EMULSIONS OF PERFLUOROCARBONS

1 . An emulsion comprising an amount of a perfluoroearbon liquid dispersed as particles within a continuous liquid phase, wherein the dispersed particles have a monomodal particle size distribution.

2 . The emulsion of claim 1 , containing less than 40 ppm residual fluoride by weight of the emulsion.

3 . The emulsion of claims 1 or 2 , containing less than 7 g/L lysophosphatidylcholine (LPTC or LPC) by weight of the emulsion.

4 . The emulsion of any one of claims 1 - 3 , wherein 90% or more of the total amount by volume of the dispersed particles have a size of less than 700 nm.

5 . The emulsion of any one of claims 1 - 4 , wherein 50% or more of the total amount by volume of the dispersed particles have a size of less than 400 nm.

6 . The emulsion of any one of claims 1 - 5 , wherein the perfluoroearbon is perfluoro(tert-butylcyclohexane), perfluorodecalin, perfluoroisopropyldecalin, perfluorotripropylamine, perfluorotributylamine, perfluoromethylcyclohexylpiperidine, perfluoro-octylbromide, perfluoro-decylbromide, perfluoro-dichlorooctane, perfluorohexane, dodecafluoropentane, or a mixture thereof.

7 . The emulsion of any one of claims 1 - 6 , wherein the perfluoroearbon contains less than 5 ppm residual conjugated olefin by weight of the perfluoroearbon.

8 . The emulsion of any one of claims 1 - 7 , wherein the perfluoroearbon contains less than 20 ppm residual organic hydrogen by weight of the perfluoroearbon.

9 . The emulsion of any one of claims 1 - 8 , wherein the emulsion comprises 20-80% w/v perfluoroearbon.

10 . The emulsion of any one of claims 1 - 9 , further comprising an emulsifier.

11 . The emulsion of claim 10 , comprising 1-10% w/v emulsifier.

12 . The emulsion of any one of claims 1 - 11 , wherein the emulsifier is a surfactant.

13 . The emulsion of claim 12 , wherein the surfactant is egg yolk phospholipid.

14 . The emulsion of any one of claims 1 - 13 , further comprising an aqueous medium.

15 . The emulsion of claim 14 , wherein the aqueous medium is isotonic.

16 . The emulsion of claims 14 or 15 , wherein the aqueous medium is buffered to a pH of 6.8-7.4.

17 . The emulsion of any one of claims 1 - 16 , wherein the emulsion further comprises Vitamin E.

18 . A method of treating sickle cell disease, decompression sickness, air embolism or carbon monoxide poisoning in a subject suffering therefrom comprising administering to the subject the emulsion of any one of claims 1 - 17 effective to treat the subject's sickle cell disease, decompression sickness, air embolism or carbon monoxide poisoning.

19 . A method of preserving an organ prior to transplant comprising contacting the organ with the emulsion of any one of claims 1 - 17 effective to increase the organ's survival time.

20 . A method of treating a wound, a burn injury, acne or rosacea in a subject suffering therefrom comprising topically administering to the skin of the subject the emulsion of any one of claims 1 - 17 effective to treat the subject's wound, burn injury, acne or rosacea.

21 . A method of increasing the firmness of the skin or reducing the appearance of fine lines, wrinkles or scars in a subject comprising topically administering to the skin of the subject the emulsion of any one of claims 1 - 17 effective to increase the firmness of the subject's skin or reduce the appearance of fine lines, wrinkles or scars on the subject's skin.

22 . A method of manufacturing a perfluoroearbon emulsion comprising the steps:

a) mixing an emulsifier and aqueous medium together;

b) adding perfluoroearbon to the mixture of step a);

c) mixing the mixture of step b) to form a coarse emulsion;

d) obtaining a sample of the coarse emulsion of step c) and determining particle size distribution of the sample;

e) if the sample of step d) has a monomodal particle size distribution, then homogenizing the coarse emulsion of step c); and

f) obtaining the emulsion.

23 . The method of claim 22 , wherein in step e) the coarse emulsion of step c) is homogenized only if the median particle size of the sample of step d) is less than 20 μm.

24 . The method of claims 22 or 23 , wherein in step e) the coarse emulsion is homogenized at or above 7,000 psi.

25 . A process for preparing a pharmaceutical product containing a PFC emulsion, the process comprising:

a) obtaining a batch of perfluoroearbon emulsion or coarse emulsion;

b)1) determining the particle size distribution of the batch;

2) determining the total amount of residual fluoride present in the batch; or

3) determining the total amount of lysophosphatidylcholine (LPTC) present in the batch; and

c) preparing the pharmaceutical product from the batch only if 1) the batch is determined to have a monomodal particle size distribution; 2) the batch is determined to have less than 40 ppm residual fluoride by weight of the emulsion; or 3) the batch is determined to have less than 7 g/L lysophosphatidylcholine (LPTC) by weight of the emulsion.

26 . A process for validating a batch of an emulsion for pharmaceutical use, the process comprising:

a)1) determining the particle size distribution of a sample of the batch;

2) determining the total amount of residual fluoride in a sample of the batch; or

3) determining i the total amount of lysophosphatidylcholine (LPTC) in a sample of the batch; and

b) validating the batch for pharmaceutical use only if 1) the sample of the batch has a monomodal particle size distribution; 2) the batch contains less than 40 ppm residual fluoride by weight of the emulsion;

 or 3) the batch contains less than 7 g/L lysophosphatidylcholine (LPTC) by weight of the emulsion.

27 . The process of claims 26 , wherein in steps a)1)-a)3) are performed after the sample of the batch has been subjected to stability testing.