Packaging system for oxygen-sensitive drugs

Patent metadata

Field	Value
Publication number	US-10781027-B2
Application number	US-201916269434-A
Country	US
Kind code	B2
Filing date	Feb 6, 2019
Priority date	Mar 14, 2013
Publication date	Sep 22, 2020
Grant date	Sep 22, 2020

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 container has an oxygen permeable component,
(ii) a hermetically sealed oxygen barrier blister packaging which houses the container, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid each comprised of an oxygen barrier material; 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 container, and the oxygen levels in the blister packaging and in the container 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 oxygen barrier material is selected from the group consisting of high density polyethylene (HDPE), low density polyethlyene (LDPE), ethylene-vinyl alcohol copolymer (EVOH), polyvinyl alcohol (PVOH), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), vinylidene chloride-methyl acrylate copolymer, polyester, polypropylene (PP), polyethylene terephthalate (PET), amorphous PET, glycol modified PET (PET-G), polyethylene naphthalate (PEN), ethylene acrylic acid copolymer (EAA), polyamide (PA), metalized film, aluminum foil, oxide coated films and combinations thereof.

3. The pharmaceutical product of claim 2 , wherein the oxygen barrier material is selected from the group consisting of EVOH, PVOH, PVC, PVDC, PCTFE, vinylidene chloride-methyl acrylate copolymer, polyamide, polyester, a metalized film, oxide coated films, and combinations thereof.

4. The pharmaceutical product of claim 2 , wherein the oxygen barrier material is present in the form of a multilayer film.

5. The pharmaceutical product of claim 4 , wherein the multilayer film comprises PVC/EVOH, PET/EVOH, PET/EVOH/PE, PET/EVOH/PET, PE/EVOH/PE, PVC/PCTFE/EVOH, paper/aluminum(Al)/PE, PET/Al/PE, paper/PE/foil/PE, paper/PET/Al, clay-coated paper/PE/foil/LDPE, or paper/LDPE/foil/EEA.

6. The pharmaceutical product of claim 1 , wherein the multilayer bottom web comprises polyethylene terephthalate (PET) and ethylene-vinyl alcohol copolymer (EVOH).

7. The pharmaceutical product of claim 1 , wherein the multilayer top web lid comprises polyethylene terephthalate (PET), aluminum foil, and paper.

8. The pharmaceutical product of claim 1 , wherein the container is a syringe, cartridge, or vial.

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

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

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

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

13. 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.

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

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

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

17. 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.

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

19. The pharmaceutical product of claim 1 , wherein the drug comprises an amine, a sulfide, an allylic alcohol, a phenol or another chemical group that can have reactivity with oxygen.

20. The pharmaceutical product of claim 1 , wherein the 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.

21. A pharmaceutical product comprising:
(i) a container filled under inert conditions with morphine, wherein the container has an oxygen permeable component,
(ii) a hermetically sealed oxygen barrier blister packaging which houses the container, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid each comprised of an oxygen barrier material; 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 container, and the oxygen levels in the blister packaging and in the container remain at about zero percent for at least one year after the initial reduction in oxygen levels.

22. A pharmaceutical product comprising:
(i) a container filled under inert conditions with hydromorphone, wherein the container has an oxygen permeable component,
(ii) a hermetically sealed oxygen barrier blister packaging which houses the container, wherein the blister packaging comprises a multilayer bottom web and a multilayer top web lid each comprised of an oxygen barrier material; 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 container, and the oxygen levels in the blister packaging and in the container remain at about zero percent for at least one year after the initial reduction in oxygen levels.

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Devouassoux Thomas
• Forat Eric
• Proctor James Kenneth

Classifications

• 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

• A61B50/3001

  for sharps · CPC title

• A61K31/485

  Morphinan derivatives, e.g. morphine, codeine · 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

• B65D75/36

  one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages {, the recess or recesses being preformed (B65D73/0057, B65D73/0092 take precedence)} · CPC title