Development of a rectal nicotine delivery system for the treatment of ulcerative colitis

International Journal of Pharmaceutics

Volumn 190, Issue 1, 1999, Pages 21-34

  Dash, Alekha K ^a   Gong, Zheng ^a   Miller, Donald W ^b   Huai Yan, Han ^b   Laforet, Jean Pierre ^c  

^a Sch Pharm All Hlth P ^*  (United States)

^b UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

^c GATTEFOSSÉ SAS   (France)

Author keywords

Bioadhesive; Caco 2 cell; Carbopol; Glycerylmonooleate; Nicotine suppository; Ulcerative colitis

Indexed keywords

CARBOMER; GLYCEROL OLEATE; NICOTINE;

ANIMAL CELL; ARTICLE; CELL STRAIN CACO 2; CONTROLLED STUDY; CYTOTOXICITY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; NONHUMAN; PRIORITY JOURNAL; ULCERATIVE COLITIS; X RAY DIFFRACTION;

ADMINISTRATION, RECTAL; CACO-2 CELLS; CHEMISTRY, PHARMACEUTICAL; COLITIS, ULCERATIVE; CRYSTALLIZATION; DRUG CARRIERS; DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; DRUG STORAGE; GLYCERIDES; HUMANS; KINETICS; NICOTINE; PHARMACEUTIC AIDS; POLYVINYLS; SUPPOSITORIES; TEMPERATURE; TIME FACTORS;

EID: 0032868421     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5173(99)00221-5     Document Type: Article

References (38)

1. Azad Khan A.K., Piris J., Truelove S.C. An experiment to determine the active therapeutic moiety of sulfasalazine. Lancet. 2:1977;2892-2895.
2. Borchardt R.T. Application of cell culture systems in drug discovery and development. J. Drug Target. 3:1995;179-182.
3. Bruckstein A.H. New salicylate therapies for ulcerative colitis. Postgrad. Med. 88:1990;79-82.
4. Calkins B.M. A meta-analysis of the role of smoking in inflamatory bowel disease. Dig. Dis. Sci. 29:1988;352-357.
5. Campieri M., Gionchetti P., Belluzzi A. et al. Retrograde spread of 5-ASA as enemas or suppositories in distal ulcerative colitis. Dis. Colon Rectum. 29:1986;108-110.
6. Campieri M., Gionchetti P., Belluzzi C. et al. 5-aminiosalicylic acid suppositories in the management of ulcerative colitis. Dis. Colon Rectum. 32:1989;398-399.
7. Cicero L.A., Abdelmacksound D., Rosenberg J.M. Does nicotine have a role in the treatment of ulcerative colitis? Drug Top. 141:1997;37.
8. Dash A.K. Determination of the physical state of drug in microcapsules and microspheres. J. Microencapsul. 14:1997;101-112.
9. Dash A.K., Miller D.W., Gong Z., Han H.H. Effect of bioadhesives on nicotine flux in caco-2 cell monolayers. Pharm. Res. 14:1997;S21.
10. Dash A.K., Suryanarayanan R. Solid-state properties of tobramycin. Pharm. Res. 8:1991;1159-1165.
11. Dash A.K., Wong S.-T. Liquid chromatographic method for the determination of nicotine in pharmaceutical formulations. J. Chromatogr. A. 749:1996;81-85.
12. David, M., Dorschel, D., 1992. A cubic-phase delivery system composed of glyceryl monooleate and water for sustained release of water-soluble drugs. Pharm. Technol. 116-130.
13. Engstrom S., Ljusberg-Wahren H., Gustafsson A. Bioadhesive properties of the monoolein-water system. Pharm. Technol. Eur. 7:1995;14-17.
14. Gan L.S., Thakker D.R. Application of the caco-2 model in the design and development of orally active drugs: elucidation of biochemical and physical barriers posed by the intestinal epithelium. Adv. Drug Deliv. Rev. 23:1997;77-98.
15. Green J.T., Thomas G.A.O., Rhodes J. et al. Pharmacokinetics of nicotine carbomer enemas: a new treatment of modality for ulcerative colitis. Clin. Pharm. Ther. 61:1997;340-348.
16. Haleblian J., McRone H. Pharmaceutical applications of polymorphism. J. Pharm. Sci. 8:1969;911-929.
17. Haney P.W., Dash A.K. Preparation and characterization of a rectal mesalamine formulation containing a bioadhesive. Pharm. Res. 11:1994;S327.
18. Hansen M.B., Nielsen S.E., Berg K. Re-examination and further development of a precise and rapid dye method for measuring cell growth/cell kill. J. Immunol. Methods. 119:1989;203-210.
19. Harris A.D., Briad A., Rhodes J. Non-smoking: a feature of ulcerative colitis. Br. Med. J. 284:1982;706.
20. Kennedy L.D. Nicotine therapy for ulcerative colitis. Ann. Pharmacother. 30:1996;1022-1023.
21. Lashner B.A., Hanauer B.A., Silverstein M.D. Testing nicotine gum for ulcerative colitis patients. Dig. Dis. Sci. 35:1990;827-832.
22. Malatjalian D.E. Pathology of inflammatory bowel disease in colorectal mucosal biopsies. Dig. Dis. Sci. 32:1987;5S-15S.
23. Miller D.W., Kato A., Ng K.Y., Chikhale E.G., Borchardt R.T. Cell culture models for examining peptide absorption. Taylor M.D., Amidon G.L. Peptide Based Drug Design: Controlling Transport and Metabolism. 1995;475-500 American Chemical Society, Washington, DC.
24. Palmieri A. Suppository dissolution testing: Apparatus design and release of aspirin. Drug Dev. Ind. Pharm. 7:1981;246-259.
25. Park H., Robinson J.R. Physico-chemical properties of water insoluble polymers important to mucin/epithelial adhesion. J. Contr. Rel. 2:1985;47-57.
26. Peskar B.M., Dreyling B.M., Schaarschmidt K., Goebell H. Possible mode of action of 5-aminosalicylic acid. Dig. Dis. Sci. 32:1987;51S-56S.
27. Pullan R.D., Rhodes J., Ganesh S., Mani V., Sawe W. Transdermal nicotine for active ulcerative colitis. New Engl. J. Med. 330:1994;811-815.
28. Rhodes J., Thomas G. Nicotine treatement in ulcerative colitis: current status. Drugs. 49:1995;157-160.
29. Robert C., Buri P., Peppas N.A. Experimental method for bioadhesive testing of various polymer. Acta Pharmtechnol. 34:1988;95-98.
30. Robinson J.R., Park K. Bioadhesive polymers as platforms for oral-controlled drug delivery. Int. J. Pharm. 198:1984;107-127.
31. Santi P., Pier L.C., Colombo P., Catherine R.-L., Christine B., Anne-Marie G.-H. Parttion and transport of verapamil and nicotine through artificial memnbranes. Int. J. Pharm. 68:1991;43-49.
32. Segars L.W., Gales B.J. Mesalamine and osalazine: 5-aminosalicylic agents for the treatment of inflammatory bowel disease. Clin. Pharm. 6:1992;514-528.
33. Tamura K., Bhatnagar P.K., Takata J.S., Lee C.P., Smith P.L., Borchardt R.T. Metabolism, uptake, and transepithelial transport of the diastereomers of val-val in the human intestinal cell line, Caco-2. Pharm. Res. 13:1996;1213-1218.
34. Budavari, S. (Ed.), 1989. The Merck Index, eleventh ed. Merck and Company, Rahway, NJ, USA, p. 6431.
35. The United States Pharmacopeia, 21st revision, 1985. United States Pharmacopeial Convention, Rockville, MD, p. 1244.
36. Thomas G.A.O., Rhodes J., Mani V., Williams G.T., Newcomb R.G., Russell M.A. Transdermal nicotine for maintenance therapy of ulcerative colitis. New Engl. J. Med. 332:1995;988-992.
37. Utoguchi N., Watanabe Y., Shida T., Matsumoto M. Nitric oxide donors enhance rectal absorption of macromolecules in rabbits. Pharm. Res. 15:1998;870-876.
38. Zins B.J., Sandborn W.J., Mays D., Lawson G., Tremaine W., Mahoney D. A study of nicotine pharmacokinetics following single dose IV, oral and enema administration. Gastroenterology. 110:1996;A1054.