The review summarizes the current state of knowledge of mannitol as an excipient in
lyophilized injectable small and large molecule formulations. When compared with glycine …

The recent advances in pharmaceutical industry in the area of drug delivery and
development have resulted into wide variety of biomolecules, particularly peptides and …

Physical characterization of formulations in frozen and freeze-dried solid states provides
indispensable information for rational development of freeze-dried pharmaceutical products …

Freeze-drying science and technology continues to evolve and increase in importance
because of the emergence of biotechnology drugs that are too unstable to be commercially …

This chapter provides an overview of the impact of protein formulation variables on different
stages of the protein freeze-drying process and offers guidance for selection of critical …

Objective The purpose of this paper is to re-visit the design of three steps in the freeze-
drying process, namely freezing, primary drying, and secondary drying steps. Specifically …

Vial breakage during or following freeze drying (lyophilization) is a well-known and
documented phenomenon in the pharmaceutical industry. However, the underlying …

Four major methods for the thermal analysis of proteins are reviewed. Thermogravimetric
analysis (TGA) is commonly used for moisture content measurements in raw materials and …

Vial breakage during lyophilization reduces yield and can lead to product contamination
with glass particulates, personnel interventions during manufacturing and damage to …

Pharmaceutical containers for parenterals have been predominantly manufactured using
glass as a packaging material of choice, especially Type-I glass, since it has been regarded …