Adjusting particle size in fluorocarbon nanoemulsions
Inventors
Unger, Evan C. • Marinelli, Edmund
Assignees
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Publication Number
US-10780060-B2
Publication Date
2020-09-22
Expiration Date
Abstract
The invention provides devices and methods for adjusting particle size in nanoemulsions of fluorocarbons and perfluorocarbons (e.g., perfluoropentane and perfluorohexane) via sonication (e.g., ultrasonication).
Core Innovation
The invention relates to fluorocarbon/perfluorocarbon nanoemulsions, including perfluorocarbon emulsions such as dodecafluoropentane, whose particle size grows out of specification over time. The disclosed problem is that such out-of-specification growth produces mean particle sizes that exceed about 1 micron, which the document describes as requiring correction back to in-spec parameters.
The core inventive concept is to reduce the particle size of an enclosed perfluorocarbon nanoemulsion by applying sonication or ultrasonication for a time duration sufficient to adjust the particle size to a pre-selected value. The approach is applied while the perfluorocarbon emulsion is enclosed in a sealed vial or pre-filled syringe.
The document further states that, after exposure to sonication or ultrasonication, the mean particle size is reduced to less than about 500 nm, including shifting the mean particle size from greater than about 1 micron to less than about 500 nm. The disclosure additionally characterizes the ultrasound as having a frequency range, and reports configurations including inline tubing sonication and device configurations (e.g., VialTweeter and integrated-transducer syringes) for rectifying particle size while emulsions remain contained in sealed containers.
Claims Coverage
The partial content includes one independent claim defining the overall method, with dependent claims adding further constraints on ultrasound frequency and the phospholipid composition and loading of the perfluorocarbon nanoemulsion. The independent claim covers adjusting an out-of-specification perfluorocarbon nanoemulsion particle size within a sealed vial or pre-filled syringe by sonication/ultrasonication to achieve specified before/after mean particle size limits.
Sealed out-of-specification perfluorocarbon nanoemulsion rectification by sonication or ultrasonication
A method for reducing particle size of a perfluorocarbon nanoemulsion that is enclosed in a sealed vial or pre-filled syringe and is out-of-specification due to growth of particle size, comprising applying sonication or ultrasonication for a time duration sufficient to adjust the particle size of the perfluorocarbon emulsion to a pre-selected value.
Phospholipid-containing dodecafluoropentane nanoemulsion with specified concentration and mean size criterion
The perfluorocarbon nanoemulsion comprises one or more phospholipids and the perfluorocarbon is dodecafluoropentane having a concentration from about 2% w/vol to about 10% w/vol, where the mean particle size is greater than about 1 micron prior to exposure and less than about 500 nm after exposure to sonication or ultrasonication.
Collectively, the independent claim defines rectifying the particle size of an out-of-specification, sealed phospholipid-containing dodecafluoropentane nanoemulsion by applying sonication or ultrasonication for a sufficient time to reach a pre-selected particle size, with mean particle size specifically stated as > about 1 micron before and < about 500 nm after. Dependent claims then further specify ultrasound frequency and define phospholipid component mixtures and loading ranges.
Stated Advantages
Adjusts an out-of-specification perfluorocarbon nanoemulsion particle size back from greater than about 1 micron to less than about 500 nm.
Enables particle size rectification while the perfluorocarbon emulsion is enclosed in a sealed vial or pre-filled syringe.
Documented Applications
Ultrasonication of aged perfluorocarbon nanoemulsions in glass vials, including multiple-vial throughput, for rectifying particle size.
On-demand preparation from combined components in sealed containers, including rectifying particle size using sonication/ultrasonication within sealed configurations.
Inline tubing sonication for real-time rectification of particle size.
Use of device configurations (e.g., VialTweeter and integrated-transducer syringes) to improve safety/efficacy and reduce contamination/waste, while emulsions remain contained.
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