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US 9,750,690 B2Granted
Circulation of components during microfluidization and/or homogenization of emulsions
AssigneeNovartis AG
InventorsHarald Rueckl, Hanno Scheffczik, Barbara Santry
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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.
Claims14
A method for a large-scale manufacture of a uniform oil-in-water emulsion, the method comprising steps of:
- providing a first emulsion;
- passing the first emulsion through a device at least two times, wherein the device operates under high pressure and high velocity sufficient to reduce the average size of oil droplets in the first emulsion so as to form a second emulsion;
- and,
- filtering the second emulsion with an asymmetric hydrophilic membrane so as to form a uniform oil-in-water emulsion, characterized in that the average oil droplet size is 220 nm or less and the number of oil droplets having a size>1.2 μm is 5×108/ml or less, and wherein the uniform oil-in-water emulsion has a volume more than or equal to 50 liters.
1 more element
A method for a large-scale manufacture of a pharmaceutical composition, the method comprising steps of:
- providing a first emulsion;
- passing the first emulsion through a device at least two times, wherein the device operates under high pressure and high velocity sufficient to reduce the average size of oil droplets in the first emulsion so as to form a second emulsion;
- filtering the second emulsion with an asymmetric hydrophilic membrane so as to form a uniform oil-in-water emulsion, characterized in that the average oil droplet size is 220 nm or less and the number of oil droplets having a size>1.2 μm is 5×108/ml or less, and wherein the
- uniform oil-in-water emulsion has a volume more than or equal to 50 liters;
- adding to the uniform oil-in-water emulsion one or more components to form a pharmaceutical composition comprising the oil-in-water emulsion.
2 more elements
Dependencies are inferred from the claim text.