Schott has begun mass production of its Schott TopLyo pharmaceutical packaging for lyophilized (freeze-dried) drugs at its Muellheim, Germany facility. The Schott TopLyo packaging solution features a special geometry and an ultrathin hydrophobic coating that is smooth and homogeneous that freeze dried drugs cannot adhere to the inside walls of the container. Initial capacity of the plant is six million packaging units a year.
Schott TopLyo is designed for the growing share of the pharmaceutical market built around biomolecule components, such as proteins, polysaccharides or carbohydrates, which are vulnerable to contamination from both ambient moisture and interaction with the glass in the container. To extend the shelf life of sensitive ingredients, these types of drugs are often lyophilized. More than 50 percent of all pharmaceutical products in development now include biomolecular elements.
Claudia Dietrich, global product manager of vials and coating at Schott, said: “Freeze-drying is the optimal solution for these biologically active drugs, because it eliminates the need for special storage, shipment and handling protocols, such as refrigeration. Schott TopLyo is the only packaging with interior surfaces that are both smooth and hydrophobic, making it ideal for all biotechnology-based pharmaceuticals.”
As claimed, the interiors of the Schott TopLyo packages are coated with hydrophobic layers using the proprietary Schott Plasma Impulse Chemical Vapor Deposition (PICVD). The coatings are only 40nm thin and have no effect on the dimensions of the container. However, Schott TopLyo vials are also robust, remaining stable throughout normal pharmaceutical procedures such as washing, sterilisation and heat treatments up to 300º C.
The Schott TopLyo vials have been especially designed to minimize breakage in all parts of the supply chain. They are available in two sizes, 2 milliliters and 10 milliliters. A 6 milliliter vial will be added to the portfolio late in the year.
The Schott TopLyo vials have been designed with a special geometry to maximise strength and minimise breakage, and also to improve heat transfer during the lyophilization process.
Dr Dietrich added: “Freeze drying answers the needs of both pharmaceutical manufacturers and patients. And SCHOTT TopLyo has distinct properties that make freeze drying more efficient. Due to the combination of the hydrophobic layer and the optimized geometry, the optical quality of the lyophilization-cake stays intact. So the advantage is apparent: a more effective process combined with lower risks equals cost reductions.”
Schott TopLyo is a registered trademark of Schott.