Packaging system for oxygen-sensitive drugs

Patent metadata

Field	Value
Publication number	US-10214338-B2
Application number	US-201615375784-A
Country	US
Kind code	B2
Filing date	Dec 12, 2016
Priority date	Mar 14, 2013
Publication date	Feb 26, 2019
Grant date	Feb 26, 2019

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

The invention claimed is:

1. A pharmaceutical product comprising:
(i) a container 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; wherein the multilayer bottom web and multilayer top web lid are comprised of different materials; and
(iii) an oxygen absorber inside the blister packaging, 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, and the oxygen levels in the blister packaging and in the syringe remain at about zero percent for at least one year after the initial reduction in oxygen levels.

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

3. The pharmaceutical product of claim 1 , wherein the blister packaging is an aluminum-based cold formed blister, or a molded blister.

4. The pharmaceutical product of claim 1 , wherein the oxygen absorber is a canister.

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

6. The pharmaceutical product of claim 1 , wherein the oxygen absorber is iron-based.

7. The pharmaceutical product 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.

8. The pharmaceutical product 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.

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

10. The pharmaceutical product of claim 1 , wherein the blister packaging is a thermoformed blister.

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

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

13. The pharmaceutical product of claim 1 , wherein the injectable oxygen-sensitive drug is selected from 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.

14. The pharmaceutical product of claim 1 , wherein the multilayer bottom web further comprises polyethylene terephthalate (PET).

15. The pharmaceutical product of claim 1 , wherein the multilayer top web lid comprises aluminum foil and paper.

16. A pharmaceutical product 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 comprising ethylene vinyl alcohol (EVOH) and a multilayer top web lid comprising aluminum foil or EVOH, wherein the multilayer bottom web and multilayer top web lid are comprised of different materials; and
(iii) an oxygen absorber inside the blister packaging, 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, and the oxygen levels in the blister packaging and in the syringe remain at about zero percent for at least one year after the initial reduction in oxygen levels.

17. The pharmaceutical product of claim 16 , wherein the multilayer bottom web further comprises polyethylene terephthalate (PET).

18. The pharmaceutical product of claim 16 , wherein the multilayer top web lid comprises aluminum foil and paper.

19. A pharmaceutical product 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 container, 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, wherein the multilayer bottom web and multilayer top web are comprised of different materials; and
(iii) an oxygen absorber inside the blister packaging, 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, and the oxygen levels in the blister packaging and in the syringe remain at about zero percent for at least one year after the initial reduction in oxygen levels.

20. The pharmaceutical product of claim 19 , wherein the multilayer bottom web further comprises polyethylene terephthalate (PET).

21. The pharmaceutical product of claim 19 , wherein the multilayer top web lid comprises aluminum foil and paper.

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Devouassoux Thomas
• Forat Eric
• Proctor James Kenneth

Classifications

• B65D81/268

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

• A61K31/5415

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

• A61B50/3001

  for sharps · CPC title

• A61K31/485

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

• B65D81/266 Primary

  for absorbing gases, e.g. oxygen absorbers or desiccants (B65D51/244, B65D51/30 take precedence) · CPC title