Document Detail

Gamma-irradiation effects on biopharmaceutical properties of PLGA microspheres loaded with SPf66 synthetic vaccine.
MedLine Citation:
PMID:  18280123     Owner:  NLM     Status:  MEDLINE    
Gamma-irradiation is currently the method of choice for terminal sterilization of drug delivery systems made from biodegradable polymers. However, the consequences of gamma-sterilization on the immune response induced by microencapsulated antigens have not yet been reported in the literature. The aim of the present work was to evaluate the effect of gamma-irradiation on the biopharmaceutical properties of PLGA microspheres containing SPf66 malarial antigen. Microspheres were prepared by a (w/o/w) double emulsion/solvent extraction method. Once prepared, part of the formulation was irradiated at a dose of 25 kGy using 60Co gamma as radiation source. The in vitro results obtained showed that the gamma-irradiation exposure had no apparent effect on SPf66 integrity and formulation properties such us morphology, size and peptide loading. Only the release rate of SPf66 was slightly faster after gamma-irradiation. Subcutaneous administration of irradiated and non-irradiated microspheres into mice induced a similar immune response (IgG, IgG1, IgG2a levels) and was comparable to that obtained with SPf66 emulsified with Freund's complete adjuvant. These observations illustrate the applicability of gamma-irradiation as a method of terminal sterilization of microparticulate delivery systems based on chemically synthesized antigens encapsulated into biodegradable PLGA microspheres.
Manoli Igartua; Rosa M A Hernández; Jaiver Eduardo Rosas; Manuel Elkin Patarroyo; José Luís Pedraz
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2007-12-25
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 Jun 
Date Detail:
Created Date:  2008-05-19     Completed Date:  2008-08-29     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  9109778     Medline TA:  Eur J Pharm Biopharm     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  519-26     Citation Subset:  IM    
University of the Basque Country (UPV-EHU), Vitoria-Gasteiz, Spain.
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MeSH Terms
Bacterial Vaccines / administration & dosage*,  chemistry
Calorimetry, Differential Scanning
Chemistry, Pharmaceutical
Chemistry, Physical
Drug Compounding
Gamma Rays
Lactic Acid / chemistry*,  radiation effects*
Mice, Inbred BALB C
Microscopy, Electron, Scanning
Physicochemical Phenomena
Polyglycolic Acid / chemistry*,  radiation effects*
Protozoan Proteins / administration & dosage*,  chemistry
Recombinant Proteins / administration & dosage*,  chemistry
Vaccines, Synthetic / administration & dosage,  chemistry
Reg. No./Substance:
0/Bacterial Vaccines; 0/Excipients; 0/Protozoan Proteins; 0/Recombinant Proteins; 0/SPf66 protein, Plasmodium; 0/Vaccines, Synthetic; 0/polylactic acid-polyglycolic acid copolymer; 26009-03-0/Polyglycolic Acid; 50-21-5/Lactic Acid

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