Pharmacokinetics and tissue distribution of a new mesalamine rectal gel in ulcerative colitis patients View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2004-02

AUTHORS

G. Aumais, M. Lefebvre, J. Massicotte, C. Tremblay, J. Kasbo, J. Brunet, C. Cardinal, J. Spénard

ABSTRACT

Mesalamine (5-ASA) has a topical action in the treatment of ulcerative colitis (UC) but many adverse events are likely related to its systemic availability. It is therefore important to assess systemic exposure to 5-ASA and tissue concentrations produced by a new dosage form. This project assessed the pharmacokinetics (PK) of 5-ASA from a new rectal gel in UC patients. 6 UC patients received a single 4 g dose of 5-ASA (Canasa-gel®) and, starting 48 hours later, 4 g HS x 4 days. Blood was collected at intervals for 30 hours and urine for 48 hours after first and last doses. Rectal biopsies were taken 8 hours after the last dose. 5-ASA was assayed by a fully validated LC-MS-MS method. After single dose, means (sd) were 2821 (1293) ng/mL for Cmax, 37638 (24370) ng h/mL for AUC0-∞, and 6.3 (8.2) h for half-life. After multiple doses means (sd) were 102 (152) ng/mL for Cmin, 2104 (743) ng/mL for Cmax, 21975 (10808) ng h/mL for AUC0-∞, and 4.0 (2.6) h for half-life. Mean (sd) total (unchanged and metabolized) urinary recovery of 5-ASA after single dose was 718 (388) mg. Mean (sd) rectal 5-ASA concentration was 25.2 (28.5) ng/mg tissue. The pharmacokinetics from this new gel compare favorably with those from enema and suppository. It delivers adequate amount of 5-ASA to disease tissues. Based on PK, this new dosage form should be at least as safe and effective as enema and suppository. Clinical trials are required to confirm this conclusion. Clinical Pharmacology & Therapeutics (2004) 75, P38–P38; doi: 10.1016/j.clpt.2003.11.146 More... »

PAGES

p38-p38

Identifiers

URI

http://scigraph.springernature.com/pub.10.1016/j.clpt.2003.11.146

DOI

http://dx.doi.org/10.1016/j.clpt.2003.11.146

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1033918163


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