Physicochemical Stability of Nab-Paclitaxel (Pazenir) Infusion Dispersions in Original Glass Vials and EVA Infusion Bags

Background/Objectives: The study objective was to determine the physicochemical stability of nab-paclitaxel (Pazenir) ready-to-use (RTU) dispersion for infusion in original glass vials and ready-to-administer (RTA) infusion dispersion in EVA infusion bags. Methods: Triplicate test dispersions were p...

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Main Authors: Helen Linxweiler (Author), Judith Thiesen (Author), Irene Krämer (Author)
Format: Book
Published: MDPI AG, 2024-10-01T00:00:00Z.
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001 doaj_8d9b1d55d3ef4e9da82895f8d182a6e5
042 |a dc 
100 1 0 |a Helen Linxweiler  |e author 
700 1 0 |a Judith Thiesen  |e author 
700 1 0 |a Irene Krämer  |e author 
245 0 0 |a Physicochemical Stability of Nab-Paclitaxel (Pazenir) Infusion Dispersions in Original Glass Vials and EVA Infusion Bags 
260 |b MDPI AG,   |c 2024-10-01T00:00:00Z. 
500 |a 10.3390/pharmaceutics16111372 
500 |a 1999-4923 
520 |a Background/Objectives: The study objective was to determine the physicochemical stability of nab-paclitaxel (Pazenir) ready-to-use (RTU) dispersion for infusion in original glass vials and ready-to-administer (RTA) infusion dispersion in EVA infusion bags. Methods: Triplicate test dispersions were prepared and stored light protected for a maximum of 28 days either in the original glass vials (RTU) at 2-8 °C or in EVA infusion bags (RTA) at 2-8 °C and at 25 °C. Directly after reconstitution and on days 1, 3, 5, 7, 14, 21, and 28 samples were withdrawn and paclitaxel concentrations assayed by a stability-indicating HPLC method. In parallel, pH and osmolality were measured. In a second series, test dispersions were stored over a 14-day period and inspected daily for visible particles and colour changes. Samples were taken daily for particle size analysis. Integrity and particle size distribution of the nanoparticles were determined by dynamic light scattering (DLS) and albumin monomers, dimers, oligomers, or polymers by size-exclusion-chromatography (SEC). Results: Non-redispersible particles were observed in test dispersions on day 5 (RTA 25 °C), day 7 (RTA 2-8 °C), and day 11 (RTU 2-8 °C). DLS analysis revealed out-of-specification results for the polydispersity index from day 7 (RTA 25 °C) and day 12 (RTU, RTA refrigerated). Paclitaxel concentrations remained >95% of the initial concentrations for 7 days (RTU 2-8 °C, RTA 25 °C) and for 14 days (RTA 2-8 °C). All test dispersions met the specifications regarding the oligomeric status of albumin, pH, and osmolality over the investigation periods. Conclusions: Stability of nab-paclitaxel dispersions is limited by the release of water-insoluble paclitaxel from the nanoparticles and subsequent crystallisation and by formation of insoluble albumin aggregates. Based on our overall results, shelf life of refrigerated RTU and RTA nab-paclitaxel dispersions is limited to 7 days. Shelf life of RTA nab-paclitaxel dispersions stored at room temperature is limited to 4 days. Careful visual inspection of nab-paclitaxel dispersions after reconstitution and prior to administration is highly recommended to detect non-redispersible particles. 
546 |a EN 
690 |a nab-paclitaxel 
690 |a nanoparticles 
690 |a in-use stability 
690 |a parenteral preparation 
690 |a Pharmacy and materia medica 
690 |a RS1-441 
655 7 |a article  |2 local 
786 0 |n Pharmaceutics, Vol 16, Iss 11, p 1372 (2024) 
787 0 |n https://www.mdpi.com/1999-4923/16/11/1372 
787 0 |n https://doaj.org/toc/1999-4923 
856 4 1 |u https://doaj.org/article/8d9b1d55d3ef4e9da82895f8d182a6e5  |z Connect to this object online.