The Industry Standard
Introduced by LIPEX® Biomembranes in 1985, the LIPEX® Extruder is the industry standard for the preparation of laboratory-scale liposome formulations. This 10 mL small-scale unit was supplemented with 100 and 800 mL units to facilitate scale-up and GMP production of early-stage clinical products. Later, 142 and 293 mm stand-alone filter holders were introduced to support large-scale batch preparation under cGMP, using both nitrogen pressure and pharmaceutical-grade pumps.
LIPEX® Extruders generate homogeneous populations of unilamellar vesicles (liposomes) without need for solvents or detergents. A simple, one-step procedure, extrusion produces liposomes by forcing aqueous suspensions of lipid through polycarbonate filters with defined pore size. This relatively gentle process exposes formulations to moderate pressures of 100-700 psi at controlled temperatures, contrasting with homogenization where temperatures fluctuate and pressures often exceed 18,000 psi.
LIPEX Extruders offer advantages over alternative lipid manufacturing strategies:
- manufactured from high grade stainless steel with no moving parts
- readily controlled homogeneous particle size
- achievable high trapping efficiencies
- wide variety of lipid compositions
- no product volume restrictions.
- low operating costs
- easy-to-use equipment
LIPEX® technology is the equipment of choice for seamless scale-up from research to clinical manufacturing.