Legacy Pharmaceuticals, the Swiss-based global contract manufacturer of sterile/aseptic pharmaceutical products in ampoules and vials has announced a collaboration with SCHOTT, a leading company in innovative glass production and technology, to strengthen their positions at the high end of the pharmaceutical market. To solve a technical challenge with a leaching issue for a life-saving antiviral drug product, Legacy turned to SCHOTT Type I plus vials. This was successful and Legacy and SCHOTT are now offering this solution to future customers with a need to provide better stability, particularly for highly sensitive formulations.
Protein adsorption and leaching from primary packaging are known to be root causes of reduced shelf life in many formulations. Ion leaching, especially for sodium, aluminium and other metal ions, forms uncoated type I glass and leads to pH shift and decreased stability or activity of biopharmaceuticals. The SCHOTT Type I Plus vials have an inside SiO2 coating with outstanding barrier properties.
“The barrier layer in the vials comes with multiple benefits: it prevents depletion of the glass container by the drug formulation and also acts as a diffusion barrier for all leachables of the glass matrix, supressing them to a level below their respective detection limit. The diffusion barrier is certified by a release test with a limit for sodium leaching (0.17 mg/l) less then 1/10 of the required sodium level for Type 1 containers (2.4 mg/l),” says Dr Bernhard Hladik, Senior Business Development Manager at SCHOTT.
This reduces the interaction between drug product and container surface, thereby providing a superior packaging solution for sensitive drug products.
“The number of injectable drugs coming to market continues to grow. However, many of the new formulations are highly sensitive. This imposes increasing demands on primary packaging – both vials and stoppers. Drawing on our longstanding expertise and knowledge of APIs and buffer systems, we proactively looked for new solutions to meet our customer’s demands. We have now identified and validated the SCHOTT Type I plus vials as a reliable option for our customers,“ commented Mike Danzi, CEO of Legacy Pharmaceuticals.