Emulsions of perfluorocarbons

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.

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.

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.