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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
摘要

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.

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铝, foil, thickness 0.25 mm, 99.999% trace metals basis
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铝, pellets, 3-12 mm, 99.99% trace metals basis
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铝, evaporation slug, diam. × L 6.3 mm × 6.3 mm, 99.999% trace metals basis
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铝, wire, diam. 0.58 mm, ≥99.99% trace metals basis
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铝, ≤30 μm, spherical powder, ≥99%
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铝, foil, thickness 0.13 mm, ≥99.99% trace metals basis
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铝, pellets, 3-8 mesh, ≥99.999% trace metals basis
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铝, ACS reagent, 99%, wire, wire diam. ~1.5 mm
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铝, rod, diam. × L 3.0 mm × 100 mm, 99.999% trace metals basis
铝, IRMM®, certified reference material, 0.1 mm foil
铝, wire reel, 25m, diameter 0.25mm, as drawn, 99.5%
铝, wire reel, 10m, diameter 0.025mm, as drawn, 99.0+%
铝, honeycomb, 300x300mm, thickness 5mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm3, phenolic adhesive (resin), 99.5%
铝, wire reel, 500m, diameter 0.5mm, as drawn, 99.5%
铝, mesh, 150x150mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh
铝, foam, 150x150mm, thickness 10mm, bulk density 0.2g/cm3, porosity 0.93, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 3.2mm, bulk density 0.2g/cm3, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 30mm, bulk density 0.2g/cm3, porosity 0.93, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 2 pores/cm, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 4 pores/cm, aluminum 6101 grade, 98.5%
铝, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, 8 pores/cm, aluminum 6101 grade, 98.5%
铝, foam, 300x400mm, thickness 6.35mm, bulk density 0.2g/cm3, porosity 0.93, aluminum 6101 grade, 98.5%
铝, foam, 33x140mm, thickness 20mm, bulk density 0.2g/cm3, porosity 0.93, aluminum 6101 grade, 98.5%
铝, honeycomb, 150x150mm, thickness 10mm, cell size 3.2mm, cell wall 0.025mm, core density 0g/cm3, phenolic adhesive (resin), 99.5%
铝, honeycomb, 150x150mm, thickness 52.3mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm3, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%

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