Cold Chain Packaging
US-2024300712-A1 · Sep 12, 2024 · US
US2019084875A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2019084875-A1 |
| Application number | US-201816185819-A |
| Country | US |
| Kind code | A1 |
| Filing date | Nov 9, 2018 |
| Priority date | Nov 30, 2012 |
| Publication date | Mar 21, 2019 |
| Grant date | — |
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Glass pharmaceutical packages comprising glass containers are disclosed. In embodiments, a coated glass pharmaceutical package includes a glass container formed from one of a borosilicate glass composition that meets Type 1 criteria according to USP <660> or an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard. A lubricous coating may be positioned on at least a portion of the exterior surface of the glass container. The portion of the coated glass pharmaceutical package with the lubricous coating has a coefficient of friction that is at least 20% less than an uncoated glass pharmaceutical package. A horizontal compression strength of the portion of the coated glass pharmaceutical package with the lubricous coating may be at least 10% greater than an uncoated glass pharmaceutical package.
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What is claimed is: 1 . A coated glass pharmaceutical package comprising: a glass container having an interior surface and an exterior surface and a wall extending therebetween, wherein the glass container is formed from one of a borosilicate glass composition that meets Type 1 criteria according to USP <660> or an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard; and a lubricous coating having a thickness of ≤100 microns positioned on at least a portion of the exterior surface, wherein: the portion of the exterior surface of the coated glass pharmaceutical package with the lubricous coating has a coefficient of friction that is at least 20% less than an uncoated glass pharmaceutical package and the coefficient of friction does not increase by more than 30% after undergoing a depyrogenation cycle; and a horizontal compression strength of the portion of the exterior surface of the coated glass pharmaceutical package with the lubricous coating is at least 10% greater than an uncoated glass pharmaceutical package and the horizontal compression strength is not reduced by more than 20% after undergoing the depyrogenation cycle. 2 . The coated glass pharmaceutical package of claim 1 , wherein the lubricous coating is thermally stable at a temperature of at least about 280° C. for 30 minutes. 3 . The coated glass pharmaceutical package of claim 1 , wherein at least the interior surface of the glass container has a delamination factor less than or equal to 10. 4 . The coated glass pharmaceutical package of claim 1 , wherein the lubricous coating is an inorganic coating comprising at least one of a metal nitride coating, a metal oxide coating, a metal sulfide coating, SiO 2 , diamond-like carbon graphenes, or a carbide coating. 5 . The coated glass pharmaceutical package of claim 4 , wherein the inorganic coating comprises at least one of TiN, BN, hBN, TiO 2 , Ta 2 O 5 , HfO 2 , Nb 2 O 5 , V 2 O 5 , SiO 2 , MoS 2 , SiC, SnO, SnO 2 , ZrO 2 , Al 2 O 3 , ZnO, or BC. 6 . The coated glass pharmaceutical package of claim 1 , wherein the coefficient of friction of the coated glass pharmaceutical package is ≤0.7. 7 . The coated glass pharmaceutical package of claim 1 , wherein the coefficient of friction of the coated glass pharmaceutical package is ≤0.6. 8 . The coated glass pharmaceutical package of claim 1 , wherein the coefficient of friction of the coated glass pharmaceutical package is ≤0.5. 9 . The coated glass pharmaceutical package of claim 1 , wherein the coefficient of friction of the coated glass pharmaceutical package is ≤0.4. 10 . The coated glass pharmaceutical package of claim 1 , wherein the coefficient of friction of the coated glass pharmaceutical package is ≤0.3. 11 . The coated glass pharmaceutical package of claim 1 , wherein the depyrogenation cycle comprises heating the coated glass pharmaceutical package to a temperature of at least 250° C. for at least 30 minutes. 12 . The coated glass pharmaceutical package of claim 1 , wherein a light transmission through the coated glass pharmaceutical package is greater than or equal to about 55% of a light transmission through an uncoated glass pharmaceutical package for each wavelength from about 400 nm to about 700 nm after undergoing the depyrogenation cycle. 13 . The coated glass pharmaceutical package of claim 1 , wherein the lubricous coating comprises a polymer. 14 . The coated glass pharmaceutical package of claim 13 , wherein the lubricous coating further comprises a coupling agent. 15 . The coated glass pharmaceutical package of claim 14 , wherein the coupling agent is in direct contact with the exterior surface of the glass container and the polymer is in direct contact with the coupling agent. 16 . The coated glass pharmaceutical package of claim 1 , wherein the depyrogenation cycle comprises heating the coated glass pharmaceutical package to a temperature of at least 260° C. for at least 30 minutes. 17 . The coated glass pharmaceutical package of claim 1 , wherein the depyrogenation cycle comprises heating the coated glass pharmaceutical package to a temperature of from about 250° C. to about 400° C. for a time period of at least 30 minutes. 18 . The coated glass pharmaceutical package of claim 1 , wherein a light transmission through the portion of the exterior surface of the coated glass pharmaceutical package with the lubricous coating is greater than or equal to about 55% of a light transmission through an uncoated glass pharmaceutical package for each wavelength from about 400 nm to about 700 nm after the depyrogenation cycle. 19 . The coated glass pharmaceutical package of claim 18 , wherein the depyrogenation cycle comprises heating the coated glass pharmaceutical package in air at a temperature of at least about 250° C. for 30 minutes and the coated glass pharmaceutical package is thermally stable after the depyrogenation cycle. 20 . The coated glass pharmaceutical package of claim 17 , wherein the glass container has at least a class S3 acid resistance or better according to DIN 12116.
with other inorganic material (C03C17/34, C03C17/44 take precedence) · CPC title
Rigid ampoules, e.g. glass ampoules · CPC title
Reinforcing or strengthening parts or members · CPC title
consisting mainly of polymeric materials (B65D23/0828 takes precedence) · CPC title
multilayered (B65D81/3837 takes precedence) · CPC title
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