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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: ashok.hajare@bharatividyapeeth.edu
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: ashok.hajare@bharatividyapeeth.edu
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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