Baxter Healthcare Corporation has received an approval from the US Food and Drug Administration for Flexbumin [albumin (human)] 25 per cent solution, the first preparation of human albumin to be packaged in a flexible container. The company plans to launch Flexbumin by early 2006.

According to a company release, Baxter's current Buminate [albumin (human)] 25 per cent solution, packaged in glass bottles, has been used in hospitals throughout the country for more than 50 years in patients undergoing cardiopulmonary bypass surgery and in patients suffering from shock, blood loss and severe burns.

Flexbumin has the same indications and provides the same stability as albumin in glass bottles, but provides improved convenience for healthcare professionals as its flexible packaging provides less risk of breakage and is more compatible with hospital inventory storage systems. The flexible containers are lighter and require less space, which may ultimately save hospitals money on disposal, informed the release.

"Our pharmacy and nursing staff will appreciate the additional handling safety benefits and convenience associated with the flexible containers over our 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. In addition, Flexbumin will make it easier for our hospital to comply with industry standards," said Larry Ligeski, manager of pharmacy purchasing and distribution, University of Michigan hospitals and health centres."

Flexbumin uses Baxter's Galaxy flexible container system, a proprietary 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 for more than 16 years to package pharmaceutical products. Flexbumin has the same indications and provides the same stability as Buminate, and can be stored for up to two years at room temperature.

Flexbumin is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. It is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, haemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery. It is contraindicated in patients with a history of allergic reactions to albumin, in severely anaemic patients, and in patients with cardiac failure.