PT - JOURNAL ARTICLE AU - Jang, Jouhn-Wern AU - Kitamura, Satoshi AU - Guillory, J. Keith TI - The Effect of Excipients on Glass Transition Temperatures for FK906 in the Frozen and Lyophilized States DP - 1995 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 166--174 VI - 49 IP - 4 4099 - http://journal.pda.org/content/49/4/166.short 4100 - http://journal.pda.org/content/49/4/166.full SO - PDA J Pharm Sci Technol1995 Jul 01; 49 AB - FK906, a tripeptide, has been used as a model compound to study the effect of excipients on the glass transition temperature for peptides and related compounds in the frozen solution and lyophilized states. Three kinds of excipients were chosen for study, low molecular weight sugars, high molecular weight polymers and salts. Our results indicate that the Gordon-Taylor equation can be used to predict the glass transition temperature of FK906 in the presence of sucrose, lactose, trehalose and maltose in the frozen solutions and in lyophilized products. Dextrans having different molecular weights can have different effects on the glass transition temperature of FK906 in the frozen state. Cooling rate can also have an effect on the glass transition temperature for FK906 frozen solutions in the presence of dextran. Finally, salts have a significant effect on the glass transition temperature of FK906 in the frozen state but not in lyophilized FK906. Funding for this Grant was provided by: The P.D.A. Foundation for Pharmaceutical Sciences, The Kapoor Charitable Foundation and Schering-Plough Corporation.