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

Patent metadata

Field	Value
Publication number	US-9908682-B2
Application number	US-201414475819-A
Country	US
Kind code	B2
Filing date	Sep 3, 2014
Priority date	Jan 9, 2007
Publication date	Mar 6, 2018
Grant date	Mar 6, 2018

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.

First claim

The invention claimed is:

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.

Assignees

• Allergan Pharmaceuticals Int Ltd

Inventors

• Mcaffer Ian Gardener Cameron
• Tasko Peter Ernest

Classifications

• A61J1/10

  Bag-type containers · CPC title

• B65D81/266 Primary

  for absorbing gases, e.g. oxygen absorbers or desiccants (B65D51/244, B65D51/30 take precedence) · CPC title

• A61P11/08

  Bronchodilators · CPC title

• A61J1/067

  Flexible ampoules, the contents of which are expelled by squeezing · CPC title

• B65D81/268

  the absorber being enclosed in a small pack, e.g. bag, included in the package · CPC title