Susan Lee Schiefelbein

A New Glass Option for Parenteral Packaging

TECHNICAL ABSTRACT: Glass is the ideal material for parenteral packaging because of its chemical durability, hermeticity, strength, cleanliness, and transparency. Alkali borosilicate glasses have been used successfully for a long time, but they do have some issues relating to breakage, delamination, and variation in hydrolytic performance. In this paper, alkali aluminosilicate glasses are introduced as a possible alternative to alkali borosilicate glasses. An example alkali aluminosilicate glass is shown to meet the compendial requirements, and to have similar thermal, optical, and mechanical attributes as the current alkali borosilicate glasses. In addition, the alkali aluminosilicate performed as well or better than the current alkali borosilicates in extractables tests and stability studies, which suggests that it would be suitable for use with the studied liquid product formulation. LAY ABSTRACT: The physical, mechanical, and optical properties of glass make it an ideal material for packaging injectable drugs and biologics. Alkali borosilicate glasses have been used successfully for a long time for these applications, but there are some issues. In this paper, alkali aluminosilicate glasses are introduced as a possible alternative to alkali borosilicate glasses. An example alkali aluminosilicate glass is shown to meet the requirements for packaging injectable drugs and biologics, and to be suitable for use with a particular liquid drug.