RT Journal Article
SR Electronic
T1 There is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2015.005934
DO 10.5731/pdajpst.2015.005934
A1 Bettine Boltres
A1 Dr. Stephan Tratzky
A1 Christof Kass
A1 Rainer Eichholz
A1 Dr. Peter Naß
YR 2016
UL http://journal.pda.org/content/early/2016/04/13/pdajpst.2015.005934.abstract
AB 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.