Enhanced colonic delivery of ciclosporin A self-emulsifying drug delivery system encapsulated in coated minispheres

References

• Watts PJ, Illum L. Colonic drug delivery. Drug Dev Ind Pharm 1997;23:893–913
   Web of Science ®Google Scholar
• Mundargi RC, Patil SA, Agnihotri SA, Aminabhavi TM. Development of polysaccharide-based colon targeted drug delivery systems for the treatment of amoebiasis. Drug Dev Ind Pharm 2007;33:255–64
   PubMed Web of Science ®Google Scholar
• Maestrelli F, Cirri M, Mennini N, et al. Influence of cross-linking agent type and chitosan content on the performance of pectinate-chitosan beads aimed for colon-specific drug delivery. Drug Dev Ind Pharm 2012;38:1142–51
   PubMed Web of Science ®Google Scholar
• Van den Mooter G. Colon drug delivery. Expert Opin Drug Deliv 2006;3:111–25
   PubMedGoogle Scholar
• Basit AW. Advances in colonic drug delivery. Drugs 2005;65:1991–2007
   PubMed Web of Science ®Google Scholar
• Dubinsky MC. Azathioprine, 6-mercaptopurine in inflammatory bowel disease: pharmacology, efficacy, and safety. Clin Gastroenterol Hepatol 2004;2:731–43
   PubMed Web of Science ®Google Scholar
• Atreya I, Neurath MF. Understanding the delayed onset of action of azathioprine in IBD: are we there yet? Gut 2009;58:325–6
   PubMed Web of Science ®Google Scholar
• Keohane J, Shanahan F. Are patients with IBD knowledgeable about the risks of their medications? Inflamm Bowel Dis 2008;14:S70–1
   Google Scholar
• Saibeni S, Virgilio T, D'Incà R, et al. The use of thiopurines for the treatment of inflammatory bowel diseases in clinical practice. Dig Liver Dis 2008;40:814–20
   PubMedGoogle Scholar
• Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol 2011;106:685–98
   PubMed Web of Science ®Google Scholar
• Moum B, Ekbom A, Vatn M, et al. Clinical course during the 1st year after diagnosis in ulcerative colitis and Crohn's disease: results of a large, prospective population-based study in southeastern Norway, 1990–93. ScandJ Gastroenterol 1997;32:1005–12
   PubMed Web of Science ®Google Scholar
• Sharkey L, Bredin F, Nightingale A, Parkes M. The use of Cyclosporin A in acute steroid-refractory ulcerative colitis: long term outcomes. J Crohn's Colitis 2011;5:91–4
   Google Scholar
• Saito T, Seike K, Koda K, et al. Effects of intravenous cyclosporin on the surgical treatment for acute severe ulcerative colitis. J Gastroenterol Hepatol Res 2013;2:814–17
   Google Scholar
• Laharie D, Bourreille A, Branche J, et al. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet 2012;380:1909–15
   PubMed Web of Science ®Google Scholar
• Arts J, D'Haens G, Zeegers M, et al. Long-term outcome of treatment with intravenous cyclosporin in patients with severe ulcerative colitis. Inflamm Bowel Dis 2004;10:73–8
   PubMed Web of Science ®Google Scholar
• Mahesh VN, Campbell R, Ahluwalia NK. Cyclosporine enema in conventional ± immunomodulator refractory distal ulcerative colitis: ready for prime time or hype? Gastroenterology 2010;138:S-700
   Google Scholar
• Beauchesne PR, Chung NSC, Wasan KM. Cyclosporine A: a review of current oral and intravenous delivery systems. Drug Dev Ind Pharm 2007;33:211–20
   PubMed Web of Science ®Google Scholar
• Drewe J, Beglinger C, Kissel T. The absorption site of cyclosporin in the human gastrointestinal tract. Br J Clin Pharmacol 1992;33:39–43
   PubMed Web of Science ®Google Scholar
• Cavalcanti OA, Mooter GVd, Caramico-Soares I, Kinget R. Polysaccharides as excipients for colon-specific coatings. Permeability and swelling properties of casted films. Drug Dev Ind Pharm 2002;28:157–64
   PubMed Web of Science ®Google Scholar
• Omwancha W, Kouba C, Yelamanchili S, Neau SH. Colon-specific drug delivery using ethylcellulose and chitosan in the coat of compression-coated tablets. Drug Dev Ind Pharm 2011;37:945–53
   PubMed Web of Science ®Google Scholar
• Prezotti FG, Meneguin AB, Evangelista RC, Ferreira Cury BS. Preparation and characterization of free films of high amylose/pectin mixtures cross-linked with sodium trimetaphosphate. Drug Dev Ind Pharm 2012;38:1354–9
   PubMed Web of Science ®Google Scholar
• Roy P, Shahiwala A. Multiparticulate formulation approach to pulsatile drug delivery: current perspectives. J Control Release 2009;134:74–80
   PubMed Web of Science ®Google Scholar
• Bautzová T, Rabišková M, Lamprecht A. Multiparticulate systems containing 5-aminosalicylic acid for the treatment of inflammatory Bowel disease. Drug Dev Ind Pharm 2011;37:1100–9
   PubMed Web of Science ®Google Scholar
• Bhardwaj U, Burgess DJ. A novel USP apparatus 4 based release testing method for dispersed systems. Int J Pharm 2010;388:287–94
   PubMed Web of Science ®Google Scholar
• Xu X, Gupta A, Faustino P, et al. Development and validation of a HPLC method for dissolution and stability assay of liquid-filled cyclosporine capsule drug products. AAPS PharmSciTech 2013;14:959–67
   PubMed Web of Science ®Google Scholar
• Chimalakonda AP, Shah RB, Mehvar R. High-performance liquid chromatographic analysis of cyclosporin A in rat blood and liver using a commercially available internal standard. J Chromatogr B Anal Technol Biomed Life Sci 2002;772:107–14
   PubMed Web of Science ®Google Scholar
• Hermann M, Christensen H, Reubsaet J. Evaluation of essential parameters in the chromatographic determination of cyclosporin A and metabolites using a D-optimal design. J Pharm Biomed Anal 2002;30:1263–76
   PubMed Web of Science ®Google Scholar
• Cano-Cebrian MJ, Zornoza T, Granero L, Polache A. Intestinal absorption enhancement via the paracellular route by fatty acids, chitosans and others: a target for drug delivery. Curr Drug Deliv 2005;2:9–22
   PubMedGoogle Scholar
• Travis SPL, Stange EF, Lemann M, et al. European evidence-based consensus on the management of ulcerative colitis: current management. J Crohn's Colitis 2008;2:24–62
   Google Scholar
• Van Assche G, D'haens G, Noman M, et al. Randomized, double-blind comparison of 4 mg/kg versus 2 mg/kg intravenous cyclosporine in severe ulcerative colitis. Gastroenterology 2003;125:1025–31
   PubMed Web of Science ®Google Scholar
• Lautenschläger C, Schmidt C, Fischer D, Stallmach A. Drug delivery strategies in the therapy of inflammatory bowel disease. Adv Drug Deliv Rev 2014;71:58–76
   PubMed Web of Science ®Google Scholar
• Yang L, Chu JS, Fix JA. Colon-specific drug delivery: new approaches and in vitro/in vivo evaluation. Int J Pharm 2002;235:1–15
   PubMed Web of Science ®Google Scholar
• Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis Part 2: current management. J Crohn's Colitis 2012;6:991–1030
   Google Scholar
• Capron A, Lerut J, Verbaandert C, et al. Validation of a liquid chromatography-mass spectrometric assay for tacrolimus in liver biopsies after hepatic transplantation: correlation with histopathologic staging of rejection. Ther Drug Monit 2007;29:340–8
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Goldman DH, Lawson GM, Perrault J. Measurement of colonic tissue cyclosporine concentration in children with severe ulcerative colitis. J Pediatr Gastroenterol Nutr 1992;15:125–9
   PubMed Web of Science ®Google Scholar
• Sandborn W, Strong R, Forland S, et al. The pharmacokinetics and colonic tissue concentrations of cyclosporine after iv, oral, and enema administration. J Clin Pharmacol 1991;31:76–80
   PubMed Web of Science ®Google Scholar
• O'Driscoll C, Griffin B. Biopharmaceutical challenges associated with drugs with low aqueous solubility – the potential impact of lipid-based formulations. Adv Drug Deliv Rev 2008;60:617–24
   PubMed Web of Science ®Google Scholar
• Čerpnjak K, Zvonar A, Vrečer F, Gašperlin M. Development of a solid self-microemulsifying drug delivery system (SMEDDS) for solubility enhancement of naproxen. Drug Dev Ind Pharm 2014:1–10
   PubMed Web of Science ®Google Scholar
• Kim C-K, Shin H-J, Yang S-G, et al. Once-a-day oral dosing regimen of cyclosporin A: combined therapy of cyclosporin A premicroemulsion concentrates and enteric coated solid-state premicroemulsion concentrates. Pharm Res 2001;18:454–9
   PubMed Web of Science ®Google Scholar
• Park M-J, Balakrishnan P, Yang S-G. Polymeric nanocapsules with SEDDS oil-core for the controlled and enhanced oral absorption of cyclosporine. Int J Pharm 2013;441:757–64
   PubMed Web of Science ®Google Scholar
• Xu C, Tan RX, Zhang JS, Mo Y. Calcium pectinate capsules for colon-specific drug delivery. Drug Dev Ind Pharm 2005;31:127–34
   PubMed Web of Science ®Google Scholar
• Semde R, Amighi K, Pierre D, et al. Leaching of pectin from mixed pectin/insoluble polymer films intended for colonic drug delivery. Int J Pharm 1998;174:233–41
   Web of Science ®Google Scholar
• Macleod GS, Fell JT, Collett JH. Studies on the physical properties of mixed pectin/ethylcellulose films intended for colonic drug delivery. Int J Pharm 1997;157:53–60
   Web of Science ®Google Scholar
• Benet LZ, Cummins CL. The drug efflux – metabolism alliance: biochemical aspects. Adv Drug Deliv Rev 2001;50:S3–11
   PubMed Web of Science ®Google Scholar
• Watkins PB. The barrier function of CYP3A4 and P-glycoprotein in the small bowel. Adv Drug Deliv Rev 1997;27:161–70
   PubMed Web of Science ®Google Scholar
• Gao X, Bhattacharya S, Chan WK, et al. Expression of P-glycoprotein and CYP3A4 along the porcine oral-gastrointestinal tract: implications on oral mucosal drug delivery. Drug Dev Ind Pharm 2014;40:599–603
   PubMed Web of Science ®Google Scholar
• Fricker G, Drewe J, Huwyler J, et al. Relevance of p-glycoprotein for the enteral absorption of cyclosporin A: in vitro-in vivo correlation. Br J Pharmacol 1996;118:1841–7
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet 2007;369:1641–57
   PubMed Web of Science ®Google Scholar