Evaluation of monoclonal antibody formulation propensity for dripping at the filling nozzle tip end.

Nonionic surfactants are commonly used as excipients in monoclonal antibody formulations. The interfacial activity of surfactants may contribute to the elongation of solution droplets at the filling nozzle tip end, leading to dripping that may impact dose accuracy and process consistency. Axisymmetric drop shape analysis was used to evaluate the propensity of monoclonal antibody solution droplets for elongation in the presence of a nonionic surfactant (polysorbate 20, polysorbate 80, poloxamer 188, Brij®35, Brij®58 or FM1000).

Development of Inherently Flame-Retardant Phosphorylated PLA by Combination of Ring-Opening Polymerization and Reactive Extrusion.

In this study, a highly efficient flame-retardant bioplastic poly(lactide) was developed by covalently incorporating flame-retardant DOPO, that is, 9,10-dihydro-oxa-10-phosphaphenanthrene-10-oxide. To that end, a three-step strategy that combines the catalyzed ring-opening polymerization (ROP) of L,L-lactide (L,L-LA) in bulk from a pre-synthesized DOPO-diamine initiator, followed by bulk chain-coupling reaction by reactive extrusion of the so-obtained phosphorylated polylactide (PLA) oligomers (DOPO-PLA) with hexamethylene diisocyanate (HDI), is described. The flame retardancy of the phosphorylated PLA (DOPO-PLA-PU) was investigated by mass loss cone calorimetry and UL-94 tests.