Vial switch improves life-saving antiviral drug
Legacy Pharmaceuticals uses SCHOTT Type I Plus vials to overcome a leaching issue.
Legacy Pharmaceuticals, a Swiss-based global contract manufacturer of sterile/aseptic pharmaceutical products in ampoules and vials, is collaborating with SCHOTT, a leading company in innovative glass production and technology, to solve a technical challenge. Legacy turned to SCHOTT Type I Plus vials to overcome a leaching issue for a life-saving antiviral drug product. 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.
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance