Multilayer film for medical solution pouches having reduced proficiency for forming bubbles

摘要

The present invention provides a multilayer film for forming medical solution pouches that help prevent or reduce the presence of bubbles or foam in the solution after heat sterilization. In particular, the present invention provides a multilayer film for forming medical solution pouches that are capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005. In particular, the present invention provides a multilayer film in which polyamide 612 or calcium stearate component has been incorporated as an anti-foaming agent. The presence of polyamide 612 or calcium stearate in one or more layers of the film helps prevent the formation of foam in the solution after heat sterilization.

主权项

1. A method for reducing or preventing the formation of bubbles in a medical solution contained in a pouch after heat sterilization, the method comprising:
cast extruding a flexible multilayer film having an outer layer comprising a copolyester having a dicarboxylic acid component and a diol component; incorporating a polyamide 612 into said copolyester layer, wherein polyamide 612 is present in an amount from about 15 to 35 weight percent based on the weight of the copolyester layer; forming the flexible multilayer film into a pouch having an interior space for receiving a medical solution therein by orienting front and rear sheets comprising said flexible multilayer film in a face-to-face relationship and heat sealing said front and rear sheets to each other along opposing adjacent edges to define said interior space, wherein upon packaging a medical solution therein, the pouch is capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005, and wherein the multilayer film further comprises a core layer comprising a combination of a metallocene very low density polyethylene having a density less than 0.910 g/cc and a high density polyethylene having a density greater than 0.940 g/cc; a second outer layer comprising a combination of a propylene/ethylene copolymer and a styrene-ethylene-butylene-styrene block copolymer; and first and second adhesive layers joining each of the outer layers to the core layer.