Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients

Patent metadata

Field	Value
Publication number	US-9849066-B2
Application number	US-201414259281-A
Country	US
Kind code	B2
Filing date	Apr 23, 2014
Priority date	Apr 24, 2013
Publication date	Dec 26, 2017
Grant date	Dec 26, 2017

Abstract

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, PEDIARIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine), HAVRIX® (Hepatitis A Vaccine), ENGERIX-B® (Hepatitis B Vaccine (Recombinant)), TWINRIX® (Hepatitis A & Hepatitis B (Recombinant) Vaccine), EPERZAN® (albiglutide), MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (astuprotimut-R), GSK2402968 (drisapersen), and HZ/su (herpes zoster vaccine).

First claim

What is claimed is:

1. A packaged pharmaceutical composition comprising:
A glass pharmaceutical container and a pharmaceutical composition contained within the glass pharmaceutical container, wherein the pharmaceutical composition comprises:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine, Hepatitis A Vaccine, Hepatitis B Vaccine (Recombinant), Hepatitis A & Hepatitis B (Recombinant) Vaccine, albiglutide, MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (astuprotimut-R), GSK2402968 (drisapersen), or HZ/su (herpes zoster vaccine) and a pharmaceutically acceptable excipient; wherein the glass pharmaceutical container comprises a glass composition comprising
SiO 2 in a an amount greater than or equal to 72 mol. % and less than or equal to 78 mol. %;
alkaline earth oxide comprising both MgO and CaO, wherein CaO is present in an amount up to about 1.0 mol. %, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5;
X mol. % Al 2 O 3 , wherein X is greater than or equal to 5 mol. % and less than or equal to 7 mol. %;
Y mol. % alkali oxide, wherein the alkali oxide comprises Na 2 O in an amount greater than 8 mol. %; and
a ratio of a concentration of B 2 O 3 (mol. %) in the glass container to (Y mol. %−X mol. %) is less than or equal to 0.3.

2. The packaged pharmaceutical composition of claim 1 , wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa.

3. The packaged pharmaceutical composition of claim 1 , wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 250 MPa.

4. The packaged pharmaceutical composition of claim 1 , wherein the glass pharmaceutical container comprises a depth of layer greater than 30 μm.

5. The packaged pharmaceutical composition of claim 1 , wherein the glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition.

6. The packaged pharmaceutical composition of claim 1 :
wherein the glass pharmaceutical container has a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 10 μm, and wherein the glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition.

7. The packaged pharmaceutical composition of claim 1 :
wherein the glass pharmaceutical container is substantially free of boron, and wherein the glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition.

8. The packaged pharmaceutical composition of claim 7 , wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 25 μm.

9. The packaged pharmaceutical composition of claim 8 , wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 300 MPa and a depth of layer greater than 35 μm.

10. The packaged pharmaceutical composition of claim 7 , wherein said glass pharmaceutical container comprises an internal homogeneous layer.

11. The packaged pharmaceutical composition of claim 10 , wherein said glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 25 μm.

12. The packaged pharmaceutical composition of claim 1 , wherein the glass pharmaceutical container comprises an internal homogeneous layer.

Assignees

• Corning Inc

Inventors

• Weeks Wendell P
• Schaut Robert Anthony
• Demartino Steven Edward
• Peanasky John Stephen

Classifications

• C12N2770/32634

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2770/32434

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2730/10134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2710/16734

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K2039/6068

  Other bacterial proteins, e.g. OMP · CPC title