Glass container and glass container system
A glass container for pharmaceutical compositions includes a hollow cylindrical body having at least one open end. At least a part of a surface of the glass container includes a coating. The coating has a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min. The crystallization temperature range and the melting temperature range overlap at a temperature of from −75° C. to −100° C.
1 . A glass container for pharmaceutical compositions, comprising:
a hollow cylindrical body having at least one open end, wherein at least a part of an inner surface of the glass container comprises a coating comprising polysiloxane structural units, the coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of from −75° C. to −100° C., wherein the hollow cylindrical body exhibits a ratio of a standardized break loose force (BLF) relative to a standardized glide force (GF) of BLF/GF >1.30 or a standardized glide force (GF) of <3.5 N, the standardized break loose force (BLF) and the standardized glide force (GF) being measured using a standard stopper made of bromobutyl rubber having a hardness of 52 Shore A and a density of 1.355 g/cm 3 and the measurement being conducted on a universal testing machine with a 50 N test cup at room temperature.
2 . The glass container of claim 1 , wherein the crystallization temperature range and the melting temperature range overlap at −80° C.
3 . The glass container of claim 1 , wherein the coating has a thickness of 250 nm or more.
4 . The glass container of claim 1 , wherein the coating has a glass transition temperature at −60° C. or below.
5 . The glass container of claim 1 , wherein the coating has a hardness such that a hardness value measured on the part of the surface comprising the coating according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from a hardness value measured on an uncoated surface of the glass container by less than 10%.
6 . The glass container of claim 1 , wherein the container has a standard ethanol-modified dye-ingress tested container closure integrity of at least 150 hours at −80° C.
7 . The glass container of claim 1 , wherein the coating was at least one of:
cured at a temperature of less than 150° C.; or
cured at a temperature of 50° C. or more.
8 . The glass container of claim 7 , wherein the coating was cured at a temperature of 50° C. or more and less than 150° C.
9 . The glass container of claim 1 , wherein the hollow cylindrical body has an open end A, the open end A being configured for receiving a stopper that is slidable relative to the hollow cylindrical body from the open end A; wherein at least a part of an inner surface of the hollow cylindrical body has the coating.
10 . The glass container of claim 1 , wherein the container has an open end B, the open end B being configured for being closed by a cap, the open end B having a nestling surface that is configured to fit snugly against a surface of the cap, wherein at least a part of the nestling surface comprises the coating.
11 . The glass container of claim 1 , wherein the coating comprises one or more cross-linked polysiloxane structural units and one or more non-cross-linked polysiloxane structural units, wherein a ratio of a weight amount of cross-linked polysiloxane structural units and a weight amount of non-cross-linked polysiloxane structural units in the coating is less than 3.00.
12 . The glass container of claim 11 , wherein the ratio of the weight amount of cross-linked polysiloxane structural units and the weight amount of non-cross-linked polysiloxane structural units in the coating is at least 0.40.
13 . The glass container of claim 1 , wherein the coating comprises at least two non-cross-linked polysiloxane structural units that differ in their viscosities.
14 . The glass container of claim 1 , wherein at least a part of an inner surface of the hollow cylindrical body has the coating, wherein a ratio of a total inner diameter variation along the part of the inner surface having the coating relative to a thickness of the coating is less than 500.
15 . The glass container of claim 1 , wherein the coating is formed from a composition having the following composition in percent by weight:
one or more cross-linkable polysiloxane
3.0 to 20.0%;
compounds
one or more non-cross-linkable polysiloxane
2.0 to 25.0%;
compounds
one or more cross-linking polysiloxane
0.10 to 1.50%;
compounds
one or more catalysts
0.03 to 0.50%; and
one or more diluents
55.0 to 92.0%.
16 . The glass container of claim 15 , wherein the composition has the following composition in percent by weight:
one or more cross-linkable polysiloxane
7.5 to 15.0%;
compounds
one or more non-cross-linkable polysiloxane
8.0 to 15.0%;
compounds
one or more cross-linking polysiloxane
0.10 to 1.00%;
compounds
one or more catalysts
0.03 to 0.50%; and
one or more diluents
55.0 to 82.0%.
17 . The glass container of claim 15 , wherein the composition has the following composition in percent by weight:
a vinyl-functionalized polysiloxane as a
3.0 to 20.0%;
cross-linkable polysiloxane compound
one or more non-cross-linkable polysiloxane
2.0 to 25.0%;
compounds
a copolymer having dimethylsiloxane and
0.10 to 1.50%;
methylhydrosiloxane monomer units as a
cross-linking polysiloxane compound,
one or more Pt-containing catalysts
0.03 to 0.50%; and
one or more diluents
55.0 to 92.0%.
18 . The glass container of claim 1 , wherein the coating comprises at least one of:
high viscosity non-cross-linked polysiloxane structural units having a viscosity of more than 10,000 cSt; or
low viscosity non-cross-linked polysiloxane structural units having a viscosity of 10,000 cSt, or less.
19 . The glass container of claim 18 , wherein the coating comprises high viscosity non-cross-linked polysiloxane structural units and low viscosity non-cross-linked polysiloxane structural units, a ratio of a weight amount of the low viscosity non-cross-linked polysiloxane structural units and the high viscosity non-cross-linked polysiloxane structural units (mass high :mass low ) being at least 0.10.
20 . The glass container of claim 19 , wherein the ratio of the weight amount of the low viscosity non-cross-linked polysiloxane structural units and the high viscosity non-cross-linked polysiloxane structural units (mass high :mass low ) is up to 5.00.
21 . The glass container of claim 1 , further comprising the standard stopper disposed in the hollow cylindrical body and in contact with the coating.