Preparation and evaluation of enteric coated tablets of hot-melt extruded lansoprazole

References

• He W, Yang M, Fan JH, et al. Influences of sodium carbonate on physicochemical properties of lansoprazole in designed multiple coating pellets. AAPS PharmSciTech 2010;11:1287–93.
   PubMed Web of Science ®Google Scholar
• Ito Y, Arai H, Uchino K, et al. Effect of adsorbents on the absorption of lansoprazole with surfactant. Int J Pharm 2005;289:69–77.
   PubMed Web of Science ®Google Scholar
• Yu M, Sun L, Li W, et al. Investigation of structure and dissolution properties of a solid dispersion of lansoprazole in polyvinylpyrrolidone. J Mol Struct 2011;1005:70–7.
   Web of Science ®Google Scholar
• Brittain HG. Analytical profiles of drug substances and excipients. Vol. 28. San Diego, CA: Academic Press; 2001:27.
   Google Scholar
• Lu Y, Guo T, Qi J, et al. Enhanced dissolution and stability of lansoprazole by cyclodextrin inclusion complexation: preparation, characterization, and molecular modeling. AAPS PharmSciTech 2012;13:1222–9.
   PubMed Web of Science ®Google Scholar
• DellaGreca M, Iesce M, Previtera L, et al. Degradation of lansoprazole and omeprazole in the aquatic environment. Chemosphere 2006;63:1087–93.
   PubMed Web of Science ®Google Scholar
• Lang B, McGinity JW, Williams IIIRO. Hot-melt extrusion – basic principles and pharmaceutical applications. Drug Dev Ind Pharm 2014;40:1133–55.
   PubMed Web of Science ®Google Scholar
• Alsulays BB, Park J-B, Alshehri SM, et al. Influence of molecular weight of carriers and processing parameters on the extrudability, drug release, and stability of fenofibrate formulations processed by hot-melt extrusion. J Drug Deliv Sci Technol 2015;29:189–98.
   PubMed Web of Science ®Google Scholar
• Zhang X, Sun N, Wu B, et al. Physical characterization of lansoprazole/PVP solid dispersion prepared by fluid-bed coating technique. Powder Technol 2008;182:480–5.
   Web of Science ®Google Scholar
• Kristl A, Vrecer F. Preformulation investigation of the novel proton pump inhibitor lansoprazole. Drug Dev Ind Pharm 2000;26:781–3.
   PubMed Web of Science ®Google Scholar
• Hong M, Xu L, Ren G, et al. Solubility of lansoprazole in different solvents. Fluid Phase Equilib 2012;331:18–25.
   Web of Science ®Google Scholar
• Repka MA, Battu SK, Upadhye SB, et al. Pharmaceutical applications of hot-melt extrusion: Part II. Drug Dev Ind Pharm 2007;33:1043–57.
   PubMed Web of Science ®Google Scholar
• Patil H, Tiwari RV, Repka MA. Hot-melt extrusion: from theory to application in pharmaceutical formulation. AAPS PharmSciTech 2015;17:20–42.
   PubMed Web of Science ®Google Scholar
• Crowley MM, Zhang F, Repka MA, et al. Pharmaceutical applications of hot-melt extrusion: Part I. Drug Dev Ind Pharm 2007;33:909–26.
   PubMed Web of Science ®Google Scholar
• Breitenbach J. Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm 2002;54:107–17.
   PubMed Web of Science ®Google Scholar
• Tiwari RV, Patil H, Repka MA. Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century. Expert Opin Drug Deliv 2016;13:451–64.
   PubMed Web of Science ®Google Scholar
• Sun WZ, Lin WJ, Alai MS. Preparation of microparticles for acid-labile lansoprazole by solvent evaporation method combined with a spray drying process. J Food Drug Anal 2012;20:438–45.
   Web of Science ®Google Scholar
• Lovgren KI, Pilbrant AG, Yasumura M, et al. Omeprazole, antisecretory agents. Google Patents 1988.
   Google Scholar
• Chen CM, Chou JCH, Weng T. Pellet comprising inert core component, omeprazole, surface active agent, filler, alkaline agent, binder and single layer of enteric coating. Google Patents 2004.
   Google Scholar
• Shimizu T, Morimoto S, Tabata T. Orally disintegrable tablets. Google Patents 2001.
   Google Scholar
• Baldi F, Malfertheiner P. Lansoprazole fast disintegrating tablet: a new formulation for an established proton pump inhibitor. Digestion 2002;67:1–5.
   Web of Science ®Google Scholar
• Kolter K, Karl M, Gryczke A. Hot-melt extrusion with BASF pharma polymers: extrusion compendium. Ludwigshafen, Germany: BASF SE Pharma Ingredients & Services; 2012.
   Google Scholar
• Phuong H-LT, Tran TT-D, Lee SA, et al. Roles of MgO release from polyethylene glycol 6000-based solid dispersions on microenvironmental pH, enhanced dissolution and reduced gastrointestinal damage of telmisartan. Arch Pharm Res 2011;34:747–55.
   PubMed Web of Science ®Google Scholar
• Sauer D, Zheng W, Coots LB, McGinity JW. Influence of processing parameters and formulation factors on the drug release from tablets powder-coated with Eudragit® L100-55. Eur J Pharm Biopharm 2007;67:464–75.
   PubMed Web of Science ®Google Scholar
• Food, Administration D. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Rockville, MD: Food and Drug Administration; 2000.
   Google Scholar
• Evonik Industries AG. Organic coating for gastro-intestinal targeting. V 3.0. Darmstadt, Germany: Evonik; 2011.
   Google Scholar
• He W, Tian Z, Yang M, et al. A comparative study of the effect of different alkaline stabilizers on physicochemical properties of lansoprazole in formulation. Asian J Pharm Sci 2011;6:89–100.
   Google Scholar
• Yang M, He S, Fan Y, et al. Microenvironmental pH-modified solid dispersions to enhance the dissolution and bioavailability of poorly water-soluble weakly basic GT0918, a developing anti-prostate cancer drug: Preparation, characterization and evaluation in vivo. Int J Pharm 2014;475:97–109.
   PubMed Web of Science ®Google Scholar
• Tran PHL, Tran HTT, Lee B-J. Modulation of microenvironmental pH and crystallinity of ionizable telmisartan using alkalizers in solid dispersions for controlled release. J Control Release 2008;129:59–65.
   PubMed Web of Science ®Google Scholar
• Papageorgiou G, Papadimitriou S, Karavas E, et al. Improvement in chemical and physical stability of fluvastatin drug through hydrogen bonding interactions with different polymer matrices. Curr Drug Deliv 2009;6:101–12.
   PubMedGoogle Scholar
• Guo Z, Lu M, Li Y, et al. The utilization of drug–polymer interactions for improving the chemical stability of hot‐melt extruded solid dispersions. J Pharm Pharmacol 2014;66:285–96.
   PubMed Web of Science ®Google Scholar
• Tabata T, Makino T, Kashihara T, et al. Stabilization of a new antiulcer drug (lansoprazole) in the solid dosage forms. Drug Dev Ind Pharm 1992;18:1437–47.
   Web of Science ®Google Scholar