Packaging system for oxygen-sensitive drugs

Patent metadata

Field	Value
Publication number	US-2016100889-A1
Application number	US-201514968351-A
Country	US
Kind code	A1
Filing date	Dec 14, 2015
Priority date	Mar 14, 2013
Publication date	Apr 14, 2016
Grant date	—

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.

First claim

What is claimed is:

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.

2 . The pharmaceutical packaging system of claim 1 , wherein the syringe is plastic or glass.

3 . The pharmaceutical packaging system of claim 1 , wherein the secondary packaging material is a thermoformed, aluminum-based cold form, or molded blister.

4 . The pharmaceutical packaging system of claim 1 , wherein the multilayer bottom web comprises ethylene/vinyl alcohol copolymer (EVOH).

5 . The pharmaceutical packaging system of claim 1 , wherein the top web lid comprises aluminum foil or EVOH.

6 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber is placed inside the blister packaging.

7 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber is a canister.

8 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber has a capacity to absorb about 30 cc oxygen at 1 atm.

9 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber is iron-based.

10 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber reduces the oxygen level in the blister packaging from the time of packaging assembly to about zero percent at about one day.

11 . The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber reduces the oxygen level in the syringe from the time of packaging assembly to about zero percent at about one month.

12 . The pharmaceutical packaging system of claim 1 , wherein the oxygen level remains at about zero percent in the syringe and the blister packaging for at least three years.

13 . The pharmaceutical packaging system of claim 1 , wherein the injectable oxygen-sensitive drug is morphine.

14 . The pharmaceutical packaging system of claim 1 , wherein the injectable oxygen-sensitive drug is hydromorphone.

15 . The pharmaceutical packaging system of claim 1 , wherein the injectable oxygen-sensitive drug is promethazine.

16 . A pharmaceutical packaging system for injectable morphine, the packaging system comprising:
(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.

17 . A pharmaceutical packaging system for injectable hydromorphone, the packaging system comprising:
(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.

18 . A pharmaceutical packaging system for injectable promethazine, the packaging system comprising:
(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.

Assignees

• Becton Dickinson France Sas

Inventors

• Devouassoux Thomas
• Forat Eric
• Proctor James Kenneth

Classifications

• A61B50/30

  Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40) · CPC title

• B65D65/40

  Applications of laminates for particular packaging purposes {(B65D1/0215, B65D1/28, B65D3/22, B65D5/0281, B65D5/563, B65D9/30, B65D29/02, B65D31/02, B65D75/26, B65D77/2024, B65D81/1275, B65D81/3811, B65D81/3823, B65D81/3834, B65D81/3846, B65D81/3858, B65D81/3874, B65D81/3886, B65D81/3897 take precedence; laminates per se or laminated packages characterised by the composition or)} · CPC title

• B65D81/268

  the absorber being enclosed in a small pack, e.g. bag, included in the package · CPC title

• A61K31/485

  Morphinan derivatives, e.g. morphine, codeine · CPC title

• A61B2050/3005

  containing a preservative liquid, e.g. an antiseptic liquid · CPC title