“…This is in agreement with Pyne et al (2003) and Sahagian and Goff (1994). The crystallization of the ice decreases the amount of unfrozen water and also the effect of water plasticization in freeze-concentrated matrix (Pyne et al 2003). The crystallization of the ice decreases the amount of unfrozen water and also the effect of water plasticization in freeze-concentrated matrix (Pyne et al 2003).…”
Section: Influence Of Annealing On Glass Transition Temperaturesupporting
confidence: 87%
“…The annealing process has a potential to allow for the crystallization of ice in the system; subsequently, the system becomes maximally freezeconcentrated. The results indicate that the annealing process influences the T g 0 1 , which refers to the T g 0 of the bulk system, whereas no effect of annealing was observed on the T g onset of ice melting and is related to the presence of solute inclusions within ice crystals (Goff et al 2003;Pyne et al 2003). The results indicate that the annealing process influences the T g 0 1 , which refers to the T g 0 of the bulk system, whereas no effect of annealing was observed on the T g onset of ice melting and is related to the presence of solute inclusions within ice crystals (Goff et al 2003;Pyne et al 2003).…”
Section: Influence Of Annealing On Glass Transition Temperaturementioning
“…This is in agreement with Pyne et al (2003) and Sahagian and Goff (1994). The crystallization of the ice decreases the amount of unfrozen water and also the effect of water plasticization in freeze-concentrated matrix (Pyne et al 2003). The crystallization of the ice decreases the amount of unfrozen water and also the effect of water plasticization in freeze-concentrated matrix (Pyne et al 2003).…”
Section: Influence Of Annealing On Glass Transition Temperaturesupporting
confidence: 87%
“…The annealing process has a potential to allow for the crystallization of ice in the system; subsequently, the system becomes maximally freezeconcentrated. The results indicate that the annealing process influences the T g 0 1 , which refers to the T g 0 of the bulk system, whereas no effect of annealing was observed on the T g onset of ice melting and is related to the presence of solute inclusions within ice crystals (Goff et al 2003;Pyne et al 2003). The results indicate that the annealing process influences the T g 0 1 , which refers to the T g 0 of the bulk system, whereas no effect of annealing was observed on the T g onset of ice melting and is related to the presence of solute inclusions within ice crystals (Goff et al 2003;Pyne et al 2003).…”
Section: Influence Of Annealing On Glass Transition Temperaturementioning
“…Such phenomena are frequently encountered even in frozen aqueous systems of single solutes and have been the subject of much discussion and speculation. [15][16][17][18] In a frozen solution containing sodium chloride (NaCl) and glycine, the two glass transitions were attributed to two phases: one rich in NaCl and the other in glycine. On similar lines, we speculate the existence of mannitol-rich and glycine-rich regions, with varying fractions of unfrozen water, reflecting the heterogeneity of the amorphous phase.…”
Section: Comparison Of the Crystallization Tendencies Of Mannitol Andmentioning
“…The amorphous phase deplasticization is manifested by a measurable increase in the glass transition temperature (4,14). The consequent supersaturation facilitates solute nucleation (15).…”
In situ IMC tris salt formation resulted in an elegant lyophile with a very short reconstitution time. Tris served two roles - as a buffer in the prelyophilization solution and as the counterion for the salt in the final lyophile. This approach for solubility enhancement could be extended to other acidic drugs wherein salt formation was observed during freeze-drying.
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