Multilayer film for medical solution pouches having reduced proficiency for forming bubbles
View Patent ↗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.
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.
2. The film of claim 1 , wherein the multilayer film is cast extruded.
3. The film of claim 1 , wherein the antifoaming agent is polyamide 612.
4. The film of claim 3 , wherein the polyamide 612 is present in an amount from about 20 to 30 weight percent based on the weight of the copolyester layer.
5. The film of claim 3 , wherein the polyamide 612 is present in an amount from about 20 to 35 weight percent based on the total weight of the first outer layer.
6. The film of claim 1 , wherein the copolyester includes a dicarboxylic acid component and a diol component.
7. A pouch comprising an interior space for receiving a medical solution therein, wherein the pouch comprises front and rear sheets comprising said film of claim 1 that are arranged in a face-to-face relationship and heat sealed to each other along opposing adjacent edges to define said interior space, and wherein a medical solution disposed in said interior space.
8. The film of claim 1 , wherein the first outer layer further comprises a fatty amide selected from the group consisting of N,N′-ethylene bis(stearamide), N,N′-methylene bis(stearamide), N,N′-ethylene bis(oleamide), N,N′-propylene bis(oleamide), N,N′ethylene-bis(12-hydroxystearamide), and N(2-hydroxethyl) 12-hydroxystearamide, and blends thereof.
9. The film of claim 8 , wherein the amount of fatty amide is from about 1 to 2 weight percent based on the total weight of the first outer layer.
10. A five layer film for use in medical applications, the film comprising:
a first outer layer comprising a copolyester and polyamide 612 wherein said copolyester has a dicarboxylic acid component and a diol component, the polyamide 612 being present in an amount from about 15 to 35 weight percent based on the total weight percent of the first outer 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 of a heat sealable material; and
a first and a second adhesive layer joining the first and second outer layers to the core layer, respectively, wherein a pouch formed of the multilayer film is capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005.
11. The film of claim 10 , wherein the second outer layer comprises a combination of a propylene/ethylene copolymer and a styrene-ethylene-butylene-styrene block copolymer.
12. The film of claim 11 , wherein the propylene/ethylene copolymer is present in amount from about 70 to 90 weight percent and the styrene-ethylene-butylene-styrene block copolymer is present in an amount that is between about 10 and 30 weight percent, based on the total weight percent of the second outer layer.
13. The film of claim 10 , wherein the first adhesive layer comprises a very low density polyethylene having a density less than 0.910 g/cc.
14. The film of claim 10 , wherein the metallocene very low density polyethylene is present in amount from about 80 to 92 weight percent and the high density polyethylene is present in an amount that is between about 8 and 20 weight percent, based on the total weight percent of the core layer.
15. The film of claim 10 , further comprising from about 1 to 2 weight percent calcium stearate in the first outer layer of the film, the amount of calcium stearate being based on the total weight of the first outer layer of the film.
16. The film of claim 10 , wherein the polyamide 612 is present in an amount from about 20 to 30 weight percent based on the weight of the copolyester layer.
17. The film of claim 10 , wherein the polyamide 612 is present in an amount from about 20 to 35 weight percent based on the total weight of the first outer layer.
18. A five layer film for use in medical applications, the film comprising:
a first outer layer comprising a copolyester having a dicarboxylic acid component and a diol component, and a fatty amide, the fatty amide having a melting point above about 100° C., and being present in an amount from about 1 to 2 weight percent based on the total weight percent of the first outer 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 of a heat sealable material; and
a first and a second adhesive layers joining the first and second outer layers to the core layer, respectively, wherein a pouch formed of the multilayer film is capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005.
19. The film of claim 18 , wherein the fatty amide is selected from the group consisting of N,N′-ethylene bis(stearamide), N,N′-methylene bis(stearamide), N,N′-ethylene bis(oleamide), N,N′-propylene bis(oleamide), N,N′ethylene-bis(12-hydroxystearamide), and N(2-hydroxethyl) 12-hydroxystearamide, and blends thereof.