Document Detail


Development and biopharmaceutical evaluation of osmotic pump tablets for controlled delivery of diclofenac sodium.
MedLine Citation:
PMID:  14769233     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Based on the principles of an elementary osmotic pump (OP), OP tablets were designed and evaluated with the aim to deliver diclofenac sodium (DS) in a controlled manner. In vitro evaluation was done in various release media and kinetics was evaluated using the regression coefficient analysis. Effects of orifice size, coating membrane type, coating thickness, static and stirred conditions and pH variation were studied. In vivo evaluation was performed on six healthy human volunteers and various pharmacokinetic parameters (c(max), t(max), AUC(0-24), MRT) and relative bioavailability were calculated. The results were compared with the performance of two commercial tablets of DS. The drug release from OP tablets was dependent on the type and thickness of the coating membrane, but was independent of the orifice size and static and stirred conditions of the release medium. The OP tablets provided a prolonged and controlled DS release compared to commercial sustained-release and conventional tablets of DS.
Authors:
Meena Rani; Rahul Surana; Chelladurai Sankar; Brahmeshwar Mishra
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article    
Journal Detail:
Title:  Acta pharmaceutica (Zagreb, Croatia)     Volume:  53     ISSN:  1330-0075     ISO Abbreviation:  Acta Pharm     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2004-02-10     Completed Date:  2004-03-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9303678     Medline TA:  Acta Pharm     Country:  Croatia    
Other Details:
Languages:  eng     Pagination:  263-73     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi-221005 (U.P.), India.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Biological Availability*
Chemistry, Pharmaceutical
Diclofenac / administration & dosage,  metabolism,  pharmacokinetics*
Excipients
Female
Humans
Hydrogen-Ion Concentration
Male
Metabolic Clearance Rate / drug effects,  physiology
Osmosis / drug effects*
Permeability / drug effects
Solubility / drug effects
Tablets, Enteric-Coated / administration & dosage,  pharmacokinetics*
Technology, Pharmaceutical / trends*
Chemical
Reg. No./Substance:
0/Excipients; 0/Tablets, Enteric-Coated; 15307-86-5/Diclofenac

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


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