I tried sonication and extrusion on a laboratory scale. I want to look at unilamellar vesicles and industrially produce them. I've seen a few methods for them but I have not got enough experience with them.
Hey Bilal
What methods have you seen for large scale production and what volume are we talking about? What volumes have you used before for laboratory scale production?
There is an industrial extrusion apparatus on the market that operates with nitrogen gas instead of syringes. I have to dig into my files to find the company link. Will post it later. This way however you can extrude up to 15 ml of liposome solution at once. For liposome formation you probably should use a rotary evaporator and use larger volume round bottom flasks to create your lipid film. That way I guess you could end up with up to 30 ml of liposome solution depending on the desired concentration of course
Well, previous suggestion (NL) is good but only on "preclinical" scale. We have in our lab 900 ml NL extruder and with repeated use it can deliver 3 liters of liposomal suspension per day. These extruders are not designed for continous production. When the membrane gets stuck (to large liposomes used for calibration to very small or to high concentration of lipids) you have to disassembly the setup and replace membranes. From the point of view of GMP and sterility it is a real weakness. Industrially the "on line" processing is used. The setup is more facilitated and has a feature to respond to clogging. When the back presure raises it reverses the flow of the fluid for unclogg membrane. But also there are some systems using sintered ceramic large area "membranes" that are more resistant to these processes, however the size distribution is broader. There are also systems using no membranes but hydrodynamic laws (splitting and joining streems of fluid at high pressure) but I have not yet met them and have no idea about homogeneity (size distribution) of resulted liposomes. The cooling of the system is also crucial in that systems.
So, by the time (for clinical application) the discontinuous extrusion seems to be one of the simplest and the best.
If you need liposomes for external applications (eg. dermatology or other external applications, oral applications) even high speed homogenizer could be fine.
You can refer to the preparation process of Caelyx(Doxorubicin Hydrochloride Liposome).
Dear Micheal and Mr. Kozubek ,
Thanks for your fruitful suggestions. I ll attitude your words, Best regards
I would be interested in this procedure. Couls you pass the reference?
Cheers
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