Circulation of components during microfluidization and/or homogenization of emulsions

a technology of emulsion and microfluidization, which is applied in the direction of antibody medical ingredients, transportation and packaging, rotary stirring mixers, etc., can solve the problems of emulsion degradation during storag

Inactive Publication Date: 2016-04-28
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

Results in a stable oil-in-water emulsion with significantly reduced large oil droplets, enhancing filtration performance and maintaining emulsion stability over time, suitable for use as a vaccine adjuvant.

Problems solved by technology

The larger oil droplets contained in these emulsions may act as nucleation sites for aggregation, leading to emulsion degradation during storage.

Method used

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  • Circulation of components during microfluidization and/or homogenization of emulsions
  • Circulation of components during microfluidization and/or homogenization of emulsions
  • Circulation of components during microfluidization and/or homogenization of emulsions

Examples

Experimental program
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Effect test

example 1

[0208]The emulsion components squalene, polysorbate 80, sorbitan trioleate and sodium citrate buffer were introduced into an in-line, high speed, rotor / stator homogenizer (IKA Super Dispax Reactor DRS 2000 / 5). Emulsion starting volumes of 280 L and 250 L were used and the speed of the homogenizer was set at 5000±1000 rpm. The temperature of the emulsion during homogenization was maintained at below 60° C.

[0209]Three test runs were carried out. In the first test run, 280 L of the emulsion components were subject to type I circulation, between the homogenizer and a first premix container, for 20 minutes followed by a single type II circulation, transferring the first emulsion components from a first premix stainless steel container, through the homogenizer to a second premix stainless steel container, and then back through the homogenizer. In the second test run, 280 L of the emulsion components were subjected to type I circulation, between the homogenizer and a first premix stainless...

example 2

[0216]In further experiments a first emulsion was formed by type I (FIG. 5) or type II (FIG. 6) circulation. For five separate runs the average number of larges particles per ml was as follows:

Coefficient ofMeanvariationType I1.70 × 1090.23Type II1.04 × 1090.13

[0217]Thus the type II circulation results in fewer large droplets and less batch-to-batch variation.

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Abstract

An improved method for the manufacture of an oil-in-water emulsion involves circulation of emulsion components between a first container and a second container via a homogenizer and / or via a microfluidization device. Usefully, all of the emulsion components from the first container are emptied before being returned.

Description

[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 513,564 filed on Jun. 1, 2012, now allowed, which is a 35 U.S.C. §371 National Stage of International Application No. PCT / IB2010 / 003394 entitled “CIRCULATION OF COMPONENTS DURING HOMOGENIZATION EMULSIONS” filed on Dec. 3, 2010, which claims the benefit of and priority to U.S. Provisional Application No. 61 / 283,518 filed Dec. 3, 2009, the complete contents of which are incorporated herein by reference for all purposes.TECHNICAL FIELD[0002]This invention is in the field of manufacturing oil-in-water emulsion adjuvants for vaccines by microfluidization.BACKGROUND ART[0003]The vaccine adjuvant known as ‘MF59’ [1-3] is a submicron oil-in-water emulsion of squalene, polysorbate 80 (also known as Tween 80), and sorbitan trioleate (also known as Span 85). It may also include citrate ions e.g. 10 mM sodium citrate buffer. The composition of the emulsion by volume can be about 5% squalene, about 0.5% Tween 80 and ...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61K9/107A61K39/39
CPCA61K39/39A61K9/107A61K2039/55566A61K9/1075A61P31/16B01F27/2711B01F33/811A61K39/145A61K9/113B01F23/41B01F25/44
InventorRUECKL, HARALDSCHEFFCZIK, HANNOSANTRY, BARBARA
OwnerNOVARTIS AG