Closure-cap and container as a two-chamber cartridge for nebulizers for producing aerosols and active substance formulations, suitable for storage

• US 6,481,435 B2
• Filed: 05/31/2001
• Issued: 11/19/2002
• Est. Priority Date: 10/17/1998
• Status: Expired due to Term

• Current Assignee: Boehringer Ingelheim Pharma GmbH & Company Kg (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Pharmaceuticals Incorporated (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Hochrainer, Dieter, Zierenberg, Bernd
• Primary Examiner(s): Lewis, Aaron J.
• Assistant Examiner(s): PATEL, MITAL B
• Application Number:
  US09/871,500
• Publication Number:
  US 20010032643A1
• Time in Patent Office: 537 Days
• Field of Search: 604/80, 604/82, 604/83, 604/85, 604/86, 604/87, 604/88, 604/89, 604/90, 604/91, 604/92, 604/410, 604/411, 604/412, 604/414, 604/415, 604/416, 604/903, 604/905, 366/130, 206/219
• US Class Current: 128/200.14
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61M 15/0033 Details of the piercing or cutting means
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/38 of the suprarenal hormones

Abstract

The invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebuliser, as well as an active substance concentrate in which the active substance is present as a solution or suspension for storage purposes.

Claims

1. An apparatus for dispensing an aerosol of a pharmaceutical formulation having at least one active ingredient comprising a closure-cap (3) and a container (2) in the form of a cartridge for separate storage of the active ingredient and for storage of a pharmacologically acceptable liquid, wherein the closure-cap (3) has a connecting piece (7) which dips into the container (2) and displaces some of the container contents when the closure-cap (3) is pushed onto the neck of the container (2), wherein the closure cap (3) is provided with a guide tube (16) for leading a capillary or canula through the closure-cap (3), the guide tube (16) reaches through to a chamber (17) which is firmly connected to or integrated in the connecting piece (7) and the chamber (17)has at least one opening, whereby the chamber (17) is tightly sealed by a moveable plunger (21) and the guide tube (16) extends from the top end of the closure-cap (3) through the connecting piece (7) to the moveable plunger (21).

2. The apparatus according to claim 1, characterised in that a penetrable septum (23) is located in the closure-cap (3) between the plunger (21) and the outside environment.

3. The apparatus according to claim 1, characterised in that a penetrable septum or an elastic O-ring seal (23) is formed in the guide tube (16).

4. The apparatus according to claim 1, characterised in that the chamber (17) has a further opening which is sealed tightly by a penetrable, tearable or moveable separating element (20).

5. The apparatus according to one of the preceding claim 4, characterised in that the separating element (20) is a sealing foil.

6. A apparatus to claim 1, wherein the chamber (17) has two or more compartments which are arranged one above the other and are each sealed from the other by a penetrable, tearable or movable separating element (25).

7. The apparatus according to claim 1, characterised in that the plunger (21) is in the shape of a cylinder with a ratio of length to diameter of about 1.2 to about 2.0.

8. The apparatus according to claim 1, characterised in that the side of the plunger (21) facing the chamber (17) is sloped or tapers to a point and/or has one or more spike(s) or cutting edge(s) on the side which is oriented towards the chamber (17).

9. The apparatus according to claim 1, characterised in that the chamber (17) is filled with an exactly-fitting plunger (2) which contains a hollow space (24) which has an opening on one side.

10. The apparatus according to claim 1, characterised in that the plunger (21) or the wall of the chamber (17) or both are coated with a pharmacologically acceptable lubricant.

11. The apparatus according to claim 10, wherein the pharmacologically acceptable lubricant is oleic acid, lecithin or sorbitan ester.

12. The apparatus according to claim 1, characterised in that the chamber (17) has only one opening (19) at the lower end of the connecting piece (7) which is sealed tightly by a plunger (21), and that the guide tube (16) for a canula leads through the chamber (17) to the plunger (21).

13. The apparatus according to claim 12, characterised in that the chamber (17) is divided into a plurality of compartments in such a way that all the compartments are sealed by the plunger (21).

14. The apparatus according to claim 1, characterised in that the plunger (21) is up to 5% wider that the opening which it closes.

15. The apparatus according to claim 1, characterised in that the closure-cap (3), together with the container (2), forms a cartridge for an atomiser.

16. The apparatus according to claim 1, characterised in that the piston (21) is made of an elastomer, soft plastic or plastic.

17. The apparatus according to claim 1, characterised in that the piston (21) is made of polyethylene, silicone or anethylene-propylene-diene-copolymer.