Pharmaceutical compositions of propofol and edetate
DCFirst Claim
1. A method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering to said animal in need thereof an anaesthetically effective amount of a sterile pharmaceutical composition 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 composition further comprises an amount of edetate sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20°
- 14 25°
C., whereafter said aliquots are incubated at 20°
-25°
C. for 24 hours and thereafter tested for viable counts of said organism, said amount of edetate being no more than 0.1% by weight of said composition.
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Accused Products
Abstract
Pharmaceutical compositions containing 2,6-diisopropylphenol (propofol) are described for use as anaesthetics.
A method for their preparation is described, as their use in producing anaesthesia including induction and maintenance of general anaesthesia and sedation.
140 Citations
37 Claims
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1. A method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering to said animal in need thereof an anaesthetically effective amount of a sterile pharmaceutical composition 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 composition further comprises an amount of edetate sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20°
- 14 25°
C., whereafter said aliquots are incubated at 20°
-25°
C. for 24 hours and thereafter tested for viable counts of said organism, said amount of edetate being no more than 0.1% by weight of said composition. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 34, 35)
- 14 25°
- 16. A method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering to said animal in need thereof an anaesthetically effective amount of a sterile pharmaceutical composition 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 composition further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range of from 3×
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36. A method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering to said animal in need thereof an anaesthetically effective amount of a sterile pharmaceutical composition which comprises an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, and which composition further comprises an amount of edetate sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20°
- -25°
C., whereafter said aliquots are incubated at 20°
-25°
C. for 24 hours and thereafter tested for viable counts of said organism, said amount of edetate being no more than 0.1% by weight of said composition.
- -25°
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37. A method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering to said animal in need thereof an anaesthetically effective amount of a sterile pharmaceutical composition which comprises an oil-in-water emulsion in which propofol is emulsified with water and stabilised by means of a surfactant, and which composition further comprises an amount of edetate wherein the amount of edetate is a molar concentration in the range of from 3×
- 10-5 to 9×
10-4.
- 10-5 to 9×
Specification