Lipid Emulsion Homogenization

Pharma application - Intravenous

Test report

Test conditions:

Product: Intravenous Lipid nutrition emulsion
Homogenizer type: Panda 2K NS1001L
Options: Second homogenizing stage.

Product preparation:

Composition: Soy oil 10%, Lecithin 1.2%, and water to make a 900ml preparation.

Product preparation: Added lecithin to hot water (75°C) stirring gently, then added 65°C oil to the mixture. Mixed the pre-emulsion with a High Shear Mixer, type IKA T50. The mixer head used: G45F . Operating conditions: 6400 rpm for 3minutes, temperature: 65°C

Homogenization conditions: Inlet temperature is 65°C; the product was homogenized at 1200bar with 50 bar on the second stage. The product has been passed 4 times using the same conditions. The outlet temperature controlled to keep the inlet temperature stable at about 60- 65°C.

Method analysis:

Particle size analyzer: Coulter LS130: A laser diffraction and patented PIDS technology to rapidly determine particle size distribution of materials in an extremely wide dynamic range (0.1-1000um) with high resolution and excellent reproducibility.

Results:

1. Particle size result

The samples were prepared by mixing gently and adding to the vessel. The optical model was one created especially for submicron emulsion based on lecithin.

Intravenous lipid nutrition emulsion

Comments:

A very good result can be achieved by homogenizing the product at 1200/50 for two passages. The 99,77% of particles are below 0,741 um. When the product is passed 4 times the percent is increased at 99,96%.

See the attached table with the statistics of all the runs:

Homogenizer:

The homogenizer used for the treatment is a machine designed for 1200 bar for

• High abrasion
• Low viscosity
• Electropolishing of wetted parts, with a final surface roughness of better than 25 Ra.
• cGMP compliant with Certification Manual for Pharma/Biotech validation