Pre-metered dose magazine for breath-actuated dry powder inhaler

• US 6,655,381 B2
• Filed: 06/23/2001
• Issued: 12/02/2003
• Est. Priority Date: 06/23/2000
• Status: Expired due to Term

• Current Assignee: Norton Healthcare Limited (Teva Pharmaceutical Industries Limited)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Keane, Laurence, OʼLeary, David
• Primary Examiner(s): DOERRLER, WILLIAM CHARLES
• Application Number:
  US09/888,277
• Publication Number:
  US 20020073997A1
• Time in Patent Office: 892 Days
• Field of Search: 128/203.15, 128/203.21, 128/200.19, 128/203.14, 128/200.23, 128/203.12, 128/203.18
• US Class Current: 128/203.15
• CPC Class Codes: A61M 1/60 Containers for suction drainage, adapted to be used with an external suction source containers not adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 15/0008 rotating by airflow
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: G06M 1/248 Discs
• CPC Class Codes: G06M 1/272 using photoelectric means

Abstract

A pre-metered dose assembly for consistently supplying precise doses of medicament is provided for a breath-actuated dry powder inhaler. The assembly includes a cap defining a dry powder delivery passageway for providing air to a dry powder supply port of a swirl chamber of a breath-actuated dry powder inhaler, and a magazine including a plurality of reservoirs for holding pre-metered doses of dry powder. One of the magazine and the cap is movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs within the delivery passageway of the cap. A breath-induced low pressure at an outlet port of the swirl chamber of the inhaler causes an air flow through the dry powder delivery passageway of the assembly and into the dry powder supply port of the swirl chamber that entrains dry powder from the reservoir positioned in the passageway for inhalation by a patient using the inhaler. The present disclosure also provides a breath-actuated dry powder inhaler including the pre-metered dose assembly in combination with a de-agglomerator for breaking up aggregates and micronizing particles of dry powder prior to inhalation of the powder by a patient.

Claims

1. A pre-metered dose assembly for use with a breath-actuated dry powder inhaler, comprising:

a cap defining a dry powder delivery passageway for providing air to a dry powder supply port of a chamber of a breath-actuated dry powder inhaler; and

a rigid unitary structure magazine including a plurality of integral reservoirs for holding pre-metered doses of dry powder, one of the magazine and the cap movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs to be adjacent to the delivery passageway of the cap;

whereby a breath-induced low pressure in the chamber of the inhaler causes an air flow through the dry powder delivery passageway and into the dry powder supply port, and the air flow entrains dry powder from the dry powder reservoir positioned in the passageway into the chamber for inhalation by a patient using the inhaler; and

a unitary structure means sealing each of the reservoirs of the magazine in a substantially airtight manner prior to the reservoir being positioned within the delivery passageway of the cap, and maintaining said reservoirs unsealed otherwise.

2. An assembly according to claim 1, wherein the magazine is movable with respect to the cap for sequentially positioning the plurality of the dry powder reservoirs within the delivery passageway of the cap.

3. An assembly according to claim 2, wherein the magazine is annular such that rotation of the annular magazine sequentially positions the plurality of the dry powder reservoirs within the delivery passageway of the cap.

4. An assembly according to claim 1, further including means for indicating the number of dry powder reservoirs containing dry powder.

5. An assembly according to claim 4, wherein the cap covers the plurality of the dry powder reservoirs of the magazine and the means for indicating comprises a transparent portion of the cap.

6. An assembly according to claim 1, wherein one of the magazine and the cap is movable with respect to the other of the magazine and the cap through a plurality of discrete increments, wherein at each increment one of the plurality of the dry powder reservoirs is positioned within the delivery passageway of the cap.

7. An assembly according to claim 1, wherein one of the magazine and the cap is movable with respect to the other of the magazine and the cap in only a single direction.

8. An assembly according to claim 1, adapted such that the magazine and the cap will be unmovable with respect to each other after all of the dry powder reservoirs of the magazine have been positioned in the dry powder delivery passageway of the cover.

9. An assembly according to claim 1, wherein:

one of the magazine and the cap includes a plurality of teeth; and

the other of the magazine and the cap includes a resilient pawl sequentially passing over the teeth during movement of one of the magazine and the cap with respect to the other of the magazine and the cap, wherein the magazine is in one of the plurality of discrete increments when the pawl is between teeth.

10. An assembly according to claim 9, wherein each of the plurality of teeth has a sloped first side allowing passage of the pawl in a first direction, and a straight second side preventing passage of the pawl in a second direction.

11. An assembly according to claim 9, wherein the plurality of teeth includes one tooth having straight first and second sides preventing passage of the pawl past said one tooth.

12. An assembly according to claim 1, further comprising dry powder contained in the reservoirs of the magazine.

13. An assembly according to claim 12, wherein each reservoir of the magazine contains a single dose of the dry powder.

14. An assembly according to claim 13, wherein the dry powder comprises a medicament composition having at least one active agent medicament adhered to a particulate carrier.

15. An assembly according to claim 1, wherein the unitary structure means for sealing comprises a film secured to the magazine and covering the reservoirs in a substantially airtight manner.

18. An assembly according to claim 1, wherein the dry powder delivery passageway of the cap includes a venturi.

19. An assembly according to claim 1, wherein:

the magazine is annular such that rotation of one of the magazine and the cap with respect to the other of the magazine and the cap sequentially positions the plurality of the dry powder reservoirs within the delivery passageway of the cap, the magazine having a top surface defining the reservoirs; and

the cap includes a lower surface received over the top surface of the magazine, the lower surface defining the dry powder delivery passageway extending radially inwardly from an outer portion to an inner portion of the cap.

20. An assembly according to claim 1, further comprising means for securing the cap to the magazine.

21. An assembly according to claim 1, further comprising means for securing the assembly to a chamber of an inhaler.

22. A breath-actuated dry powder inhaler including an assembly according to claim 1, and further comprising:

a chamber extending along an axis between a first end and a second end;

a dry powder supply port in the first end of the chamber in fluid communication with the dry powder delivery port of the cap; and

an outlet port at a second end of the chamber;

whereby a breath-induced low pressure at the outlet port causes air flow into the chamber through the dry powder supply port, with the air flow through the dry powder supply port entraining dry powder into the chamber from the reservoir of the magazine positioned in the delivery passageway.

23. An inhaler according to claim 22, further comprising a de-agglomerator having:

an inner wall defining the chamber extending along an axis from a first end to a second end;

at least one inlet port in the inner wall adjacent to the first end of the chamber providing fluid communication between a region exterior to the de-agglomerator and the first end of the chamber;

whereby a breath-induced low pressure at the outlet port also causes an air flow into the chamber through the inlet port.

24. An inhaler according to claim 23, wherein the de-agglomerator further comprises vanes at the first end of the chamber extending at least in part radially outwardly from the axis of the chamber, each of the vanes having an oblique surface facing at least in part in a direction transverse to the axis.

25. An inhaler according to claim 24, wherein the chamber of the de-agglomerator includes cross-sectional areas arranged transverse to the axis, the cross-sectional areas decreasing monotonically from the first end to the second end of the chamber.

16. A pre-metered dose assembly, comprising:

a cap defining a delivery passageway;

a rigid unitary structure magazine including a plurality of integral reservoirs, one of the magazine and the cap movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs to be adjacent to the delivery passageway of the cap;

doses of dry powder contained in the reservoirs of the magazine;

a film secured to the magazine and covering the dry powder in the reservoirs in a substantially airtight manner; and

the cap includes means for piercing the film above each of the reservoirs prior to the reservoir being positioned within the delivery passageway of the cap.

17. An assembly according to claim 16, wherein the dry powder delivery passageway of the cap includes a venturi.

51. An assembly according to claim 16, wherein the film secured to the magazine and covering the reservoirs in a substantially airtight manner comprises a plastic film.

52. An assembly according to claim 16, wherein the film secured to the magazine and covering the dry powder in the reservoirs in a substantially airtight manner comprises a plastic film.

26. An inhaler comprising:

a cap defining a dry powder delivery passageway;

a magazine including a plurality of reservoirs for holding pre-metered doses of dry powder, one of the magazine and the cap movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs within the delivery passageway of the cap;

a chamber having an inner wall extending along an axis between a first end attached to the cap and the magazine and a second end, and cross-sectional areas arranged transverse to the axis and decreasing monotonically from the first end to the second end of the chamber;

a dry powder supply port in the first end of the chamber in fluid communication with the dry powder delivery port of the cap, wherein the dry powder supply port faces in a direction substantially parallel to the axis;

an outlet port at a second end of the chamber, wherein the outlet port extends substantially transverse to the axis;

vanes at the first end of the chamber extending at least in part radially outwardly from the axis of the chamber, each of the vanes having an oblique surface facing at least in part in a direction transverse to the axis; and

at least one inlet port in the inner wall adjacent to the first end of the chamber providing fluid communication between a region exterior to the inhaler and the first end of the chamber, wherein the at least one inlet port extends in a direction substantially transverse to the axis and substantially tangential to the chamber.

27. An inhaler according to claim 26, wherein the at least one inlet port of the de-agglomerator comprises two diametrically opposed inlet ports.

28. An inhaler according to claim 27, wherein:

the de-agglomerator comprises a cup-like base closed with a cover to form the chamber, the base defining the inner wall, and the second end of the chamber and the outlet port, the cover defining the first end of the chamber, the vanes and the supply port, and the base and the cover in combination defining the at least one inlet port, the cover including a cylindrical guide extending upwardly from the chamber and a chimney extending upwardly within the cylindrical guide from the supply port;

the magazine is annular and has an inner circumferential surface received coaxially on the cylindrical guide of the de-agglomerator for rotation of the magazine with respect to the de-agglomerator, the magazine having a top surface defining the dry powder reservoirs; and

the cap includes a lower surface received over the top surface of the magazine, the lower surface defining the dry powder delivery passageway extending radially inwardly from from an outer portion to an inner portion of the cap, the cap further including a hood extending downwardly from the inner portion and received over the chimney of the de-agglomerator, the hood connecting the delivery passageway to the chimney and preventing rotation of the cap with respect to the de-agglomerator.

29. An inhaler according to claim 28, further comprising:

indicators attached to the magazine corresponding to the dry powder reservoirs; and

a detector mounted on the de-agglomerator providing a dose signal upon an indicator passing the detector as the magazine is moved with respect to the de-agglomerator to position one of the reservoirs in the dry powder delivery passageway, whereby a dose signal from the detector is indicative of the dispensing of a single reservoir of dry powder through the inhaler.

30. An inhaler according to claim 29, further comprising:

a counter providing a sum of the number of dose signals provided by the detector;

a clock for providing a time for each dose signal provided by the detector;

a processor for providing predetermined calculations based upon the sum provided by the counter and the times provided by the clock;

memory for storing the calculations provided by the processor; and

means for transmitting the stored calculations to a remote device for utilizing the calculations.

31. A method of providing pre-metered doses of dry powder for patient inhalation through a breath-actuated dry powder inhaler including a chamber extending along an axis from a first end to a second end, a dry powder supply port in the first end of the chamber, and an outlet port at the second end of the chamber, the method comprising:

pre-metering a plurality of doses of dry powder;

defining a dry powder delivery passageway for providing air to the dry powder supply port of the chamber;

positioning at least one of the pre-metered doses of dry powder within the delivery passageway;

inducing a low pressure at the outlet port of the chamber of the inhaler through patient inhalation to create an air flow through the dry powder delivery passageway, the dry powder supply port, the chamber, and the outlet port and into the patient'"'"'s lungs; and

restricting the air flow through the delivery passageway so that the air flow entrains the pre-metered dose of dry powder;

directing the breath-actuated air flow entraining the pre-metered dose of dry powder through the supply port in a substantially longitudinal direction into the first end of the chamber with respect to the axis of the chamber;

directing a second breath-actuated air flow in a substantially transverse direction into the first end of the chamber with respect to the axis of the chamber such that the second air flow collides and substantially combines with the entraining air flow;

deflecting a portion of the combined air flows in a substantially axial direction towards the second end of the chamber;

directing the remaining portion of the combined air flows in a substantially spiral path towards the second end of the chamber; and

directing all the combined air flows from the second end of the chamber through the outlet port in a substantially transverse direction with respect to the axis of the chamber.

32. A method according to claim 31, further comprising:

sealing the pre-metered doses in an airtight manner; and

unsealing the at least one pre-metered dose in the dry powder delivery passageway prior to inducing a low pressure at the outlet port of the inhaler.

33. A method according to claim 31, further comprising:

indicating the number of pre-metered doses entrained through the delivery passageway.

34. A method according to claim 31, further comprising:

indicating a sum of the doses entrained through the delivery passageway;

indicating chronological times of when the doses were entrained through the delivery passageway;

providing predetermined calculations based upon the indicated sum and times; and

storing the calculations.

35. A method according to claim 31, wherein the second breath-actuated air flow is also directed tangentially into the first end of the chamber.

36. A method according to claim 35, wherein a third breath-actuated air flow is directed in a substantially transverse direction into the first end of the chamber with respect to the axis of the chamber such that the third air flow collides and substantially combines with the entraining air flow and the second air flow.

37. A method according to claim 35, wherein the combined air flows are constricted between the first end and the second end of the chamber.

38. A method of providing pre-metered doses of dry powder for patient inhalation through a breath-actuated dry powder inhaler including a chamber extending along an axis from a first end to a second end, a dry powder supply port in the first end of the chamber, and an outlet port at the second end of the chamber, the method comprising:

defining a dry powder delivery passageway for providing air to the dry powder supply port of the chamber of the breath-actuated dry powder inhaler; and

providing a rigid unitary structure magazine including a plurality of integral reservoirs;

pre-metering at least one dose of dry powder within each reservoir of the magazine;

moving the magazine with respect to the dry powder delivery passageway to sequentially position one of the reservoirs within the delivery passageway;

inducing a low pressure at the outlet port of the chamber of the inhaler through patient inhalation to create an air flow through the dry powder delivery passageway, the dry powder supply port, the chamber, and the outlet port and into the patient'"'"'s lungs; and

restricting the air flow through the delivery passageway so that the air flow entrains the at least one pre-metered dose of dry powder from the reservoir positioned in the passageway; and

sealing the pre-metered doses in an airtight maimer within the reservoirs of the magazine using a film.

39. A method according to claim 38, wherein the film is provided as a plastic film.

40. A method according to claim 39, further comprising:

unsealing a portion of the film above the reservoir positioned in the dry outlet powder delivery passageway prior to inducing a low pressure at the outlet port of the inhaler.

41. A breath-actuated dry powder inhaler comprising:

a pre-metered dose assembly including a cap defining a delivery passageway, and a magazine including a plurality of reservoirs, and wherein one of the magazine and the cap is movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs within the delivery passageway of the cap; and

a de-agglomerator including,

an inner wall defining a chamber extending along an axis from a first end to a second end having an outlet port, wherein the chamber of the de-agglomerator includes cross-sectional areas arranged transverse to the axis and decreasing monotonically from the first end to the second end of the chamber,

a dry powder supply port in the first end of the chamber facing in a direction substantially parallel to the axis, and in fluid communication with the dry powder delivery port of the cap,

an outlet port at a second end of the chamber extending substantially transverse to the axis,

at least one inlet port in the inner wall adjacent to the first end of the chamber and extending substantially transverse to the axis and substantially tangential to the chamber, and

vanes at the first end of the chamber extending at least in part radially outwardly from the axis of the chamber, each of the vanes having an oblique surface facing at least in part in a direction transverse to the axis.

42. An inhaler according to claim 41, wherein the at least one inlet port of the de-agglomerator comprises two diametrically opposed inlet ports.

43. An inhaler according to claim 42, wherein:

the de-agglomerator comprises a cup-like base closed with a cover to form the chamber, the base defining the inner wall, and the second end of the chamber and the outlet port, the cover defining the first end of the chamber, the vanes and the supply port, and the base and the cover in combination defining the at least one inlet port, the cover including a cylindrical guide extending upwardly from the chamber and a chimney extending upwardly within the cylindrical guide from the supply port;

the magazine is annular and has an inner circumferential surface received coaxially on the cylindrical guide of the de-agglomerator for rotation of the magazine with respect to the de-agglomerator, the magazine having a top surface defining the dry powder reservoirs; and

the cap includes a lower surface received over the top surface of the magazine, the lower surface defining the dry powder delivery passageway extending radially inwardly from an outer portion to an inner portion of the cap, the cap further including a hood extending downwardly from the inner portion and received over the chimney of the de-agglomerator, the hood connecting the delivery passageway to the chimney and preventing rotation of the cap with respect to the de-agglomerator.

44. An assembly according to claim 41, wherein the magazine is movable with respect to the cap for sequentially positioning the plurality of the dry powder reservoirs within the delivery passageway of the cap.

45. An assembly according to claim 44, wherein the magazine is annular such that rotation of the annular magazine sequentially positions the plurality of the dry powder reservoirs within the delivery passageway of the cap.

46. An assembly according to claim 41, wherein:

one of the magazine and the cap includes a plurality of teeth; and

the other of the magazine and the cap includes a resilient pawl sequentially passing over the teeth during movement between the magazine and the cap.

47. An assembly according to claim 46, wherein each of the plurality of teeth has a sloped first side allowing passage of the pawl in a first direction, and a straight second side preventing passage of the pawl in a second direction.

48. An assembly according to claim 46, wherein the plurality of teeth includes one tooth having straight first and second sides preventing passage of the pawl past said one tooth.

49. An assembly according to claim 41, further comprising dry powder contained in the reservoirs of the magazine.

50. An assembly according to claim 49, wherein each reservoir of the magazine contains a single dose of the dry powder.

53. A pre-metered dose assembly, comprising:

a. cap defining a delivery passageway; and

a rigid unitary structure magazine including a plurality of integral reservoirs, one of the magazine and the cap movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs within the delivery passageway of the cap;

a unitary structure means sealing each of the reservoirs of the magazine in a substantially airtight manner prior the reservoir being positioned within the delivery passageway of the cap, and maintaining said reservoirs unsealed otherwise.

54. An assembly according to claim 53, wherein the unitary structure means for sealing comprises a film secured to the magazine and covering the reservoirs in a substantially airtight manner.

55. An assembly according to claim 54, wherein the film comprises a plastic film.

56. An assembly according to claim 54, wherein the cap includes means for piercing the film above each of the reservoirs prior to the reservoir being positioned within the delivery passageway of the cap.

57. An assembly according to claim 53, wherein the reservoirs are formed in a surface of the magazine and the unitary structure means for sealing comprises a unitary surface of the cap adapted to overlie each of the reservoirs prior to the reservoir being positioned within the delivery passageway of the cap, and continuous, resilient seals positioned on the surface of the magazine around each of the reservoirs, the resilient seals compressed between the overlying surface of the cap and the surface of the magazine.

58. An assembly according to claim 53, further comprising dry powder contained in the reservoirs of the magazine.

59. An assembly according to claim 58, wherein each reservoir of the magazine contains a single dose of the dry powder.