Patent EA-002581-B1 (EA)
Title: Two chamber cartridge for atomizers
Inventor: HOCHRAINER DIETER
IPC: A61B19/00
Filed: 1999-10-09
Abstract: 1. An apparatus comprising a sealing cap (3) and a container (2) in the form of a cartridge for separate storage of an active ingredient and a pharmacologically acceptable liquid, wherein the sealing cap (3) has a connecting piece (7) which displaces a part of the container contents when the sealing cap (3) is pushed onto the neck of the container (2), whilst a guide tube (16) is formed in this connecting piece (7) for passage of a capillary or canula (15) through the sealing cap (3), leading to a chamber (17) which is firmly connected to the connecting piece (7) or integrated therein and contains at least one opening, characterised in that the chamber (17) is sealed tightly by a movable plunger (21) and the guide tube (16) leads to the plunger (21). 2. An apparatus according to claim 1, characterised in that a penetrable septum (23) is located in the sealing cap between the plunger (21) and the outside environment. 3. An apparatus according to one of preceding claims 1 and 2, characterised in that a penetrable septum or an elastic O-ring seal (23) is located in the guide tube (16). 4. An apparatus according to one of the preceding claims 1 to 3, characterised in that the chamber has a further opening which is sealed tightly by a penetrable, removable or movable separating element (20). 5. An apparatus according to claim 4, characterised in that the separating element (20) is formed as a sealing foil. 6. A sealing cap according to one of the preceding claims 1 to 5, characterised in that 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, breakable or movable separating element (25). 7. A sealing cap according to one of the preceding claims 1 to 6, characterised in that the plunger (21) has the shape of a cylinder with a ratio, length to diameter, of 1.2 to 2.0. 8. A sealing cap according to one of the preceding claims 1 to 7, characterised in that the side of the plunger (21) facing the chamber (17) is sloped or tapers to a point or has one or more spike(s) or cutting edge(s) on the side which is orientated towards the chamber (17). 9. An apparatus according to one of the preceding claims 1 to 8, characterised in that the chamber (17) is filled with an exactly-fitting plunger (21) which contains a hollow space (24) which has an opening on one side. 10. An apparatus according to one of the preceding claims 1 to 9, characterised in that the opening of the hollow space (24) is sealed by the separating element (20) or the side wall of the chamber (17). 11. An apparatus according to claim 10, characterised in that the hollow space (24) is divided into two or more compartments which are tightly sealed from one another and that each compartment is sealed by the separating element (20) or the side wall of the chamber (17). 12. An apparatus according to one of the preceding claims 1 to 11, characterised in that a recess (28) is formed in the plunger (21) which is orientated towards the head of the sealing cap (3) with its opening. 13. An apparatus according to one of the preceding claims 1 to 12, characterised in that the plunger (21) and/or the wall of the chamber (17) is coated with a pharmacologically-harmless lubricant, preferably oleic acid, lecithin or a sorbitan ester such as sorbitan trioleate. 14. A sealing cap according to one of the preceding claims 1, 2, 3, 7, 8, 9, 10, 11, 12 or 13, 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 capillaries or canulae leads through the chamber (17) up to the plunger (21). 15. An apparatus according to claim 14, characterised in that the chamber is divided into a plurality of compartments in such a way that all compartments are sealed by the plunger (21). 16. An apparatus according to one of the preceding claims 9, 10, 11, 12, 13, 14 or 15, characterised in that the plunger (21) with the hollow space (24) is attached via one or more openings of the plunger (21) by means of one or more stopper-like projection(s) (27) formed on the connecting piece (7). 17. An apparatus according to one of the preceding claims 1 to 16, characterised in that the plunger (21) is up to 5% wider than the opening which it closes. 18. An apparatus according to one of the preceding claims 1 to 17, characterised in that the chamber (17) contains a pharmaceutical concentrate, preferably a suspension or solution, most preferably a suspension, in a pharmacologically acceptable propellant-free liquid, preferably water, an aqueous solution with a pharmacologically acceptable salt, ethanol or a mixture thereof, with one or more active ingredient(s), wherein the active ingredient (or ingredients) is (or are) especially suitable for inhalative therapy. 19. An apparatus according to claim 18, characterised in that the active ingredient (or ingredients) is (or are) selected from the group of betamimetics, anticholinergics, antiallergics, leukotriene antagonists and/or steroids. 20. An apparatus according to claim 18 or 19, characterised in that the active ingredient (or ingredients) is (or are) formoterol, tiotropium and/or salbutamol and/or a salt thereof. 21. An apparatus according to one of the preceding claims 18 to 20, characterised in that the concentration of the active substances is between 75 mg/ml and 1000 mg/ml, more preferably between 75 mg/ml and 500 mg/ml, most preferably between 100 mg/ml and 400 mg/ml. 22. An apparatus according to claim 20 or 21, characterised in that the chamber (17) contains a suspension of formoterol in a concentration of between 75 mg/ml and 500 mg/ml, preferably between 100 and 400 mg/ml, most preferably between 250 and 350 mg/ml. 23. An apparatus according to one of claims 1 to 22, characterised in that the active substance concentrate in the chamber (17) contains an acid, a preservative and/or a complex former. 24. An apparatus according to one of the preceding claims 1 to 23, characterised in that the container (2) contains a pharmacologically acceptable propellant-free liquid, preferably water, an aqueous saline solution, ethanol or a mixture thereof, which optionally contains an acid, a complex former, a preservative, a surfactant and/or a buffer substance. 25. An apparatus according to claim 24, characterised in that the solvent or suspension agent contains one or more medicament(s) which is (are) preferably selected from among the betamimetics, anticholinergics, antiallergics, leukotriene antagonists and/or steroids. 26. An apparatus according to one of claims 24 or 25, characterised in that the chamber ( 17) contains a buffer substance, preferably sodium or potassium dihydrogen phosphate and/or disodium or dipotassium hydrogen phosphate and/or mixtures thereof. 27. An apparatus according to one of claims 18 to 26, characterised in that the container contains a solution of tiotropium bromide with a content of between 0.002 and 0.4% by weight, preferably between 0.0005 and 0.2 % by weight, most preferably 0.1 % by weight, which has a pH of 2.0 to 4.0, preferably 2.0 to 3.0 and most preferably 2.8. 28. An apparatus according to one of the preceding claims 1 to 27, characterised in that the sealing cap (3), together with the container (2), forms a cartridge for an atomiser. 29. Use of an apparatus according to one of the claims 1 to 28 as a container for fluid medicament formulations in inhalers for the production of aerosols suitable for medical therapy, especially for inhalative therapy.