Document Detail


Optimisation of an enteric coated, layered multi-particulate formulation for ileal delivery of viable recombinant Lactococcus lactis.
MedLine Citation:
PMID:  18423993     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Layering of pellets with recombinant Lactococcus lactis Thy 12 was optimised for the production of a dosage form with a high load of viable recombinant L. lactis. Shear stress induced during the atomisation and the type of carrier used for the layering process did not influence the viability. A 5% lactose matrix resulted in the highest viability of L. lactis (8.9+/-1.7%) which could be maintained for at least 12 months at -20 degrees C. A higher bacterial cell load on the pellets was obtained using a longer process time, but the addition of 10% skim milk was essential to maintain the stabilising capacity of the matrix. Increasing the load of viable L. lactis was also possible using a higher bacterial cell concentration of the layering suspension and increasing the amount of stabilising matrix to 10% lactose/20% skim milk, yielding a formulation with 1.7 x 10(9)cfu/100 mg pellets. To protect the bacteria during gastric passage and to obtain ileum targeting, the formulation was enteric coated with 5% Eudragit FS30D, but after coating and gastric residence for 2 h HCl about 1% of the bacteria remained viable. Application of a subcoating, previous to enteric coating, did not result in a higher viability.
Authors:
Nele Poelvoorde; Nathalie Huyghebaert; Chris Vervaet; Jean-Paul Remon
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Publication Detail:
Type:  Journal Article     Date:  2008-02-29
Journal Detail:
Title:  European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V     Volume:  69     ISSN:  0939-6411     ISO Abbreviation:  Eur J Pharm Biopharm     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-04     Completed Date:  2008-10-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9109778     Medline TA:  Eur J Pharm Biopharm     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  969-76     Citation Subset:  IM    
Affiliation:
Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
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MeSH Terms
Descriptor/Qualifier:
Animals
Cellulose
Chemistry, Pharmaceutical
Crohn Disease / therapy
Culture Media
Drug Delivery Systems
Excipients
Humans
Ileum / metabolism*
Interleukin-10 / genetics,  metabolism
Lactococcus lactis / chemistry*
Milk / chemistry
Polymethacrylic Acids
Polyvinyl Alcohol / chemistry
Starch
Stomach / metabolism
Tablets, Enteric-Coated
Thymidine / administration & dosage
Chemical
Reg. No./Substance:
0/Culture Media; 0/Excipients; 0/Polymethacrylic Acids; 0/Tablets, Enteric-Coated; 0/microcrystalline cellulose; 130068-27-8/Interleukin-10; 25086-15-1/methylmethacrylate-methacrylic acid copolymer; 50-89-5/Thymidine; 9002-89-5/Polyvinyl Alcohol; 9004-34-6/Cellulose; 9005-25-8/Starch

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


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