Development of pharmaceutical compositions based on animal and plant-derived squalene
Abstract
Objective: This study aimed to develop and evaluate stable pharmaceutical compositions based on squalene derived from both animal (shark liver) and plant (amaranth oil) sources.
Methods: Oil-in-water nanoemulsions were prepared and stored at 4 °C for six months to evaluate stability. Key stability parameters, including droplet size and zeta potential, were determined using Dynamic Light Scattering (DLS). The immunogenicity of VLP-based rotavirus vaccine formulations containing these adjuvants was evaluated in a guinea pig model. Humoral and cellular immune responses were quantified using Enzyme-Linked Immunosorbent Assay (ELISA) for IgG titers, Neutralization Assays (NA) for virus-neutralizing activity, and the Lymphocyte Blast Transformation Reaction (LBTR) to assess cell-mediated immunity.
Results: Both formulations exhibited high stability at 4 °C. Mean droplet diameters were 157 ± 3 nm (animal-derived) and 149 ± 3 nm (plant-derived), which were smaller than the commercial reference (174 ± 4 nm). Zeta potential values (-35 to -39 mV) confirmed robust colloidal stability. Immunization elicited potent responses; no statistically significant differences were observed between the two squalene sources regarding specific IgG titers (GM = 126 267) or virus-neutralizing activity (VNA GM = 640 vs 452.5, p > 0.05). Cellular immunity was induced by both adjuvants, yielding Proliferation Stimulation Index (PSI) values of 3.11 for the plant-derived formulation and 2.10 for the animal-derived variant.
Conclusion: Plant-derived squalene from amaranth oil is a highly effective, sustainable alternative to shark-derived components, providing comparable stability and immunogenic potency for vaccine delivery.
Keywords: pharmaceutical compositions, adjuvants, squalene, amaranth oil, nanoemulsions, virus-like particles, VLPs, vaccine formulations.
Keywords:
pharmaceutical compositions, adjuvants, squalene, amaranth oil, nanoemulsions, virus-like particles, VLPs, vaccine formulationsDOI
https://doi.org/10.22270/jddt.v16i6.7577References
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Copyright (c) 2026 Maria M. Silaenkova , Timur M. Garaev; Ilya I. Yudin; Oleg V. Ledenev , Olesya V. Eliseeva, Oleg E. Latyshev, Anton V. Syroeshkin , Tatyana V. Grebennikova
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