Registered since 1993 (NL), paclitaxel concentrate for solution for infusion has become a key chemotherapeutical agent against several tumours, e.g. breast cancer. Due to its insolubility in water, paclitaxel concentrate contains Cremophor EL and dehydrated ethanol as solvents instead. These solvents may cause adverse effects, like hypersensitivity reactions, therefore requiring glucocorticoids and antihistamines for premedication. Moreover, administration of paclitaxel concentrate requires non-PVC infusion sets. In 2008 first-in-class powder for dispersion for infusion nanoparticle albumin-bound (nab)-paclitaxel was registered. In 2019 TEVA launched the first generic nab-paclitaxel, manufactured in Haarlem, The Netherlands. nab-Paclitaxel does not require anti-allergic premedication, is infused as an aqueous nanosuspension and is appreciated as a valuable medicine in the treatment of metastatic breast cancer and other . Furthermore, nab-paclitaxel was reported to have pharmacokinetic advantages over organic solvent-based paclitaxel .
nab-Paclitaxel compounding will be presented high-level: addition of paclitaxel organic solution to aqueous albumin solution and subsequent homogenization leads to formation of a nano-emulsion; rapid dilution with saline results in the nanosuspension, mean diameter: 130 nm particles, where paclitaxel is non-covalently bound to albumin; organic solvent is removed by evaporation and aqueous saline rinsing (using Tangential Flow Filtration). Equipment setup as well as parameter checks during compounding will be presented.
1 Arpino G et al. Tailoring dose schedule of nab-paclitaxel in metastatic breast cancer according to patient and disease characteristics: Recommendations from a panel of experts. CritRevOncol/Hematol 2016;99:81-90.
2 Yardley DA. nab-Paclitaxel mechanisms of action and delivery. J Controlled Rel 2013;170:365-72.