Document Detail

Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis.
MedLine Citation:
PMID:  16128685     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Local treatment with foams in patients suffering from ulcerative proctitis or proctosigmoiditis is considered a rational treatment option. AIMS: To investigate colonic spread, safety, tolerability and acceptance of a newly developed budesonide foam formulation. METHODS: Twelve patients (four females, eight males) with acute proctosigmoiditis or left-sided ulcerative colitis were rectally administered a single dose of [99Tcm]-labelled budesonide foam (Budenofalk; Dr Falk Pharma GmbH, Freiburg, Germany) containing 2 mg budesonide in 20 mL foam after diagnostic colonoscopy. Thereafter, the colonic spread was assessed by means of gamma-scintigraphy for 6 h. Serum samples were taken simultaneously. RESULTS: Budesonide foam spread with a maximum between 11 and 40 cm, thus reaching the sigmoid colon in all patients. In some patients, the foam even extended into the distal third and the middle of the descending colon with maximum radioactivity at 4 h. Systemic budesonide absorption was rapid and pharmacokinetic data were comparable with published data on marketed budesonide enemas, with mean serum C(max) and AUC(0-8 h) values of 0.8 +/- 0.5 ng/mL and 3.7 +/- 1.9 ng h/mL, respectively. The new formulation was well accepted by all patients, who could retain the foam for at least 4 h. CONCLUSIONS: In the majority of patients, budesonide foam effectively spread up to the left-sided colon and thus qualifies for the local treatment of proctosigmoiditis.
M Brunner; H Vogelsang; R Greinwald; K Kletter; H Kvaternik; C Schrolnberger; H-G Eichler; H Brunner; R Dudczak; M Müller
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  22     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-08-30     Completed Date:  2005-11-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  463-70     Citation Subset:  IM    
Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical University of Vienna, Vienna, Austria.
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MeSH Terms
Administration, Rectal
Anti-Inflammatory Agents / administration & dosage,  pharmacokinetics*
Budesonide / administration & dosage,  pharmacokinetics*
Colitis, Ulcerative / drug therapy*,  radionuclide imaging
Colon / metabolism*,  radionuclide imaging
Gamma Cameras
Proctocolitis / drug therapy*
Prospective Studies
Technetium / diagnostic use
Reg. No./Substance:
0/Anti-Inflammatory Agents; 51333-22-3/Budesonide; 7440-26-8/Technetium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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