PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS
First Claim
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1. A pharmaceutical packaging system for an injectable oxygen-sensitive drug, the packaging system comprising:
- (i) a syringe filled under inert conditions with an injectable oxygen-sensitive drug, wherein the syringe has an oxygen permeable tip cap,(ii) a hermetically sealed oxygen barrier blister packaging which houses the syringe, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid; and
(iii) an oxygen absorber, wherein the oxygen absorber reduces the oxygen level present from the time of packaging assembly to about zero percent in about one to three days in the blister packaging and in about one to three months in the syringe.
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Abstract
Described herein are pharmaceutical packaging systems which prevent oxidative degradation of oxygen-sensitive drugs, such systems including a primary packaging container with an oxygen permeable component, a secondary packaging with very low permeability to oxygen and an oxygen absorber.
42 Citations
18 Claims
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1. A pharmaceutical packaging system for an injectable oxygen-sensitive drug, the packaging system comprising:
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(i) a syringe filled under inert conditions with an injectable oxygen-sensitive drug, wherein the syringe has an oxygen permeable tip cap, (ii) a hermetically sealed oxygen barrier blister packaging which houses the syringe, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid; and (iii) an oxygen absorber, wherein the oxygen absorber reduces the oxygen level present from the time of packaging assembly to about zero percent in about one to three days in the blister packaging and in about one to three months in the syringe. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A pharmaceutical packaging system for injectable morphine, the packaging system comprising:
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(i) a syringe filled under inert conditions with morphine, wherein the syringe has an oxygen permeable tip cap, (ii) a hermetically sealed oxygen barrier blister packaging which houses the syringe, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid; and (iii) an oxygen absorber, wherein the oxygen absorber reduces the oxygen level from the time of packaging assembly to about zero percent in about one to three days in the blister packaging and in about one to three months in the syringe.
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17. A pharmaceutical packaging system for injectable hydromorphone, the packaging system comprising:
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(i) a syringe filled under inert conditions with hydromorphone, wherein the syringe has an oxygen permeable tip cap, (ii) a hermetically sealed oxygen barrier blister packaging which houses the syringe, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid; and (iii) an oxygen absorber, wherein the oxygen absorber reduces the oxygen level from the time of packaging assembly to about zero percent in about one to three days in the blister packaging and in about one to three months in the syringe.
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18. A pharmaceutical packaging system for injectable promethazine, the packaging system comprising:
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(i) a syringe filled under inert conditions with promethazine, wherein the syringe has an oxygen permeable tip cap, (ii) a hermetically sealed oxygen barrier blister packaging which houses the syringe, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid; and (iii) an oxygen absorber, wherein the oxygen absorber reduces the oxygen level from the time of packaging assembly to about zero percent in about one to three days in the blister packaging and in about one to three months in the syringe.
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Specification