Carrier systems for the treatment of inflammatory bowel disease

Drugs of the Future

Volumn 27, Issue 10, 2002, Pages 961-971

  Lamprecht, Alf ^a   Stallmach, Andreas ^b   Kawashima, Yoshiaki ^a   Lehr, Claus Michael ^c  

^a GIFU PHARMACEUTICAL UNIVERSITY   (Japan)

^b SAARLAND UNIVERSITY   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CELLULOSE; CYTOKINE; DRUG CARRIER; ENEMA; ETANERCEPT; ETHYL CELLULOSE; EUDRAGIT; GLUCOCORTICOID; INFLIXIMAB; LIPOSOME; MESALAZINE; NANOPARTICLE; OPRELEUKIN; PRODRUG; RHLL 10; RHLL 11; SALAZOSULFAPYRIDINE; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; TUMOR NECROSIS FACTOR ANTIBODY; UNCLASSIFIED DRUG;

BACTERIAL CYTOKINE EXPRESSION; CONTROLLED DRUG RELEASE; CROHN DISEASE; CYTOKINE PRODUCTION; DELAYED DRUG RELEASE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG SOLUBILITY; ENTERITIS; INTESTINE FLORA; INTESTINE TRANSIT TIME; PATIENT COMPLIANCE; PROTEIN EXPRESSION; RECTAL DRUG ADMINISTRATION; REVIEW; SLOW DRUG RELEASE; STOMACH PH; SUSTAINED RELEASE PREPARATION; ULCERATIVE COLITIS; VIRAL GENE THERAPY;

EID: 0036821160     PISSN: 03778282     EISSN: None     Source Type: Journal    
DOI: 10.1358/dof.2002.027.10.740182     Document Type: Review

References (93)

1. Pallone, F., Boirivant, M., Stazi, M.A., Cosintino, R., Prantera, C., Torsoli, A. Analysis of clinical course of postoperative recurrence in Crohn's disease of distal ileum. Dig Dis Sci 1992, 37: 215-9.
2. Both, H., Torp-Pedersen, K., Kreiner, S. et al. Clinical appearance at diagnosis of ulcerative colities and Crohn's disease in a regional patient group. Scand J Gastroenterol 1983, 18: 987-91.
3. Fraser, A.G., Orchard, T.R., Jewell, D.P. The efficacy of azathioprine for the treatment of inflammatory bowel disease: A 30 year review. Gut 2002, 50: 485-9.
4. Kusunoki, M., Möeslein, G., Shoji, Y. et al. Steroid complications in patients with ulcerative colitis. Dis Colon Rectum 1992, 35: 1003-9.
5. Spencer, C.M., McTavish, D. Budesonide, a review of its pharmacological and therapeutic efficacy in inflammatory bowel disease. Drugs 1995, 50: 854-72.
6. Edsbacker, S., Jonsson, S., Lindberg, C. et al. Metabolic pathways of the topical glucocorticoid budesonide in man. Drug Metab Dispos 1983, 11: 590-6.
7. Robinson, M. Medical therapy of inflammatory bowel disease for the 21st century. Eur J Surg Suppl 1998, 582: 90-8.
8. Sandborn, W.J. Cyclosporine in ulcerative colitis: State of the art. Acta Gastroenterol Belg 2001, 64: 201-4.
9. Bousvaros, A., Mueller, B. Thalidomide in gastrointestinal disorders. Drugs 2001, 61: 777-87.
10. Aiko, S., Conner, E.M., Fuseler, J.A., Grisham, M.B. Effects of cyclosporine or FK506 in chronic colitis. J Pharmacol Exp Ther 1997, 280: 1075-84.
11. Lang, K.A., Peppercorn, M.A. Promising new agents for the treatment of inflammatory bowel disorders. Drugs RD 1999, 1: 237-44.
12. Baert, F.J., D'Haens, G.R., Peeters, M. et al. Tumor necrosis factor a antibody (infliximab) therapy profoundly down-regulates the inflammation in Crohn's ileocolitis. Gastroenterology 1999, 116: 22-8.
13. Rutgeerts, P.J. Medical therapy of inflammatory bowel disease. Digestion 1998, 59: 453-69.
14. Kuhn, R., Lohler, J., Rennick, D., Rajewsky, K., Muller, W. Interleukin-10-deficient mice develop chronic enterocolitis. Cell 1993, 75: 263-74.
15. Schreiber, S., Heinig, T., Thiele, H.G., Raedler, A. Immunoregulatory role of interleukin 10 in patients with inflammatory bowel disease. Gastroenterology 1995, 108: 1434-44.
16. Sands, B.E., Bank, S., Sninsky, C.A. et al. Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease. Gastroenterology 1999, 117: 58-64.
17. van Hogezand, R.A., Verspaget, H.W. The future role of anti-tumour necrosis factor-α products in the treatment of Crohn's disease. Drugs 1998, 56: 299-305.
18. Woodley, J.F. Enzymatic barriers for GI peptide and protein delivery. Crit Rev Ther Drug Carrier Syst 1994, 11: 61-95.
19. Rubinstein, A. Approaches and opportunities in colon-specific drug delivery. Crit Rev Ther Drug Carrier Syst 1995, 12: 101-49.
20. Wilding, I.R., Davis, S.S., Ohagan, D.T. Targeting of drugs and vaccines to the gut. Pharmacol Ther 1994, 62: 97-124.
21. Friend, D.R. Colon-specific drug delivery. Adv Drug Del Rev 1991, 7: 149-99.
22. Watts, P.J., Illum, L. Colonic drug delivery. Drug Dev Ind Pharm 1997, 23: 893-913.
23. Friend, D.R. Review article: Issues in oral administration of locally acting glucocorticosteroids for treatment of inflammatory bowel disease. Aliment Pharmacol Ther 1998, 12: 591-603.
24. Rubinstein, A. Microbially controlled drug delivery to the colon. Biopharm Drug Dispos 1990, 11: 465-75.
25. Friend, D.R., Chang, G.W. A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria. J Med Chem 1984, 27: 261-6.
26. Minami, K., Hirayama, F., Uekama, K. Colon-specific drug delivery based on a cyclodextrin prodrug: Release behavior of biphenylylacetic acid from its cyclodextrin conjugates in rat intestinal tracts after oral administration. J Pharm Sci 1998, 87: 715-20.
27. Azad Khan, A.K., Piris, J., Truelove, S.C. An experiment to determine the active therapeutic moiety of sulphasalazine. Lancet 1977, 8044: 892-5.
28. Miller, B. Side effects of salicylazosulfapyridine therapy. Dtsch Med Wochenschr 1980, 105: 1596-7.
29. Fedorak, R.N., Haeberlin, B., Empey, L.R. et al. Colonic delivery of dexamethasone from a prodrug accelerates healing of colitis in rats without adrenal suppression. Gastroenterology 1995, 108: 1688-99.
30. Sinha, V.R., Kumria, R. Colonic drug delivery: Prodrug approach. Pharm Res 2001, 18: 557-64.
31. Lee, D.A.H., Taylor, M., James, V.T.H. et al. Rectally administered prednisolone evidence for a predominantly local action. Gut 1980, 21: 215-8.
32. Sandle, G.I., Hayslett, J.P., Binder, H.J. Effect of glucocorticoids on rectal transport in normal subjects and patients with ulcerative colitis. Gut 1986, 27: 309-16.
33. Halpern, Z., Sold, O., Baratz, M. et al. A controlled trial of beclomethasone versus betamethasone enemas in distal ulcerative colitis. J Clin Gastroenterol 1991, 13: 38-41.
34. Kumana, C.R., Seaton, T., Casteli, M. et al. Beclomethasone dipropionate enemas for treating inflammatory bowel disease without producing Cushing's syndrome or hypothalamic-pituitary-adrenal suppression. Lancet 1982, 8272: 579-83.
35. Nyman-Pantelidls, N., Nilsson, A., Wagner, Z.G. et al. Pharmacokinetics and retrograde colonic spread of budesonide enemas in patients with distal ulcerative colitis. Aliment Pharmacol Ther 1994, 8: 617-22.
36. Campieri, M., Corbelli, C., Giochetti, P. et al. Spread and distribution of 5-ASA colonic foam and 5-ASA enema in patients with ulcerative colitis. Dig Dis Sci 1992, 37: 1890-7.
37. Williams, C.N. Role of rectal formulations: Suppositories. Scand J Gastroenterol Suppl 1990, 172: 60-2.
38. Ruddel, W.S.J., Dickinson, R.J., Dixon, M.F. et al. Treatment of distal ulcerative colitis (proctosidmoiditis) in relapse: Comparison of hydrocortisone enemas and rectal hydrocortisone foam. Gut 1980, 21: 885-9.
39. Moody, G.A., Eaden, J.A., Helyes, Z. et al. Oral or rectal administration of drugs in IBD. Aliment Pharmacol Ther 1997, 11: 999-1000.
40. Zeitz, M. Consequences of galenic considerations and clinical results for therapy of ulcerative colitis. Med Klin 1999, 94 Suppl 1: 41-3.
41. Kelm, G.R., Manring, G.L. Pharmaceutical dosage form for colonic delivery. US 5686106.
42. Faber, S.M., Korelitz, B.I. Experience with Eudragit-S-coated mesalamine (Asacol) in inflammatory bowel disease. An open study. J Clin Gastroenterol 1993, 17: 213-8.
43. Ashford, M., Fell, J.T., Attwood, D., Sharma, H., Woodhead, P.J. An in vivo investigation into the suitability of pH-dependent polymers for colonic targeting. Int J Pharm 1993, 95: 193-9.
44. Evans, D.F., Pye, G., Bramley, R., Clark, A.G., Dyson, T.J., Hardcastle, J.D. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut 1988, 29: 1035-41.
45. Press, A.G., Hauptmann, I.A., Hauptmann, L. et al. Gastrointestinal pH profiles in patients with inflammatory bowel disease. Aliment Pharmacol Ther 1998, 12: 673-8.
46. Sasaki, Y., Hada, R., Nakajima, H., Fukuda, S., Munakata, A. Improved localizing method of radiopill in measurement of entire gastrointestinal pH profiles: Colonic luminal pH in normal subjects and patients with Crohn's disease. Am J Gastroenterol 1997, 92: 114-8.
47. Fallingborg, J., Christensen, L.A., Jacobsen, B.A., Rasmussen, S.N. Very low intraluminal colonic pH in patients with active ulcerative colitis. Dig Dis Sci 1993, 38: 1989-93.
48. Leopold, C.S., Eikeler, D. Eudragit E as coating material for the pH-controlled drug release in the topical treatment of inflammatory bowel disease (IBD). J Drug Target 1998, 6: 85-94.
49. Ishibashi, T., Hatano, H., Kobayashi, M., Mizobe, M., Yoshino, H. In vivo drug release behavior in dogs from a new colon-targeted delivery system. J Control Release 1999, 57: 45-53.
50. Ishibashi, T., Pitcairn, G.R., Yoshino, H., Mizobe, M., Wilding, I.R. Scintigraphic evaluation of a new capsule-type colon specific drug delivery system in healthy volunteers. J Pharm Sci 1998, 87: 531-5.
51. Wilding, I.R., Davis, S.S., Pozzi, F., Furlani, P., Gazzaniga, A. Enteric coated timed release systems for colonic targeting. Int J Pharm 1994, 111: 99-102.
52. Gazzaniga, A., Iamartino, P., Maffione, G., Sangalli, M.E. Oral delayed-release system for colonic specific delivery. Int J Pharm 1994, 108: 77-83.
53. Ueda, S., Ibuki, R., Kawamura, A. et al. Development of a novel drug delivery system, time-controlled explosion system (TES). IV. In vivo drug release behavior. J Drug Target 1994, 2: 133-40.
54. Niwa, K., Takaya, T., Morimoto, T., Takada, K. Preparation and evaluation of a time-controlled release capsule made of ethylcellulose for colon delivery of drugs. J Drug Target 1995, 3: 83-9.
55. Davis, S.S., Hardy, J., Fara, J.W. Transit of pharmaceutical dosage forms through the small intestine. Gut 1986, 27: 886-92.
56. Davis, S.S., Hardy, J.G., Taylor, M.J. et al. A comparative study of the gastrointestinal transit of a pellet and tablet formulation. Int J Pharm 1984, 21: 167-77.
57. Hardy, J.G., Wilson, C.A., Wood, E. Drug delivery to the proximal colon. J Pharm Pharmacol 1985, 37: 874-8.
58. Adkin, D.A., Davis, S.S., Sparrow, R.A. et al. Colonic transit of different size tablets in healthy subjects. J Control Release 1993, 23: 147-56.
59. Hardy, J.G., Wood, E., Wilson, C.G. The intestinal transit of capsules and pellets. Dig Dis Sci 1985, 30: 772.
60. Eastwood, M.A. Medical and dietary management. Clin Gastroenterol 1975, 4: 85-97.
61. Duthie, H.L., Watts, J.M., Dedombal, F.T. et al. Serum electrolytes and colonic transfer of water and electrolytes in chronic ulcerative colitis. Gastroenterology 1964, 47: 525.
62. Davis, S.S., Robertson, C., Wilding, I.R. Gastrointestinal transit of a multiparticulate tablet formulation in patients with active ulcerative colitis. Int J Pharm 1991, 68: 199-204.
63. Rao, S.S.C., Holdsworth, C.D., Read, N.W. Symptoms and stool patterns in patients with ulcerative colitis. Gut 1988, 29: 342-5.
64. Van den Mooter, G., Samyn, C., Kinget, R. In vivo evaluation of a colon-specific drug delivery system: An absorption study of theophylline from capsules coated with azo polymers in rats. Pharm Res 1995, 12: 244-7.
65. Van den Mooter, G., Maris, B., Samyn, C., Augustijns, P., Kinget, R. Use of azo polymers for colon-specific drug delivery. J Pharm Sci 1997, 86: 321-7.
66. Sekigawa, F., Onda, Y. Coated solid medicament form having releasability in large intestine. US 5217720.
67. Deasy, P.B., El-Mahdi, I.M. Development of coated ketoprofen pellets for oral colon-specific drug delivery. Proc Int Symp Control Release Bioact Mater 1997, 24: 279-80.
68. el-Mahdi, I.M., Deasy, P.B. Tableting of coated ketoprofen pellets. J Microencapsul 2000, 17: 133-44.
69. Hartley, G., Hudson, M.J., Swarbrick, E.T. et al. The rectal mucosa-associated microflora in patients with ulcerative colitis. J Med Microbiol 1992, 36: 96-103.
70. Benno, P., Leijonmarck, C.E., Monsen, U. et al. Functional alterations of the microflora in patients with ulcerative colitis. Scand J Gastroenterol 1993, 28: 839-44.
71. Gorbach, S.L., Nahas, L., Plaut, A.G. et al. Studies of intestinal microflora V. Fecal microbial ecology in ulcerative colitis and regional enteritis: Relationship to severity of disease and chemotherapy. Gastroenterology 1968, 54: 575-87.
72. Shameen, M., Katori, N., Aoyagi, N. et al. Oral solid controlled release dosage forms role of GI-mechanical destructive forces and colonic release in drug absorption under fasted and fed conditions in humans. Pharm Res 1995, 12: 1049-54.
73. Katori, N., Aoyagi, N., Terao, T. Estimation of agitation intensity in the GI tract in humans and dogs based on in vitro/in vivo correlation. Pharm Res 1995, 12: 237-43.
74. Macheras, P., Argyrakis, P. Gastrointestinal drug absorption: Is it time to consider heterogeniety as well as homogeniety. Pharm Res 1997, 14: 842-7.
75. Mooren, F.C., Berthold, A., Domschke, W., Kreuter, J. Influence of chitosan microspheres on the transport of prednisolone sodium phosphate across HT-29 cell monolayers. Pharm Res 1998, 15: 58-65.
76. Lamprecht, A., Rodero Torres, H., Schafer, U., Lehr, C.M. Biodegradable microparticles as a two-drug controlled release formulation: A potential treatment of inflammatory bowel disease. J Control Rel 2000, 69: 445-54.
77. Lorenzo-Lamosa, M.L., Remunan-Lopez, C., Vila-Jato, J.L., Alonso, M.J. Design of microencapsulated chitosan microspheres for colonic drug delivery. J Control Rel 1998, 52: 109-18.
78. Rodriguez, M., Vila-Jato, J.L., Torres, D. Design of a new multiparticulate system for potential site-specific and controlled drug delivery to the colonic region. J Control Rel 1998, 55: 67-77.
79. Rodriguez, M., Antunez, J.A., Taboada, C., Seijo, B., Torres D. Colon-specific delivery of budesonide from microencapsulated cellulosic cores: Evaluation of the efficacy against colonic inflammation in rats. J Pharm Pharmacol 2001, 53: 1207-15.
80. Actis, G.C., Aimo, G., Priolo, G., Moscato, D., Rizzetto, M., Pagni, R. Efficacy and efficiency of oral microemulsion cyclosporin versus intravenous and soft gelatin capsule cyclosporin in the treatment of severe steroid-refractory ulcerative colitis: An open-label retrospective trial. Inflamm Bowel Dis 1998, 4: 276-9.
81. Actis, G.C., Volpes, R., Rizzetto, M. Oral microemulsion cyclosporin to reduce steroids rapidly in chronic active ulcerative colitis. Eur J Gastroenterol Hepatol 1999, 11: 905-8.
82. Navazo, L., Salata, H., Morales, S., Dorta, M.C., Perez, F., de las Casas, D., Aviles, J. Oral microemulsion cyclosporine in the treatment of steroid-refractory attacks of ulcerative and indeterminate colitis. Scand J Gastroenterol 2001, 36: 610-4.
83. Brouwers, A.H., De Jong, D.J., Dams, E.T. et al. Tc-99mPEG-liposomes for the evaluation of colitis in Crohn's disease. J Drug Target 2000, 8: 225-33.
84. Rogy, M.A., Beinhauer, B.G., Reinisch, W., Huang, L., Pokieser, P. Transfer of interleukin-4 and interleukin-10 in patients with severe inflammatory bowel disease of the rectum. Hum Gene Ther 2000, 11: 1731-41.
85. Barbara, G., Xing, Z., Hogaboam, C.M., Gauldie, J., Collins, S.M. Interleukin 10 gene transfer prevents experimental colitis in rats. Gut 2000, 46: 344-9.
86. Lindsay, J.O., Ciesielski, C.J., Scheinin, T., Hodgson, H.J., Brennan, F.M. The prevention and treatment of murine colitis using gene therapy with adenoviral vectors encoding IL-10. J Immunol 2001, 166: 7625-33.
87. Prud'homme, G.J. Gene therapy of autoimmune diseases with vectors encoding regulatory cytokines or inflammatory cytokine inhibitors. J Gene Med 2000, 2: 222-32.
88. Steidler, L., Hans, W., Schotte, L. et al. Treatment of murine colitis by Lactococcus lactis secreting interleukin-10. Science 2000, 289: 1352-5.
89. Tabata, Y., Inoue, Y., Ikada, Y. Size effect on systemic and mucosal immune responses induced by oral administration of biodegradable microspheres. Vaccine 1996, 14: 1677-85.
90. Nakase, H., Okazaki, K., Tabata, Y. et al. New cytokine delivery system using gelatin microspheres containing interleukin-10 for experimental inflammatory bowel disease. J Pharmacol Exp Ther 2002, 301: 59-65.
91. Nakase, H., Okazaki, K., Tabata, Y. et al. Development of an oral drug delivery system targeting immune-regulating cells in experimental inflammatory bowel disease: A new therapeutic strategy. J Pharmacol Exp Ther 2000, 292: 15-21.
92. Lamprecht, A., Ubrich, N., Yamamoto, H. et al. Biodegradable nanoparticles for targeted drug delivery in treatment of inflammatory bowel disease. J Pharmacol Exp Ther 2001, 299: 775-81.
93. Lamprecht, A., Schafer, U., Lehr, C.M. Size-dependent bioadhesion of micro- and nanoparticulate carriers to the inflamed colonic mucosa. Pharm Res 2001, 18: 788-93.