FDA approves first flexible packaged Albumin solution
human albumin preparation to be packaged in a flexible container,
reducing the risk of breakage while being more compatible with
hospital inventory storage systems.
The development in this kind of packaging is a departure from current methods. Albumin is normally packaged in glass bottles as a result of technical requirements related to manufacturing, including inertness, sturdiness and a high water vapour and oxygen barrier that no single plastic material has been able to fulfil.
Indeed, Baxter's own Buminate (Albumin (Human)) 25 per cent solution is packaged in glass bottles and has been used in hospitals throughout the US for patients undergoing cardiopulmonary bypass surgery and in patients suffering from shock, blood loss and severe burns.
Flexbumin also shares Baxter's Galaxy container system, a multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature.
Galaxy, which employs barrier technology and a continuous aseptic filling process, has been used in the United States since 1989 to package pharmaceutical products.
The product, Flexbumin, is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.
Flexbumin is suitable for the treatment of hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, haemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.
The company, a unit of Baxter International, said that it was the first to receive approval for a formulation of human albumin to be packaged in a plastic container for easier storage.
The company plans to launch the product in early 2006.
"Pharmacy and nursing staff will appreciate the additional handling safety benefits and convenience associated with the flexible containers over current use of glass albumin vials, including the decreased risk of breakage, improved product storage and a significant reduction in our volume of hazardous waste material," said Larry Ligeski, manager of pharmacy purchasing and distribution, University of Michigan Hospitals and Health Centres.
"In addition, Flexbumin will make it easier for our hospital to comply with industry standards," he added.
