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Preparation and evaluation of a freeze-dried oral killed cholera vaccine formulation

Författare och institution:
Annika Borde (Institutionen för kemi- och bioteknik, Farmaceutisk teknologi); Anette Larsson (Institutionen för kemi- och bioteknik, Farmaceutisk teknologi); Jan Holmgren (Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi, GU); Erik Nygren (Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi, GU)
Publicerad i:
European journal of pharmaceutics and biopharmaceutics, 79 ( 3 ) s. 508-518
ISSN:
0939-6411
Publikationstyp:
Artikel, refereegranskad vetenskaplig
Publiceringsår:
2011
Språk:
engelska
Fulltextlänk:
Sammanfattning (abstract):
Different oral liquid cholera vaccines have proved to be safe and effective, but their formulations present problems for use in low-income countries, since large package volumes have to be transported and cold chain maintenance is required. A solid state formulation would here be more advantageous, and consequently, the possibility to develop a dry cholera vaccine formulation by freeze-drying was investigated. The ability of sucrose, trehalose and mannitol to provide process stabilization during freeze-drying was tested on a formalin-killed whole-cell Vibrio cholerae model vaccine. A matrix of sucrose or trehalose prevented bacterial aggregation, preserved cell morphology and maintained practically completely the protective lipopolysaccharide (LPS) antigen on the cell surface and its reactivity with specific antibody in vitro. After reconstitution, this formulation also retained the capacity to elicit a strong serum and gut mucosal anti-LPS antibody response in orally immunized mice, as compared to the corresponding liquid vaccine formulation. The full preservation of the in vivo immunogenicity was also maintained when the internationally widely licensed oral cholera vaccine Dukoral (TM), which comprises a cocktail of inactivated V. cholerae together with cholera toxin B-subunit (CTB), was freeze-dried using sucrose for stabilization. Thus, we present a process generating a dry oral inactivated whole-cell cholera vaccine formulation with attractive features for public health use in cholera-afflicted settings.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
NATURVETENSKAP ->
Kemi
MEDICIN OCH HÄLSOVETENSKAP ->
Medicinska grundvetenskaper ->
Farmaceutisk vetenskap ->
Galenisk farmaci
MEDICIN OCH HÄLSOVETENSKAP ->
Medicinska grundvetenskaper ->
Mikrobiologi inom det medicinska området
Nyckelord:
Freeze-drying, Stabilization, Mannitol, Sucrose, Trehalose, Vibrio, cholerae, toxin b-subunit, vibrio-cholerae, field trial, escherichia-coli, immunization, antibodies, bangladesh, membranes, risk, Administration, Oral, Animals, Antibodies, Bacterial, biosynthesis, blood, Calorimetry, Differential Scanning, Chemistry, Pharmaceutical, Cholera Toxin, immunology, Cholera Vaccines, administration & dosage, chemistry, immunology, Enzyme-Linked Immunosorbent Assay, Freeze Drying, Immunoglobulin A, biosynthesis, blood, Intestine, Small, immunology, Lipopolysaccharides, immunology, Mice, Mice, Inbred BALB C, Microscopy, Electron, Scanning, Surface Properties, Technology, Pharmaceutical, Vaccines, Inactivated, administration & dosage, chemistry, immunology, Vibrio cholerae, immunology, X-Ray Diffraction
Chalmers styrkeområden:
Materialvetenskap
Postens nummer:
149507
Ingår i post nr:
Posten skapad:
2011-12-05 14:26
Posten ändrad:
2014-01-14 16:44

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