Prefilled syringe stability
The stability of Lantus when it is prefilled into syringes and stored up to 7 days was evaluated using four different types of syringes (Aventis, data on file). The following syringes were tested (200 syringes of each type): 1) BD Ultra-fine, U-100, 0.5 ml, 30 G 1⁄2 inch (Becton Dickinson [BD]); 2) BD Ultra-fine II (short needle), U-100, 0.5 ml, 30 G 5/16 inch (BD); 3) Walgreens super thin syringes, U-100, 0.5 ml, 29 G 1⁄2 inch (Walgreens); and 4) Reli-On insulin syringes, U-100, 0.5 ml, 30 G 5/16 inch (Wal-Mart). The syringes were stored either at 41°F (5°C) or 77°F (25°C) for up to 7 days, after which the Lantus solution was tested for filtration time, byproducts, insulin glargine content, and m-cresol (preservative) content. The Lantus solution was visually inspected and pH measured every day (except days 4 and 5). Microbial contamination was not evaluated in this study. Results Visual appearance at 41°F (5°C). The Lantus solution became turbid more quickly in the Walgreens syringes compared with those of BD and Reli-On. By day 3, the Lantus solution was turbid in all four syringe types. After 2 days of storage in the Walgreens syringes, the Lantus solution did not meet specification.
Visual appearance
at 77°F (25°C). The Lantus solution became turbid in the Reli-On syringes by day 2, and turbidity occurred in the Walgreens and BD Ultrafine II syringes by day 3. After 6 days of storage in the Walgreens syringes, the Lantus solution did not meet specification. A placebo solution stored in the Walgreens syringes at each temperature did not become turbid over 7 days. Insulin glargine content, byproducts, filtration, and pH. For each syringe type, the Lantus solution complied with specifications. m-Crescol content. For each syringe type, the Lantus solution complied with specifications.
Summary
Aventis Pharmaceuticals does not recommend prefilling syringes with Lantus and storing for any period longer than needed for application. In addition BD states the following (9): “BD does not recommend that any of our syringes be prefilled more than a few minutes in advance of the injection. There are no conclusive studies to determine the safety or risks associated with this practice."