11-09-2009, SCHOTT North America, Inc.
SCHOTT Begins Mass Production of SCHOTT TopLyo® Pharma Packaging for Freeze-Dried Drugs
New stability for biomolecule-based pharmaceuticals by specially engineered hydrophobic glass vials; efficient lyophilization process, breakage minimizedLos Angeles, November 8, 2009 (at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition) – SCHOTT announced today that it 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 so 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 their highly sensitive ingredients, these types of drugs are often lyophilized. More than 50 percent of all pharmaceutical products in development now include biomolecular elements.
“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,” said SCHOTT Global Product Manager Vials & Coating Dr. Claudia Dietrich. “SCHOTT TopLyo is the only packaging with interior surfaces that are both smooth and hydrophobic, making it ideal for all biotechnology-based pharmaceuticals.”
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 40 nanometers 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, sterilization and heat treatments up to 300º C.
Because the hydrophobic layers of the interiors keep the freeze-dried drugs from adhering to the sides of the vials, SCHOTT TopLyo containers also maintain the aesthetic standards required by pharmaceutical companies for their packaging. 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.
Medicines stored in SCHOTT TopLyo packaging retain their fine powder without clumping and instantly dissolve into their liquid form when required. To administer the medicines, the doctor or nurse simply rehydrates them with sterile water. The medicines can then be administered to the patient.
The SCHOTT TopLyo vials have been designed with a special geometry to maximize strength and minimize breakage, and also to improve heat transfer during the lyophilization process. By cutting the processing time needed for freeze-drying, pharmaceutical companies save production costs.
“Freeze drying answers the needs of both pharmaceutical manufacturers and patients,” Dr. Dietrich observed. “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 AG.
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