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

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Oncology

Background:

• Extemporaneous anticancer drug formulations are vital for personalized therapy but often discarded due to unknown stability.
• Residual compounded drugs represent significant waste and increased healthcare costs.
• There's a need to integrate analytical techniques for assessing drug stability in clinical practice.

Purpose of the Study:

• To demonstrate the feasibility of using analytical techniques for routine stability analysis of compounded anticancer drugs.
• To assess the stability of Active Pharmaceutical Ingredients (APIs) in residual antiblastic drugs for potential reuse.
• To improve the cost-benefit of personalized anticancer therapy.

Main Methods:

• Analysis of two drug subsets: small molecules and monoclonal antibodies.
• Optimization of High-Performance Liquid Chromatography with Diode-Array Detection (HPLC-DAD) for small molecules.
• Development of a combined Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and size exclusion chromatography approach for monoclonal antibodies.

Main Results:

• Existing stability data in product summaries are insufficient for determining the shelf-life of compounded anticancer drugs.
• Stability testing revealed a longer physicochemical shelf-life for tested compounded drugs than typically stated.
• Analytical methods successfully assessed API stability in residual compounded medications.

Conclusions:

• Hospital pharmacists can extend the clinical use of compounded anticancer drugs based on stability data.
• Implementing routine analytical stability testing enhances the cost-benefit of personalized anticancer therapy.
• This approach reduces pharmaceutical waste and optimizes resource utilization in healthcare.