Measurement of Solution Composition as an Alternative to Titration for Evaluating the Hydrolytic Resistance of Glass.

The measurement of solution composition is proposed as an alternative to titration to determine titration volume, which is the figure of merit for evaluating the hydrolytic resistance of glass containers for pharmaceutical packaging. In the new method, instead of titrating the sample and blank solutions, their compositions are measured by inductively coupled plasma mass spectrometry, and these compositions are converted to titration volume using a set of coefficients and a simple equation. The coefficients were derived using the well-developed thermodynamic data and models for dilute aqueous solutions, which make it possible to calculate the pH from the solution composition and then simulate a titration as a series of pH calculations as titrant is progressively added to the solution.

Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers.

An essential role of packaging material for the storage and delivery of drug products is to provide adequate protection against contamination and loss of sterility. This is especially important for parenteral containers, as lack of sterility or contamination can result in serious adverse events including death. Nonetheless, cracked parenteral containers are an important source of container integrity failures for injectable drugs and pose a serious risk for patients.

Historical Review of Glasses Used for Parenteral Packaging.

Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its unique combination of hermeticity, transparency, strength, and chemical durability make it the optimal material for such an important role. Today's life-saving drugs are stored in borosilicate glasses, which evolved from applications in microscope optics and thermometers.

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.