Rubrik: Originale
(Treffer aus pharmind, Nr. 08, Seite 1064 (2020))
ter Mors B | Pemp D | Lehmann L | Lorson T | Meinel L
Comparison of polysorbate 20 qualities / ter Mors et al. • Polysorbate 20 qualities · ter Mors B, Pemp D, Lehmann L, Lorson T, Meinel L · Institute for Pharmacy and Food Chemistry, University of Würzburg, Würzburg und
polysorbate 20 dynamic light scattering fatty acid critical micelle concentration Polysorbates (PS) are frequently used as solubilizing and emulsifying excipients in various pharmaceutical formulations, for their low critical micelle concentration (CMC), low toxicity and high hydrophilic-lipophilic balance [ 1 – 3 ]. The European Pharmacopoeia (Ph. Eur.) details four PS monographs (PS 20, 40, 60, and 80) with PS20 playing a major role in biopharmaceutical product formulations [ 4 ], stabilizing biopharmaceutical products during processing against protein aggregation during manufacture, or aggregation during reconstitution. PS20 concentrations in biopharmaceutical products typically range between 0.01 to 1 mg/mL [ 5 – 7 ]. ...