Formulation and Stability of Doxorubicin-Albumin Gel: Implication for Cancer Therapy

Albumin hydrogels have emerged as promising nanoparticle-based systems for the delivery of anticancer drugs. Gel formation is achieved by modulating factors such as pH, temperature, ionic strength, and albumin concentration, which influence the ionic crosslinking behavior of albumin. Our previous work demonstrated that divalent cations significantly enhance the formation of clear, transparent albumin gels at lower temperatures compared to monovalent cations. The sol–gel transition of thermally denatured albumin is temperature-dependent, shifting from a soluble form to a structured gel network. In this study, injectable doxorubicin (DOX)-loaded albumin hydrogels were formulated using monovalent cations (NaCl) to investigate controlled drug release and stability over 37 days. A robust, stability-indicating HPLC method was developed and validated for interday and intraday specificity to quantify doxorubicin within the gel matrix. Using this method, we successfully established the 1-month stability profile of DOX-albumin hydrogels.