Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 104, Issue 4, Pages 1352-1361Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.24337
Keywords
vaccines; vaccine adjuvants; squalene; emulsion; particle size; formulation; self-emulsifying; physical characterization
Funding
- Novartis Vaccines
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Microfluidization is an established technique for preparing emulsion adjuvant formulations for use in vaccines. Although this technique reproducibly yields high-quality stable emulsions, it is complex, expensive, and requires proprietary equipment. For this study, we developed a novel and simple low shear process to prepare stable reproducible emulsions without the use of any proprietary equipment. We found this process can produce a wide range of differently sized emulsions based on the modification of ratios of oil and surfactants. Using this process, we prepared a novel 20-nm-sized emulsion that was stable, reproducible, and showed adjuvant effects. During evaluation of this emulsion, we studied a range of emulsions with the same composition all sized below 200; 20, 90, and 160 nm in vivo and established a correlation between adjuvant size and immune responses. Our studies indicate that 160-nm-sized emulsions generate the strongest immune responses. (C) 2015 Wiley Periodicals, Inc. and the American Pharmacists Association
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