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Claims for Patent: 5,714,520

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Claims for Patent: 5,714,520

Title: Propofol compostion containing edetate
Abstract:Sterile pharmaceutical compositions for parenteral administration containing 2,6-diisopropylphenol (propofol) are described for use as anesthetics. The compositions comprise an oil-in-water emulsion of propofol additionally containing a amount of edetate sufficient to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination.
Inventor(s): Jones; Christopher Buchan (Prestbury, GB), Platt; John Henry (Congleton, GB)
Assignee: Zeneca Limited (London, GB)
Application Number:08/408,707
Patent Claims: 1. 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 stabilized by means of a surfactant, and which 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.degree.-25.degree. C., whereafter said aliquots are incubated at 20.degree.-25.degree. C. and are tested for viable counts of said organism after 24 hours, said amount of edetate being no more than 0.1% by weight of said composition.

2. A sterile pharmaceutical composition according to claim 1 wherein the edetate is disodium edetate.

3. A sterile pharmaceutical composition according to claim 1 which comprises up to about 30% by weight of water-immiscible solvent.

4. A sterile pharmaceutical composition according to claim 3 which comprises from about 10% to about 20% by weight of water-immiscible solvent.

5. A sterile pharmaceutical composition according to claim 1 wherein the water-immiscible solvent is a vegetable oil or ester of a fatty acid.

6. A sterile pharmaceutical composition according to claim 5 wherein the vegetable oil is soy bean oil.

7. A sterile pharmaceutical composition according to claim 1 wherein the surfactant is a naturally occurring phosphatide.

8. A sterile pharmaceutical composition according to claim 7 wherein the phosphatide is egg phosphatide or soya phosphatide.

9. A sterile pharmaceutical composition according to claim 1 wherein the pH is between about 6.0 and about 8.5.

10. A sterile pharmaceutical composition according to claim 9 wherein sodium hydroxide is present.

11. A sterile pharmaceutical composition according to claim 1 which is isotonic with blood.

12. A sterile pharmaceutical composition according to claim 11 which is made isotonic with blood by incorporation of glycerol.

13. A sterile pharmaceutical composition according to claim 1 which comprises from about 1% to about 2% by weight of propofol.

14. A sterile pharmaceutical composition according to claim 13 which contains about 1% by weight of propofol.

15. A sterile pharmaceutical composition according to claim 13 which contains about 2% by weight of propofol.

16. 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.times.10.sup.-5 to 9.times.10.sup.-4.

17. A sterile pharmaceutical composition according to claim 16 wherein the amount of edetate is a molar concentration in the range 3.times.10.sup.-5 to 7.5.times.10.sup.-4.

18. A sterile pharmaceutical composition according to claim 17 wherein the amount of edetate is a molar concentration in the range 1.5.times.10.sup.-4 to 3.0.times.10.sup.-4.

19. A sterile pharmaceutical composition according to claim 18 wherein the amount of edetate is a molar concentration of about 1.5.times.10.sup.-4.

20. A sterile pharmaceutical composition according to any one of claims 16 to 19 wherein the source of edetate is disodium edetate.

21. A sterile pharmaceutical composition according to claim 16 which comprises up to about 30% by weight of water-immiscible solvent.

22. A sterile pharmaceutical composition according to claim 21 which comprises from about 10% to about 20% by weight of water-immiscible solvent.

23. A sterile pharmaceutical composition according to any one of claims 16 to 19 wherein the water-immiscible solvent is a vegetable oil or ester of a fatty acid.

24. A sterile pharmaceutical composition according to claim 23 wherein the vegetable oil is soy bean oil.

25. A sterile pharmaceutical composition according to any one of claims to 16 to 19 wherein the surfactant is a naturally occurring phosphatide.

26. A sterile pharmaceutical composition according to claim 25 wherein the phosphatide is egg phosphatide or soya phosphatide.

27. A sterile pharmaceutical composition according to any one of claims 16 to 19 wherein the pH is between about 6.0 and about 8.5.

28. A sterile pharmaceutical composition according to claim 27 wherein sodium hydroxide is present.

29. A sterile pharmaceutical composition according to any one of claims 16 to 19 which is isotonic with blood.

30. A sterile pharmaceutical composition according to claim 29 which is made isotonic with blood by incorporation of glycerol.

31. A sterile pharmaceutical composition according to any one of claims 16 to 19 which comprises from about 1% to about 2% by weight of propofol.

32. A sterile pharmaceutical composition according to claim 31 which contains about 1% by weight of propofol.

33. A sterile pharmaceutical composition according to claim 31 which contains about 2% by weight of propofol.

34. 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%.

35. 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%.

36. A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol is emulsified with water and stabilized by means of a surfactant, and which 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.degree.-25.degree. C., whereafter said aliquots are incubated at 20.degree.-25.degree. C. and are tested for viable counts of said organism after 24 hours, said amount of edetate being no more than 0.1% by weight of said composition.

37. 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.times.10.sup.-5 to 9.times.10.sup.-4.

38. 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 stabilized by means of a surfactant, and which 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.degree.-25.degree. C., whereafter said aliquots are incubated at 20.degree.-25.degree. C. and are tested for viable counts of said organism after 24 hours, said amount of edetate being no more than 0.1% by weight of said composition, wherein the edetate does not physically destabilise said emulsion.

39. 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.times.10.sup.-5 to 9.times.10.sup.-4 and does not physically destabilise said composition.
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