- Aluminum adjuvant dose guidelines in vaccine formulation for preclinical evaluations.
Aluminum adjuvant dose guidelines in vaccine formulation for preclinical evaluations.
Journal of pharmaceutical sciences (2011-09-16)
Simone Vecchi, Simone Bufali, David A G Skibinski, Derek T O'Hagan, Manmohan Singh
PMID21918987
ABSTRACT
Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. A table with conversion factors is included in order to provide a tool for calculation of doses with different Al salts.
MATERIALS
Product Number
Brand
Product Description
Sigma-Aldrich
Aluminum, evaporation slug, diam. × L 6.3 mm × 6.3 mm, 99.999% trace metals basis
Aluminum, IRMM®, certified reference material, 1.0 mm foil
Aluminum, IRMM®, certified reference material, 1.0 mm wire
Aluminum, honeycomb, 300x300mm, thickness 5mm, cell size 13mm, cell wall 0.1mm, core density 0.062g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 2 pores/cm, aluminum 6101 grade, 98.5%
Aluminum, honeycomb, 300x300mm, thickness 13.9mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm3, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%
Aluminum, honeycomb, 300x300mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm3, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%
Aluminum, honeycomb, 600x600mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm3, phenolic adhesive (resin), facing skin carbon fiber / epoxy, 99.9%
Aluminum, honeycomb, 300x300mm, thickness 5mm, cell size 19mm, cell wall 0.064mm, core density 0.029g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, foam, 300x400mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, aluminum 6101 grade, 98.5%
Aluminum, honeycomb, 600x600mm, thickness 20mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, honeycomb, 300x300mm, thickness 20mm, cell size 4.8mm, cell wall 0.038mm, core density 0.070g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, honeycomb, 600x600mm, thickness 10mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, honeycomb, 600x600mm, thickness 5mm, cell size 13mm, cell wall 0.1mm, core density 0.062g/cm3, phenolic adhesive (resin), 99.5%
Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 8 pores/cm, aluminum 6101 grade, 98.5%
Aluminum, microfoil, disks, 25mm, thinness 1.0μm, specific density 269.9μg/cm2, permanent mylar 3.5μm support, 99.999%
Aluminum, insulated wire, 2m, conductor diameter 0.1mm, insulation thickness 0.005mm, polyimide insulation, 99.95+%
Aluminum, microleaf disks, 25mm, thinness 0.15μm, specific density 41.28μg/cm2, removable support, 99.999%
Aluminum, microleaf disks, 25mm, thinness 0.25μm, specific density 68.8μg/cm2, removable support, 99.999%
Aluminum, microleaf disks, 25mm, thinness 0.5μm, specific density 120.6μg/cm2, removable support, 99.999%
Aluminum, insulated wire, 1m, conductor diameter 0.1mm, insulation thickness 0.005mm, polyimide insulation, 99.95+%
Aluminum, tube, 0.1m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%
Aluminum, wire reel, 0.5m, diameter 1.0mm, as drawn, 99.999%
Aluminum, mesh, 900x900mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh