Glass containers for storing pharmaceutical compositions

Patent metadata

Field	Value
Publication number	US-12186267-B2
Application number	US-202318310956-A
Country	US
Kind code	B2
Filing date	May 2, 2023
Priority date	Sep 30, 2021
Publication date	Jan 7, 2025
Grant date	Jan 7, 2025

Abstract

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 d1 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 Ti that is less than or equal to 0.85*s1, wherein s1 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.

First claim

What is claimed is:

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 an external organic coating and a cold storage factor of at least 2.25, as determined in accordance with a Freeze-Thaw Test.

2. 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.

3. 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.

4. The glass pharmaceutical vial of claim 1 , 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.

5. 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.

6. 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.

7. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial is formed from an aluminosilicate glass composition.

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 a mass of glass used to make the glass pharmaceutical vial of greater than or equal to 10%.

9. 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%.

10. 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%.

11. 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%.

12. The glass pharmaceutical vial of claim 1 , wherein the glass pharmaceutical vial has a Type 1 chemical durability according to USP <660>.

13. 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.

14. 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.

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; and
a FWHM Factor of at least 1.2 as determined in accordance with the Dynamic Impact Test.

16. 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.

Assignees

• Corning Inc

Inventors

• Chapman Christy Lynn
• Gomez-Mower Sinue
• Jiang Weirong
• Matusick Joseph Michael
• Mccarthy Christie Leigh
• O'Malley Connor Thomas
• Peanasky John Stephen
• Polasani Shivani Rao
• Webb James Ernest
• Ruotolo Jr Michael Clement
• Musk Bryan James
• Aaldenberg Jared Seaman
• Allington Eric Lewis
• Noni Jr Douglas Miles
• Tremper Amber Leigh
• Waight Kristen Dae
• Mcnelis Kevin Patrick
• Cimo Patrick Joseph
• Demartino Steven Edward
• Schaut Robert Anthony
• Sarafian Adam Robert

Classifications

• B65D23/0821

  consisting mainly of polymeric materials (B65D23/0828 takes precedence) · CPC title

• A61J1/1468 Primary

  Containers characterised by specific material properties · CPC title

• A61J1/06 Primary

  Ampoules or carpules (syringe ampoules or carpules A61M5/28) · CPC title