Pharmaceutical packaging comprising a chemically resistant glass

Patent metadata

Field	Value
Publication number	US-10315948-B2
Application number	US-201715586345-A
Country	US
Kind code	B2
Filing date	May 4, 2017
Priority date	May 4, 2016
Publication date	Jun 11, 2019
Grant date	Jun 11, 2019

Abstract

A pharmaceutical packaging is provided including a glass, comprising at least the following components (given in mol % on oxide basis): SiO2: 5 9-84, Al2O3: 7-18.5, CaO: 1-25, SrO: 0-6.5, BaO: 0-5, ZrO2: 0-3, TiO2: 0-5, B2O3: 0-1, wherein the ratio (CaO+SrO+BaO)/Al2O3<2.8, wherein the ratio (CaO+SrO+BaO)/SiO2≤0.39, wherein the hydrolytic resistance according to DIN ISO 720 is class HGA 1, and wherein the glass, apart from unavoidable contaminations, is free of alkali oxides and magnesium oxides.

First claim

What is claimed is:

1. A pharmaceutical packaging comprising:
a container made of a glass, said glass comprising at least the following components (given in mol % on oxide basis):

SiO 2
59-84

Al 2 O 3
  7-18.5

CaO
 1-25

SrO
  0-6.5

BaO
0-5

ZrO 2
0.5-3  

TiO 2
0-5

B 2 O 3
 0-1,

wherein said glass comprise a ratio (CaO+SrO+BaO)/Al 2 O 3 <2.8;
wherein said glass comprises a ratio (CaO+SrO+BaO)/SiO 2 ≤0.39;
wherein said glass comprises a hydrolytic resistance according to DIN ISO 720 that is class HGA 1; and
wherein said glass, apart from unavoidable contaminations, is free of alkali oxides and of magnesium oxide.

2. The pharmaceutical packaging of claim 1 , wherein the ratio (CaO+SrO+BaO)/Al 2 O 3 is smaller than 2.3.

3. The pharmaceutical packaging of claim 1 , wherein the ratio (CaO+SrO+BaO)/Al 2 O 3 is larger than 1.9.

4. The pharmaceutical packaging of claim 1 , wherein the ratio (CaO+SrO+BaO)/SiO 2 >0.25.

5. The pharmaceutical packaging of claim 1 , wherein the content of BaO≤3.

6. The pharmaceutical packaging of claim 1 , wherein the content of Al 2 O 3 is smaller than 12 mol %.

7. The pharmaceutical packaging of claim 1 , wherein the content of Al 2 O 3 is larger than 9 mol %.

8. The pharmaceutical packaging of claim 1 , wherein the content of CaO is larger than 15 mol %.

9. The pharmaceutical packaging of claim 1 , wherein the content of SrO is smaller than 4 mol %.

10. The pharmaceutical packaging of claim 1 , wherein said glass comprises a total content of TiO 2 +ZrO 2 that is at least 0.8 mol %.

11. The pharmaceutical packaging of claim 1 , wherein said glass comprises a total content of TiO 2 +ZrO 2 that is 6 mol % at most.

12. The pharmaceutical packaging of claim 1 , wherein the content of SiO 2 is larger than 60 mol %.

13. The pharmaceutical packaging of claim 1 , wherein the content of SiO 2 is smaller than 70 mol %.

14. The pharmaceutical packaging of claim 1 , wherein the content of:
B 2 O 3 is 0.1-1.

15. The pharmaceutical packaging of claim 1 , wherein said glass has a maximum processing temperature T4 of 1350° C.

16. The pharmaceutical packaging of claim 1 , wherein said glass has a weight loss according to DIN ISO 720 that is smaller than 50 μg Na 2 O/g.

17. The pharmaceutical packaging of claim 1 , wherein said glass further comprises 0.01 to 2 mol % of refining agents.

18. The pharmaceutical packaging of claim 1 , wherein said glass comprises a content of As 2 O 3 , Sb 2 O 3 , Cl—, F— and SO 4 2− that is a maximum of 1.5 mol % each, and wherein the content of SnO 2 and CeO 2 is a maximum of 1 mol % each.

19. The pharmaceutical packaging of claim 1 , wherein said container is at least one container selected from the group consisting of: a bottle, a syringe, a carpule, and an ampoule.

20. A pharmaceutical packaging, comprising a container made of glass and, within said container and in direct contact with said glass, at least one selected from a group consisting of: an active pharmaceutical agent, a buffering solution within a pH-range of 1-11, and water for injection, said glass comprising at least the following components (given in mol % on oxide basis):

SiO 2
59-84

Al 2 O 3
  7-18.5

CaO
 1-25

SrO
  0-6.5

BaO
0-5

ZrO 2
0-3

TiO 2
0-5

B 2 O 3
 0-1,

wherein said glass comprises a ratio (CaO+SrO+BaO)/Al 2 O 3 <2.8;
wherein said glass comprises a ratio (CaO+SrO+BaO)/SiO 2 ≤0.39;
wherein said glass comprises a hydrolytic resistance according to DIN ISO 720 that is class HGA 1; and
wherein said glass, apart from unavoidable contaminations, is free of alkali oxides and of magnesium oxide.

Assignees

• Schott Ag

Inventors

• Schwall Michael
• Kass Christof
• Tratzky Stephan
• Eichholz Rainer
• Nass Peter

Classifications

• B65D1/0207

  characterised by material, e.g. composition, physical features · CPC title

• C03C2204/00

  Glasses, glazes or enamels with special properties · CPC title

• A61J1/062

  Carpules · CPC title

• C03C3/087 Primary

  containing calcium oxide, e.g. common sheet or container glass · CPC title

• C03C4/20

  for chemical resistant glass · CPC title