Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation

Alimentary Pharmacology and Therapeutics

Volumn 17, Issue 3, 2003, Pages 395-402

  Brunner, M ^a   Assandri, R ^b   Kletter, K ^a   Tschurlovits, M ^c   Corrado, M E ^b   Villa, R ^d   Eichler, H G ^a   Muller M ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Cross Research SA   (Switzerland)

^c TU WIEN   (Austria)

^d Cosmo SpA ^*  (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

MESALAZINE; SAMARIUM;

ABDOMINAL PAIN; ADULT; ARTICLE; ASCENDING COLON; CONTROLLED STUDY; DRUG ABSORPTION; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; FLATULENCE; GAMMA SCINTIGRAPHY; GASTROINTESTINAL TRANSIT; HUMAN; HUMAN EXPERIMENT; ILEUM; MALE; NAUSEA; NORMAL HUMAN; PRIORITY JOURNAL; RADIOACTIVITY; SIDE EFFECT; SMALL INTESTINE; STEADY STATE; TABLET; TRANSVERSE COLON; URINARY EXCRETION; VOMITING;

ADULT; DELAYED-ACTION PREPARATIONS; GASTROINTESTINAL TRANSIT; HUMANS; INTESTINAL ABSORPTION; MALE; MESALAMINE; TABLETS;

EID: 0037330928     PISSN: 02692813     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2036.2003.01445.x     Document Type: Article

References (20)

1. Crotty B, Jewell P. Drug therapy of ulcerative colitis. Br J Clin Pharmacol 1992; 34: 189-98.
2. Klotz U. The role of aminosalicylates at the beginning of the new millennium in the treatment of chronic inflammatory bowel disease. Eur J Clin Pharmacol 2000; 56: 353-62.
3. Zhou SY, Fleisher D, Pao LH, Li C, Winward B, Zimmermann EM. Intestinal metabolism and transport of 5-aminosalicylate. Drug Metab Dispos 1999; 27(4): 479-85.
4. Peppercorn MA, Goldman P. Distribution studies of salicylazosulfapyridine and its metabolites. Gastroenterology 1973; 64: 240-5.
5. Nielsen OH, Bondesen S. Kinetics of 5-aminosalicylic acid after jejunal instillation in man. Br J Clin Pharmacol 1983; 16: 738-40.
6. Schröder H, Campbell DES. Absorption, metabolism and excretion of salicylazosulfapyridine in man. Clin Pharmacol Ther 1972; 13: 539-51.
7. Patent WO 00/76481: Mesalazine Controlled Release Oral Pharmaceutical Compositions, 2000.
8. Digenis GA, Sandefer EP, Parr AF, et al. Gastrointestinal behavior of orally administered radiolabelled erythromycin pellets in man as determined by gamma scintigraphy. J Clin Pharmacol Ther 1991; 5: 69-75.
9. Hardy JG, Harvey WJ, Sparrow RA, et al. Localization of drug release sites from an oral sustained-release formulation of 5-ASA (Pentasa®) in the gastrointestinal tract using gamma scintigraphy. J Clin Pharmacol 1993; 33: 712-8.
10. Davis SS, Hardy JG, Newman SP, Wilding IR. Gamma scintigraphy in the evaluation of pharmaceutical dosage forms. Eur J Nucl Med 1992; 19: 971-86.
11. Krevsky B, Malmud LS, D'Ecrole F, Maurer AH, Fisher RS. Colonic transit scintigraphy - a physiologic approach to the quantitative measurement of colonic transit in humans. Gastroenterology 1986; 91: 1102-12.
12. Parr AF, Beihn R, Franz RM, Szpunar GJ, Jay M. Correlation of ibuprofen bioavailability with gastrointestinal transit by scintigraphic monitoring of 171Er labelled sustained-release tablets. Pharm Res 1987; 4: 486-9.
13. Wilding IR, Hardy JG, Maccari M, Ravelli V, Davis SS. Scintigraphic and pharmacokinetic assessment of a multiparticulate sustained release formulation of diltiazem. Int J Pharm 1991; 76: 133-43.
14. Wilding IR, Davis SS, Bakhshaee M, Stevens HNE. Sparrow RA, Brennan J. Gastrointestinal transit and systemic absorption of captopril from a pulsed release formulation. Pharm Res 1992; 9: 654-7.
15. Brendel E, Meineke I, Witsch D, Zschunke M. Simultaneous determination of 5-aminosalicylic acid and 5-acetylaminosalicylic acid by high-performance liquid chromatography. J Chromatogr 1987; 385: 299-304.
16. Fischer C, Maier K, Klotz U. Simplified high-performance liquid chromatographic method for 5-aminosalicylic acid in plasma and urine. J Chromatogr 1981; 225: 498-503.
17. De Vos M. Clinical pharmacokinetics of slow release mesalazine. Clin Pharmacokinet 2000; 39: 85-97.
18. Staerk Laursen L, Stokholm M, Bukhave K, Rask-Madsen J, Lauritsen K. Disposition of 5-aminosalicylic acid by olsalazine and three mesalazine preparations in patients with ulcerative colitis: comparison of intraluminal colonic concentrations, serum values, and urinary excretion. Gut 1990; 31(11): 1271-6.
19. Corey AE, Rose GM, Conklin JD. Bioavailability of single and multiple doses of enteric-coated mesalamine and sulphasalazine. J Int Med Res 1990; 18: 441-53.
20. Hussain FN, Ajjan RA, Kaput K, Moustafa M, Riley SA. Once versus divided daily dosing with delayed-release mesalazine: a study of tissue drug concentrations and standard pharmacokinetic parameters. Aliment Pharmacol Ther 2001; 15: 53-62.