Container for storing a drug such as insulin
Inventors
Bianchi, François • Lettieri, Gian-Luca • Proennecke, Stephan
Assignees
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Publication Number
US-11266567-B2
Publication Date
2022-03-08
Expiration Date
Abstract
A polymeric container for storing a drug such as insulin which comprises a hard shell (2) and a flexible film (1), wherein both elements are made from the same material.
Core Innovation
The invention relates to a polymeric container for storing a drug that includes a hard shell made from a first rigid polymeric material and a flexible film made from a blend of the first rigid polymeric material and a second material forming a single layer. The flexible film has a pre-formed shape that causes a collapsing of the flexible film onto the hard shell such that an inner surface of the flexible film closely fits an inner surface of the hard shell.
The hard shell and the flexible film are connected to form the polymeric container, forming a deformable enclosure. The deformable enclosure has variable volume for the drug, where the variable volume is located between the inner surface of the hard shell and the inner surface of the flexible film, and the flexibility of the flexible film allows the flexible film to expand and collapse to provide for the variable volume.
The disclosed polymeric drug container is used in a skin patch infusion system for providing a drug to the skin patch. The container can include an inlet port for filling, including a septum sealed inlet, and a dispensing arrangement including an outlet port and an internal filter within the deformable enclosure.
Claims Coverage
The document includes three independent claims, all centered on a hard shell plus a single-layer flexible film formed from a blend with a pre-formed collapsing shape, thereby creating a deformable enclosure with variable volume located between the hard shell and flexible film inner surfaces.
Hard shell and pre-collapsing flexible film forming variable-volume deformable enclosure
A polymeric container for storing a drug comprising a hard shell made from a first rigid polymeric material; and a flexible film made from a blend of the first rigid polymeric material and a second material forming a single layer, the flexible film having a pre-formed shape causing a collapsing of the flexible film onto the hard shell such that an inner surface of the flexible film closely fits an inner surface of the hard shell; wherein the hard shell and the flexible film are connected to each other to form the polymeric container, the polymeric container forming a deformable enclosure, a flexibility of the flexible film allowing the deformable enclosure to have a variable volume for the drug, such that the variable volume for the drug is located between the inner surface of the hard shell and the inner surface of the flexible film.
Skin patch infusion system with container having pre-collapsing variable-volume deformable enclosure
An infusion system comprising a skin patch infusion device; and a container for storing and providing a drug to the skin patch, the container including a hard shell made from a first rigid polymeric material; and a flexible film made from a blend of the first rigid polymeric material and a second material forming a single layer, the flexible film having a pre-formed shape causing a collapsing of the flexible film onto the hard shell such that an inner surface of the flexible film closely fits an inner surface of the hard shell; and wherein the hard shell and the flexible film are connected to each other to form the container, the container forming a deformable enclosure by a flexibility of the flexible film, the flexibility of the flexible film allowing the deformable enclosure to have a variable volume for the drug such that the variable volume for the drug is located between the inner surface of the hard shell and the inner surface of the flexible film.
Flexible film expandable/collapsible variable volume with blended single-layer material
A container for storing a drug comprising a hard shell; and a flexible film, the hard shell and the flexible film connected to each other to form the container having a variable volume for the drug, the flexible film having a pre-formed shape causing a collapsing of the flexible film onto the hard shell such that an inner surface of the flexible film closely fits an inner surface of the hard shell; wherein the variable volume is located between the inner surface of the hard shell and the inner surface of the flexible film; wherein the flexible film and the hard shell form a deformable enclosure within the container, the deformable enclosure including the variable volume, a flexibility of the flexible film allows the flexible film to expand and collapse onto the hard shell to provide for the variable volume for the drug, and wherein a material used for the flexible film is a blend of a rigid polymeric material used for the hard shell and an elastomer made of the rigid polymeric material such that the flexible film forms a single layer.
Across the independent claims, the core coverage is the combination of a rigid hard shell, a single-layer flexible film formed from a blend of the rigid polymeric material and an elastomer made of the rigid polymeric material, and a pre-formed collapsing shape that makes the flexible film inner surface closely fit the hard shell inner surface, thereby creating a variable-volume deformable enclosure located between the two inner surfaces.
Stated Advantages
Minimizes dead volume and air bubbles, as described in the disclosed container design summary.
Provides drug compatibility and integrity for extended incubation, with reported acceptance criteria for insulin potency and preservatives.
Provides barrier performance for the drug container, with reported MVTR and evaporation barrier comparisons.
Supports mechanical and pressure behavior in which the flexible film exerts a steady-state pressure within a specified tolerance.
Improves container material and process compatibility including sterilizability and non-leachability/extractables testing results.
Documented Applications
Use in a skin patch CSII infusion system to store and provide a drug to the skin patch.
Use of the container with a syringe-sealed inlet (septum) and drug dispensing through an outlet arranged in the hard shell with an internal filter within the deformable enclosure.
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