Methods for producing oil-in-water emulsions

A method for producing an oil-in-water emulsion, comprising a water phase and 1 to 40% of an oil phase, in relation to the total weight of the emulsion, wherein the method comprises the following steps:

• a) providing an oil phase, comprising one or a plurality of oils selected from the group consisting of animal oils, microbially produced oils, algae oils, fungal oils, synthetic or partially synthetic oils and vegetable oils;
• and,
• optionally a pharmaceutically acceptable antioxidant and/or at least one pharmaceutically acceptable co-emulsifier;
• b) providing a water phase 1, comprising water and optionally at least one pharmaceutically acceptable co-emulsifier and/or at least one substance for setting the pH value and/or at least one pharmaceutically acceptable preservative and/or at least one pharmaceutically acceptable isotonic agent, wherein the isotonic agent is present in a concentration of at most 18%, in relation to the total weight of the water phase;
• c) producing a pre-emulsion by mixing the oil phase, provided in step a), with the water phase 1, provided in step b);
• d) producing a first emulsion by homogenizing the pre-emulsion, provided in step c);
• e) providing a water phase 2, comprising water and optionally at least one pharmaceutically acceptable isotonic agent and/or at least one substance for setting the pH value and/or at least one pharmaceutically acceptable preservative;
• f) producing the emulsion by mixing the first emulsion, provided in step d), with the water phase 2, provided in step e);
• and
• g) sterilizing the emulsion, obtained in step f);
• wherein the emulsion is filled into a suitable container before or after being sterilized;
• wherein at least one pharmaceutically acceptable emulsifier is added in step a) and/or in step b);
• and
• wherein the water phase 1, provided in step b), provides no more than 30% of the total amount of water contained in the emulsion.