Glass containers for storing pharmaceutical compositions
Disclosed herein are glass pharmaceutical vials having sidewalls of reduced thickness. In embodiments, the glass pharmaceutical vial may include a glass body comprising a sidewall enclosing an interior volume. An outer diameter D of the glass body is equal to a diameter d 1 of a glass vial of size X as defined by ISO 8362-1, wherein X is one of 2R, 3R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R, and 100R as defined by ISO 8362-1. However, the sidewall of the glass pharmaceutical vial comprises an average wall thickness T i that is less than or equal to 0.85*s 1 , wherein s 1 is a wall thickness of the glass vial of size X as defined by ISO 8362-1 and X is one of 2R, 3R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R, and 100R as defined by ISO 8362-1.
1 . A glass pharmaceutical vial comprising:
a glass body comprising a sidewall enclosing an interior volume and an outer diameter D, wherein:
the outer diameter D of the glass body is greater than or equal to 84% and less than or equal to 116% of a diameter d 1 of a glass vial of size designation X as defined by ISO 8362-1:2018, wherein X is a smallest size designation of 2R, 3R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R, and 100R, as defined by ISO 8362-1:2018, for which 116% of the diameter d 1 is greater than or equal to D;
the sidewall of the glass pharmaceutical vial comprises an average wall thickness T i that is less than or equal to 0.85*s 1 , wherein s 1 is a wall thickness of the glass vial of size designation X as defined by ISO 8362-1:2018; and
the glass pharmaceutical vial comprises a coating disposed on at least a portion of an outer surface of the glass body.
2 . The glass pharmaceutical vial of claim 1 , wherein the coating is an inorganic coating.
3 . The glass pharmaceutical vial of claim 2 , wherein the inorganic coating is applied to the at least the portion of the outer surface of the glass body by a soot deposition process or a vapor deposition process.
4 . The glass pharmaceutical vial of claim 1 , wherein the coating is an organic coating.
5 . The glass pharmaceutical vial of claim 4 , wherein the organic coating comprises a coupling agent layer and a polymer layer.
6 . The glass pharmaceutical vial of claim 5 , wherein the organic coating is a thermally stable polyimide coating.
7 . The glass pharmaceutical vial of claim 1 , wherein the coating is thermally stable at 250° C.
8 . The glass pharmaceutical vial of claim 1 , wherein the coating has a coefficient of thermal expansion greater than or equal to a coefficient of thermal expansion of the glass body.
9 . The glass pharmaceutical vial of claim 1 , wherein the coating has a thickness greater than or equal to 20 nm and less than or equal to 40 nm.
10 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a horizontal strength factor of at least 1.5, as determined in accordance with Horizontal Compression Test.
11 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a breakage factor of at least 50, as determined in accordance with a Pendulum Impact Test.
12 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a cold storage factor of at least 2.25, as determined in accordance with a Freeze-Thaw Test.
13 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has an intervention rate, according to an Accumulator Table Experiment, of less than or equal to 0.90×R I , wherein Rr is an intervention rate of the glass vial of size designation X as defined by ISO 8362-1:2018.
14 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has a jam rate, according to an Accumulator Table Experiment, of less than or equal to 3 jams/minute.
15 . The glass pharmaceutical vial of claim 1 , further comprising a shoulder extending from the sidewall and a neck extending from the shoulder, wherein the neck has an outside diameter N OD that is smaller than a neck outside diameter of the glass vial of size designation X as defined by ISO 8362-1:2018.
16 . The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has a Type 1 chemical durability according to USP <660>.
17 . The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness T i that is less than or equal to 0.85*s 1 correlates to a reduction in a mass of glass used to make the glass pharmaceutical vial of greater than or equal to 10%.
18 . The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness T i that is less than or equal to 0.85*s 1 correlates to a reduction in an amount of energy used to convert the glass pharmaceutical vial from stock glass tubing of greater than or equal to 5%.
19 . The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness T i that is less than or equal to 0.85*s 1 correlates to a reduction in an amount of CO 2 emitted to produce the glass pharmaceutical vial of greater than or equal to 5%.
20 . The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness T i that is less than or equal to 0.85*s 1 correlates to a reduction in an amount of energy used to separate the glass pharmaceutical vial from stock glass tubing of greater than or equal to 20%.