Design of the Lyophilization Process of a Doxorubicin Formulation Based on Thermal Properties
Department of Pharmaceutical Technology, Bharati Vidyapeeth College of Pharmacy, Kolhapur-416 013, India
Department of Pharmaceutical Technology, Bharati Vidyapeeth College of Pharmacy, Kolhapur-416 013, India, E-mail: [email protected]
The frontline chemotherapy used for treatment of several forms of cancer is doxorubicin, which is required to be lyophilized due to its limited storage stability. Results from differential thermal analysis/impedance and freeze drying microscopy determinations, signifies that the freezing step product temperature must be well below –59.8°, while throughout the primary drying stage product temperature at sublimation front cannot exceed –19.7°. The use of a procedure based on the critical parameters allowed freeze drying of doxorubicin laboratory scale batches that would help to reduce process cycle time, energy and costs at commercial production.