Claims for Patent: 11,484,671

Summary for Patent: 11,484,671

Title:	Aerosolization apparatus with capsule puncture alignment guide
Abstract:	An aerosolization apparatus comprises a housing defining a chamber having one or more air inlets. The chamber is sized to receive a capsule which contains an aerosolizable pharmaceutical formulation. The aerosolization apparatus further comprises a puncturing mechanism within the housing. The puncturing mechanism comprises an alignment guide and a puncture member, wherein the alignment guide comprises a surface adapted to contact the capsule while the puncture member is advanced into the capsule to create an opening in the capsule. At least a portion of the surface is sloped relative to the longitudinal axis of the capsule. Alternatively or additionally, the surface may comprise one or more protrusions. An end section is associated with the housing. The end section is sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. The alignment guide allows for more consistent puncturing of the capsule and a longer lifetime of the apparatus.
Inventor(s):	Michael John Dunkley, Jon David Tuckwell, Edward William Vernon-Harcourt, Mark Glusker, Steve Paboojian
Assignee:	BGP Products Operations GmbH
Application Number:	US16/259,492
Patent Claims:	1. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing, the puncturing mechanism comprising an alignment guide and a plunger comprising a proximal end configured to be contacted by a user to actuate the apparatus and a distal end including a puncture member, wherein the alignment guide comprises a surface adapted to contact the capsule while the puncture member is advanced into the capsule to create an opening in the capsule, wherein the surface comprises: at least one passageway, wherein the puncture member is configured to slide within the passageway; one or more protrusions; and one or more troughs, wherein the one or more protrusions are configured to direct residue of the aerosolizable pharmaceutical formulation to the one or more troughs after an opening is created in the capsule; a biasing member arranged between and in contact with the plunger and the housing, the biasing member configured to bias the plunger proximally, away from the chamber; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule, and wherein the surface is configured to be advanced within the housing to contact the capsule prior to the puncturing member being advanced into the capsule. 2. The aerosolization apparatus of claim 1, wherein at least a portion of the surface is sloped at an angle which is less than 55 degrees relative to a longitudinal axis of the chamber. 3. The aerosolization apparatus of claim 1, wherein the surface comprises at least a second passageway, wherein the puncture member is configured to also slide within the at least a second passageway. 4. The aerosolization apparatus of claim 1, wherein the one or more inlets are shaped to create a swirling airflow within the chamber. 5. The aerosolization apparatus of claim 1, wherein the aerosolization apparatus further includes the capsule containing the aerosolizable pharmaceutical formulation and the puncturing mechanism is configured to create one or more openings in a convex end of the capsule. 6. The aerosolization apparatus of claim 1, the capsule comprising at least two convex ends, wherein the puncturing mechanism is configured to create one or more openings in only one of the at least two convex ends of the capsule. 7. The aerosolization apparatus of claim 1, wherein the puncturing mechanism is configured to create two openings in a convex end of the capsule. 8. The aerosolization apparatus of claim 1, wherein the aerosolization apparatus further includes the capsule containing the aerosolizable pharmaceutical formulation and the aerosolizable pharmaceutical formulation comprises an aminoglycoside. 9. The aerosolization apparatus of claim 1, wherein the aerosolization apparatus further includes the capsule containing the aerosolizable pharmaceutical formulation and the aerosolizable pharmaceutical formulation comprises tobramycin. 10. The aerosolization apparatus of claim 1, wherein the aerosolization apparatus further includes the capsule containing the aerosolizable pharmaceutical formulation and the aerosolizable pharmaceutical formulation comprises ciprofloxacin. 11. The aerosolization apparatus of claim 1, wherein the aerosolization apparatus further includes the capsule containing the aerosolizable pharmaceutical formulation and the aerosolizable pharmaceutical formulation comprises amphotericin B. 12. A method of administering an aerosolizable pharmaceutical formulation to a patient, comprising: inserting, into the chamber of an apparatus according to claim 1, a capsule containing an aerosolizable pharmaceutical formulation; contacting the capsule with the surface of the alignment guide, advancing the puncture member through a wall of the capsule to create an opening in the capsule; and administering the pharmaceutical formulation to the patient via inhalation. 13. The method of claim 12, wherein inhalation by the patient causes air to flow into the chamber to aerosolize the pharmaceutical formulation. 14. The method of claim 12, wherein at least a portion of the puncture member is advanced through at least one passageway in the surface. 15. The method of claim 14, wherein at least a portion of the puncture member is advanced through at least a second passageway in the surface. 16. The method of claim 13, wherein the aerosolizable pharmaceutical formulation comprises an aminoglycoside. 17. The method of claim 13, wherein the aerosolizable pharmaceutical formulation comprises tobramycin. 18. A method of aerosolizing a pharmaceutical formulation, the method comprising: providing an aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing, the puncturing mechanism comprising an alignment guide and a plunger comprising a proximal end configured to be contacted by a user to actuate the apparatus and a distal end including a puncture member, wherein the alignment guide comprises a surface adapted to contact the capsule while the puncture member is advanced into the capsule to create an opening in the capsule, wherein the surface comprises: at least one passageway, wherein the puncture member is configured to slide within the passageway; one or more protrusions; and one or more troughs, wherein the one or more protrusions are configured to direct residue of the aerosolizable pharmaceutical formulation to the one or more troughs after an opening is created in the capsule; a biasing member arranged between and in contact with the plunger and the housing, the biasing member configured to bias the plunger proximally, away from the puncturing mechanism; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule, and wherein the surface is configured to be advanced within the housing to contact the capsule prior to the puncturing member being advanced into the capsule inserting a capsule containing an aerosolizable pharmaceutical formulation in the chamber; contacting the capsule with the surface of the alignment guide; advancing the puncture member through a wall of the capsule to create an opening in the capsule; aerosolizing the pharmaceutical formulation in the capsule by flowing air through the chamber; and administering the aerosolized pharmaceutical formulation to the respiratory tract of the user during the user's inhalation. 19. The method of claim 18, wherein the user's inhalation causes the air to flow through the chamber. 20. The method of claim 18, wherein the aerosolizable pharmaceutical formulation comprises tobramycin.