Saccharides, including sucrose, trehalose, mannitol, and sorbitol, are commonly employed
as stabilizers, cryoprotectants, and/or tonicity adjusters in protein formulations. During the …

The storage of drug substance at subzero temperatures mitigates potential risks associated
with liquid storage, such as degradation and shipping stress, making it the best solution for …

In order to enhance the storage stability of water labile molecules the common practice is to
employ lyophilization (freeze drying) process to create dry glassy state dosage form. The …

Formulated bulk drug substances (DS) are often frozen to prolong shelf life, allow
operational flexibility, and maintain quality of poorly stable products. Aside from the active …

Stabilising excipients are essential in formulations of protein drug lyophilisates. Sugars such
as sucrose and trehalose are classically used as amorphous matrix formers, embedding the …

Freeze-drying is commonly used to improve stability of liquid formulations of labile
biopharmaceuticals. Lyo-and cryoprotectants such as sucrose are traditionally utilized as …

Glass transition temperature is a unique thermal characteristic of amorphous systems and is
associated with changes in physical properties such as heat capacity, viscosity, electrical …

Storage of protein therapeutics in a frozen state provides operational flexibility for fill and
finish of drug products and extends the shelf life of protein solutions. However, freezing of …

Purpose The physical state of excipients in freeze-dried formulations directly affects the
stability of the active pharmaceutical ingredient (API). Crystallization of trehalose and …

The purpose of this study was evaluation of mannitol and its blends with other excipients
commonly used as freeze-drying cryoprotectants or bulking agents in simulated …