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

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.

材料

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品牌

产品描述

11009

Sigma-Aldrich

铝, powder, ≥91% (complexometric)

266558

Sigma-Aldrich

铝, wire, diam. 1.0 mm, 99.999% trace metals basis

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Sigma-Aldrich

铝, granular, <1 mm, 99.7% trace metals basis

326852

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铝, foil, thickness 0.25 mm, 99.999% trace metals basis

266523

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铝, ReagentPlus^®, beads, 5-15 mm, 99.9% trace metals basis

653608

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铝, powder, <5 μm particle size, 99.5% trace metals basis

338788

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铝, pellets, 3-12 mm, 99.99% trace metals basis

266574

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铝, foil, thickness 0.45-0.55 mm, 99.999% trace metals basis

310360

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铝, ACS reagent, 99%, wire, wire diam. ~1.5 mm

326860

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铝, foil, thickness 0.13 mm, ≥99.99% trace metals basis

266515

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铝, ≤30 μm, spherical powder, ≥99%

326887

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铝, wire, diam. 0.58 mm, ≥99.99% trace metals basis

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202584

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铝, powder, <75 μm, ≥99.95% trace metals basis

GF44675781

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266957

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326941

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433705

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铝, sphere, 100pcs, diameter 1.0mm, aluminum alloy 2017 precision sphere, grade 200, 95.2%

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