Novel process

Abstract

The present invention provides processes for the production of a submicron oil in water emulsion comprising the steps of preparing a submicron oil in water emulsion; pre-filtering the oil in water emulsion through a first sterile grade filter and again filtering the oil in water emulsion through a second sterile grade filter.

1 . A process for the production of a submicron oil in water emulsion comprising the steps:
 a. preparing a submicron oil in water emulsion;   b. pre-filtering the oil in water emulsion through sterile grade filter.   c. filtering an oil in water emulsion filtered according to step b) through a sterile grade filter separate to that of step b).   
     
     
         2 . The process as claimed in  claim 1  comprising the steps:
 a. preparing a submicron oil in water emulsion; 
 b. pre-filtering the oil in water emulsion through sterile grade filter; 
 c. filtering an oil in water emulsion pre-filtered according to step b) through a filter separate to that of step b); and 
 d. filtering an oil in water emulsion filtered according to step c) through a filter separate to that of step b) or c). 
 
     
     
         3 . The process according to  claim 2  comprising the steps;
 a. preparing a submicron oil in water emulsion; 
 b. pre-filtering the oil in water emulsion; 
 c. filtering an oil in water emulsion pre-filtered according to step b) through a sterile grade filter; 
 d. filtering an oil in water emulsion filtered according to step c) through a filter separate to that of step b) or step c); 
 e. filtering an oil in water emulsion filtered according to step d) through a sterile grade filter separate to that of steps b), c) and/or d). 
 
     
     
         4 . The process of any preceding claim where one or more filter membranes comprise polyethersulfone, for example hydrophilic polyethersulfone. 
     
     
         5 . The process of any one of  claims 1  to  4  wherein the sterile grade filter has a pore size of about 0.2 μm, for example 0.22 μm. 
     
     
         6 . The process according to any one of  claim 2 ,  4  or  5  wherein the filter used in step c) has a pose size from between sterile grade to about 2 μm for example about 2 μm, about 1.5 μm, about 1 μm, about 0.9 μm, about 0.8 μm, about 0.9 μm, about 0.7 μm, about 0.6 μm, about 0.5 μm, 0.45 μm or sterile grade for example about 0.2 μm, for example 0.22 μm. 
     
     
         7 . The process of any one of  claims 3  to  5  wherein the filter used in step b) and/or step d) can have pores with the size ranging from sterile grade filter (about 0.2 μm) to about 2 μm, in particular sterile grade filter to about 1 μm, for example, about 2 μm, about 2.5 μm, about 1 μm, about 0.9 μm, about 0.8 μm, about 0.9 μm, about 0.7 μm, about 0.6 μm, about 0.5 μm, 0.45 μm or sterile grade for example about 0.2 μm, for example 0.22 μm. 
     
     
         8 . The process of any preceding claim wherein the differential pressure of each filter is about 1 to about 1.5 bar, for example about 1 bar. 
     
     
         9 . The process of any preceding claim where in filtration is performed between 15° C. and 30° C., 16° C. and 29° C., 17° C. and 28° C., 16° C. and 27° C., 16 ° C. and 28° C. or about 22° C±4° C. 
     
     
         10 . The process according to any preceding claim wherein the oil in water emulsion comprises between 2% and 15% (v/v) oil. 
     
     
         11 . The process of claim wherein the submicron oil in water emulsion comprises between 4% and 6% (v/v) oil. 
     
     
         12 . The process of any preceding claim wherein the oil in water emulsion comprises between 8 and 12% (v/v) oil. 
     
     
         13 . The process according to any preceding claim wherein the submicron oil in water emulsion comprises squalene and one or more surfactants. 
     
     
         14 . The process according to any one of claims wherein the submicron oil in water emulsion comprises squalene, a tocol and a surfactant. 
     
     
         15 . The process of  claim 14  wherein the tocol is α-tocopherol. 
     
     
         16 . The process of any one of  claims 13  to  15  where in the surfactant is polyoxyethylene sorbitan monooleate (TWEEN 80/POLYSORBATE 80). 
     
     
         17 . The process of  claim 16  wherein the submicron oil in water emulsion comprises squalene, polyoxyethylene sorbitan monooleate (TWEEN 80) and sorbitan trioleate (SPAN 85). 
     
     
         18 . The process according to  claim 13  wherein the submicron oil in water emulsion comprises squalene, a polyoxyethylene alkyl ether hydrophilic non-ionic surfactant and a hydrophobic non-ionic surfactant.