Document Detail

Enhancement of ursodeoxycholic acid bioavailability by cross-linked sodium carboxymethyl cellulose.
MedLine Citation:
PMID:  10813547     Owner:  NLM     Status:  MEDLINE    
The bioavailability of ursodeoxycholic acid from a new formulation based on drug-loaded cross-linked sodium carboxymethyl cellulose was studied in man. The plasma levels of ursodeoxycholic acid were determined by gas chromatography-mass spectrometry after derivatization and sample purification by solid-phase extraction. Capsules containing the drug/polymer system were prepared and compared with conventional commercial ursodeoxycholic acid capsules after single oral administration using a randomized crossover experimental design. Although the drug/polymer system improved the in-vitro dissolution rate of ursodeoxycholic acid in simulated intestinal fluid, statistical evaluation of the area under the plasma concentration curves indicated no significant difference in the extent of bioavailability between the two formulations (14.93+/-4.43 vs 14.95+/-5.79 microM h; P > 0.2). However, following the administration of the ursodeoxycholic acid/cross-linked sodium carboxymethyl cellulose system with an enteric-coated capsule, the mean area under the plasma concentration curve (27.60+/-10.11 microM h) was significantly higher than that obtained after treatment with the commercially available ursodeoxycholic acid capsule (16.24+/-8-38 microM h; P < 0.05). We concluded that improved intestinal absorption of the drug was obtained with enteric-coated capsules filled with the ursodeoxycholic acid/polymer system. Moreover, the simplicity of the preparation and the non-toxicity of the polymer used as the carrier represented additional advantages of this dosage form.
S Scalia; P Giunchedi; P Pazzi; U Conte
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The Journal of pharmacy and pharmacology     Volume:  52     ISSN:  0022-3573     ISO Abbreviation:  J. Pharm. Pharmacol.     Publication Date:  2000 Apr 
Date Detail:
Created Date:  2000-07-12     Completed Date:  2000-07-12     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0376363     Medline TA:  J Pharm Pharmacol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  383-8     Citation Subset:  IM    
Dipartimento di Scienze Farmaceutiche, Università di Ferrara, Italy.
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MeSH Terms
Area Under Curve
Biological Availability
Carboxymethylcellulose / administration & dosage*,  chemistry
Cholagogues and Choleretics / chemistry,  pharmacokinetics*
Cross-Linking Reagents
Cross-Over Studies
Delayed-Action Preparations
Ursodeoxycholic Acid / blood,  chemistry,  pharmacokinetics*
Reg. No./Substance:
0/Capsules; 0/Cholagogues and Choleretics; 0/Cross-Linking Reagents; 0/Delayed-Action Preparations; 128-13-2/Ursodeoxycholic Acid; 9000-70-8/Gelatin; 9004-32-4/Carboxymethylcellulose

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

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