Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients

Patent metadata

Field	Value
Publication number	US-9717649-B2
Application number	US-201414259261-A
Country	US
Kind code	B2
Filing date	Apr 23, 2014
Priority date	Apr 24, 2013
Publication date	Aug 1, 2017
Grant date	Aug 1, 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, Prolia® (denosumab), Xgeva® (denosumab), Aranesp® (darbepoetin alfa), AMG-145, romosozumab (AMG-785), ganitumab (AMG-479), trebananib (AMG-386), brodalumab (AMG-827), and rilotumumab (AMG-102).

First claim

What is claimed is:

1. A pharmaceutical product comprising:
denosumab, darbepoetin alfa, AMG-145, romosozumab (AMG-785), ganitumab (AMG-479), trebananib (AMG-386), brodalumab (AMG-827), or rilotumumab (AMG-102) and a pharmaceutically acceptable excipient;
contained within a glass pharmaceutical container comprising a glass composition comprising:
SiO 2 in a an amount greater than or equal to about 72 mol. % and less than or equal to about 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 about 5 mol. % and less than or equal to about 7 mol. %;
Y mol. % alkali oxide, wherein the alkali oxide comprises Na 2 O in an amount greater than about 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 pharmaceutical product of claim 1 , wherein the pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa.

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

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

5. The pharmaceutical product of claim 1 , wherein the pharmaceutical product comprises increased stability, product integrity, or efficacy.

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

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

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

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

10. The pharmaceutical product of claim 7 , wherein said glass pharmaceutical container comprises a substantially homogeneous inner layer.

11. The pharmaceutical product of claim 10 , wherein the pharmaceutical container comprises a compressive stress layer with a surface compressive stress greater than or equal to 150 MPa and a depth of layer greater than or equal to 25 μm.

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

Assignees

• Corning Inc

Inventors

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

Classifications

• C07K2317/94

  Stability, e.g. half-life, pH, temperature or enzyme-resistance · CPC title

• C07K16/2875

  against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154 (against NGF C07K16/22, against TNF C07K16/241) · CPC title

• A61K38/1816

  Erythropoietin [EPO] · CPC title

• C03C4/20

  for chemical resistant glass · CPC title

• B65D1/00

  Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material (with curved or partially-curved cross-section made by winding or bending paper B65D3/00; with polygonal cross-section formed by folding B65D5/00; specially constructed to be opened by cutting, piercing or tearing of wall portions B65D17/00; rigid pallets with side walls B65D19/02) · CPC title