Journal of Pharmaceutical Sciences 1999-05-01

Freeze-drying above room temperature.

M S Tesconi, K Sepassi, S H Yalkowsky

Index: J. Pharm. Sci. 88(5) , 501-6, (1999)

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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.


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