High pH Formulation

The customer has an difficult drug formulation >pH 11-11.4 that could not be packaged in a traditional glass vial, due to the risk of glass delamination. A drug stability study was initiated by the customer with SiO2 vials.

SiO2 supplied both 6 mL and 10 mL vial sizes. The stability study and a leachable study were conducted over 24 months with the following drug formulation:

After 24 months, the stability of the drug was maintained in the SiO2 vials with no evidence of delamination and no degradation of the drug formulation. The leachable study showed no interaction between the drug and vial.

The vial has been qualified and the customer is moving forward with the SiO2 vials.