Pharmaceuticals compositions
OwnerChristopher Buchan Jones, John Henry Plattinventors
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Abstract
Pharmaceutical compositions containing 2,6-diisopropylphenol (propofol) are described for use as anesthetics. A method for their preparation is described, as their use in producing anesthesia including induction and maintenance of general anesthesia and sedation.
Claims59
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
A sterile pharmaceutical composition according to any one of claims to 21 to 24 wherein the surfactant is a naturally occurring phosphatide.
A sterile pharmaceutical composition for parenteral administration in the form of an oil-in-water emulsion which comprises:
- a) about 1% by weight of propofol,
- b) about 10% by weight of soy bean oil,
- c) about 1.2% by weight of egg phosphatide,
- d) about 2.25% by weight of glycerol,
- e) about 0.005% by weight of disodium edetate,
- f) sodium hydroxide
- g) water to 100%.
A sterile pharmaceutical composition for parenteral administration in the form of an oil-in-water emulsion which comprises:
- a) about 2% by weight of propofol,
- b) about 10% by weight of soy bean oil,
- c) about 1.2% by weight of egg phosphatide,
- d) about 2.25% by weight of glycerol,
- e) about 0.005% by weight of disodium edetate,
- f) sodium hydroxide
- g) water up to 100%.
A method for limiting the potential for microbial growth in a sterile pharmaceutical composition for parenteral administration which comprises the use of edetate in an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant, wherein the amount of edetate is sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A method for limiting the potential for microbial growth in a sterile pharmaceutical composition for parenteral administration which comprises the use of edetate in an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant, wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
A method for limiting the potential for microbial growth in a sterile pharmaceutical composition for parenteral administration which comprises the use of edetate in an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, wherein the amount of edetate is sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A method for limiting the potential for microbial growth in a sterile pharmaceutical composition for parenteral administration which comprises the use of edetate in an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
A method of improving the time for administration, and/or the time between the changes of giving sets, for an oil-in-water emulsion of propofol by including in said emulsion an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A method of improving the time for administration, and/or the time between the changes of giving sets, for an oil-in-water emulsion of propofol by including in said emulsion edetate in a molar concentration in the range 3×10−5 to 9×10−4.
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination wherein the edetate does not physically destabilise said composition.
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4 and does not physically destabilise said composition.
A sterile, aqueous composition for parenteral administration which comprises an oil-in-water emulsion which is emulsified with water and stabilised by means of a surfactant and which further comprises an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A sterile, aqueous composition for parenteral administration which comprises an oil-in-water emulsion which is emulsified with water and stabilised by means of a surfactant, and which further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
A sterile pharmaceutical composition which comprises an oil-in-water emulsion containing a therapeutic or pharmaceutical agent, in which the agent, either alone or dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant and which further comprises an amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
A sterile pharmaceutical composition which comprises an oil-in-water emulsion containing a therapeutic or pharmaceutical agent, in which the agent, either alone or dissolved in a water-immiscible solvent, is emulsified with water and stabilised by means of a surfactant and which further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range 3×10−5 to 9×10−4.
Dependencies are inferred from the claim text.