Floating modular drug delivery systems with buoyancy independent of release mechanisms to sustain amoxicillin and clarithromycin intra-gastric concentrations

References

• Kusters JG, van Vliet AHM, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev 2006;19:449–90
   PubMed Web of Science ®Google Scholar
• WGO Global Guidelines. Helicobacter pylori in developing countries. World Gastroenterology Organisation Global Guidelines; 2010
   Google Scholar
• Scarpignato C, Pelosini C. Antisecretory drugs for eradication of Helicobacter pylori: antibacterial activity and synergism with antimicrobial agents. In: Scarpignato C, Bianchi Porro G, eds. Clinical pharmacology and therapy of Helicobacter pylori infection. Basel: Karger Medical and Scientific Publishers; 1999:136–80
   Google Scholar
• Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol 2007;21:315–24
   PubMed Web of Science ®Google Scholar
• Malfertheiner P, Mégraud F, O’Morain C, et al. Current concepts in the management of Helicobacter pylori infection – the Maastricht 2-2000 Consensus Report. Aliment Pharmacol Ther 2002;16:167–80
   PubMed Web of Science ®Google Scholar
• Graham DY, Lu H, Yamaoka Y. Therapy for Helicobacter pylori infection can be improved: sequential therapy and beyond. Drugs 2008;68:725–36
   PubMed Web of Science ®Google Scholar
• Raijnkanth PS, Balasubramaniam J, Mishra B. Development and evaluation of a novel floating in situ gelling system of amoxicillin for eradication of Helicobacter pylori. Int J Pharm 2007;335:114–22
   PubMed Web of Science ®Google Scholar
• Whitehead L, Collett JH, Fell JT. Amoxicillin release from a floating form based on alginates. Int J Pharm 2000;210:45–9
   PubMed Web of Science ®Google Scholar
• Gòmez-Burgaz M, Garcià-Ochoa B, Torrado-Santiago S. Chitosan-carboxymethylcellulose inter-polymer complexes for gastric-specific delivery of clarithromycin. Int J Pharm 2008;359:135–43
   PubMed Web of Science ®Google Scholar
• Nama M, Gonugunta CSR, Veerareddy PR. Formulation and evaluation of gastro-retentive dosage forms of clarithromycin. AAPS PharmSciTech 2008;9:231–7
   PubMed Web of Science ®Google Scholar
• Patel SS, Ray S, Thakur RS. Formulation and evaluation of floating drug delivery system containing clarithromycin for Helicobacter pylori. Acta Pol Pharm 2006;63:53–61
   PubMedGoogle Scholar
• Thakar K, Joshi G, Sawant KK. Bioavailability enhancement of baclofen by gastroretentive floating formulation: statistical optimization, in vitro and in vivo pharmacokinetic studies. Drug Dev Ind Pharm 2013;39:880–8
   PubMed Web of Science ®Google Scholar
• Rapolu K, Sanka K, Vemula PK, et al. Optimization and characterization of gastroretentive floating drug delivery system using Box–Behnken design. Drug Dev Ind Pharm 2013;39:1928–35
   PubMed Web of Science ®Google Scholar
• Losi E, Bettini R, Santi P, et al. Assemblage of novel release modules for the development of adaptable drug delivery systems. J Control Release 2006;111:212–18
   PubMed Web of Science ®Google Scholar
• Losi E, Peppas NA, Ketcham RA, et al. Investigation of the swelling behavior of Dome Matrix drug delivery modules by high-resolution X-ray computed tomography. J Drug Del Sci Tech 2013;23:165–70
   Web of Science ®Google Scholar
• Colombo P, Santi P, Bettini R, et al. Modules, new assemblage kits and new assembles for the controlled release of substances. PCT WO 2008/067829 A1, 2008
   Google Scholar
• Strusi OL, Sonvico F, Bettini R, et al. Module assemblage technology for floating system: in vitro flotation and in vivo gastro-retention. J Control Release 2008;129:88–92
   PubMed Web of Science ®Google Scholar
• Hascicek C, Rossi A, Colombo P, et al. Assemblage of drug release modules: effect of module shape and position in the assembled systems on floating behavior and release rate. Eur J Pharm Biopharm 2011;77:116–21
   PubMed Web of Science ®Google Scholar
• Ishii K, Katayama Y, Itai S, et al. In vitro dissolution tests corresponding to the in vivo dissolution of clarithromycin tablets in the stomach and intestine. Chem Pharm Bull 1995;43:1943–8
   PubMed Web of Science ®Google Scholar
• Strusi OL, Barata P, Traini D, et al. Artesunate-clindamycin multi-kinetics and site-specific oral delivery system for antimalaric combination products. J Control Release 2010;146:54–60
   PubMed Web of Science ®Google Scholar
• Timmermans J, Moës AJ. Measuring the resultant weight of an immersed test material. Part I. Validation of an apparatus and a method dedicated to pharmaceutical applications. Acta Pharm Tech 1990;36:171–5
   Web of Science ®Google Scholar
• Goetze O, Steingoetter A, Menne D, et al. The effect of macronutrients on gastric volume responses and gastric emptying in humans: a magnetic resonance imaging study. Am J Physiol Liver Physiol 2007;229:G11–17
   Google Scholar
• Kortejarvi H, Urtti A, Yliperttula M. Pharmacokinetic simulation for biowaiver criteria: the effect of gastric emptying, dissolution, absorption and elimination rates. Eur J Pharm Sci 2007;30:155–66
   PubMed Web of Science ®Google Scholar
• Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and scientific purposes. Official Journal of the European Communities, L 358/1986, pp. 1–28
   Google Scholar
• Nakagawa Y, Itai S, Yoshida T, Nagai T. Physicochemical properties and stability in the acidic solution of a new macrolide antibiotic, clarithromycin, in comparison with erythromycin. Chem Pharm Bull 1992;40:725–8
   PubMed Web of Science ®Google Scholar
• Emara LH, Abdou AR, El-Ashmawy AA, et al. In vitro release evaluation of gastroretentive amoxicillin floating tablets employing a specific design of the flow-through cell. Diss Tech 2013;20:27–33
   Web of Science ®Google Scholar
• Tsuji A, Nakashima E, Hamano S, Yamana T. Physicochemical properties of amphoteric β-lactam antibiotics I: stability, solubility, and dissolution behavior of amino penicillins as a function of pH. J Pharm Sci 1978;67:1059–66
   PubMed Web of Science ®Google Scholar
• Peppas NA. Analysis of Fickian and non-Fickian drug release in polymers. Pharm Acta Helv 1985;60:110–11
   PubMedGoogle Scholar
• Simonian HP, Vo L, Doma S, et al. Regional postprandial differences in pH within the stomach and gastroesophageal junction. Digest Dis Sci 2005;50:2276–85
   PubMed Web of Science ®Google Scholar
• Zuleger S, Lippold BC. Polymer particle erosion controlling drug release. I. Factors influencing drug release and characterization of the release mechanism. Int J Pharm 2001;217:1139–52
   Web of Science ®Google Scholar
• Colombo P, Sonvico F, Colombo G, Bettini R. Novel platforms for oral drug delivery. Pharm Res 2009;26:601–11
   PubMed Web of Science ®Google Scholar
• Colombo P, Catellani PL, Peppas NA, et al. Swelling characteristics of hydrophilic matrices for controlled release. New dimensionless number to describe the swelling and release behavior. Int J Pharm 1992;88:99–109
   Web of Science ®Google Scholar
• De Francesco V, Zullo A, Ierardi E, Vaira D. Minimal inhibitory concentration (MIC) values and different point mutations in the 23S rRNA gene for clarithromycin resistance in Helicobacter pylori. Dig Liver Dis 2009;41:610–11
   PubMedGoogle Scholar
• Boyanova L, Koumanova R, Gergova G, et al. Prevalence of resistant Helicobacter pylori isolates in Bulgarian children. J Med Microbiol 2002;51:786–90
   PubMed Web of Science ®Google Scholar
• Stella Systems Thinking for Education and Research, Isee Systems. Available from: http://www.iseesystems.com [last accessed 2 Sep 2014]
   Google Scholar
• Gustavson LE, Kaiser JF, Edmonds AL, et al. Effect of omeprazole on concentrations of clarithromycin in plasma and gastric tissue at steady state. Antimicrob Agents Chemother 1995;39:2078–83
   PubMed Web of Science ®Google Scholar
• Wu H, Shi XD, Wang HT. Resistance of Helicobacter pylori to metronidazole, tetracycline and amoxicillin. J Antimicrob Chemother 2000;46:121–3
   PubMed Web of Science ®Google Scholar
• Zhang X, Zou M, Sanming L, et al. Bioavailability of clarithromycin cyclodextrin ternary complexes upon oral administration to healthy beagle dogs. Drug Dev Ind Pharm 2008;34:1048–53
   PubMed Web of Science ®Google Scholar
• Vree TB, Dammers E, van Duuren E. Variable absorption of clavulanic acid after an oral dose of 25 mg/kg of clavubactin and synulox in healthy dogs. J Vet Pharmcol Therap 2003;26:165–71
   PubMed Web of Science ®Google Scholar
• Pillbox website by US National Library of Medicine, NIH. Available from: http://pillbox.nlm.nih.gov/pillimage/search.php [last accessed 16 Nov 2014]
   Google Scholar