Long-term physico-chemical stability of diluted trastuzumab

✍ Scribed by Paul, Muriel; Vieillard, Victoire; Da Silva Lemos, Ricardo; Escalup, Laurence; Astier, Alain

• Book ID: 120932238
• Publisher: Elsevier Science
• Year: 2013
• Tongue: English
• Weight: 502 KB
• Volume: 448
• Category: Article
• ISSN: 0378-5173
• DOI: 10.1016/j.ijpharm.2013.02.039

✦ Synopsis

Using several complementary analytical methods, we demonstrated that the monoclonal antibody Trastuzumab (Tz), diluted in 0.9% sodium chloride can be stored in polyolefin infusion bags at 4°C or room temperature up to 6 months with no evidence of chemical or physical instability. No aggregation of Tz was observed and its three dimensional structure remains unaltered. Thus, the practical use of diluted Tz can be safely extended to optimize the workload of centralized preparation units and to minimize costs.