Container for a medicinal liquid

• US 6,685,691 B1
• Filed: 02/26/1999
• Issued: 02/03/2004
• Est. Priority Date: 02/27/1998
• Status: Expired due to Term

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Reinecke, Holger, Hochrainer, Dieter, Kladders, Heinrich, Eicher, Joachim, Geser, Johannes, Freund, Bernhard, Essing, Martin, Zierenberg, Bernd
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/258,357
• Time in Patent Office: 1,803 Days
• Field of Search: 604/403, 604/408, 604/415, 215/11.1, 215/247-257, 215/390-391, 220/9--, 220/495.01, 220/495.03, 220/495.05, 220/495-6-4, 220/265-280, 222/82, 222/83, 222/88, 222/92, 222/95, 222/105, 222/183, 222/541--54
• US Class Current: 604/403
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65D 2575/583 the non-integral spout having an elongate cross-sectional shape, e.g. canoe or boat shaped
• CPC Class Codes: B65D 75/5877 connected to a planar surface of the package wall
• CPC Class Codes: B65D 75/5883 connected to the package at the sealed junction of two package walls
• CPC Class Codes: B65D 83/0061 the contents of a flexible bag being expelled by the contracting forces inherent in the bag or a sleeve fitting snugly around the bag
• CPC Class Codes: B65D 83/62 by membrane, bag, or the like containers in which the content is delivered by the contracting forces inherent in the bag B65D83/0061

Abstract

Foil bags are used as a primary packaging for liquids, the bags permitting the liquid to be taken therefrom without the application of a considerable amount of force. A container is provided for a medicinal liquid, the container being gas-tight and liquid-tight so that it is storable over many months. The container includes a collapsible foil bag on which a flange, which is stable in respect of shape, is disposed. The flange is designed for fitting onto a discharge connection member. The container can be disposed in a casing which is stable in respect of shape. The medicinal liquid does not come into contact with air and is protected from the effect of light. The medicinal liquid may be dispensed from the foil bag in many partial quantities over a prolonged period of time, with a respective partial amount thereof being converted into an aerosol by means of an atomizer.

Claims

1. A propellant gas-free atomizer with a discharge connection member for dispensing medicament in inhalable metered doses, comprising:

a container including;

a foil bag being closed at both its ends and which is collapsible at a differential pressure below 300 hPa (300 mbar) and having a welded seam for closing a first end of said foil bag, wherein said welded seam extends substantially transversely with respect to a longitudinal axis of said foil bag and at least a portion of said welded seam extends partially in the longitudinal direction of said foil bag, and wherein said foil bag plastically and irreversibly collapses in a predetermined manner such that said foil bag retains its initial length after emptying,

a flange for closing a second end of said foil bag, wherein said flange is sealingly disposed on said second end of said foil bag, said flange including

a guide passage formed in said flange, and

a sealing location disposed within said guide passage for sealingly fitting said container onto said discharge connection member, and

a pierceable membrane to seal said container whereby said pierceable membrane is pierced by said discharge connection member when said container is fitted onto said discharge connection member; and

an inhalable medicament preparation disposed in said container, that is deliverable in a dosage of 10 μ

l to 50 μ

l.

2. The atomizer according to claim 1, wherein the inhalable medicament preparation is in a solution of ethanol, water, or a mixture thereof.

3. The atomizer according to claim 1, wherein the inhalable medicament preparation includes at least one active substance selected from the group consisting of one or more of the following:

Berotec (fenoterol-hydrobromide;

1-(3,5-dihydroxyphenyl)-2-[[1-(4-hydrozybenzyl)-ethyl]-amino]-ethanol-hydrobromide), Atrovent (ipratropium bromide), Berodual (combination of fenoterol-hydrobromide and ipratropium-bromide), Salbutamol (or Albuterol), Combivent, Oxivent (oxitropium bromide), Ba 679 (tiotropium bromide), BEA 2108 (di(2-thienyl)-glycol acid tropenol ester), Flunisolid, Budesonid, and Beclomethason.

4. The atomizer according to claim 1, wherein said container is disposed in a casing made of a metal or a plastic material and wherein said casing is connected to said flange.

5. The atomizer according to claim 4, wherein said casing has a diameter within the range from 10 mm to 30 mm.

6. The atomizer according to claim 4, wherein said casing has a diameter within the range from 12 mm to 17 mm.

7. The atomizer according to claim 4, wherein said casing has an overall length within the range from 20 mm to 60 mm.

8. The atomizer according to claim 4, wherein said casing has an overall length within the range from 30 mm to 50 mm.

9. The atomizer according to claim 4, wherein said casing is closed substantially all around its periphery and has an opening formed therein.

10. The atomizer according to claim 4, wherein said casing is closed substantially all around its periphery and has a gap at the location where said casing is connected to said flange.

11. The atomizer according to claim 4, wherein said casing is in the form of a basket having a plurality of openings.

12. The atomizer according to claim 4, wherein the container is configured to be fit into a discharge device having a connecting portion, and wherein said connecting portion comprises a releasable, positively locking, push-in snap connection between said connecting portion in said discharge device and said flange of the container.

13. The atomizer according to claim 12, wherein said snap connection comprises snap noses and snap hooks, and wherein said flange has a peripherally extending groove into which said snap noses of said snap hooks engage when the container is fit into said connecting portion.

14. The atomizer according to claim 1, wherein said foil bag is made from a composite material comprising at least two layers.

15. The atomizer according to claim 14, wherein a first layer of said composite material includes a metal selected from the group consisting of aluminum, gold and copper.

16. The atomizer according to claim 14, wherein said composite material comprises an inner foil of a plastic material and an outer foil of a metal material.

17. The atomizer according to claim 14, wherein said composite material comprises two foils of different plastic materials.

18. The atomizer according to claim 14, wherein said composite material comprises:

an inner foil made of a copolymer;

a diffusion-tight central layer; and

an outer foil of a plastic material, wherein the melting temperature of said plastic material is higher than the melting temperature of said inner foil.

19. The atomizer according to claim 18, wherein said diffusion-tight central layer is made from a material selected from the group consisting of a plastic material, a metal material, a glass and a ceramic.

20. The atomizer according to claim 14, wherein said composite material includes an inner layer of a plastic material of a thickness from 20 μ

m to 100 μ

m and an outer layer of metal of a thickness from 8 μ

m to 20 μ

m.

21. The atomizer according to claim 14, wherein said composite material includes

an inner foil of a plastic material of a thickness from 20 μ

m to 100 μ

m,

a central foil of a metal of a thickness from 8 μ

m to 20 μ

m, and

an outer foil of a plastic material of a thickness from 10 μ

m to 40 μ

m.

22. The atomizer according to claim 14, wherein said composite material includes a plastic foil of a thickness from 20 μ

m to 100 μ

m.

23. A container for a medicinal liquid for use as an interchangeable cartridge in an inhaler, the container being gas-tight and liquid-tight, comprising:

a foil bag being closed at both ends and which is collapsible at a differential pressure below 300 hPa (300 mbar), said foil bag having a welded seam for closing a first end of said foil bag wherein said welded seam extends substantially transversely with respect to the longitudinal axis of said foil bag and at least a portion of said welded seam extends partially in the longitudinal direction of said foil bag, wherein said foil bag plastically and irreversibly collapses in a predetermined manner such that said foil bag retains its initial length after emptying, and wherein said foil bag is made from a composite material, said composite material comprising an inner foil made of a copolymer, a diffusion-tight central layer, and an outer foil of a plastic material, wherein the melting temperature of said plastic material is higher than the melting temperature of said inner foil;

a flange for sealingly closing a second end of said foil bag, wherein said foil bag is welded to said flange on a periphery thereof and having a guide passage formed therein, wherein said guide passage includes a press fit and/or a sealing location for sealingly fitting said container onto a discharge connection member of the inhaler, whereby the sealing location is required if the sealing effect of the press fit is not sufficient;

a pierceable membrane being disposed at an end of or within said guide passage whereby said pierceable membrane is pierced by said discharge connection member when said container is positioned within the inhaler; and

a casing made of a metal of plastic material, wherein said casing is connected to said flange so that said foil bag is disposed within said casing.

24. The container according to claim 23, wherein said outer foil consists of polyethylene terephthalate.

25. The container according to claim 23, wherein said copolymer is a polyethylene copolymer of ethylene-acrylic acid.