Abstract Design of freeze-drying processes is often approached with a “trial and error”
experimental plan or, worse yet, the protocol used in the first laboratory run is adopted without …

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 …

Purpose To quantitatively assess the solubility advantage of amorphous forms of nine insoluble
drugs with a wide range of physico-chemical properties utilizing a previously reported …

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 …

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 …

Increased interest in molecular time scales below the glass transition temperature, T g , has
arisen from the desire to identify the conditions (eg, temperature) where the molecular …

The solid state is preferred for many proteins due to their marginal stability in solution. However,
even in the solid state, chemical and physical degradation can occur on the time scale …

Purpose. This study aims to assess the pH changes induced by salt precipitation during far-from-equilibrium
freezing of sodium phosphate buffers as a function of buffer composition, …

Immunogenicity of aggregated or otherwise degraded protein delivered from depots or other
biopharmaceutical products is an increasing concern, and the ability to deliver stable, active …

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 …