AU2017204342B2 - Airflow adaptor for a breath-actuated dry powder inhaler - Google Patents

Airflow adaptor for a breath-actuated dry powder inhaler Download PDF

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Publication number
AU2017204342B2
AU2017204342B2 AU2017204342A AU2017204342A AU2017204342B2 AU 2017204342 B2 AU2017204342 B2 AU 2017204342B2 AU 2017204342 A AU2017204342 A AU 2017204342A AU 2017204342 A AU2017204342 A AU 2017204342A AU 2017204342 B2 AU2017204342 B2 AU 2017204342B2
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Australia
Prior art keywords
airflow
conduit
breath
dry powder
adaptor
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AU2017204342A
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AU2017204342A1 (en
Inventor
Julian Alexander Blair
Daniel Buck
Jan Geert Hazenberg
Xian-Ming Zeng
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Norton Healthcare Ltd
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Norton Healthcare Ltd
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Priority claimed from GBGB0919465.5A external-priority patent/GB0919465D0/en
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

An airflow adaptor (200) for a breath-actuated dry powder inhaler. The airflow adaptor comprises a conduit (202) having a proximal end (201) and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further comprises means (204, 205, 206, 210, 211, 212) for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor. (Figure 2) ,106

Description

Field of the Invention
The present invention relates to an airflow adaptor for a breath-actuated dry powder inhaler. In particular, the present invention relates to an airflow adaptor for a deagglomerator of a breathactuated dry powder inhaler; a deagglomerator for a breath-actuated dry powder inhaler; a method for deagglomerating dry powder medicaments; and a method for modifying airflow through the outlet port of a deagglomerator of a breath-actuated dry powder inhaler.
Background to the Invention
Breath-actuated dry powder inhalers are used to deliver medicament to the respiratory tracts of patients. Typically such inhalers comprise a reservoir, or reservoirs, for storing dry powder medicament, means for aerosolising the dry powder medicament for inhalation, and means for
0 delivering the aerosolised medicament to the patient, such as a mouthpiece. Typically, in use, the dry powder medicament is dispensed from a reservoir and then aerosolised as a result of a breath-induced low pressure at the mouthpiece. Once aerosolised, the medicament will generally leave the inhaler through the mouthpiece and be inhaled.
5 Known dry powder medicament is composed of very small particles and often provided in a composition including a carrier, such as lactose. Consequently, non-defmed agglomerates or aggregates of the dry powder medicament may form at random prior to being delivered to the patient. There has therefore been a need for breath-actuated dry powder inhalers with means for breaking down the agglomerates of medicament, or medicament and carrier, prior to inhalation.
Deagglomerators for breath-actuated dry powder inhalers are disclosed in WOOl/97889.
There is, however, a continued need to reduce the flow rate dependence of breath-actuated dry powder inhalers and, in particular, the flow rate dependence of the delivered dose of the
9431981 1
2017204342 31 Aug 2018 medicament they deliver. In particular, there is a need to ensure that different patient groups receive substantially the same delivered dose from the same breath-actuated dry powder inhaler.
There is also a need for providing breath-actuated dry powder inhalers, and in particular those 5 with deagglomerators, which provide better delivered dose characteristics. Particularly, there is a need for breath-actuated dry powder inhalers which provide improved delivered dose uniformity.
Summary of the Invention
In accordance with the first aspect, the present invention provides, an airflow adaptor for a breath-actuated dry powder inhaler, the airflow adaptor comprising:
a first conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the first conduit, and wherein the airflow adaptor further comprises at least one second conduit configured to allow air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the first conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor, and wherein the distal end of the first conduit is located at the distal end of the airflow adaptor and
0 comprises a first aperture in a first circumferential flange, and the second conduit is in the form of at least one second aperture in the first circumferential flange wherein airflow exits the dry powder inhaler.
In an embodiment, the ratio of the sum of the cross-sectional areas of the at least one second
5 conduit to the cross-sectional area of the first conduit is such that when a breath induced low pressure is applied to the distal end of the airflow adaptor at least 5 %, preferably at least 20%, of the resulting airflow is through the at least one second conduit.
In embodiments, the first circumferential flange comprises two, preferably four apertures.
In an embodiment, the airflow adaptor comprises a second circumferential flange at the proximal end of the airflow adaptor, wherein the first conduit comprises a first aperture, the second circumferential flange further comprising at least one second aperture which forms part of the second conduit, preferably four second apertures.
2017204342 31 Aug 2018
In an embodiment, the ratio of the sum of the cross-sectional areas of the second apertures in the second circumferential flange to the cross-sectional area of the first conduit is such that when a pressure breath induced low pressure is applied to the distal end of the airflow adaptor at least 5 %, preferably at least 20%, of the resulting airflow is through the second apertures.
In accordance with the second aspect, the present invention provides a deagglomerator for a breath-actuated dry powder inhaler, the deagglomerator comprising an airflow adaptor in accordance with the first aspect.
In embodiments, the deagglomerator comprises:
an inner wall defining a swirl chamber extending along an axis from a first end to a second end; a dry powder supply port in the first end of the swirl chamber for providing fluid communication between a dry powder delivery passageway of an inhaler and the first end of the swirl chamber;
at least one inlet port in the inner wall of the swirl chamber adjacent to the first end of the swirl chamber providing fluid communication between a region exterior to the deagglomerator and the first end of the swirl chamber;
an outlet port providing fluid communication between the second end of the swirl chamber and the airflow adaptor;
0 whereby a breath induced low pressure at the distal end of the airflow adaptor causes air to flow into the swirl chamber through the dry powder supply port and the inlet port.
In accordance with the third aspect, the present invention provides a deagglomerator for a breath-actuated dry powder inhaler, the deagglomerator comprising:
5 an inner wall defining a swirl chamber extending along an axis from a first end to a second end;
a dry powder supply port in the first end of the swirl chamber for providing fluid communication between a dry powder delivery passageway of an inhaler and the first end of the swirl chamber;
at least one inlet port in the inner wall of the swirl chamber adjacent to the first end of the swirl
0 chamber providing fluid communication between a region exterior to the deagglomerator and the first end of the swirl chamber;
an outlet port providing fluid communication between the second end and the airflow adaptor, the airflow adaptor providing fluid communication between the outlet port and a region exterior to the deagglomerator via a first conduit, wherein the distal end of the first conduit is located at
5 the distal end of the airflow adaptor and comprises a first aperture in a first circumferential
2017204342 31 Aug 2018 flange; and wherein the airflow adaptor comprises at least one second conduit that by-passes the swirl chamber and directs air to flow from a proximal end of the airflow adaptor to a distal end of the airflow adaptor independently of the first conduit when a breath-induced low pressure is applied to the distal end of the airflow adaptor, wherein the second conduit comprises as second aperture in the first circumferential flange where airflow exits the deagglomerator.
In an embodiment, the breath induced low pressure at the distal end of the airflow adaptor causes air to flow into the swirl chamber through the dry powder supply port and the inlet port.
In embodiments, the ratio of the sum of the cross- sectional areas of the at least one second conduit to the cross-sectional area of outlet port is such that that when a pressure breath induced low pressure is applied to the distal end of the airflow adaptor at least 5%, preferably at least 20%, of the resulting airflow is directed through the at least one second conduit.
In accordance with the fourth aspect, the present invention provides a breath-actuated dry powder inhaler comprising an airflow adaptor in accordance with the first aspect.
In accordance with the fifth aspect, the present invention provides a breath-actuated dry powder 2 0 inhaler comprising a deagglomerator in accordance with the second aspect.
In some embodiments, the inhaler comprises a dry powder medicament. The dry powder medicament may comprise an active ingredient selected from the group consisting of an antiinflammatory agent, an anti-cholinergic agent, a 32-adrenoreceptor agonist, an anti-infective
5 agent, an antihistamine and combinations thereof. Further, the active ingredient may comprise fluticasone propionate. In some instances, the active ingredient may comprise a combination of fluticasone propionate and salmeterol xinafoate.
In accordance with the sixth aspect, the present invention provides a method for de3 0 agglomerating dry powder in a breath-actuated dry powder inhaler, comprising:
directing a first breath-actuated airflow for entraining a dry powder from an inhaler into a first end of a swirl chamber extending along a longitudinal axis from the first end to a second end, the first airflow directed in a longitudinal direction;
directing a second breath-actuated airflow in a substantially transverse direction into the first 3 5 end of the swirl chamber such that the first and the second breath-actuated airflows collide and
2017204342 31 Aug 2018 substantially combine;
directing a portion of the combined airflows in a spiral path towards the second end of the swirl chamber;
delivering all the combined airflows and any dry powder entrained therein through an outlet 5 port in the second end of the chamber to a proximal end of an airflow adaptor, said airflow adaptor comprising a first conduit, said first conduit having a first circumferential flange at the distal end thereof; and directing a third breath-actuated airflow to the airflow adaptor having by-passed the swirl chamber; wherein the third breath-actuated airflow exits the airflow adaptor as it passes through at least one aperture in the first circumferential flange.
In some embodiments, the third breath-actuated airflow is combined with the combined first and second breath-actuated airflows once they have left the airflow adaptor.
In accordance with the seventh aspect, the present invention provides method for modifying airflow through an outlet port of a deagglomerator of a breath-actuated dry powder inhaler comprising the steps of:
a) providing an airflow adaptor comprising a first conduit having a proximal end and a distal end, the airflow adaptor further comprising at least one second conduit configured to allow air
0 to flow from a proximal end of the adaptor to a distal end of the adaptor independently of airflow in the first conduit, wherein the distal end of the first conduit is located at the distal end of the airflow adaptor and comprises a first aperture in a first circumferential flange, and the second conduit is in the form of at least one second aperture in the first circumferential flange where airflow exits that dry powder inhaler; and
5 b) arranging the first conduit such that it provides fluid communication from the outlet port of the deagglomerator to the distal end of the first conduit.
In some embodiments, the method further comprises the step of applying a breath induced low pressure to the distal end of the airflow adaptor such that air flows through the first and second conduits.
Throughout the description where references are made to percentages they refer to the percent by volume.
2017204342 31 Aug 2018
Description of the Figures
Figure 1 shows a view of the distal end of an airflow adaptor.
Figure 2 shows a view of the proximal end of an airflow adaptor.
Figure 3 shows an alternative embodiment of the airflow adaptor.
Figure 4 shows a deagglomerator for use with airflow adaptor.
Figure 5 shows a deagglomerator including a swirl chamber bypass port.
2017204342 31 Aug 2018

Claims (20)

  1. Claims
    1. An airflow adaptor for a breath-actuated dry powder inhaler, the airflow adaptor comprising:
    a first conduit having a proximal end and a distal end, wherein the proximal end 5 allows fluid communication from a deagglomerator outlet port to the distal end of the first conduit, and wherein the airflow adaptor further comprises at least one second conduit configured to allow air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the first conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor, and
    1 o wherein the distal end of the first conduit is located at the distal end of the airflow adaptor and comprises a first aperture in a first circumferential flange, and the second conduit is in the form of at least one second aperture in the first circumferential flange wherein airflow exits the dry powder inhaler.
  2. 2. An airflow adaptor according to claim 1 wherein the ratio of the sum of the cross15 sectional areas of the at least one second conduit to the cross-sectional area of the first conduit is such that when a breath induced low pressure is applied to the distal end of the airflow adaptor at least 5 %, preferably at least 20%, of the resulting airflow is through the at least one second conduit.
  3. 3. An airflow adaptor according to claim 1 or 2 wherein the first circumferential flange
    2 o comprises two, preferably four apertures.
  4. 4. An airflow adaptor according to any one of claims 1 to 3 wherein the airflow adaptor comprises a second circumferential flange at the proximal end of the airflow adaptor, wherein the first conduit comprises a first aperture, the second circumferential flange further comprising at least one second aperture which forms part of the second conduit,
    2 5 preferably four second apertures.
  5. 5. An airflow adaptor according to claim 4 wherein the ratio of the sum of the crosssectional areas of the second apertures in the second circumferential flange to the crosssectional area of the first conduit is such that when a pressure breath induced low
    2017204342 31 Aug 2018 pressure is applied to the distal end of the airflow adaptor at least 5 %, preferably at least 20%, of the resulting airflow is through the second apertures.
  6. 6. A deagglomerator for a breath-actuated dry powder inhaler, the deagglomerator comprising an airflow adaptor according to any one of claims 1 to 5.
    5
  7. 7. A deagglomerator according to claim 6, the deagglomerator comprising:
    an inner wall defining a swirl chamber extending along an axis from a first end to a second end;
    a dry powder supply port in the first end of the swirl chamber for providing fluid communication between a dry powder delivery passageway of an inhaler and the first
    10 end of the swirl chamber;
    at least one inlet port in the inner wall of the swirl chamber adjacent to the first end of the swirl chamber providing fluid communication between a region exterior to the deagglomerator and the first end of the swirl chamber;
    an outlet port providing fluid communication between the second end of the 15 swirl chamber and the airflow adaptor;
    whereby a breath induced low pressure at the distal end of the airflow adaptor causes air to flow into the swirl chamber through the dry powder supply port and the inlet port.
  8. 8. A deagglomerator for a breath-actuated dry powder inhaler, the deagglomerator 2 o comprising:
    an inner wall defining a swirl chamber extending along an axis from a first end to a second end; a dry powder supply port in the first end of the swirl chamber for providing fluid communication between a dry powder delivery passageway of an inhaler and the first end of the swirl chamber;
    2 5 at least one inlet port in the inner wall of the swirl chamber adjacent to the first end of the swirl chamber providing fluid communication between a region exterior to the deagglomerator and the first end of the swirl chamber;
    2017204342 31 Aug 2018 an outlet port providing fluid communication between the second end and the airflow adaptor, the airflow adaptor providing fluid communication between the outlet port and a region exterior to the deagglomerator via a first conduit, wherein the distal end of the first conduit is located at the distal end of the airflow adaptor and comprises
    5 a first aperture in a first circumferential flange; and wherein the airflow adaptor comprises at least one second conduit that by-passes the swirl chamber and directs air to flow from a proximal end of the airflow adaptor to a distal end of the airflow adaptor independently of the first conduit when a breathinduced low pressure is applied to the distal end of the airflow adaptor, wherein the
    10 second conduit comprises as second aperture in the first circumferential flange where airflow exits the deagglomerator.
  9. 9. A deagglomerator according to claim 8 wherein the breath induced low pressure at the distal end of the airflow adaptor causes air to flow into the swirl chamber through the dry powder supply port and the inlet port.
    15
  10. 10. A deagglomerator according to claims 8 wherein the ratio of the sum of the crosssectional areas of the at least one second conduit to the cross-sectional area of outlet port is such that that when a pressure breath induced low pressure is applied to the distal end of the airflow adaptor at least 5%, preferably at least 20%, of the resulting airflow is directed through the at least one second conduit.
    2 0
  11. 11. A breath-actuated dry powder inhaler comprising an airflow adaptor according to any one of claims 1 to 5.
  12. 12. A breath-actuated dry powder inhaler comprising a deagglomerator according to any one of claims 8 to 10.
  13. 13. The breath-actuated dry powder inhaler according to claim 11 or claim 12 wherein
    2 5 the inhaler comprises a dry powder medicament.
  14. 14. The breath-actuated dry powder inhaler according to claim 13 wherein the dry powder medicament comprises an active ingredient selected from the group consisting of an anti-inflammatory agent, an anti-cholinergic agent, a 32-adrenoreceptor agonist, an anti-infective agent, an antihistamine and combinations thereof.
    2017204342 31 Aug 2018
  15. 15. The breath-actuated dry powder inhaler according to claim 14 wherein the active ingredient comprises fluticasone propionate.
  16. 16. The breath-actuated dry powder inhaler according to claim 15 wherein the active ingredient comprises a combination of fluticasone propionate and salmeterol xinafoate.
    5
  17. 17. A method for de-agglomerating dry powder in a breath-actuated dry powder inhaler, comprising:
    directing a first breath-actuated airflow for entraining a dry powder from an inhaler into a first end of a swirl chamber extending along a longitudinal axis from the first end to a second end, the first airflow directed in a longitudinal direction;
    1 o directing a second breath-actuated airflow in a substantially transverse direction into the first end of the swirl chamber such that the first and the second breath-actuated airflows collide and substantially combine;
    directing a portion of the combined airflows in a spiral path towards the second end of the swirl chamber;
    15 delivering all the combined airflows and any dry powder entrained therein through an outlet port in the second end of the chamber to a proximal end of an airflow adaptor, said airflow adaptor comprising a first conduit, said first conduit having a first circumferential flange at the distal end thereof; and directing a third breath-actuated airflow to the airflow adaptor having by-passed
    2 o the swirl chamber; wherein the third breath-actuated airflow exits the airflow adaptor as it passes through at least one aperture in the first circumferential flange.
  18. 18. A method according to claim 17 wherein the third breath-actuated airflow is combined with the combined first and second breath-actuated airflows once they have left the airflow adaptor.
    2 5
  19. 19. A method for modifying airflow through an outlet port of a deagglomerator of a breath-actuated dry powder inhaler comprising the steps of:
    2017204342 31 Aug 2018
    a) providing an airflow adaptor comprising a first conduit having a proximal end and a distal end, the airflow adaptor further comprising at least one second conduit configured to allow air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of airflow in the first conduit, wherein the distal end of the first
    5 conduit is located at the distal end of the airflow adaptor and comprises a first aperture in a first circumferential flange, and the second conduit is in the form of at least one second aperture in the first circumferential flange where airflow exits the dry powder inhaler; and
    b) arranging the first conduit such that it provides fluid communication from the l o outlet port of the deagglomerator to the distal end of the first conduit.
  20. 20. The method of claim 19 further comprising the step of applying a breath induced low pressure to the distal end of the airflow adaptor such that air flows through the first and second conduits.
    2017204342 27 Jun 2017
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    305.
    FIG. 3
    301
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    FIG. 4
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    506
    FIG. 5
    5/6
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    FIG. 6
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    2017204342 27Jun2017
    700
    703
    FIG. 7
AU2017204342A 2009-11-06 2017-06-27 Airflow adaptor for a breath-actuated dry powder inhaler Ceased AU2017204342B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2017204342A AU2017204342B2 (en) 2009-11-06 2017-06-27 Airflow adaptor for a breath-actuated dry powder inhaler

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
GB0919465.5 2009-11-06
GBGB0919465.5A GB0919465D0 (en) 2009-11-06 2009-11-06 Airflow adaptor for a breath-actuated dry powder inhaler
US29870510P 2010-01-27 2010-01-27
US61/298,705 2010-01-27
PCT/EP2010/006744 WO2011054527A1 (en) 2009-11-06 2010-11-05 Airflow adaptor for a breath-actuated dry powder inhaler
AU2010314369A AU2010314369B2 (en) 2009-11-06 2010-11-05 Airflow adaptor for a breath-actuated dry powder inhaler
AU2014201778A AU2014201778B2 (en) 2009-11-06 2014-03-25 Airflow adaptor for a breath-actuated dry powder inhaler
AU2017204342A AU2017204342B2 (en) 2009-11-06 2017-06-27 Airflow adaptor for a breath-actuated dry powder inhaler

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
AU2014201778A Division AU2014201778B2 (en) 2009-11-06 2014-03-25 Airflow adaptor for a breath-actuated dry powder inhaler

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AU2017204342A1 AU2017204342A1 (en) 2017-07-13
AU2017204342B2 true AU2017204342B2 (en) 2018-11-08

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AU2017204342A Ceased AU2017204342B2 (en) 2009-11-06 2017-06-27 Airflow adaptor for a breath-actuated dry powder inhaler

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Citations (3)

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US5301666A (en) * 1991-12-14 1994-04-12 Asta Medica Aktiengesellschaft Powder inhaler
US5647349A (en) * 1995-06-01 1997-07-15 Unisia Jecs Corporation Medicine administering inhaling device
US20060231096A1 (en) * 2003-06-11 2006-10-19 Hitachi, Ltd. Inhalation type medication apparatus

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Publication number Priority date Publication date Assignee Title
AR028747A1 (en) * 2000-06-23 2003-05-21 Norton Health Care Ltd DEGREME FOR DRY POWDER INHALER OPERATED BY BREATHING, A DRY POWDER INHALER AND A DRY POWDER DEFAULT METHOD.
US6681768B2 (en) * 2001-06-22 2004-01-27 Sofotec Gmbh & Co. Kg Powder formulation disintegrating system and method for dry powder inhalers
GB2398252B (en) * 2003-02-11 2005-09-21 Bespak Plc Dispensing apparatus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5301666A (en) * 1991-12-14 1994-04-12 Asta Medica Aktiengesellschaft Powder inhaler
US5647349A (en) * 1995-06-01 1997-07-15 Unisia Jecs Corporation Medicine administering inhaling device
US20060231096A1 (en) * 2003-06-11 2006-10-19 Hitachi, Ltd. Inhalation type medication apparatus

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AU2017204342A1 (en) 2017-07-13
AU2014201778A1 (en) 2014-04-17
AU2014201778B2 (en) 2017-03-30

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