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FORMULATION DESIGN AND DEVELOPMENT OF LYOPHILZATION CYCLES FOR NOVEL FORMULATION OF PROTEASOME INHIBITOR: BORTEZOMIB
Yaswanth Allamneni*, T.E.G.K Murthy, Mandava Venkata Basaveswara Rao, Y. Udaya Bhaskara Rao
ABSTRACT
is a proteasome inhibitor which acts by binding with the catalytic site of 26s proteasome which leads into arresting of cell cycle. Developing the novel stable lyophilized dosage form over the brand product is the major objective of our study and the main focus is minimize the total drying time without impacting the quality of the drug product. Suitable solvent system and the excipients for the lyophilization process were selected based on the past knowledge in the pre-formulation study of the selected drug candidate. Critical collapse temperature for bortezomib in the selected solvent system was determined and the value was found to be -22°C. Based on the critical temperature, majority of the time the product was sublimated at -30°C Keywords: proteasome inhibitor, critical collapse temperature, pre-formulation study, critical quality attributes and quality target product profile. [Download Article] [Download Certifiate] |