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 multilayer film having a reduced proficiency for producing foam and being suitable for use in medical applications, the film including
a first outer layer comprising a copolyester and an anti-foaming agent selected from the group consisting of polyamide 612, calcium stearate, and combinations thereof, wherein when the antifoaming agent is polyamide 612, the polyamide is present in an amount from about 15 to 35 weight percent based on the weight of the copolyester layer, and when the anti-foaming agent is calcium stearate, the calcium stearate is present in an amount from about 1 to 2 weight percent based on the weight of the copolyester layer; 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; wherein upon packaging a medical solution in a pouch prepared from said film, the pouch is capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005.