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-9522222-B2
Publication Date
2016-12-20
Expiration Date
Abstract
An application arrangement for a medicinal substance fluid includes an application syringe with a plastic container, wherein the plastic container is filled with an oxygen-sensitive medicinal substance fluid and an oxygen-tight cover which surrounds the application syringe in oxygen-tight manner.
Core Innovation
The invention relates to a delivery arrangement comprising a delivery syringe with a transparent plastic receptacle filled with an oxygen-sensitive active pharmaceutical ingredient fluid, wherein the oxygen-sensitive active pharmaceutical ingredient fluid is an active pharmaceutical ingredient emulsion. The syringe is enveloped in a transparent oxygen-tight envelope in an oxygen-tight manner and the envelope comprises an ethylene-vinyl alcohol copolymer barrier. The oxygen-tight envelope is filled with a fluid which is low in oxygen or binds oxygen, and an oxygen absorber is placed in the oxygen-tight envelope.
To protect the oxygen-sensitive active pharmaceutical ingredient emulsion, the plastic receptacle is formed from plastic comprising at least one of cyclic olefin copolymer, cyclic olefin polymer, or Crystal Clear Polymer. In addition, an inner surface of the plastic receptacle is siliconized at least in sections. This combination is used within the delivery arrangement so that the transparent oxygen-tight envelope and the specified syringe receptacle materials cooperate to maintain an oxygen-protective environment around the oxygen-sensitive fluid.
In more specific embodiments, the oxygen-tight envelope includes structural barrier elements and defined barrier performance. The oxygen-tight envelope comprises a transparent shell formed from thermoplastic being thermoformed, where the thermoplastic comprises an amorphous polyethylene terephthalate film comprising an ethylene-vinyl alcohol copolymer barrier. The oxygen-tight envelope has an oxygen transmission rate less than or equal to 5 cm3/m2·d·bar and a water vapor transmission rate less than or equal to 5 g/m2·d.
Claims Coverage
The partial content includes three independent claims (clm-00001, clm-00014, clm-00016). Across these claims, the inventive features center on an oxygen-protective delivery arrangement using a transparent syringe receptacle made from specified plastics with a siliconized inner surface, a transparent oxygen-tight envelope including an ethylene-vinyl alcohol copolymer barrier, and an oxygen-protective fill with an oxygen absorber, with additional material and performance constraints in clm-00016 and ingredient specificity in clm-00014.
Oxygen-tight envelope with ethylene-vinyl alcohol copolymer barrier and oxygen-protective fill
A transparent oxygen-tight envelope which envelopes the delivery syringe in an oxygen-tight manner and comprises an ethylene-vinyl alcohol copolymer barrier, wherein the oxygen-tight envelope is filled with a fluid which is low in oxygen or binds oxygen.
Oxygen absorber placed in the oxygen-tight envelope
An oxygen absorber which is placed in the oxygen-tight envelope.
Transparent plastic receptacle made from specified cyclic olefin/Crystal Clear Polymer
The plastic receptacle is formed from plastic comprising at least one of cyclic olefin copolymer, cyclic olefin polymer, or Crystal Clear Polymer.
Siliconized inner surface of the plastic receptacle
An inner surface of the plastic receptacle is siliconized at least in sections.
Oxygen-sensitive active pharmaceutical ingredient emulsion
The plastic receptacle is filled with an oxygen-sensitive active pharmaceutical ingredient fluid, wherein the oxygen-sensitive active pharmaceutical ingredient fluid is an active pharmaceutical ingredient emulsion.
Propofol-containing oxygen-sensitive active pharmaceutical ingredient emulsion
The oxygen-sensitive active pharmaceutical ingredient fluid is an active pharmaceutical ingredient emulsion and comprises propofol.
Thermoformed transparent shell with amorphous polyethylene terephthalate film and ethylene-vinyl alcohol copolymer barrier
The oxygen-tight envelope comprises a transparent shell which is formed from thermoplastic being thermoformed and the thermoplastic comprises an amorphous polyethylene terephthalate film comprising an ethylene-vinyl alcohol copolymer barrier.
Defined oxygen and water vapor transmission rate limits
The oxygen-tight envelope has an oxygen transmission rate of less than or equal to 5 cm3/m2 d bar and a water vapor transmission rate of less than or equal to 5 g/m2 d.
Taken together, the independent claims define a delivery arrangement in which a transparent plastic receptacle containing an oxygen-sensitive active pharmaceutical ingredient emulsion is surrounded by a transparent oxygen-tight envelope incorporating an ethylene-vinyl alcohol copolymer barrier. The oxygen-tight envelope is filled with a low-oxygen or oxygen-binding fluid and includes an oxygen absorber, while the receptacle uses specified transparent cyclic olefin or Crystal Clear Polymer materials with a siliconized inner surface. Further constraints specify propofol in clm-00014 and, in clm-00016, a thermoformed transparent shell structure with an amorphous polyethylene terephthalate film barrier plus defined oxygen and water vapor transmission rate limits.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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