While water is the solvent of choice for the lyophilization of pharmaceuticals, the addition of an organic co-solvent can confer several advantages including increased solubility of hydrophobic drugs, decreased drying time, improved product stability, and reconstitution characteristics. The objective of this webinar is to demonstrate the utility of tertiary-butyl alcohol (TBA), a popular co-solvent for freeze-drying applications. Using a combination of synchrotron X-ray diffractometry and differential scanning calorimetry, the temperature and composition of TBA hydrate-water eutectic were identified. In protein formulations, a cryoprotectant is generally added to impart stability. Mannitol, a popular and widely used bulking agent when added to TBA-water systems was retained amorphous during freezing. Amorphous excipients can provide the necessary cryoprotection during freezing. Interestingly, mannitol crystallized as the anhydrous δ-polymorph in the final lyophile. The ability of mannitol to serve as a cryoprotectant in frozen solutions, and as a bulking agent in the lyophilized product was demonstrated using human serum albumin (HSA) as the model protein. This dual functionality of mannitol in presence of TBA provides a potential avenue for the use of organic co-solvents in frozen and freeze-dried formulations. Presented by Dr. Jayesh Sonje, PhD of the University of Minnesota
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