Integrating Analytical Procedures in Routine Practices of Centralized Antiblastic Compounding Units for Valorization...

Although extemporaneous formulations of anticancer drug products for personalized therapy are produced according to Good Hospital Pharmacy Manufacturing Practice, the lack of knowledge about drug stability under clinical conditions limits the second-time use of these highly costly medications in clinical practice. Therefore, the residual compounded drugs are considered waste and a cost item that negatively affects the healthcare system. In the context of the ever-increasing interest of the health system in applying practices in line with personalized medicine and spending review policies, this research aimed to demonstrate the feasibility of incorporating analytical techniques into daily routine practice. Specifically, the present research focused on fast stability analysis of Active Pharmaceutical Ingredients (APIs) in antiblastic residual compounded drugs with the purpose of demonstrating their potentialities as a resource for possible second-time use.

Two different subsets of drug products were analyzed, i.e., medicines containing small molecules and medicines containing monoclonal antibodies. In relation to their different physicochemical properties, two analytical approaches were optimized and involved in the stability investigation: HPLC-DAD for small molecules and a combined approach of LC-MS/MS with size exclusion chromatography for monoclonal antibodies analysis.

Results underlined that the stability data, as available in the summary of product characteristics related to each medicine, do not completely describe the physicochemical shelf-life of anticancer compounded drugs.

In fact, for all tested products, our results suggested a longer shelf-life in comparison to the datasheet, giving hospital pharmacists the possibility to extend the clinical use of compounded drugs, improving the cost-benefit of anticancer personalized therapy.