| Properties of enteric coated sodium valproate pellets. | |
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MedLine Citation:
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PMID: 12972338 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The influence of subcoat application and micro-environmental pH on the dissolution properties of enteric coated sodium valproate pellets was investigated. The pellets were prepared by solution-layering or wet-mass extrusion-spheronization methods. In order to pass the USP enteric test, the solution-layered and wet-mass extruded pellets required 35 and 25% weight gain of Eudragit L 30D-55, respectively. The application of a subcoat of either Methocel-E5 (HPMC) or Opadry AMB to the pellets resulted in a delay in sodium valproate release in 0.1N HCl. Further delay in drug release was observed when citric acid was present in a HPMC subcoat or when added to the core pellet formulation. The amount of drug released from coated pellets was a function of the level of citric acid in the pellet core or subcoat and subsequent micro-environmental pH of the pellets. Citric acid exerted a plasticizing effect on the enteric polymer film and improved film formation and polymer coalescence. When greater than 10% (w/w) citric acid was present in the pellets, a decrease in drug content was observed due to the conversion of sodium valproate to the volatile compound, valproic acid. Pellets containing less than 10% (w/w) citric acid maintained potency during processing. |
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Authors:
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L Diane Bruce; Hans-Ulrich Petereit; Thomas Beckert; James W McGinity |
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Publication Detail:
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Type: Comparative Study; Journal Article |
Journal Detail:
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Title: International journal of pharmaceutics Volume: 264 ISSN: 0378-5173 ISO Abbreviation: Int J Pharm Publication Date: 2003 Oct |
Date Detail:
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Created Date: 2003-09-15 Completed Date: 2004-02-20 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7804127 Medline TA: Int J Pharm Country: Netherlands |
Other Details:
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Languages: eng Pagination: 85-96 Citation Subset: IM |
Affiliation:
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Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA. diane.bruce@quintiles.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anticonvulsants
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chemistry* Chemistry, Pharmaceutical Citric Acid / chemistry Drug Compounding Drug Delivery Systems Excipients / chemistry Hydrogen-Ion Concentration Mass Spectrometry Methacrylates / chemistry Microscopy, Electron, Scanning Polymers / chemistry Solubility Tablets, Enteric-Coated Thermogravimetry Time Factors Valproic Acid / chemistry* Water / chemistry |
| Chemical | |
Reg. No./Substance:
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0/Anticonvulsants; 0/Eudragit L 30 D-55; 0/Excipients; 0/Methacrylates; 0/Polymers; 0/Tablets, Enteric-Coated; 77-92-9/Citric Acid; 7732-18-5/Water; 99-66-1/Valproic Acid |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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