Transparent, flexible, impermeable plastic container for storage of pharmaceutical liquids
First Claim
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1. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
- a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol;
the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein when the chamber is filled with water and when it is stored at a temperature of about 5°
C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and
when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 5°
C. for 24 months, the change in the concentration of phenol in the liquid is less than about 10%.
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Abstract
A container consisting of a PCTFE monolayer, the thickness of said layer being about 40-100 μm, which container is equipped with a device where the liquid can be lead out through when desired and which container is transparent, shows superior properties for storing liquid pharmaceutical compositions, especially insulin compositions containing preservatives.
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Citations
31 Claims
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1. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
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a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein when the chamber is filled with water and when it is stored at a temperature of about 5°
C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and
when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 5°
C. for 24 months, the change in the concentration of phenol in the liquid is less than about 10%. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
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a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein when the chamber is filled with water and when it is stored at a temperature of about 5°
C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and
when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 37°
C. for 12 weeks, the change in the concentration of phenol in the liquid is less than about 10%.
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29. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
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a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein when the chamber is filled with water and when it is stored at a temperature of about 5°
C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and
when said chamber is filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of about 5°
C. for 24 months, the change in the concentration of m-cresol is less than about 10%.
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30. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
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a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein when the chamber is filled with water and when it is stored at a temperature of about 5°
C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and
when said chamber is filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of about 37°
C. for 12 weeks, the change in the concentration of m-cresol is less than about 10%.
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31. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the container comprising:
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a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; the container wall material (6) consisting essentially of a weldable PCTFE monolayer, forming a chamber (5) wherein the thickness of the wall material being above about 40 μ
m, and being below about 100 μ
m.
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Specification