A novel once daily microparticulate dosage form comprising lansoprazole to prevent nocturnal acid breakthrough in the case of gastro-esophageal reflux disease: preparation, pharmacokinetic and pharmacodynamic evaluation

References

• Adibkia K, Siahi Shadbad MR, Nokhodchi A, Javadzedeh A, Barzegar-Jalali M, Barar J, Mohammadi G, Omidi Y. Piroxicam nanoparticles for ocular delivery: Physicochemical characterization and implementation in endotoxin-induced uveitis. J Drug Target 2007; 15: 407–16
   PubMed Web of Science ®Google Scholar
• Agnihotri SM, Vavia PR. Diclofenac-loaded biopolymeric nanosuspensions for ophthalmic application. Nanomedicine 2009; 5: 90–5
   PubMed Web of Science ®Google Scholar
• Barakat NS, Almurshedi AS. Design and development of gliclazide-loaded chitosan for oral sustained drug delivery: In vitro/in vivo evaluation. J Microencapsul 2011; 28: 122–33
   PubMed Web of Science ®Google Scholar
• Bejugam NK, Uddin AN, Gayakwad SG, D'Souza MJ. Formulation and evaluation of albumin microspheres and its enteric coating using a spray-dryer. J Microencapsul 2008; 25: 577–83
   PubMed Web of Science ®Google Scholar
• Bolourtchian N, Karimi K, Aboofazeli R. Preparation and characterization of ibuprofen microspheres. J Microencapsul 2005; 22: 529–38
   PubMed Web of Science ®Google Scholar
• Choi HG, Jung JH, Yong CS, Rhee CD, Lee MK, Han JH, Park KM, Kim CK. Formulation and in vivo evaluation of omeprazole buccal adhesive tablet. J Control Release 2000; 68: 405–12
   PubMed Web of Science ®Google Scholar
• Comoglu T, Gonul N, Dogan A, Basci N. Development and in vitro evaluation of pantoprazole-loaded microspheres. Drug Deliv 2008; 15: 295–302
   PubMed Web of Science ®Google Scholar
• Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001; 13: 123–33
   PubMed Web of Science ®Google Scholar
• Dai J, Nagai T, Wang X, Zhang T, Meng M, Zhang Q. pH-sensitive nanoparticles for improving the oral bioavailability of cyclosporine A. Int J Pharm 2004; 280: 229–40
   PubMed Web of Science ®Google Scholar
• Gabor F, Ertl B, Wirth M, Mallinger R. Ketoprofen-poly(D,L-lactic-co-glycolic acid) microspheres: Influence of manufacturing parameters and type of polymer on the release characteristics. J Microencapsul 1999; 16: 1–12
   PubMed Web of Science ®Google Scholar
• Haznedar S, Dortunc B. Preparation and in vitro evaluation of Eudragit microspheres containing acetazolamide. Int J Pharm 2004; 269: 131–40
   PubMed Web of Science ®Google Scholar
• He W, Fan LF, Du Q, Xiang B, Li CL, Bai M, Chang YZ, Cao DY. Design and in vitro/in vivo evaluation of multi-layer film coated pellets for omeprazole. Chem Pharm Bull 2009; 57: 122–8
   PubMed Web of Science ®Google Scholar
• Horn JR, Howden CW. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther 2005; 22(Suppl 3)20–4
   PubMedGoogle Scholar
• Ibrahim HM, Ahmed TA, Lila AEA, Samy AM, Kaseem AA, Nutan MTH. Mucoadhesive controlled release microcapsules of indomethacin: Optimization and stability study. J Microencapsul 2010; 27: 377–86
   PubMed Web of Science ®Google Scholar
• Ito Y, Arai H, Uchino K, Iwasaki K, Shibata N, Takada K. Effect of adsorbents on the absorption of lansoprazole with surfactant. Int J Pharm 2005; 289: 69–77
   PubMed Web of Science ®Google Scholar
• Jyothi NVN, Prasanna PM, Sakarkar SN, Prabha KS, Ramaiah PS, Srawan GY. Microencapsulation techniques, factors influencing encapsulation efficiency. J Microencapsul 2010; 27: 187–97
   PubMed Web of Science ®Google Scholar
• Katz PO, Hatlebakk JG, Castell DO. Gastric acidity and acid breakthrough with twice-daily omeprazole or lansoprazole. Aliment Pharmacol Ther 2000; 14: 709–14
   PubMed Web of Science ®Google Scholar
• Katz PO, Koch FK, Ballard ED, Bagin RG, Gautille TC, Checani GC, Hogan DL, Pratha VSV. Comparison of the effects of immediate-release omeprazole oral suspension, delayed-release lansoprazole capsules and delayed-release esomeprazole capsules on nocturnal gastric acidity after bedtime dosing in patients with night-time GERD symptoms. Aliment Pharmacol Ther 2007; 25: 197–205
   PubMed Web of Science ®Google Scholar
• Khamanga SM, Walker RB. The use of response surface methodology in the evaluation of captopril microparticles manufactured using an oil in oil solvent evaporation technique. J Microencapsul 2012; 29: 39–53
   PubMed Web of Science ®Google Scholar
• Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm 1983; 15: 25–35
   Web of Science ®Google Scholar
• Krishnamachari Y, Madan P, Lin S. Development of pH- and time-dependent oral microparticles to optimize budesonide delivery to ileum and colon. Int J Pharm 2007; 338: 238–47
   PubMed 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
• Madhusudhan S, Panda AK, Parimalakrishnan S, Manavalan R, Manna PK. Design, in vitro and in vivo evaluation of glipizide Eudragit microparticles. J Microencapsul 2010; 27: 281–91
   PubMed Web of Science ®Google Scholar
• Maghsoodi M, Esfahani M. Preparation of microparticles of naproxen with Eudragit RS and talc by spherical crystallization technique. Pharm Dev Technol 2009; 14: 442–50
   PubMed Web of Science ®Google Scholar
• Martin RM, Dunn NR, Freemantle S, Shakir S. The rates of common adverse events reported during treatment with proton pump inhibitors used in general practice in England: Cohort studies. Br J Clin Pharmacol 2000; 50: 366–72
   PubMed Web of Science ®Google Scholar
• Mateovic T, Kriznar B, Bogataj M, Mrhar A. The influence of stirring rate on biopharmaceutical properties of Eudragit RS microspheres. J Microencapsul 2002; 19: 29–36
   PubMed Web of Science ®Google Scholar
• Miehlke S, Madisch A, Kirsch C, Lindner F, Kuhlisch E, Laass M, Knoth H, Morgner A, Labenz J. Intragastric acidity during treatment with esomeprazole 40 mg twice daily or pantoprazole 40 mg twice daily – A randomized, two-way crossover study. Aliment Pharmacol Ther 2005; 21: 963–7
   PubMed Web of Science ®Google Scholar
• Pignatello R, Bucolo C, Ferrara P, Maltese A, Puleo A, Puglisi G. Eudragit RS100 nanosuspensions for the ophthalmic controlled delivery of ibuprofen. Eur J Pharm Sci 2002; 16: 53–61
   PubMed Web of Science ®Google Scholar
• Raffin RP, Colome LM, Pohlmann AR, Guterres SS. Preparation, characterization, in vivo anti-ulcer evaluation of pantoprazole-loaded microparticles. Eur J Pharm Biopharm 2006; 63: 198–204
   PubMed Web of Science ®Google Scholar
• Rattes ALR, Oliveira WP. Spray drying conditions and encapsulating composition effects on formation and properties of sodium diclofenac microparticles. Powder Technol 2007; 171: 7–14
   Web of Science ®Google Scholar
• Shah PJ, Gandhi MS, Shah MB, Goswami SS, Santani D. Study of Mimusops elengibark in experimental gastric ulcers. J Ethnopharmacol 2003; 89: 305–11
   PubMed Web of Science ®Google Scholar
• Shaker R, Castell DO, Schoenfeld PS, Spechler SJ. Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: The results of a Gallup survey conducted on behalf of the American Gastroenterological Association. Am J Gastroenterol 2003; 98: 1487–93
   PubMed Web of Science ®Google Scholar
• Shimizu T, Nakano Y, Morimoto S, Tabata T, Hamaguchi N, Igari Y. Formulation study for lansoprazole fast-disintegrating tablet. I. Effect of compression on dissolution behavior. Chem Pharm Bull (Tokyo) 2003; 5: 942–7
   Google Scholar
• Song M, Gao X, Hang TJ, Wen AD. Pharmacokinetic properties of lansoprazole (30-mg enteric-coated capsules) and its metabolites: A single-dose, open-label study in healthy Chinese male subjects. Curr Therap Res Clin Exp 2009; 70: 228–39
   PubMedGoogle Scholar
• Takeuchi K, Konaka A, Nishijima M, Kato S, Yasuhiro T. Effects of pantoprazole, a novel H+/K+-ATPase inhibitor, on duodenal ulcerogenic and healing responses in rats: A comparative study with omeprazole and lansoprazole. J Gastroenterol Hepatol 1999; 14: 251–7
   PubMed Web of Science ®Google Scholar
• Tewa-Tagne P, Briancon S, Fessi H. Spray-dried microparticles containing polymeric nanocapsules: Formulation aspects, liquid phase interactions and particles characteristics. Int J Pharm 2006; 325: 63–74
   PubMed Web of Science ®Google Scholar
• Trapani A, Laquintana V, Denora N, Lopedota A, Cutrignelli A, Franco M, Trapani G, Liso G. Eudragit RS 100 microparticles containing 2-hydroxypropyl-beta-cyclodextrin and glutathione: Physicochemical characterization, drug release and transport studies. Eur J Pharm Sci 2007; 30: 64–74
   PubMed Web of Science ®Google Scholar
• Tsung MJ, Burgess DJ. Preparation and characterization of gelatin surface modified PLGA microspheres. AAPS PharmSci 2001; 3: E11
   Google Scholar
• Vlase L, Popa A, Neag M, Muntean D, Leucuta SE. Effect of fluoxetine on the pharmacokinetics of lansoprazole: A two-treatment period study in healthy male subjects. Clin Drug Investig. 2011; 31: 727–33
   PubMed Web of Science ®Google Scholar
• Wang XQ, Dai JD, Chen Z, Zhang T, Xia GM, Nagai T, Zhang Q. Bioavailability and pharmacokinetics of cyclosporine A-loaded pH-sensitive nanoparticles for oral administration. J Control Release 2004; 97: 421–9
   PubMed Web of Science ®Google Scholar
• Yuksel N, Kanik AE, Baykara T. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm 2000; 209: 57–67
   PubMed Web of Science ®Google Scholar