… MJ Pikal. Mechanisms of protein stabilization during freezedrying and storage: the relative
importance of thermodynamic stabilization and glassy state relaxation dynamics. Drugs Pharm…

Early in the development of a protein therapeutic it is essential to design a formulation that
is stable during shipping and long-term storage. Obviously, an aqueous liquid formulation is …

Although proteins are often frozen during processing or freeze-dried after formulation to
improve their stability, they can undergo degradation leading to losses in biological activity …

The purpose of this study is to investigate the mechanism of protein stabilization by sugars in
the solid state. That is, explore whether the stabilization is controlled by “glass dynamics” or …

Though there is an advantage in using the higher solubility amorphous state in cases where
low solubility limits absorption, physical instability poses a significant barrier limiting its use …

Flow of water vapor is impeded by three barriers or resistances: resistance of the dried‐product
layer, resistance of the semistoppered vial, and resistance of the chamber. The …

In recent years there has been growing interest in advancing amorphous pharmaceuticals
as an approach for achieving adequate solubility. Due to difficulties in the experimental …

Accurate determination of the maximum allowable product temperature during primary drying
is critical to optimization of the freeze drying process. For an amorphous solute system, this …

Secondary drying involves removal of water which did not freeze. This report emphasizes
the phenomenological description of the effects of temperature and chamber pressure on the …

… Hairless mouse skin data taken from Pikal and Shah [5] and data for human skin taken from
… calculated for each of the three pore types in the Pikal model [14] and the calculated net flux …