Delamination resistant glass containers with heat-tolerant coatings

Patent metadata

Field	Value
Publication number	US-11608290-B2
Application number	US-201916355797-A
Country	US
Kind code	B2
Filing date	Mar 17, 2019
Priority date	Jun 28, 2012
Publication date	Mar 21, 2023
Grant date	Mar 21, 2023

Abstract

Disclosed herein are delamination resistant glass pharmaceutical containers which may include a glass body having a Class HGA1 hydrolytic resistance when tested according to the ISO 720:1985 testing standard. The glass body may have an interior surface and an exterior surface. The interior surface of the glass body does not comprise a boron-rich layer when the glass body is in an as-formed condition. A heat-tolerant coating may be bonded to at least a portion of the exterior surface of the glass body. The heat-tolerant coating may have a coefficient of friction of less than about 0.7 and is thermally stable at a temperature of at least 250° C. for 30 minutes.

First claim

What is claimed is:

1. A method of making a delamination-resistant glass pharmaceutical container, the method comprising the steps of:
combining constituent elements of a glass composition into a glass melt;
forming the glass melt into a glass tube;
re-forming the glass tube into a glass pharmaceutical container having an interior surface and an exterior surface, wherein an interior surface of the glass pharmaceutical container does not comprise a boron-rich layer when the glass pharmaceutical container is in as-formed condition;
chemically strengthening the glass pharmaceutical container; and
applying a coating having a thickness of less than 100 microns to the exterior surface such that a portion of the glass pharmaceutical container with the coating has a coefficient of friction less than or equal to 0.7.

2. The method of claim 1 , further comprising the step of subjecting the glass pharmaceutical container to a depyrogenation cycle whereby the coefficient of friction does not increase by more than 30% after the depyrogenation cycle.

3. The method of claim 2 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for at least 30 minutes.

4. The method of claim 2 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for up to 72 hours.

5. The method of claim 2 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of from about 250° C. to about 400° C. for a time period of from about 30 minutes to about 72 hours.

6. The method of claim 1 , wherein the step of applying a coating comprises:
applying a coupling agent layer in direct contact with the exterior surface; and
applying a polymer layer in direct contact with the coupling agent layer.

7. The method of claim 1 , further comprising subjecting the glass container to a lyophilization cycle, whereby the coefficient of friction does not increase by more than 30% after the lyophilization cycle.

8. The method of claim 7 , wherein the lyophilization cycle comprises filling the glass container with a liquid that contains protein and then freezing at a temperature of −100° C., followed by water sublimation for 20 hours at −15° C. under vacuum.

9. The method of claim 1 , wherein the glass composition comprises more than or equal to 67 mol. % SiO 2 and less than or equal to about 80 mol. % SiO 2 .

10. A method of manufacturing a glass pharmaceutical container comprising:
providing a glass composition;
melting the glass composition to form a molten glass;
forming the molten glass into the glass pharmaceutical container having an interior surface and an exterior surface, wherein an interior surface of the glass pharmaceutical container does not comprise a boron-rich layer when the glass pharmaceutical container is in an as-formed condition; and
coating the exterior surface of the glass pharmaceutical container with a coating material wherein a portion of the glass pharmaceutical container comprising the coating comprises a coefficient of friction of ≤0.7, the coating material comprising a thickness of ≤100 μm.

11. The method of claim 10 , wherein the glass composition comprises, in mol. %:
SiO 2 68-80%;
Al 2 O 3 2-10%;
alkaline earth oxides 3-10%;
alkali oxides 8-15%;
SnO 2 <1.0%; and
B 2 O 3 0-5%.

12. The method of claim 10 , further comprising the step of subjecting the glass pharmaceutical container to a depyrogenation cycle whereby the coefficient of friction does not increase by more than 30% after the depyrogenation cycle.

13. The method of claim 12 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for at least 30 minutes.

14. The method of claim 12 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for up to 72 hours.

15. The method of claim 12 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of from about 250° C. to about 400° C. for a time period of from about 30 minutes to about 72 hours.

16. The method of claim 10 , wherein the step of applying a coating comprises:
applying a coupling agent layer in direct contact with the exterior surface; and
applying a polymer layer in direct contact with the coupling agent layer.

17. The method of claim 10 , further comprising subjecting the glass container to a lyophilization cycle, whereby the coefficient of friction does not increase by more than 30% after the lyophilization cycle.

18. The method of claim 17 , wherein the lyophilization cycle comprises filling the glass container with a liquid that contains protein and then freezing at a temperature of −100° C., followed by water sublimation for 20 hours at −15° C. under vacuum.

19. The method of claim 10 , wherein the glass composition comprises more than or equal to 67 mol. % SiO 2 and less than or equal to about 80 mol. % SiO 2 .

20. A method of manufacturing a glass pharmaceutical container comprising:
providing a glass composition;
melting the glass composition to form a molten glass;
forming the molten glass into a tube; and
converting the tube into the glass pharmaceutical container having an interior surface and an exterior surface, wherein an interior surface of the glass pharmaceutical container does not comprise a boron-rich layer when the glass pharmaceutical container is in an as-formed condition; and
coating the exterior surface of the glass pharmaceutical container with a coating material wherein a portion of the glass pharmaceutical container comprising the coating comprises a coefficient of friction of ≤0.7, the coating material comprising a thickness of ≤100 μm.

21. The method of claim 20 , wherein the glass composition comprises, in mol. %:
SiO 2 68-80%;
Al 2 O 3 2-10%;
alkaline earth oxides 3-10%;
alkali oxides 8-15%;
SnO 2 <1.0%; and
B 2 O 3 0-5%.

22. The method of claim 20 , further comprising the step of subjecting the glass pharmaceutical container to a depyrogenation cycle whereby the coefficient of friction does not increase by more than 30% after the depyrogenation cycle.

23. The method of claim 22 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for at least 30 minutes.

24. The method of claim 22 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of at least 250° C. for up to 72 hours.

25. The method of claim 22 , wherein the depyrogenation cycle comprises heating the glass pharmaceutical container with the coating to a temperature of from about 250° C. to about 400° C. for a time period of from about 30 minutes to about 72 hours.

26. The method of claim 20 , wherein the step of applying a coating comprises:
applying a coupling agent layer in direct contact with the exterior surface; and
applying a polymer layer in direct contact with the coupling agent layer.

27. The method of claim 20 , further comprising subjecting the glass container to a lyophilization cycle, whereby the coefficient of friction doe

Assignees

• Corning Inc

Inventors

• Adib Kaveh
• Bookbinder Dana Craig
• Chang Theresa
• Danielson Paul Stephen
• Demartino Steven Edward
• Drake Melinda Ann
• Fadeev Andrei Gennadyevich
• Hamilton James Patrick
• Morena Robert Michael
• Pal Santona
• Peanasky John Stephen
• Saha Chandan Kumar
• Schaut Robert Anthony
• Schiefelbein Susan Lee
• Timmons Christopher Lee

Classifications

• C03C21/002

  to perform ion-exchange between alkali ions (C03C21/005 takes precedence) · CPC title

• C03C17/42

  at least one coating of an organic material and at least one non-metal coating · CPC title

• C03C17/3405

  with at least two coatings of organic materials (C03C17/36, C03C17/42 take precedence) · CPC title

• C03C17/32

  with synthetic or natural resins (C03C17/30 takes precedence) · CPC title

• C03C17/30

  with silicon-containing compounds · CPC title