Abstract

Design of the Lyophilization Process of a Doxorubicin Formulation Based on Thermal Properties

Author(s): A. A. Hajare* and H. N. More
Department of Pharmaceutical Technology, Bharati Vidyapeeth College of Pharmacy, Kolhapur-416 013, India

Correspondence Address:
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.



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