PT - JOURNAL ARTICLE AU - Williams, N. Adeyinka AU - Schwinke, David L. TI - Low Temperature Properties of Lyophilized Solutions and Their Influence on Lyophilization Cycle Design: Pentamidine Isethionate DP - 1994 May 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 135--139 VI - 48 IP - 3 4099 - http://journal.pda.org/content/48/3/135.short 4100 - http://journal.pda.org/content/48/3/135.full SO - PDA J Pharm Sci Technol1994 May 01; 48 AB - Pentamidine isethionate is a lyophilized antiprotozoal drug. Its solutions, when lyophilized, have been found to exhibit a range of properties that depend on its concentration and the manner in which it is allowed to freeze. These properties were examined by Differential Scanning Calorimetry (DSC), freeze-drying microscopy and X-ray powder diffraction. In DSC studies, the drug exhibited eutectic behavior with a eutectic temperature of –2.8°C. Freeze-drying microscopic examination of a sample of solution after cooling at about 1°C/min showed that the sample dried with retention up to –4°C, where melting was observed. By using the appropriate drug concentration and manipulating the freezing stage, crystallization of the drug from solution could be induced during cooling to yield a crystalline end-product.