i used (10% DMSO, 15% Solutol, 75% steril water) as a vehicle to the Fenofibrate and i prepared an emulsified drug delivery solution ... so i would like to ask if there is a requirement to make filtration to the solution ... and if i should make filtration ... how i could avoid the trapping of the droplets within the filter
Thanks in advance
No need to filter..filtration may give you false results due to filter cut off size..
but how i will ensure the sterility of my solution before injecting it intraperitoneally???
If possible, sterilization by gamma rays irradiation is a good alternate.
One practice performed at commercial scale is to formulate the emulsion using sterile filtered raw materials into a pre-sterilized reactor and then use aseptic hollow fiber cross flow filtration to perform the purification/formulation. A large (>200 nm) liposome will not pass a 0.2 micron membrane pore. Typical polymeric MF hollow fiber modules work well, but may be sensitive to high solvent concentrations. Pre-dilution may be required to avoid solvent attack. Pacira has a patent on their process.