Improving the clarity and sensitization of polysorbate 80 by ultrasonic-assisted ultrafiltration technology

Abstract

The safety problem of injections caused by clarity has lately become a widely shared concern. Due to the synthesis process, polysorbate 80 had a wide molecular weight distribution, which is also related to the clinical anaphylaxis. In this paper, ultrasonic-assisted ultrafiltration (UAU) technology was firstly applied to regulate colloidal structure and remove macromolecules from polysorbate 80 to improve injection clarity. In the separation process, ultrafiltration molecular weight cut off (MWCO), ultrasonic power and polysorbate 80 concentraion were selected as variables to adjust the separation efficiency. The ultrasonic frequency and power were provided by KQ-700DE ultrasonic system, based on the data analysis by response surface methodology (RSM), the optimal UAU parameters were as follows: ultrafiltration MWCO of 50,000, ultrasonic power of 900 W and polysorbate 80 concentration of 15.00 mg/mL. The experimental transmittance of polysorbate 80 was 87.6% and the qualification rate of clarity was 94.5%, which solved the separation contradiction among yield, clarity and safety. As an innovation in colloidal separation fields, UAU had a vast range of prospects for making use in pharmaceutical area.