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 di 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;
a shoulder extending from the sidewall; and
a neck extending from the shoulder;
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 further comprises a flange extending from the neck, the flange having a reduced glass volume relative to a glass volume of a flange of the glass vial of size designation X as defined by ISO 8362-1:2018.
2. The glass pharmaceutical vial of claim 1 , wherein the flange comprises:
an underside surface extending from the neck; and
an outer surface extending from the underside surface and being radially recessed inwardly thereby defining a cutout portion of the flange.
3. The glass pharmaceutical vial of claim 2 , wherein the cutout portion of the flange correlates to a reduction in a mass of glass used to make the glass pharmaceutical vial of greater than or equal to 5%.
4. 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%.
5. The glass pharmaceutical vial of claim 4 , wherein the cutout portion of the flange correlates to a further reduction in a mass of glass used to make the glass pharmaceutical vial of greater than or equal to 5%.
6. 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%.
7. 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%.
8. 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%.
9. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has a Type 1 chemical durability according to USP <660>.
10. The glass pharmaceutical vial of claim 1 , further comprising an external organic coating is an organic coating having a thickness greater than or equal to 20 nm and less than or equal to 40 nm.
11. The glass pharmaceutical vial of claim 1 , wherein
the glass pharmaceutical vial comprises an external organic coating and has an intervention rate, according to an Accumulator Table Experiment, of less than or equal to 0.90×R I , wherein R I is an intervention rate of the glass vial of size designation X as defined by ISO 8362-1:2018.
12. The glass pharmaceutical vial of claim 11 , wherein the glass pharmaceutical vial has a jam rate, according to the Accumulator Table Experiment, of less than or equal to 3 jams/minute.
13. The glass pharmaceutical vial of claim 11 , wherein the glass pharmaceutical vial has an intervention rate, according to the Accumulator Table Experiment, of less than or equal to 50 events/hour.
14. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a compliance factor of at least 1.75, as determined in accordance with a Vial Compliance Test.
15. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a Dynamic Impact Factor of less than 0.9, as determined in accordance with a Dynamic Impact Test.
16. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises a FWHM Factor of at least 1.2, as determined in accordance with a Dynamic Impact Test.
17. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises:
a Dynamic Impact Factor of less than 0.9, as determined in accordance with a Dynamic Impact Test; and
a FWHM Factor of at least 1.2, as determined in accordance with the Dynamic Impact Test.
18. The glass pharmaceutical vial of claim 10 , wherein the external organic coating is an organic coating having a thickness greater than or equal to 20 nm and less than or equal to 40 nm.
19. The glass pharmaceutical vial of claim 11 , wherein the neck has a neck outside diameter N OD such that the neck outside diameter N OD is smaller than a neck outside diameter of the glass vial of size designation X as defined by ISO 8362-1:2018.
20. The glass pharmaceutical vial of claim 18 , wherein the neck outside diameter Non of the glass pharmaceutical vial is at least 0.4 mm less than the neck outside diameter of the glass vial of size designation X as defined by ISO 8362-1:2018.