DEVICE FOR THE ORAL APPLICATION OF A SUBSTANCE

• US 20100063473A1
• Filed: 04/10/2008
• Published: 03/11/2010
• Est. Priority Date: 04/10/2007
• Status: Active Grant

• Current Assignee: Sandoz Ag (Novartis Ag)
• Original Assignee: Sandoz Ag (Novartis Ag)
• Inventors: Jakob, Thomas, Reichenberger, Robert, Schwarz, Franz Xaver
• Granted Patent: US 9,375,108 B2
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A47G 21/183 with means for changing the flavour of the liquid
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers

Abstract

A device for oral application of a substance, comprising an inner tube surrounding a first volume an outer tube surrounding a second volume, the second volume comprising a cavity section adjoining an inlet opening of the outer tube being adapted for containing the substance, a separation area arranged in the second volume, the separation area adjoining the cavity section and the first volume, and a selective connecting passage between the cavity section and a pressure compensation space to selectively enable a flow of the substance from the cavity section though the first volume. A kit-of-parts, comprises the inventive device a predefined amount of a substance being contained in a receptacle or the cavity section, and instructions for the use of the substance. Methods for filling the inventive device as well as to a method for oral application using the inventive device are provided.

Claims

1. A device for oral application of a substance, comprising:

an inner tube surrounding a first volume;

an outer tube surrounding a second volume, the second volume comprising a cavity section adjoining an inlet opening of the outer tube being adapted for containing the substance;

a separation area arranged in the second volume, the separation area adjoining the cavity section and the first volume; and

a selective connection passage between the cavity section and a pressure compensation space configured to selectively enable a flow of the substance from the cavity section though the first volume.

2. The device according to claim 1, wherein the pressure compensation space is the first volume (or the surrounding space.

3. The device according to claim 1, wherein the selective connection passage comprises a non-return valve, an actuatable valve, and/or a pressure-breakable separation membrane for providing the flow with an adjustable fluid rate.

4. The device according to claim 1, wherein a flow of fluid from the cavity section to the first volume of the inner tube is provided by the selective connection passage only in the case that a pressure in the cavity section exceeds a pressure in the first volume by a non-negative threshold pressure and/or upon activation by a user;

or wherein a flow of fluid from the cavity section to the first volume of the inner tube is provided by the selective connection passage only, if the pressure in the cavity section has exceeded the pressure in the first volume by a non-negative break through pressure and/or upon activation by a user.

5. The device according to claim 1, the selective connection passage being arranged in at least one of the separation area, in the inner tube, a mouth piece connected to the inner tube, in the inlet opening and the cavity section.

6. The device according to claim 1, the separation area being movable relative to at least one of the outer tube and/or the inlet opening.

7. The device according to claim 1, wherein the second volume has a cylindrical shape with a constant cross section at least in the cavity section, the separation area corresponding to the constant cross section, the cross section of the second volume having the shape of a circle, an oval, a square, a rectangular, a triangle or any other polygon.

8. The device according to claim 1, wherein the separation area comprises an elastic section for providing a sealing connection between a circumference of the separation area and an inner surface of the outer tube.

9. The device according to claim 1, wherein the inlet opening comprises at least one tapering section.

10. The device according to claim 1, wherein the length of the inner tube is equal to or greater than the length of the outer tube.

11. The device according to claim 1, wherein the surface area of the outer cross section of the inner tube is equal to or less than the surface area of the inner cross section of the outer tube.

12. The device according to claim 1, further comprising a first grip section arranged at the outer surface the inner tube and/or a second grip section arranged at the outer surface the outer tube, the first and/or the second grip section comprising grooves, pits, protrusions and/or non-slip material.

13. The device according to claim 1, wherein the outer tube or a window section thereof comprises a translucent or transparent material at least in the cavity section.

14. The device according to claim 1, wherein the outer tube comprises scaling marks and/or filling marks adapted for measuring units, a level, a volume and/or quantity of the substance contained in the cavity section.

15. The device according to claim 1, wherein at least one of the inner and the outer tube is formed of a thermoplastic material and/or a material adapted for medical use.

16. The device according to claim 1, wherein the substance comprises at least one of a fluid, a liquid, a suspension, a dilution, a semiliquid, a mixture of a solid agent and liquid carrier, an active agent, an active agent formulation, a water soluble drug, soluble and/or coated or uncoated particles containing a drug, a binder, a stabilizers and an active drug in form of a liquid, a semiliquid, or solid particles.

17. The device according to claim 1, wherein the cavity section contains a predefined amount of the substance.

26. A kit-of-parts comprising the device of claim 1, a predefined amount of the substance being contained in the cavity section of the device or a receptacle containing a predefined amount of the substance, and, optionally, instructions for the use of the substance.

27. A method for filling the device of claim 1, comprising the steps of

arranging the separation area near to the inlet opening;

immersing the inlet opening in the substance;

pulling the separation area away from said inlet opening thereby drawing said substance into the cavity section.

28. The method of claim 27, wherein the step of pulling the separation area comprises pulling the inner tube being attached to the separation area partly out of the outer tube.

29. The method of claim 27, further comprising the step of sealing the inlet opening with at least one of a removable sealing cap, a removable plug or and a removable sealing lid.

30. A method for oral application of a substance, comprising the steps of

providing the device of claim 1, the cavity section containing the substance;

immersing the inlet opening in a drinkable liquid;

and

drawing the substance and the drinkable liquid through the inner tube, including enabling a flow though the selective connecting passage by actuating the selective connecting passage.

31. The method of claim 30, wherein actuating the selective connecting passage comprises providing a pressure in the first volume, which is lower than the pressure in the cavity section by drawing at the inner tube and/or manually activating a flow control element of the selective connecting passage.

32. A substance for use in a method for oral administration of the substance to a subject, wherein the substance is administered by means of the device of claim 1.

33. Use of the device of claim 1 for manufacture of an administration package for the treatment of diseases treatable by oral application of a substance.

18. A dosing device for administering doses of a free-flowing composition together with a free-flowing carrier medium, comprising:

a storage chamber for the composition, said storage chamber communicating with the surroundings via at least one inlet opening,

a plunger tube that is disposed in the storage chamber for sealed displacement between

a rest position in which the plunger tube is completely inserted in the storage chamber, and

a dosing position in which the plunger tube is removed from the storage chamber along a path that corresponds to a desired amount of the composition to be dispensed,

wherein the plunger tube is hollow and opens a fluid connection between

a through-opening arranged between the storage chamber and an inside of the plunger tube, and

a suction opening disposed at a free end of the plunger tube, said free end projecting out of the storage chamber,

wherein a one-way valve is disposed in the through-opening, the one-way valve opening a fluid path from the storage chamber into the inside of the plunger tube and shuts off said fluid path in the opposite direction.

19. The dosing device according to claim 18, wherein the one-way valve is composed of an elastic plastic material.

20. The dosing device according to claim 19, wherein the one-way valve that is unitary.

21. The dosing device according to claim 19, wherein the one-way valve has a through-slit between two elastic walls that bear against one another whilst forming a defined angle between each other.

22. The dosing device according to claim 21, wherein the elastic walls have a thickness of between 0.3 and 0.6 mm.

23. The dosing device according to claim 21, wherein the through-slit has a length of between 2 and 5 mm.

24. The dosing device according to claim 18, wherein the one-way valve is integrally connected to the plunger tube.

25. (canceled)