizzi C, Tuccori M, Colucci R, et al. Clinical efficacy of esomeprazole in the prevention and healing of gastrointestinal toxicity associated with NSAIDs in elderly patients. Drugs Aging 2008;25:197–208.
   PubMed Web of Science ®Google Scholar
• Morgner A, Miehlke S, Labenz J. Esomeprazole: prevention and treatment of NSAID-induced symptoms and ulcers. Expert Opin Pharmacother 2007;8:975–88.
   PubMed Web of Science ®Google Scholar
• Miner P, Plachetka J, Orlemans E, et al. Clinical trial: evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxen/esomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: a randomized, open-label, Phase I study in healthy volunteers. Aliment Pharm Ther 2010;32:414–24.
   PubMed Web of Science ®Google Scholar
• Missaghi S, Young C, Fegely K, et al. Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies. Drug Dev Ind Pharm 2010;36:180–9.
   PubMed Web of Science ®Google Scholar
• Wang-Smith L, Fort J, Zhang Y, et al. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol 2012;52:670–80.
   PubMed Web of Science ®Google Scholar
• Colucci R, Fornai M, Antonioli L, et al. Characterization of mechanisms underlying the effects of esomeprazole on the impairment of gastric ulcer healing with addition of NSAID treatment. Dig Liver 2009;41:395–405.
   PubMedGoogle Scholar
• Pastoris O, Verri M, Boschi F, et al. Effects of esomeprazole on glutathione levels and mitochondrial oxidative phosphorylation in the gastric mucosa of rats treated with indomethacin. Naunyn Schmiedebergs Arch Pharmacol 2008;378:421–9.
   PubMed Web of Science ®Google Scholar
• Koch TR, Petro A, Darrabie M, et al. Effect of the H, K-ATPase inhibitor, esomeprazole magnesium, on gut total antioxidant capacity in mice. J Nutr Biochem 2004;15:522–6.
   PubMed Web of Science ®Google Scholar
• Le QL. The effect of esomeprazole on gastric mucosal protection in rats. J China Misdiagn 2007;7:1673–5.
   Google Scholar
• Piao ZZ, Lee MK, Lee BJ. Colonic release and reduced intestinal tissue damage of coated tablets containing naproxen inclusion complex. Int J Pharm 2008;350:205–11.
   PubMed Web of Science ®Google Scholar
• Kan SL, Lu J, Liu JP, et al. Preparation and in vitro/in vivo evaluation of esomeprazole magnesium-modified release pellets. Drug Deliv 2014;0:1–8.
   PubMed Web of Science ®Google Scholar
• Ishibashi T, Pitcairn GR, Yoshino H, et al. Scintigraphic evaluation of a new capsule-type colon specific drug delivery system in healthy volunteers. J Pharm Sci 1998;87:531–5.
   PubMed Web of Science ®Google Scholar
• Fukui E, Miyamura N, Uemura K, et al. Preparation of enteric coated timed-release press-coated tablets and evaluation of their function by in vitro and in vivo tests for colon targeting. Int J Pharm 2000;204:7–15.
   PubMed Web of Science ®Google Scholar
• Kan SL, Lu J, Liu JP, et al. A quality by design (QbD) case study on enteric-coated pellets: screening of critical variables and establishment of design space at laboratory scale. Asian J Pharm Sci 2014;9:268–78.
   Google Scholar
• Jain DK, Jain N, Charde R, et al. The RP-HPLC method for simultaneous estimation of esomeprazole and naproxen in binary combination. Pharm Methods 2011;2:167–72.
   PubMedGoogle Scholar
• Zhang Y, Huo M, Zhou J, et al. PKSolver: an add-in program for pharmacokinetic and pharmacodynamic data analysis in Microsoft Excel. Comput Methods Programs Biomed Prog 2010;99:306–14.
   PubMed Web of Science ®Google Scholar
• Pawar MD, Chopane VS, Khan MM, et al. Formulation development and evaluation of pH and time dependent drug delivery using Gantrez® S-97 and PVP K30. J Pharm Res 2011;4:1603–5.
   Google Scholar
• Qi M, Wang P, Wu D. A novel pH- and time-dependent system for colonic drug delivery. Drug Dev Ind Pharm 2003;29:661–7.
   PubMed Web of Science ®Google Scholar
• Dvořáčková K, Rabišková M, Muselík J, et al. Coated hard capsules as the pH-dependent drug transport systems to ileo-colonic compartment. Drug Dev Ind Pharm 2011;37:1131–40.
   PubMed Web of Science ®Google Scholar
• Mura P, Maestrelli F, Cirri M. Ternary systems of naproxen with hydroxypropyl-beta-cyclodextrin and aminoacids. Int J Pharm 2003;260:293–302.
   PubMed Web of Science ®Google Scholar
• Galmiche JP, Bruley Des Varannes S, Ducrotte P, et al. 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 Pharm2004;19:655–62.
   PubMed Web of Science ®Google Scholar
• Kwiecien S, Brzozowski T, Konturek SJ. Effects of reactive oxygen species action on gastric mucosa in various models of mucosal injury. J Physiol Pharmacol 2002;53:39–50.
   PubMed Web of Science ®Google Scholar
• Nejadkey F, Nahavandi A, Dehpour AR, et al. Role of nitric oxide in the gastro-protective effect of lithium. Pathophysiology 2006;13:85–9.
   PubMedGoogle Scholar
• Gana TJ, Huhlewych R, Koo J. Focal gastric mucosal blood flow in aspirin-induced ulceration. Ann Surg 1987;205:399–403
   PubMed Web of Science ®Google Scholar
• Kitahora T, Guth PH. Effect of aspirin plus hydrochloric acid on the gastric mucosal microcirculation. Gastroenterology 1987;93:810–17.
   PubMed Web of Science ®Google Scholar
• Rodriguez-Stanley S, Redinger N, Miner PB. Effect of naproxen on gastric acid secretion and gastric pH. Aliment Pharmacol Ther Pharm 2006;23:1719–24.
   PubMed Web of Science ®Google Scholar
• Heidelbaugh JJ, Goldberg KL, Inadomi JM. Overutilization of proton pump inhibitors: a review of cost-effectiveness and risk in PPI. Am J Gastroenterol 2009;104:S27–32.
   PubMed Web of Science ®Google Scholar