Treatment with ammonium sulphate
In general, the influence which the drug delivery system can have on product stability should not be underestimated. With the glass material used (type I), the main factor influencing stability is the resistance property of its surface, measured by its alkalinity. As some drugs frequently cannot be kept stable in solution long enough under the conditions typical for glass application systems, they can be marketed only as a freeze-dried substance in a glass vial.
A specific surface treatment process developed at Gerresheimer Bünde helps to overcome this serious problem and offers an optimised drug delivery system approach for non-buffered/low-buffered drug solutions or WFI delivery systems. Together with the use of a special glass composition with lower alkali content (KG33 glass), treatment with ammonium sulphate offers a significant improvement in the pH stability of solution-based or WFI delivery systems.
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