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Freeze-drying above room temperature
M S Tesconi1, K Sepassi, S H Yalkowsky
1Department of Pharmaceutical Science, College of Pharmacy, University of Arizona, Tucson, Arizona 85721, USA.
Abstract:
This study investigates the use of solid, organic compounds to lyophilize drugs without conventional freeze-drying equipment. The aim of the investigation is to find a pharmaceutically acceptable solvent or solvent combination that is appropriate for freeze-drying on the basis of its ability to (1) solubilize hydrophobic drugs, (2) provide a stable environment for water-sensitive compounds, (3) be rapidly and completely removed from the product under vacuum, and (4) produce cakes that are readily reconstituted. A eutectic formed from 1,1,1-trichloro-2-methyl-2-propanol (chlorobutanol) hemihydrate and dimethyl sulfone (DMSO2) is determined to be a suitable medium.