AN IMPROVED LIPOSOME MANUFACTURING PROCESS

THERE EXISTS A NEED FOR LARGE SCALE LIPOSOME MANUFACTURING PROCESSES WHICH CAN MEET THE GROWING MARKET DEMAND FOR LIPOSOMAL DRUG DELIVERY AND CONTROLLED RELEASE VEHICLES WITHIN CONSTRAINTS OF STABILITY, STERILITY AND COST. WE PROPOSE TO DEVELOP AN IMPROVED LARGE SCALE LIPOSOME MANUFACTURING PROCESS. WE PROPOSE TO DO SO BY REPLACING THE ORGANIC SOLVENTS USED IN THE PREPARATION OF LIPOSOMES WITH NEAR CRITICAL OR SUPERCRITICAL FLUID (SCF) SOLVENTS. WE ALSO PLAN TO EVALUATE THE USE OF SCFS AS A REPLACEMENT FOR LIPOSOME MANUFACTURING BY HIGH PRESSURE HOMOGENIZATION. THE DISPLACEMENT OF ORGANIC SOLVENTS WITH SUPERCRITICAL FLUID SOLVENTS IN THE LIPOSOMAL MANUFACTURING PROCESS WILL REDUCE THE DEGRADATION OF THE PHOSPHOLIPIDS AND ENCAPSULATEDTHERAPEUTICS AND ALLOW RAPID SOLVENT SEPARATION, RECOVERY AND REUSE. THERE ARE SEVERAL POTENTIAL BENEFITS TO THE PROPOSED PROCESSES OVER EXISTING LABORATORY AND COMMERCIAL PROCESSES FOR THE PREPARATION OF LIPOSOMES. THE ANTICIPATED BENEFITS ARE: NON-USE OF ORGANIC SOLVENTS; TERMINAL STERILIZATION OF THE MANUFACTURED LIPOSOMES; AN OXYGEN FREE ATMOSPHERE; REPLACEMENT OF SIGNIFICANT HEATING EFFECTS WITH COOLING ONES; LOWER PRESSURE REQUIREMENTS WHEN COMPARED TO HIGH PRESSURE HOMOGENIZATION; LOWER O&M COSTS; HIGHER SPEED OF PROCESSING; THE POTENTIAL FORMATION OF UNIFORM FATMLVS; THE ABILITY TO OPERATE CONTINUOUSLY; ANDSCALABILITY.