Inulin glasses for the stabilization of therapeutic proteins

Ablett, 1993, 189 Cardona, 1997, Thermal stability of invertase in reduced-moisture amorphous matrices in relation to glassy state and trehalose crystallization, J. Food Sci., 62, 105, 10.1111/j.1365-2621.1997.tb04378.x Carpenter, 1997, Rational design of stable lyophilized protein formulations: some practical advice, Pharm. Res., 14, 969, 10.1023/A:1012180707283 Colaco, 1992, Extraordinary stability of enzymes dried in trehalose: simplified molecular biology, Bio-Technol., 10, 1007, 10.1038/nbt0992-1007 Colaco, 1994, Chemistry of protein stabilization by trehalose, ACS Symp. Ser., 567, 222, 10.1021/bk-1994-0567.ch014 Costantino, 1998, Effect of mannitol crystallization on the stability and aerosol performance of spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody, J. Pharm. Sci., 87, 1406, 10.1021/js9800679 Crowe, 1996, Is trehalose special for preserving dry biomaterials, Biophys. J., 71, 2087, 10.1016/S0006-3495(96)79407-9 Ding, 1996, Vitrification of trehalose by water loss from its crystalline dihydrate, J. Therm. Anal., 47, 1391, 10.1007/BF01992835 Duddu, 1997, Effect of glass transition temperature on the stability of lyophilized formulations containing a chimeric therapeutic monoclonal antibody, Pharm. Res., 14, 591, 10.1023/A:1012144810067 Ford, 1993, The adverse effect of glycation of human serum albumin on its preservative activity in the freeze-drying and accelerated degradation of alkaline phosphatase, J. Pharm. Pharmacol., 45, 900, 10.1111/j.2042-7158.1993.tb05617.x Ford, 1993, The effect of carbohydrate additives in the freeze-drying of alkaline phosphatase, J. Pharm. Pharmacol., 45, 86, 10.1111/j.2042-7158.1993.tb03689.x Franks, 1990, Freeze drying: from empiricism to predictability, Cryo-Lett., 11, 93 Franssen, 1997, Delayed release of a model protein from enzymatically-degrading dextran hydrogels, J. Control. Release, 44, 237, 10.1016/S0168-3659(96)01527-1 Her, 1994, Measurement of glass transition temperatures of freeze-concentrated solutes by differential scanning calorimetry, Pharm. Res., 11, 54, 10.1023/A:1018989509893 Iglesias, 1997, Adsorption isotherm of amorphous trehalose, J. Sci. Food Agr., 75, 183, 10.1002/(SICI)1097-0010(199710)75:2<183::AID-JSFA860>3.0.CO;2-T Izutsu, 1994, Physical stability and protein stability of freeze-dried cakes during storage at elevated temperatures, Pharm. Res., 11, 995, 10.1023/A:1018931319772 Jang, 1995, The effect of excipients on glass transition temperatures for FK906 in frozen and lyophilized states, PDA J. Pharm. Sci. Technol., 49, 166 Li, 1996, Effects of reducing sugars on the chemical stability of human relaxin in the lyophilized state, J. Pharm. Sci., 85, 873, 10.1021/js950456s Luckel, 1997, A strategy for optimization the lyophilization of biotechnological products, Pharm. Sci., 3, 3 Mazzobre, 1997, Glass transition and thermal stability of lactose in low-moisture amorphous polymeric matrices, Biotechnol. Progr., 13, 195, 10.1021/bp9700014 Mazzobre, 1997, Protective role of trehalose on the thermal stability of lactase in relation to its glass and crystal forming properties and effect of delaying crystallization, Lebensm. -Wiss. u.-Technol., 30, 324, 10.1006/fstl.1996.0231 McComb, 1979 O'Brien, 1996, Stability of trehalose, sucrose and glucose to nonenzymatic browing in model systems, J. Food Sci., 61, 679, 10.1111/j.1365-2621.1996.tb12180.x Poelstra, 1997, A physiologic function for alkaline phosphatase: endotoxin detoxification, Lab. Invest., 76, 319 Poelstra, 1997, Dephosphorylation of endotoxin by alkaline phosphatase in vivo, Am. J. Path., 151, 1163 Randolph, 1997, Phase separation of excipients during lyophilization: effects on protein stability, J. Pharm. Sci., 86, 1198, 10.1021/js970135b Rossi, 1997, Stabilization of the restriction enzyme EcoRI dried with trehalose and other selected glass-forming solutes, Biotechnol. Progr., 13, 609, 10.1021/bp970061+ Schebor, 1996, Glassy state in relation to the thermal inactivation of the enzyme invertase in amorphous dried matrices of trehalose, maltodextrin and PVP, J. Food Eng., 30, 269, 10.1016/S0260-8774(96)00058-1 Schebor, 1997, Glassy state and thermal inactivation of invertase and lactase in dried amorphous matrices, Biotechnol. Progr., 13, 857, 10.1021/bp970093x Schenz, 1993, 469 Shamblin, 1998, Water vapor sorption by peptides, proteins and their formulations, Eur. J. Pharm. Biopharm., 45, 239, 10.1016/S0939-6411(98)00006-X Shamblin, 1998, Mixing behavior of colyophilized binary systems, J. Pharm. Sci., 87, 694, 10.1021/JS9704801 Slade, 1988, Non-equilibrium behavior of small carbohydrate-water systems, Pure Appl. Chem., 60, 1841, 10.1351/pac198860121841 Slade, 1991, Beyond water activity: recent advances based on an alternative approach to the assessment of food quality and safety, Crit. Rev. Food Sci. Nutr., 30, 115, 10.1080/10408399109527543 Slade, 1993, The glassy state phenomenon in applications for the food industry: applications of the food polymer science approach to structure-function relationships of sucrose in cooky and cracker systems, J. Sci. Food Agri., 63, 133, 10.1002/jsfa.2740630202 Slade, 1995, Water and the glass transition: dependence of the glass transition on the composition and chemical structure: special implications for flour functionality in cooky baking, J. Food Eng., 24, 431, 10.1016/0260-8774(95)90766-5 Sun, 1999, Protein inactivation in amorphous sucrose and trehalose matrices: effects of phase separation and crystallization, Biochim. Biophys. Acta, 1425, 235, 10.1016/S0304-4165(98)00076-2 Taylor, 1998, Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures, J. Pharm. Sci., 87, 1615, 10.1021/js9800174 Terebiznik, 1997, Thermal stability of dehydrated amylase in trehalose matrices in relation to its phase transitions, Lebensm-Wiss. u.- Technol., 30, 513, 10.1006/fstl.1996.0210 Timmerman, 1994, Quantitative analysis of the molecular weight distribution of inulin by means of anion exchange HPLC with pulsed amperometric detection, J. Carbohyd. Chem., 13, 881, 10.1080/07328309408011688 Tzannis, 1999, Moisture effects on protein-excipient interactions in spray-dried powders. Nature of destabilizing effects of sucrose, J. Pharm. Sci., 88, 360, 10.1021/js9800127 Wolkers, 1998, A fourier transform infrared microscopy study of sugar glasses: application to anhydrobiotic higher plant cells, Biochim. Biophys. Acta, 1379, 83, 10.1016/S0304-4165(97)00085-8