Foil
AssigneeNovo Nordisk A/S
InventorsNils Madsen, John Nielsen
Life of this patent
Estimating the term…
Abstract
A container consisting of at least two layers, the inner layer consisting of a PE or PP film and the PCTFE layer consisting of a PCTFE film, and the thickness of the PCTFE 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.
Claims41
A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5° C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (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% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight).
A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5° C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weigh/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% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight).
A container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and another layer consisting of a PCTFE film which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner layer consisting of a PE or PP film, and either said inner layer and said PCTFE layer being a coextrudate or an extrusion-laminate or said inner layer and said PCTFE layer being joined together, and the thickness of said PCTFE layer being above about 40 μm, and being below about 100 μm, preferably below about 75 μm.
A use of a container according to any one of the above claims for storing a liquid pharmaceutical composition mentioned in any of the preceding claims.
A film material comprising at least two layers, said layers being joined intimately together, characterized in that the film material can be used for preparing a transparent container according to any one of the above claims.
Dependencies are inferred from the claim text.