Manufacture of surfactant-containing compositions with enhanced stability
Improved methods for the manufacture of pharmaceutical compositions comprising at least one surfactant, involving prefiltration of the surfactant prior to formulation into final products.
1. A process for preparing a pharmaceutically acceptable composition comprising steps of: (a) filtering a polysorbate 80 through a filter membrane having a pore size between 5-50 μm, to provide purified polysorbate 80 as a filtrate; and (b) using the purified polysorbate 80 to formulate the pharmaceutically acceptable composition.
2. The process of claim 1 , wherein the purified polysorbate 80 contains less than 0.85 ppm acetaldehyde.
3. The process of claim 1 , wherein step (a) comprises:
filtering non-aqueous polysorbate 80 through a polypropylene filter having a pore size between 5-50 μm.
4. The process of claim 1 , wherein the purified polysorbate 80 is a bulk preparation of purified polysorbate 80 having a volume of at least 50 liters.