Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
Inventors
Cope, Steven M. • Titus, Allan E.
Assignees
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Publication Number
US-12714681-B2
Publication Date
2026-08-25
Expiration Date
Abstract
A packaged, sealed container system for stable storage of a formulation of an oxygen-sensitive pharmaceutical compound, the packaged, sealed container system comprising a primary container including therein a formulation of an oxygen-sensitive pharmaceutical compound, a secondary outer container comprising a first flexible sheet layer, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, such that the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. An oxygen scavenger is also disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. The oxygen scavenger is in fluid communication with the contents of the primary container.
Core Innovation
The invention describes a packaged, sealed container system in which an intravenous bag containing a ready-to-use norepinephrine formulation is enclosed in a sealed secondary container with an oxygen scavenger. The formulations include norepinephrine bitartrate monohydrate and dextrose, with specified claims also describing formulations without an antioxidant or sodium chloride, or with pH adjusters.
The disclosed system addresses the stability of ready-to-use norepinephrine formulations during storage. The description reports that oxygen scavenging reduces dissolved oxygen, while oxygen in an otherwise comparable package increases over time. It also describes avoiding dilution before administration, which reduces handling, contamination, and dosing-error risks.
Claims Coverage
The provided claims identify four independent claims comprising five inventive features: claims 1, 8, 14, and 20. Their claim elements cover a sealed secondary container enclosing an IV bag and an oxygen scavenger, together with specified ready-to-use norepinephrine formulation compositions.
Sealed IV bag packaging with an oxygen scavenger
Claims 1, 8, 14, and 20 cover a primary container that is an IV bag, enclosed between flexible sheet layers of a sealed secondary container. An oxygen scavenger is enclosed in the secondary container and is in fluid communication with the contents of the primary container.
Antioxidant-free formulation without sodium chloride
Claim 1 specifies a ready-to-use norepinephrine formulation that is free of an antioxidant and does not comprise sodium chloride. It includes dextrose, has a specified pH range, and is defined by retention of at least about 90% of initial activity after storage.
Formulation consisting essentially of norepinephrine, dextrose, and water
Claim 8 specifies a formulation consisting essentially of norepinephrine, dextrose, and water, with hydrochloric acid and/or sodium hydroxide optionally present as pH adjusters. The claim also specifies norepinephrine bitartrate monohydrate, a pH range, and retention of at least about 90% of initial activity after storage.
Formulation consisting of norepinephrine and dextrose
Claim 14 specifies a formulation consisting of norepinephrine and dextrose. It identifies norepinephrine bitartrate monohydrate and a pH range, and requires retention of at least about 90% of initial activity after storage.
Formulation with pH adjusters
Claim 20 specifies a formulation consisting of norepinephrine, dextrose, and hydrochloric acid and/or sodium hydroxide as pH adjusters. It identifies norepinephrine bitartrate monohydrate and requires retention of at least about 90% of initial activity after storage.
The four independent claims center on the sealed IV-bag and oxygen-scavenger package, with differences in the stated formulation composition. They also specify pH and stability characteristics; the dependent claims further define oxygen-scavenger materials and narrower formulation ranges.
Stated Advantages
The oxygen-scavenger package supports long-term stability of ready-to-use norepinephrine formulations without an antioxidant.
Avoiding dilution before administration can reduce handling, contamination, and dosing-error risks.
The description reports reduced dissolved oxygen in the oxygen-scavenger package compared with an otherwise comparable package.
Documented Applications
Storage and use of ready-to-use norepinephrine formulations in an IV bag.
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