Application arrangement with a medicinal substance fluid
Inventors
Kerschbaumer, Andreas • Gorges, Roland • Grigoleit, Patricia • Krenn, Christian • Schloegl, Johann
Assignees
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Publication Number
US-11452811-B2
Publication Date
2022-09-27
Expiration Date
Abstract
A pharmaceutical product includes a delivery syringe comprising a plastic receptacle and an oxygen-tight envelope which envelopes the delivery syringe in an oxygen-tight manner, wherein the plastic receptacle is filled with an oxygen-sensitive active pharmaceutical ingredient fluid and an inner surface of the plastic receptacle is siliconized at least in sections.
Core Innovation
The invention describes an oxygen-sensitive pharmaceutical delivery arrangement comprising a delivery syringe with a transparent plastic receptacle filled with an oxygen-sensitive active pharmaceutical ingredient fluid. The delivery syringe is enclosed by an oxygen-tight envelope in an oxygen-tight manner to protect the oxygen-sensitive active pharmaceutical ingredient fluid.
The oxygen-tight envelope is characterized by an oxygen transmission rate less than or equal to 10 cm3/m2 d bar and a water vapor transmission rate less than or equal to 10 g/m2 d. The inner surface of the plastic receptacle is siliconized at least in sections to influence the internal interaction with the plunger.
In particular embodiments for propofol, the oxygen-sensitive active pharmaceutical ingredient fluid is a propofol emulsion and the transparent plastic receptacle is formed from plastic comprising cyclic olefin copolymer, cyclic olefin polymer, Crystal Clear Polymer, or a combination thereof. Oxygen-tight envelope constructions are described as blister/multilayer films with an EVOH barrier or as thermoformed thermoplastic shells sealed with peelable or EVOH-barrier films, optionally combined with an oxygen absorber.
The document further describes possible envelope packaging and mechanical impact mitigation concepts, including axially shiftable and/or spacer-separated arrangements between the receptacle and a plunger. A production approach is described for providing a syringe receptacle, filling with an oxygen-sensitive active pharmaceutical ingredient fluid, and then enveloping and sealing the syringe in an oxygen-tight package.
Claims Coverage
The independent claims define a pharmaceutical product with four inventive features: a transparent plastic delivery syringe receptacle filled with an oxygen-sensitive active pharmaceutical ingredient fluid, an oxygen-tight envelope with specified oxygen and water vapor transmission limits, a propofol emulsion and cyclic olefin-based receptacle in one claim, and a siliconized inner surface of the plastic receptacle.
Transparent plastic receptacle filled with oxygen-sensitive active pharmaceutical ingredient fluid
A delivery syringe comprising a transparent plastic receptacle, wherein the plastic receptacle is filled with an oxygen-sensitive active pharmaceutical ingredient fluid.
Oxygen-tight envelope with oxygen and water vapor transmission limits
An oxygen-tight envelope which envelopes the delivery syringe in an oxygen-tight manner, wherein the oxygen-tight envelope has an oxygen transmission rate of less than or equal to 10 cm3/m2 d bar and a water vapor transmission rate of less than or equal to 10 g/m2 d.
Oxygen-sensitive emulsion comprising propofol and cyclic olefin-based receptacle
The oxygen-sensitive active pharmaceutical ingredient fluid is an active pharmaceutical ingredient emulsion and comprises propofol and wherein the plastic receptacle is formed from plastic comprising cyclic olefin copolymer, cyclic olefin polymer, Crystal Clear Polymer, or a combination thereof.
Siliconized inner surface of the plastic receptacle
An inner surface of the plastic receptacle is siliconized at least in sections.
Overall, the claims cover an oxygen-protective pharmaceutical product formed by combining a transparent, siliconized plastic syringe receptacle containing an oxygen-sensitive active pharmaceutical ingredient fluid with an oxygen-tight envelope that enforces specific oxygen and water vapor transmission limits. In the more specific independent claim, the oxygen-sensitive fluid is a propofol emulsion and the receptacle material is limited to cyclic olefin copolymer, cyclic olefin polymer, and/or Crystal Clear Polymer.
Stated Advantages
No transfer of the oxygen-sensitive active pharmaceutical ingredient fluid to other containers.
Breakage resistance compared with glass.
Reduced preparation steps and reduced waste.
Documented Applications
Use as an oxygen-sensitive pharmaceutical delivery product in a delivery syringe arrangement protected by an oxygen-tight envelope.
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