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

التفاصيل البيبلوغرافية
العنوان: Improving the clarity and sensitization of polysorbate 80 by ultrasonic-assisted ultrafiltration technology
المؤلفون: Zhi Xinglei, Cunyu Li, Yun Ma, Guo-Ping Peng, Li Ma
المصدر: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 159
سنة النشر: 2020
مصطلحات موضوعية: Technology, Materials science, Ultrafiltration, Pharmaceutical Science, Polysorbates, 02 engineering and technology, 030226 pharmacology & pharmacy, Polyvinyl alcohol, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, law, Ultrasonic assisted, Ultrasonics, Response surface methodology, Process engineering, business.industry, 021001 nanoscience & nanotechnology, Separation process, Molecular Weight, chemistry, CLARITY, Ultrasonic sensor, 0210 nano-technology, business, Molecular weight cut-off
الوصف: 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.
تدمد: 1879-0720
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d916db25ddd32f2da9dabd980107a2af
https://pubmed.ncbi.nlm.nih.gov/33465475
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....d916db25ddd32f2da9dabd980107a2af
قاعدة البيانات: OpenAIRE