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Oil/surfactant mixtures for self-emulsification

A surfactant, surfactant-free technology applied in the field of oil-in-water emulsions

Pending Publication Date: 2022-01-28
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Attempts to replace squalene with sunflower or soybean oil and polysorbate 80 with polysorbate 20, sodium lauryl sulfate, or polyoxyethylene 10 lauryl ether concluded that the alternative oils tested None were suitable substitutes for squalene, and none of the tested alternative surfactant components were useful

Method used

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  • Oil/surfactant mixtures for self-emulsification
  • Oil/surfactant mixtures for self-emulsification
  • Oil/surfactant mixtures for self-emulsification

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0261] Example 1 - Measurement of the formation and average particle size of the water in milk milk

[0262] Study squalene, mixtures of various proportions of α- tocopherol and polysorbate 80 emulsion droplets ability to form spontaneously when mixed with water.

[0263] method

[0264] Emulsion preparation

[0265] The appropriate proportion of the percentage listed in Table 1 consisting of squalene, D / L-α- tocopherol and polysorbate 80 was stirred at room temperature overnight.

[0266] The Dulbecco's phosphate buffered saline (DPBS) was adjusted to pH 6.65-6.95. The DPBS was then warmed to about 35-40 ℃, after addition of the oil phase (DPBS: Oil 9: 1 v / v ratio). The mixture was kept for about 1 hour at about 40 ℃, periodic reversals of the container.

[0267] Particle measurement

[0268] Emulsions are typically diluted 100X (990uL water emulsion + 10uL), then further diluted 5-fold (400uL water emulsion + 100X dilution) to obtain a 500X dilution. Particle size was...

Embodiment 2

[0277] Example 2 - Test of other surfactants

[0278] Use of alternative surfactants studies to determine the effect on the particle size and PdI.

[0279] method

[0280] Additional formulations are prepared by methods similar to those described in Example 1 was prepared comprising an active component of the alternative surface. A series of surfactants having different HLB values ​​(Table 2).

[0281] Table 2 - The surfactant HLB value and associated

[0282] Surfactant HLB TWEEN 80 / polysorbate 80 15 Tween 20 / polysorbent 20 16.7 Span85 1.8 Span80 4.3 Span20 8.6 TPGS 13-13.2 Poloham 188 29 Poloham 407 22

[0283] result

[0284] Table 3 - Additional tocopherol-containing oil in water emulsion composition and particle size / PdI

[0285]

[0286]

[0287] * All formulations for formulation and 36 a-c,% Surfactant B other than 100% of squalene, a tocopherol, and a surfactant of A. For the preparation of d-f, surfactant ...

Embodiment 3

[0289] Example 3 - Potential use of water-clad oil emulsions as adjuvants

[0290] In vivo tests in mice from Example 1 and 2 of the oil in water emulsion, to demonstrate their use as a vaccine adjuvant. Two studies performed tetravalent H1N1 A / Singapore, A / Hong Kong (H3N2), B / Phuket and B / Brisbane influenza vaccine (QIV) to 0.01 ug (total of 0.04 ug) and 0.1 ug (total 0.4 ug) doses ( Table 4). Also be administered without adjuvant with an antigen or control experiments with known emulsion adjuvants AS03 SEA160 or administered with antigen.

[0291] ELISA IgG subtypes were to evaluate the overall humoral response. Analysis of T cell activation, T cells into CD4 + and CD8 + populations, and generated by activated T cells to determine cell cytokine response.

[0292] method

[0293] For in vivo studies, an emulsifiable concentrate from Example 1 and 2 embodiment using 0.22um PES membrane filter sterilized.

[0294] Emulsifiable concentrate with an equal volume of aqueous an...

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Abstract

Methods of manufacturing squalene and alpha-tocopherol-containing oil-in-water emulsions having small oil droplet particle sizes. Such emulsions being of use as vaccine adjuvants.

Description

Technical field [0001] The present invention relates to an improved method of preparing an α-plasma-containing water-clad oil emulsion containing a small oil droplet size. Such emulsions can be used as a vaccine adjuvant. The invention also relates to an emulsion prepared by an improved method and a composition for the improved method. Background technique [0002] Vaccine adjuvants called 'MF59' (WO90 / 14837; PODDA, 2003; PODDA, 2001) are flagene, polysorbent 80 (also known as Tween 80TM) and sorbitan trisoleate (Also known as SPAN 85TM) submicron water lactilot. It can also include citrate ions, such as 10 mm sodium citrate buffer. The volume of the emulsion may be approximately 5% flachane, about 0.5% polysorbate 80 and about 0.5% sorbitol trisoleate. Adjuvant and its production more detailed Vaccine Design: The Subunit and Adjuvant Approach (Chapter 10), Vaccine Adjuvants: Preparation Methods and Research Protocols (Chapter 12) and New generation Vaccines (Chapter 19). For...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39
CPCA61K39/39A61K2039/55555A61K2039/55566A61K47/06A61K47/22
Inventor R·洛达亚M·阿米吉D·奥哈根
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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