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-10350346-B2
Publication Date
2019-07-16
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 relates to a pharmaceutical product comprising a delivery syringe with a transparent plastic receptacle filled with an oxygen-sensitive active pharmaceutical ingredient fluid. The delivery syringe is enveloped in a transparent oxygen-tight envelope that is oxygen-tight and provides an internal space for an oxygen absorber and for a fluid which is low in oxygen or binds oxygen.
The oxygen-tight envelope remains transparent and is defined by 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. The inner surface of the plastic receptacle is siliconized at least in sections.
In disclosed embodiments, oxygen-sensitive propofol emulsion is used as the oxygen-sensitive active pharmaceutical ingredient fluid. The plastic receptacle is formed from plastic comprising at least one of cyclic olefin copolymer, cyclic olefin polymer, or Crystal Clear Polymer, and the oxygen-tight envelope includes oxygen barrier materials, such as ethylene-vinyl alcohol copolymer layers in multilayer plastic structures.
The document further addresses oxygen-sensitive delivery arrangements using a transparent plastic syringe receptacle and oxygen-tight enveloping packaging to reduce oxygen exposure while maintaining transparency. It additionally provides siliconization of the receptacle inner surface, and optionally an oxygen absorber, to create and protect an internal oxygen-controlled environment.
Claims Coverage
The document includes two independent claims. Both independently require a transparent oxygen-sensitive delivery syringe assembly with a siliconized transparent plastic receptacle surrounded by a transparent oxygen-tight envelope defined by oxygen and water-vapor transmission-rate limits, and both include an internal space for an oxygen absorber and an oxygen-low or oxygen-binding fluid, with claim 18 further limiting the active fluid, envelope environment, and the plastic polymer selection.
Transparent oxygen-tight enveloped oxygen-sensitive delivery syringe with internal oxygen control
A pharmaceutical product comprising a delivery syringe comprising a transparent plastic receptacle filled with an oxygen-sensitive active pharmaceutical ingredient fluid, and a transparent oxygen-tight envelope which envelopes the delivery syringe in an oxygen-tight manner and provides an internal space for an oxygen absorber and for a fluid which is low in oxygen or binds oxygen.
Oxygen and water vapor transmission-rate limited transparent oxygen-tight envelope
The transparent oxygen-tight envelope is transparent and 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.
Siliconized inner surface of the transparent plastic receptacle
An inner surface of the plastic receptacle is siliconized at least in sections.
Propofol emulsion as the oxygen-sensitive active pharmaceutical ingredient fluid
The oxygen-sensitive active pharmaceutical ingredient fluid is an active pharmaceutical ingredient emulsion and comprises propofol.
Specified plastic receptacle polymers
The plastic receptacle is formed from plastic comprising at least one of the following polymers: cyclic olefin copolymer, cyclic olefin polymer or Crystal Clear Polymer.
Across the independent claims, the core coverage is a transparent syringe receptacle for oxygen-sensitive active pharmaceutical ingredient fluid, surrounded by a transparent oxygen-tight envelope with defined oxygen and water-vapor transmission limits and an internal oxygen absorber/low-oxygen or oxygen-binding environment, together with siliconization of the receptacle inner surface. Claim 18 additionally restricts the oxygen-sensitive fluid to a propofol emulsion and restricts the receptacle polymer to cyclic olefin copolymer, cyclic olefin polymer, or Crystal Clear Polymer.
Stated Advantages
Reduced breakage risk compared with glass.
Avoids transfer steps and contamination.
Documented Applications
Oxygen-sensitive delivery of a transparent syringe formulation enclosed in an oxygen-tight transparent envelope, providing an internal oxygen-controlled environment for the oxygen-sensitive active pharmaceutical ingredient fluid.
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