The objective of the research was to study the atypical secondary drying dynamics observed during the freeze-drying of a protein formulation containing mannitol, trehalose, and sodium chloride, where “bursts” of water vapor release were observed during secondary drying as detected by comparative pressure measurement. “Thief” samples were removed and examined by X-ray powder diffraction (XRPD) and thermal analysis. The data demonstrated that mannitol crystallized predominantly as its hemihydrate and its crystallinity changed from the hemihydrate form to anhydrous forms during secondary drying. The influence of excipients on the freezing behavior of mannitol hemihydrate was also investigated. Finally, the impact of humidity on the conversion of the hemihydrate was evaluated. Presented by Jayasree Srinivasan, PhD Researcher at R&D group at Baxter BioPharma Solutions
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