Emulsions of highly fluorinated organic compounds
AssigneeHemaGen/PFC
InventorsRobert J. Kaufman, Thomas J. Richard
Life of this patent
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Abstract
Improved emulsions of highly fluorinated organic compounds. The emulsions comprise a highly fluorinated organic compound, an oil, that is not substantially surface active and not significantly water soluble, and a surfactant. They are characterized by a well-defined relationship in the relative amounts of the three components.
Claims9
A contrast agent for biological imaging comprising a physiologically acceptable emulsion in an amount clinically effective for imaging by modalities selected from the group consisting of nuclear magnetic resonance, x-ray, ultrasound and positron emission tomography, wherein the emulsion comprises a highly fluorinated organic compound, an oil that is not substantially surface active and not significantly water soluble, and a surfactant, and wherein
- (a) the highly fluorinated organic compound is present in the emulsion in an amount between about 20% and about 60% by volume and
- (b) the amounts of the surfactant and oil in the emulsion are dependent on the volume percent of highly fluorinated organic compound and are present in amounts effective to produce emulsions characterized by (1) a particle size distribution of less than 400 nm after sterilization, (2) a serum stability characterized by a particle size distribution of less than 400 nm after 5 days in serum or ionic solutions, (3) an LD.sub.50 in rats of at least 16 ml/kg of the highly fluorinated organic compound component of the emulsion, (4) an at least 70% survival upon total exchange in rats, and (5) a shelf stability of at least several months at 4.degree. c.
A contrast agent for biological imaging comprising a physiologically acceptable emulsion in an amount clinically effective for imaging by modalities selected from the group consisting of nuclear magnetic resonance, x-ray, ultrasound and positron emission tomography, wherein the emulsion comprises a highly fluorinated organic compound, an oil that is not substantially surface active and not significantly water soluble, and a surfactant, and wherein
- (a) the highly fluorinated organic compound is present in the emulsion in an amount between about 20% and about 60% by volume and
- (b) the amounts of the surfactant and oil in the emulsion are dependent on the volume percent of highly fluorinated organic compound and are present in amounts effective to produce emulsions characterized by (1) a particle size distribution of less than 300 nm after sterilization, (2) a serum stability characterized by a particle size distribution of less than 300 nm after 5 days in serum or ionic solutions, (3) an LD.sub.50 in rats of at least 16 ml/kg of the highly fluorinated organic compound component of the emulsion, (4) an at least 70% survival upon total exchange in rats, and (5) a shelf stability of at least several months at 25.degree. C.
Dependencies are inferred from the claim text.