There is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging

Bettine Boltres; Dr. Stephan Tratzky; Christof Kass; Rainer Eichholz; Dr. Peter Naß

doi:10.5731/pdajpst.2015.005934

Abstract

For pharmaceutical parenteral packaging the glass compositions have always been either Type I borosilicate or Type III soda-lime glass. As both the compositions and certain chemical and physical properties are mandated by international standards, there has not been room for any changes. However, by applying only minor adjustments, a borosilicate glass was developed which showed improved chemical stability. The chemical composition is still in the range of currently used borosilicate glasses which makes it a Type I glass according to all current pharmacopeia. A study was performed on glass vials comparing the new glass with the standard FIOLAX® and two other publicly available glasses. In an extraction study with water at 121°C the new glass showed the highest chemical stability with the lowest amount of extractables. In an accelerated ageing study which was done with water, phosphate and carbonate buffer at 40°C for 12 months the new glass also proved to have the lowest amount of leachables. In this article the new glass and the results from the studies are presented, showing the reader how much of an effect can be attained with only minor adjustments if the scientific fundamentals are clear.

Received August 12, 2015.
Accepted February 29, 2016.

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