Pharmaceutical glass coating for achieving particle reduction

Patent metadata

Field	Value
Publication number	US-11939259-B2
Application number	US-202016925297-A
Country	US
Kind code	B2
Filing date	Jul 9, 2020
Priority date	Feb 28, 2012
Publication date	Mar 26, 2024
Grant date	Mar 26, 2024

Abstract

Embodiments of the present disclosure are directed to coated glass articles which reduce glass particle formation caused by glass to glass contact in pharmaceutical glass filling lines.

First claim

What is claimed is:

1. A coated glass container comprising:
a glass body formed from an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard or a borosilicate glass that meets the Type 1 criteria according to USP <660>, the glass body having a first surface and a second surface opposite the first surface, wherein the first surface is an exterior surface of the glass body; and
a coating disposed on at least a portion of the exterior surface of the glass body, the coating comprising a polymer and a coupling agent, wherein the polymer comprises a polyimide, the coupling agent comprises a silsesquioxane, and the coated glass container reduces particle generation when the coated glass container undergoes processing,
wherein the coated glass container demonstrates at least a 50% reduction in average glass particle count for generated glass particles compared to an average particle count of generated glass particles by an uncoated glass container that undergoes the processing, wherein the average glass particle count is computed for glass particles equal to or greater than 10 μm and glass particles equal to or greater than 25 μm using light obscuration according to United States Pharmacopoeia Standard 788 and the % reduction is determined for the sum of the average glass particle count for glass particles equal to or greater than 10 μm and the average glass particle count for glass particles equal to or greater than 25 μm.

2. The coated glass container of claim 1 wherein the processing of the coated glass container involves subjecting the coated glass container to non-breakage inducing glass contact in pharmaceutical glass filling lines.

3. The coated glass container of claim 2 wherein the non-breakage inducing glass contact involves glass to glass contact.

4. The coated glass container of claim 1 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 75% compared to the average glass particle count for the uncoated glass container.

5. The coated glass container of claim 4 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 90% compared to the average glass particle count for the uncoated glass container.

6. The coated glass container of claim 5 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 99% compared to the average glass particle count for the uncoated glass container.

7. The coated glass container of claim 1 wherein the first surface comprises side walls of a container, a bottom of the container, or both.

8. The coated glass container of claim 1 wherein the first surface is only partially coated with the coating.

9. The coated glass container of claim 1 wherein the processing involves thermal treatment steps.

10. The coated glass container of claim 9 wherein the thermal treatment steps include one or more of depyrogenation, autoclaving, or lyophilization.

11. The coated glass container of claim 1 , wherein the coated glass container is a coated glass vial.

12. The coated glass container of claim 2 wherein:
the average glass particle count for glass particles with a size of 25 to 50 μm is from 0.01 to 1 when the coated glass container has a container volume of 3 mL and undergoes filling; and
the average glass particle count for glass particles with a size of 10 to 25 μm is from 1 to 20 when the coated glass article container has a container volume of 3 mL and undergoes filling.

13. The coated glass container of claim 2 wherein the pharmaceutical glass filling line involves subjecting the coated glass container to horizontal compression forces ranging from 0.1 N to 30 N at scratch velocities ranging from 6 to 120 mm/min.

14. The coated glass container of claim 1 wherein the coated glass container is chemically strengthened glass.

15. A coated glass container comprising:
a glass body formed from an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard or a borosilicate glass that meets the Type 1 criteria according to USP <660>, the glass body having a first surface and a second surface opposite the first surface, wherein the first surface is an exterior surface of the glass body; and
a coating disposed on at least a portion of the exterior surface of the glass body, the coating comprising a polymer and a coupling agent, wherein:
the polymer comprises a polyimide;
the coupling agent comprises a silsesquioxane;
the coated glass container reduces glass particle formation caused by non-breakage inducing glass contact in pharmaceutical glass filling lines, the reduction in glass particle formation being defined as follows:
wherein an average glass particle count of generated sub-visible glass particles having a size of equal to or greater than 10 μm and equal to or greater than 25 μm is below allowable levels defined by United States Pharmacopoeia Reference Standard 788, the average particle count being computed using light obscuration; and
wherein the coated glass container demonstrates at least a 50% reduction in average glass particle count for generated glass particles compared to an average glass particle count of generated glass particles by an uncoated glass container in the pharmaceutical glass filling lines, wherein the average glass particle count is computed for glass particles equal to or greater than 10 μm and glass particles equal to or greater than 25 μm using light obscuration according to United States Pharmacopoeia Standard 788 and the % reduction is determined for the sum of the average glass particle count for glass particles equal to or greater than 10 μm and the average glass particle count for glass particles equal to or greater than 25 μm.

16. The coated glass container of claim 15 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 75% compared to the average glass particle count for the uncoated glass container.

17. The coated glass container of claim 16 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 90% compared to the average glass particle count for the uncoated glass container.

18. The coated glass container of claim 17 wherein the coated glass container demonstrates a reduction in average glass particle count of at least 99% compared to the average glass particle count for the uncoated glass container.

19. The coated glass container of claim 15 , wherein the coated glass container is a coated glass vial.

20. The coated glass container of claim 15 , wherein:
the average glass particle count for glass particles with a size of 25 to 50 μm is from 0.01 to 1 when the coated glass container has a container volume of 3 mL and undergoes filling; and
the average glass particle count for glass particles with a size of 10 to 25 μm is from 1 to 20 when the coated glass container has a container volume of 3 mL and undergoes filling.

21. The coated glass container of claim 15 , wherein the pharmaceutical glass filling line involves subjecting the coated glass container to horizontal compression forces ranging from 0.1 N to 30 N at scratch velocities ranging from 6 to 120 mm/min.

22. The coated glass container of claim 15 wherein the coated glass container is chemically strengthened glass.

Assignees

• Corning Inc

Inventors

• Bayne John Frederick
• Bookbinder Dana Craig
• Chang Theresa
• Demartino Steven Edward
• Fadeev Andrei Gennadyevich
• Hoff Kyle Christopher
• Morley Jamie Lynne
• Pal Santona
• Peanasky John Stephen
• Saha Chandan Kumar
• Timmons Christopher Lee

Classifications

• C03C17/30 Primary

  with silicon-containing compounds · CPC title

• A61J1/00

  Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) · CPC title

• A61J1/1468

  Containers characterised by specific material properties · CPC title

• B65D1/09 Primary

  Ampoules · CPC title

• B65D23/0821

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