Dual-chamber solution packaging system

• US 20070075714A1
• Filed: 09/28/2006
• Published: 04/05/2007
• Est. Priority Date: 09/29/2005
• Status: Abandoned Application

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Markwardt, Kerry, Masterson, Christian, Dollinger, Harli, McCune, William
• Application Number:
  US11/529,184
• Publication Number:
  US 20070075714A1
• Time in Patent Office: Days
• US Class Current: 383/38
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: B65D 81/3266 separated by a common rupturable seal, a clip or other removable fastening device

Abstract

A solution packaging system and method of administering a solution are disclosed. One embodiment of the solution packaging system of the present invention comprises a gas-impermeable dual-chamber bag, having a first chamber and a second chamber separated by a frangible (releasable) seal, and an over-wrap member enclosing and containing the dual-chamber inner bag. The dual-chamber bag can be used to package two-part medicinal solutions containing bicarbonate, such as ophthalmic irrigation solutions. The first chamber can be filled with and contain a first part of such an irrigation solution, comprising, for example, a buffer such as bicarbonate. The second chamber can contain the second part of such a solution, comprising, for example, glutathione (GSSG), or other anti-oxidant, and dextrose, or other energy source. Both parts may contain other excipients. The over-wrap member can serve as a dust cover and need not be a moisture or gas barrier, as the dual-chamber inner bag will have sufficient gas barrier properties to minimize the loss of CO₂ from the first part of the solution (e.g., the bicarbonate). All of the components of the dual-chamber solution packaging system can withstand steam sterilization. The dual-chamber bag can be fitted with an administration port, which can be manufactured of, for example, polypropylene (PP), and sealed with a stopper (e.g., butyl rubber stopper) and an aluminum crimp seal. The dual-chamber bag can further comprise fill-ports to fill each chamber. The fill port openings can be sealed after filling the chambers and the fill ports cut from the dual-chamber bag. The frangible seal between the chambers of the embodiments of this invention can be broken by the end user to mix and reconstitute the two parts of the solution prior to use.

Claims

1. A solution packaging system, comprising:

a dual-chamber gas-impermeable bag having a first chamber and a second chamber, wherein the chambers are operable to enclose contents and are separated by a releasable seal; and

an over-wrap member operable to enclose and contain the dual-chamber gas-impermeable bag.

2. The solution packaging system of claim 1, wherein the solution is a two-part solution having a first part and a second part to be mixed together prior to use, and wherein the first part is enclosed in the first chamber and the second part is enclosed in the second chamber.

3. The solution packaging system of claim 2, wherein the solution is a two-part ophthalmic irrigating solution, and wherein the first part comprises a bicarbonate buffer and the second part comprises glutathione (GSSG) and dextrose.

4. The solution packaging system of claim 2, wherein the releasable seal is operable to be broken by a user to allow mixing of the first part and the second part to reconstitute the solution.

5. The solution packaging system of claim 1, wherein the releasable seal is a frangible seal.

6. The solution packaging system of claim 1, wherein the dual-chamber gas-impermeable bag and the over-wrap member are composed of plastic laminate.

7. The solution packaging system of claim 1, wherein the dual-chamber gas-impermeable bag and the over-wrap member can be steam-sterilized.

8. The solution packaging system of claim 1, wherein the dual-chamber gas-impermeable bag further comprises an administration port operable to release the dual-chamber bag contents, and a fill port for each of the first and second chambers.

9. The solution packaging system of claim 8, wherein the administration port is operable to receive an administration set operable to couple the dual-chamber gas-impermeable bag to a fluidic system of an ophthalmic surgical system.

10. The solution packaging system of claim 8, wherein the administration port is in fluid communication with only one chamber when the releasable seal is intact.

11. The solution packaging system of claim 8, wherein the administration port comprises a stopper and a crimp seal operable to seal the administration port.

12. The solution packaging system of claim 8, wherein the fill ports are adapted to be cut from the dual-chamber gas-impermeable bag following a filling of their respective chambers, and wherein openings on the dual-chamber gas-impermeable bag corresponding to the fill ports can be sealed to contain the contents.

13. The solution packaging system of claim 1, wherein the dual-chamber gas-impermeable bag further comprises a hanging interface for hanging the dual-chamber bag during use.

14. The solution packaging system of claim 13, wherein the chamber that is the lower chamber when the dual-chamber bag is hung from the hanging interface during use contains a more physiologically compatible component of the two chambers, and wherein the dual-chamber gas-impermeable bag further comprises an administration port operable to release the dual-chamber bag contents, wherein the administration port is in fluid communication with only the lower chamber when the releasable seal is intact.

15. The solution packaging system of claim 14, wherein the contents of the dual-chamber gas-impermeable bag flow out of the administration port during use, wherein the administration port hangs lower than either of the first and second chambers.

16. A solution packaging system, comprising:

a gas-impermeable bag; and

an over-wrap member operable to enclose and contain the gas-impermeable bag.

17. The solution packaging system of claim 16, wherein the gas-impermeable bag is a dual-chamber gas-impermeable bag having a first chamber and a second chamber, wherein the chambers are operable to enclose contents and are separated by a releasable seal.

18. The solution packaging system of claim 17, wherein the solution is a two-part solution having a first part and a second part to be mixed together prior to use, and wherein the first part is enclosed in the first chamber and the second part is enclosed in the second chamber.

19. The solution packaging system of claim 18, wherein the solution is a two-part ophthalmic irrigating solution, and wherein the first part comprises a bicarbonate buffer and the second part comprises glutathione (GSSG) and dextrose.

20. The solution packaging system of claim 18, wherein the releasable seal is operable to be broken by a user to allow mixing of the first part and the second part to reconstitute the solution.

21. The solution packaging system of claim 17, wherein the releasable seal is a frangible seal.

22. The solution packaging system of claim 16, wherein the gas-impermeable bag and the over-wrap member are composed of plastic laminate.

23. The solution packaging system of claim 16, wherein the gas-impermeable bag and the over-wrap member can be steam-sterilized.

24. The solution packaging system of claim 16, wherein the gas-impermeable bag further comprises an administration port operable to release the gas-impermeable bag contents.

25. The solution packaging system of claim 24, wherein the administration port is operable to receive an administration set operable to couple the gas-impermeable bag to a fluidic system of an ophthalmic surgical system.

26. The solution packaging system of claim 16, wherein the gas-impermeable bag further comprises a hanging interface for hanging the gas-impermeable bag during use.

27. The solution packaging system of claim 16, wherein the gas-impermeable bag has a plurality of chambers, wherein the chambers are operable to enclose contents and wherein each chamber is separated from the others by one or more releasable seals.

28. A solution packaging system, comprising:

a dual-chamber gas-impermeable bag, comprising;

a first chamber;

a second chamber, wherein the first and second chambers are intercommunicable and operable to enclose contents and are separated by a releasable seal;

an administration port operable to release the dual-chamber bag contents;

a fill port for each of the first and second chambers; and

a hanging interface for hanging the dual-chamber bag during use; and

an over-wrap member operable to enclose and contain the dual-chamber gas-impermeable bag.

29. The solution packaging system of claim 28, wherein the solution is a two-part solution having a first part and a second part to be mixed together prior to use, and wherein the first part is enclosed in the first chamber and the second part is enclosed in the second chamber.

30. The solution packaging system of claim 29, wherein the solution is a two-part ophthalmic irrigating solution, and wherein the first part comprises a bicarbonate buffer and the second part comprises glutathione (GSSG) and dextrose.

31. The solution packaging system of claim 29, wherein the releasable seal is operable to be broken by a user to allow mixing of the first part and the second part to reconstitute the solution.

32. The solution packaging system of claim 28, wherein the releasable seal is a frangible seal.

33. The solution packaging system of claim 28, wherein the dual-chamber gas-impermeable bag and the over-wrap member can be steam-sterilized.

34. The solution packaging system of claim 28, wherein the administration port is operable to receive an administration set operable to couple the dual-chamber gas-impermeable bag to a fluidic system of an ophthalmic surgical system.

35. The solution packaging system of claim 28, wherein the administration port is in fluid communication with only one chamber when all the releasable seals are intact.

36. The solution packaging system of claim 28, wherein the administration port comprises a stopper and a crimp seal operable to seal the administration port.