IP Library Granted Patent US 9,908,682
Granted Patent B2
US 9,908,682 · App. 14/475,819 · Granted Mar 6, 2018

Storage of ampoules containing pharmaceutical formulations using a sealed container comprising an oxygen scavenger

Inventors: Ian Gardener Cameron McAffer (Tatsfield, GB); Peter Ernest Tasko (Westerham, GB)
Assignee: Allergan Pharmaceuticals International Limited
B65D81/266A61J1/10B65D81/268A61J1/067
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Quick Facts
Patent No.
US 9,908,682
App. No.
14/475,819
Granted
Mar 6, 2018
Kind
B2
Abstract

Ampoules made of plastics material and containing 0.5 to 5 ml of a pharmaceutical formulation are sealed, together with an oxygen scavenger, within a pouch.

Claims (13)

1. A method of reducing oxidative degradation of the contents of ampoules comprising the steps of:

(a) preparing a plurality of ampoules consisting essentially of a plastics material and manufactured using a blow-fill-seal method under normal atmospheric conditions, wherein the ampoules contain a solution of an inhalation pharmaceutical in a pharmaceutically acceptable carrier,

(b) sealing a packet or sachet comprising an oxygen scavenger and the plurality of ampoules in a resealable container under normal atmospheric conditions, wherein the resealable container is made of a material comprising a metal or metal compound and is gas impermeable;

(c) unsealing the container under normal atmospheric conditions and removing one or more ampoules; and

(d) resealing the container under normal atmospheric conditions while the packet or sachet comprising the oxygen scavenger and at least one ampoule remain in the container,

wherein, in the absence of an oxygen scavenger, the plurality of ampoules and the resealable container maintain separate environments, and

wherein a first oxygen concentration in a headspace of at least one ampoule prior to sealing in the resealable container is greater than a second oxygen concentration in the headspace of the at least one ampoule after sealing the resealable container.

2. The method of claim 1 wherein the plurality of ampoules is 10 or more ampoules.

3. The method of claim 1 wherein the oxygen scavenger can absorb 20 to 2000 cc of oxygen.

4. The method of claim 1 wherein the metal or metal compound is aluminum.

5. The method of claim 1 wherein the container is a pouch.

6. The method of claim 1 wherein the plurality of ampoules contain up to 10 mL of the solution of the inhalation pharmaceutical in the pharmaceutically acceptable carrier.

7. The method of claim 1 wherein the inhalation pharmaceutical comprises levalbuterol and ipratropium bromide.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2017
From: MCAFFER, IAN GARDNER CAMERON; TASKO, PETER ERNEST
To: BREATH LTD
Reel/Frame 044317/0195 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2017
From: BREATH LTD
To: ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
Reel/Frame 044317/0536 →
Priority Claims (1)
GB 0700380.9 · Jan 9, 2007 · national
Continuity (2)
Continuation 12522680
Related Publication 20140366491A1 · Dec 18, 2014