Legacy Pharmaceuticals, SCHOTT Collaborate to Solve Leaching Issue for AntiViral

Swiss-based contract manufacturer, Legacy Pharmaceuticals, has entered into a collaboration with glass production and technology company, SCHOTT, to solve a technical challenge of leaching that is occurring with an antiviral drug.

The companies have employed SHOTT’s Type I Plus vials, which have an inside SiO₂ coating that acts as a barrier layer, to overcome the leaching problem. This solution will now be offered to future customers that need to provide stability for highly sensitive formulations, by both Legacy and SCHOTT.

“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,” said Bernhard Hladik, senior business development manager at SCHOTT in an April 8, 2019 press release. “The diffusion barrier is certified by a release test with a limit for sodium leaching (0.17 mg/L) less than a tenth of the required sodium level for Type 1 containers (2.4 mg/L).”

“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,” added Mike Danzi, CEO of Legacy Pharmaceuticals. “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.”

Source: Legacy Pharmaceuticals