Packaging system for oxygen-sensitive drugs

Patent metadata

Field	Value
Publication number	US-9545473-B2
Application number	US-201514968351-A
Country	US
Kind code	B2
Filing date	Dec 14, 2015
Priority date	Mar 14, 2013
Publication date	Jan 17, 2017
Grant date	Jan 17, 2017

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 comprising ethylene vinyl alcohol (EVOH) and a multilayer top web lid comprising aluminum foil or EVOH; 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 blister packaging is an aluminum-based cold formed blister, or a molded blister.

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

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

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

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

8. 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.

9. 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.

10. 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.

11. The pharmaceutical packaging system of claim 1 , wherein the blister packaging is a thermoformed blister.

12. The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber is selected from the group consisting of reduced iron compounds, catechol, ascorbic acid and analogs thereof, metal ligands, unsaturated hydrocarbons and polyamides.

13. The pharmaceutical packaging system of claim 1 , wherein the oxygen absorber is a sachet, pouch, canister, capsule, label, sticker, strip, patch, cartridge or container.

14. The pharmaceutical packaging system of claim 1 , wherein the injectable oxygen-sensitive drug is selected from the group consisting of morphine, hydromorphone, promethazine, dopamine, epinephrine, norepinephrine, esterified estrogen, ephedrine, pseudoephedrine, acetaminophen, ibuprofen, danofloxacin, erythromycin, penicillin, cyclosporine, methyldopate, cetirizine, diltiazem, verapamil, mexiletine, chlorothiazide, carbamazepine, selegiline, oxybutynin, vitamin A, vitamin B, vitamin C, L- cysteine and L-tryptophan.

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Devouassoux Thomas
• Forat Eric
• Proctor James Kenneth

Classifications

• 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

• A61M5/002 Primary

  Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics (needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001) · CPC title

• 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

• A61K31/485

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

• A61K31/5415

  ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam · CPC title