# US 10,441,505 B2 · Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients

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- Number: US 10,441,505 B2
- Document ID: US10441505B2
- Status: Granted
- Kind: B2
- Application number: 14/965,007
- Filed: 2015-12-10
- Published: 2016-04-07
- Granted: 2019-10-15
- Earliest claimed: 2011-10-25
- Assignees: Corning Incorporated
- Applicants: Corning Incorporated
- Inventors: Wendell P. Weeks; Robert Anthony Schaut; Steven Edward DeMartino; John Stephen Peanasky
- Web page: https://patentgrep.com/patent/US10441505B2

## CPC

- A61J 1/1468: {Containers characterised by specific material properties}
- A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00)
- A61J 1/065: {Rigid ampoules, e.g. glass ampoules}
- A61K 31/403: condensed with carbocyclic rings, e.g. carbazole
- A61K 38/17: from animals; from humans {(enzyme inhibitors A61K38/005)}
- A61K 38/1816: {Erythropoietin [EPO]}
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 38/28: Insulins
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- C03C 3/087: containing calcium oxide, e.g. common sheet or container glass
- C03C 3/091: containing aluminium
- C03C 4/20: for chemical resistant glass
- C03C 21/002: {to perform ion-exchange between alkali ions (C03C21/005 takes precedence)}
- C07K 16/241: {Tumor Necrosis Factors}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- Y10T 428/131: Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.]
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C03C: CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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, LEVEMIR, NOVOLOG, NOVOLIN 70-30, NOVOLIN R, NOVOLIN N, NOVOLOG MIX 70-30 and NOVOLIN L.

## Claims

### Claim 1

A pharmaceutical composition comprising:
an active pharmaceutical ingredient selected from the group consisting of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, and Lente insulin; and
a pharmaceutically acceptable excipient;
wherein the pharmaceutical composition is contained within a delamination resistant glass container such that the pharmaceutical composition has increased stability, product integrity, or efficacy; and
wherein the delamination resistant glass container comprises a glass composition having X mol. % Al2O3, wherein X is greater than or equal to 2 mol. % and less than or equal to 10 mol. %, Y mol. % alkali oxide, wherein Y is greater than or equal to 8 mol. % and less than or equal to 18 mol. %, the ratio of Y:X is greater than about 0.9 and less than or equal to 2, and a boron content defined by the ratio B2O3/(Y-X) is less than 0.3.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein the delamination resistant glass container comprises a depth of layer greater than 30 μm.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the delamination resistant glass container is free of boron and compounds of boron.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the delamination resistant glass container comprises, on average, less than 3 glass particles with a minimum width of 50 μm and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-stable glass container.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the delamination-stable glass container comprises, on average, less than 2 glass particles with a minimum width of 50 μm and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-proof glass container.

### Claim 10 (depends on 9)

The pharmaceutical composition of claim 9, wherein the delamination-proof glass container comprises, on average, less than 1 glass particle with a minimum width of 50 μm and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

### Claim 11 (depends on 1)

The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-free glass container.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, wherein the delamination-free glass container comprises 0 glass particles with a minimum width of 50 μm and an aspect ratio of greater than 50 per trial following accelerated delamination testing.