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 compliance factor of at least 1.75, as determined in accordance with a Vial Compliance Test.
2. The glass pharmaceutical vial of claim 1 , comprising a horizontal strength factor of at least 0.5, as determined in accordance with Horizontal Compression Test.
3. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises an external organic coating and a horizontal strength factor of at least 1.5, as determined in accordance with Horizontal Compression Test.
4. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial comprises an external organic coating.
5. The glass pharmaceutical vial of claim 4 , 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.
6. The glass pharmaceutical vial of claim 4 , wherein the glass pharmaceutical vial comprises a breakage factor of at least 50, as determined in accordance with a Pendulum Impact Test.
7. The glass pharmaceutical vial of claim 4 , wherein the glass pharmaceutical vial comprises a cold storage factor of at least 2.25, as determined in accordance with a Freeze-Thaw Test.
8. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial is formed from a Type I, Class B glass according to ASTM Standard E438-92.
9. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial is formed from an aluminosilicate glass composition.
10. The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
11. The glass pharmaceutical vial of claim 1 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
12. 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%.
13. 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%.
14. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has a Type 1 chemical durability according to USP <660>.
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 1 , further comprising:
a shoulder extending from the sidewall;
a neck extending from the shoulder; and
a flange extending from the neck, the flange comprising:
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.
19. 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 equal to a diameter d 1 of a glass vial of size X as defined by ISO 8362-1:2018, wherein X is one of 2R, 3R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R, and 100R as defined by ISO 8362-1:2018;
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 8362-1:2018; and
the glass pharmaceutical vial comprises a compliance factor of at least 1.75, as determined in accordance with a Vial Compliance Test.
20. The glass pharmaceutical vial of claim 19 , comprising a horizontal strength factor of at least 0.5, as determined in accordance with Horizontal Compression Test.
21. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial comprises an external organic coating and a horizontal strength factor of at least 1.5, as determined in accordance with Horizontal Compression Test.
22. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial comprises an external organic coating.
23. The glass pharmaceutical vial of claim 22 , 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.
24. The glass pharmaceutical vial of claim 22 , wherein the glass pharmaceutical vial comprises a breakage factor of at least 50, as determined in accordance with a Pendulum Impact Test.
25. The glass pharmaceutical vial of claim 22 , wherein the glass pharmaceutical vial comprises a cold storage factor of at least 2.25, as determined in accordance with a Freeze-Thaw Test.
26. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial is formed from a Type I, Class B glass according to ASTM Standard E438-92.
27. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial is formed from an aluminosilicate glass composition.
28. The glass pharmaceutical vial of claim 19 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
29. The glass pharmaceutical vial of claim 19 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
30. The glass pharmaceutical vial of claim 19 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
31. The glass pharmaceutical vial of claim 19 , wherein the sidewall of the glass pharmaceutical vial having an average wall thickness Ti 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%.
32. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial has a Type 1 chemical durability according to USP <660>.
33. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial comprises a Dynamic Impact Factor of less than 0.9, as determined in accordance with a Dynamic Impact Test.
34. The glass pharmaceutical vial of claim 19 , wherein the glass pharmaceutical vial comprises a FWHM Factor of at least 1.2, as determined in accordance with a Dynamic Impact Test.
35. The glass pharmaceutical vial of claim 19 , 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.
36. A glass pharmaceutical vial comprising:
a glass body comprising a sidewall enclosing an interior volume, an outer diameter D, and an external organic coating on the sidewall, 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; and
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
a breakage factor of at least 50, as determined in accordance with a Pendulum Impact Test.
37. The glass pharmaceutical vial of claim 36 , wherein the external organic coating has a thickness greater than or equal to 20 nm and less than or equal to 40 nm.
38. The glass pharmaceutical vial of claim 36 , comprising a cold storage factor of at least 2.25, as determined in accordance with a Freeze-Thaw Test.
39. The glass pharmaceutical vial of claim 36 , comprising a compliance factor of at least 1.75, as determined in accordance with a Vial Compliance Test.
40. The glass pharmaceutical vial of claim 36 , comprising a horizontal strength factor of at least 1.5, as determined in accordance with Horizontal Compression Test.
41. The glass pharmaceutical vial of claim 36 , wherein the glass pharmaceutical vial comprises a Dynamic Impact Factor of less than 0.9, as determined in accordance with a Dynamic Impact Test.
42. The glass pharmaceutical vial of claim 36 , wherein the glass pharmaceutical vial comprises a FWHM Factor of at least 1.2, as determined in accordance with a Dynamic Impact Test.
43. The glass pharmaceutical vial of claim 36 , 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.