IP Library Granted Patent US 10,124,128
Granted Patent B2
US 10,124,128 · App. 10/298,177 · Granted Nov 13, 2018

Aerosolization apparatus with removable mouthpiece

Inventors: John D. Burr (Redwood City, CA); Jeff R. Wood (Mountain View, CA); Adrian E. Smith (Belmont, CA); John A. Howard (Palo Alto, CA); Fabrizio Niccolai (Milan, IT)
Assignee: BGP Products Operations GmbH
A61M15/0028A61M15/003A61M15/08A61M2202/064A61M2202/206A61M2210/0618A61M2210/0625
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Quick Facts
Patent No.
US 10,124,128
App. No.
10/298,177
Granted
Nov 13, 2018
Kind
B2
Abstract

An aerosolization apparatus comprises a body having an inlet, an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber. The apparatus further includes a connection mechanism to provide selective connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect or disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber. When a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet. The connection mechanism prevents inadvertent disconnection of the endpiece from the body.

Claims (63)

1. An aerosolization apparatus comprising:

a body having an inlet;

an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber and wherein the inlet is shaped to provide a swirling air flow in the chamber;

a connection mechanism comprising engageable threads to provide selective connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect and to disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber, wherein the endpiece may be disconnected from the body to allow for insertion or removal of the capsule, and wherein the threads extend for less than two complete turns around the body;

a cap insertable over the endpiece and which covers at least a portion of the inlet when the endpiece is connected to the body, wherein the cap is connectable to the body by a press fit arrangement; and

a puncturing mechanism capable of providing an opening in the capsule;

whereby when a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet.

2. An aerosolization apparatus according to claim 1 wherein the body has a plurality of inlets.

3. An aerosolization apparatus according to claim 1 wherein the connection mechanism comprises engageable threads having a thread angle of less than about 9 degrees.

4. An aerosolization apparatus according to claim 1 wherein the connection mechanism comprises engageable threads having a thread angle of less than about 7 degrees.

5. An aerosolization apparatus according to claim 1 wherein the connection mechanism comprises engageable threads and wherein the threads include a recessed portion.

6. An aerosolization apparatus according to claim 1 wherein the connection mechanism comprises engageable threads and wherein the threads include a recessed portion that is recessed at an angle of less than about 75 degrees.

7. An aerosolization apparatus according to claim 1 wherein the puncturing mechanism is adapted to puncture a single end of the capsule.

8. An apparatus according to claim 1 wherein the chamber is elongated and has a longitudinal axis, and wherein the longitudinal axis of the chamber and the longitudinal axis of the capsule form an angle of less than about 45 degrees during use.

9. An apparatus according to claim 1 wherein the chamber is elongated and wherein the capsule is received lengthwise within the elongated chamber.

10. An aerosolization apparatus according to claim 1 wherein the width of the chamber is less than the length of the capsule.

11. An aerosolization apparatus according to claim 1 further comprising the capsule containing the pharmaceutical formulation and wherein the pharmaceutical formulation comprises an antibiotic.

12. An aerosolization apparatus according to claim 11 wherein the antibiotic comprises an aminoglycoside.

13. An aerosolization apparatus according to claim 12 wherein the aminoglycoside comprises tobramycin.

14. An aerosolization apparatus according to claim 11 wherein the antibiotic comprises a fluoroquinolone.

15. An aerosolization apparatus according to claim 14 wherein the fluoroquinolone comprises ciprofloxacin.

16. An aerosolization apparatus comprising:

a body having an inlet;

an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber and wherein the inlet is shaped to provide a swirling air flow in the chamber;

a cap that is insertable over the endpiece and that covers at least a portion of the inlet when the endpiece is connected to the body, wherein the cap is connectable to the body by a press fit arrangement;

a connection mechanism to provide selective connection of the endpiece to the body, wherein the connection mechanism comprises engageable threads, and wherein the endpiece may be disconnected from the body to allow for insertion or removal of the capsule; and

a puncturing mechanism capable of providing an opening in the capsule;

whereby when a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet.

17. An aerosolization apparatus according to claim 16 wherein the engageable threads have a thread angle of less than about 9 degrees.

18. An aerosolization apparatus according to claim 16 wherein the engageable threads have a thread angle of less than about 7 degrees.

19. An aerosolization apparatus according to claim 16 wherein the engageable threads include a recessed portion.

20. An aerosolization apparatus according to claim 16 wherein the engageable threads include a recessed portion that is recessed at an angle of less than about 75 degrees.

21. An aerosolization apparatus according to claim 16 further comprising the capsule containing the pharmaceutical formulation and wherein the pharmaceutical formulation comprises an antibiotic.

22. An aerosolization apparatus according to claim 21 wherein the antibiotic comprises an aminoglycoside.

23. An aerosolization apparatus according to claim 22 wherein the aminoglycoside comprises tobramycin.

24. An aerosolization apparatus according to claim 21 wherein the antibiotic comprises a fluoroquinolone.

25. An aerosolization apparatus according to claim 24 wherein the fluoroquinolone comprises ciprofloxacin.

26. An aerosolization apparatus according to claim 16 wherein the cap is threadless.

27. A method of providing an aerosolized pharmaceutical formulation, the method comprising:

providing a body having an inlet and providing an endpiece having an outlet, the endpiece and the body having engageable threads that extend less than two complete turns, the endpiece being connectable to and disconnectable from the body when a rotational force is applied thereto to define a chamber, the chamber being sized to receive a capsule containing a pharmaceutical formulation, wherein the rotational force is applied about an axis that passes through the chamber, and wherein the endpiece may be disconnected from the body to allow for insertion or removal of the capsule;

providing a cap that may be removed from the endpiece by disconnecting a press fit arrangement to expose the inlet; and

aerosolizing the pharmaceutical formulation when a user inhales by causing air to flow through an inlet in the body, within the chamber, and through an outlet in the endpiece to provide the aerosolized pharmaceutical formulation to the user and wherein the inlet is shaped to provide a swirling air flow in the chamber.

28. A method according to claim 27 wherein the threads have a thread angle of less than about 7 degrees.

29. A method according to claim 27 wherein the threads have a recessed portion.

30. A method according to claim 27 wherein the pharmaceutical formulation comprises a dry powder.

31. A method of aerosolizing a pharmaceutical formulation, the method comprising:

removing a cap from an endpiece by disconnecting a press fit arrangement to exposed an inlet;

rotating the endpiece relative to a body to expose a chamber in the body, wherein the body contains the inlet;

inserting a capsule containing a pharmaceutical formulation into the chamber in the body;

thereafter, rotating the endpiece relative to the body to connect the endpiece to the body, the rotation being about an axis passing through the chamber;

before, during, or after inserting the capsule into the chamber, providing an opening in the capsule;

inhaling through an opening in the endpiece to cause air to flow into the chamber through an inlet in the body thereby aerosolizing the pharmaceutical formulation, wherein the flow of air through the inlet causes a swirling flow in the chamber.

32. A method according to claim 31 wherein the chamber is elongated and wherein the capsule is inserted lengthwise into the elongated chamber.

33. A method according to claim 31 wherein the flow of air is through a plurality of inlets in the body.

34. A method according to claim 31 wherein the flow of air is through a plurality of inlets in the body.

35. A method of aerosolizing a pharmaceutical formulation, the method comprising:

inserting a capsule containing a pharmaceutical formulation into a chamber in a body;

thereafter, rotating an endpiece relative to the body to connect the endpiece to the body by engageable threads, the rotation being about an axis passing through the chamber and complete rotation being less than two turns;

before, during, or after inserting the capsule into the chamber, providing an opening in the capsule;

inhaling through an opening in the endpiece to cause air to flow into the chamber through an inlet in the body thereby aerosolizing the pharmaceutical formulation, wherein the flow of air through the inlet causes a swirling flow in the chamber; and

thereafter, rotating the endpiece relative to the body to disconnect the endpiece from the body and expose the chamber;

thereafter, rotating the endpiece relative to the body to reconnect the endpiece to the body; and

thereafter, installing a cap over the endpiece to cover at least a portion of the in inlet by connecting the cap to the body by a press fit arrangement.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 26, 2018
From: NOVARTIS PHARMA AG
To: BGP PRODUCTS OPERATIONS GMBH
Reel/Frame 047152/0017 →
ASSIGNMENT OF PATENT RIGHTS Recorded Jan 7, 2009
From: NEKTAR THERAPEUTICS
To: NOVARTIS PHARMA AG
Reel/Frame 022071/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2003
From: BURR, JOHN D.; WOOD, JEFF R.; SMITH, ADRIAN E.; HOWARD, JOHN A.; NICCOLAI, FABRIZIO
To: NEKTAR THERAPEUTICS; PH&T
Reel/Frame 013591/0482 →
CHANGE OF NAME Recorded Feb 25, 2003
From: INHALE THERAPEUTIC SYSTEMS, INC.
To: NEKTAR THERAPEUTICS
Reel/Frame 013525/0753 →
Continuity (2)
Provisional Application 60336320 · Nov 14, 2001
Related Publication 20030150454A1 · Aug 14, 2003
Cited By (1)
US 12,496,413