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WO2001078817A1 - Systeme de dosage pour un inhalateur de poudre seche - Google Patents

Systeme de dosage pour un inhalateur de poudre seche Download PDF

Info

Publication number
WO2001078817A1
WO2001078817A1 PCT/US2001/005797 US0105797W WO0178817A1 WO 2001078817 A1 WO2001078817 A1 WO 2001078817A1 US 0105797 W US0105797 W US 0105797W WO 0178817 A1 WO0178817 A1 WO 0178817A1
Authority
WO
WIPO (PCT)
Prior art keywords
inhaler
shaft
cartridge
powder
fill hole
Prior art date
Application number
PCT/US2001/005797
Other languages
English (en)
Inventor
Charles F. Ganem
Andrew W. Gieschen
Original Assignee
Dura Pharmaceuticals, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dura Pharmaceuticals, Inc. filed Critical Dura Pharmaceuticals, Inc.
Priority to AU2001241697A priority Critical patent/AU2001241697A1/en
Publication of WO2001078817A1 publication Critical patent/WO2001078817A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Definitions

  • the field of the invention is dry powder inhalers. Dry powder inhalers are used to deliver a pharmaceutical, typically in a finely powdered form, to the lungs of a patient.
  • the active pharmaceutical powder is typically mixed with an excipient, such as lactose, to better facilitate handling and delivery.
  • the dry powder mixture is generally contained in sealed blisters, or similar containers, or it may be stored within a bulk powder reservoir within the inhaler.
  • a long-standing challenge in the design of dry powder inhalers having bulk powder storage is maintaining the particle size, flow and dosing characteristics of the bulk powder.
  • Many pharmaceutical powders have a tendency to absorb moisture from the environment. The moisture can cause the powder to clump or cake up, or change the particle size distribution within the powder, resulting in inconsistent doses.
  • a bulk pharmaceutical powder storage container in a dry powder inhaler must be repeatedly opened, so that individual doses may be metered out for inhalation. Moisture may penetrate into the powder, each time the bulk powder storage container is opened. Consequently, over time, dose consistency can be degraded, especially in humid environments.
  • a dry powder inhaler has an inhaler housing including a cartridge slot above a mixing chamber.
  • a removable powder cartridge containing a pharmaceutical powder is installed within the cartridge slot in the inhaler housing.
  • the powder cartridge includes a cartridge housing having a tapered lower end terminating at a fill hole.
  • a pivotable shaft has a dose cup aligned under the fill hole. The shaft is pivotable from a first position where the dose cup faces the fill hole, to a second ">
  • the powder cartridge can advantageously be removed from the inhaler, and replaced with a new powder cartridge.
  • the bulk pharmaceutical powder within the powder cartridge is metered out in uniform doses by pivoting the shaft.
  • the tapered lower end of the cartridge housing has conical lower end walls terminating in a round fill hole. The lower end walls form a leveling angle with the shaft of from about 30-80 degrees. As a result, dose delivery precision is improved.
  • a powder storage chamber is provided in an inhaler housing or in a powder cartridge.
  • a spring in the powder storage chamber has a lower end extending into the dose cup. The pivoting movement of the shaft which occurs with the delivery of each individual dose causes the spring to shift positions within the powder storage chamber, to agitate the powder and better facilitate powder flow.
  • Fig. 1 is a perspective view of a first embodiment of the present inhaler;
  • Fig. 2 is a side section view thereof;
  • Fig. 3 is a front section view thereof
  • Fig. 4 is a perspective view of the powder cartridge shown in Figs. 2 and 3;
  • Fig. 5 is a perspective view of the mouthpiece shown in Figs. 1 and 2;
  • Fig. 6 is a side view of an alternative powder cartridge embodiment;
  • Fig. 7 is a front section view thereof;
  • Fig. 8 is a front view of the cap and spring shown in Fig. 7;
  • Fig. 9 is an enlarged front view of the cartridge housing shown in Fig. 6;
  • Fig. 10 is a side view of the dosator shown in Fig. 6;
  • Fig. 11 is a section view taken along line 11-11 of Fig. 10;
  • Fig. 12 is a schematic illustration of an alternative powder cartridge or reservoir geometry;
  • Fig. 13 is a schematic illustration of the powder cartridge or reservoir geometry shown in Figs. 2 and 6;
  • Fig. 14 is a schematic illustration of yet another powder cartridge or reservoir geometry; and Fig. 15 is a schematic illustration of the measurement of leveling angles.
  • an inhaler 20 has a lid 24 attached to a housing 22.
  • a mouthpiece 26 is movable between a retracted position, to an extended position (shown in Fig. 1) via finger movement of a slide button 92.
  • a circuit board 30, batteries 32, and a motor 34 are contained within the housing 22.
  • a propeller 36 attached to the motor 34 spins within a mixing chamber 38. as described e.g., in U.S. Patent No. 5,577,497.
  • a powder cartridge 50 is installed within a cartridge slot 40 in the inhaler housing 22, as shown in Fig. 2.
  • a powder cartridge 50 has a cartridge housing 52 including an upper cylindrical section 54, a conical lower section 56, and a shaft section 58.
  • the upper cylindrical section 54 and conical lower section 56 define a powder storage chamber 60 for storing powder.
  • a lid 62 closes off the upper end of the upper cylindrical section 54.
  • a desiccant 64 is optionally provided on the lid or another location in the cartridge 50..
  • the conical lower section 56 of the cartridge housing 52 terminates in a fill hole 80, which provides a passageway from the powder storage chamber 60 into a shaft bore 78 extending through the shaft section 58.
  • a drop hole 66 aligned with the fill hole 80 extends out through the bottom of the bore 78 and into the mixing chamber 38.
  • a dosator 70 is installed within the cartridge housing 52, as shown in Figs. 3 and 4
  • the dosator includes a shaft 72 extending through the bore 78.
  • a dose cup 74 is formed on or in the shaft 72.
  • the dose cup 74 is aligned with the fill hole 80 and the drop hole 66.
  • a spur gear 76 is attached at one end of the shaft 72.
  • the mouthpiece 26 has a tube 84 attached to spaced apart legs 86.
  • One of the legs 86 has a rack gear 88 having teeth 90, adapted to mesh with the spur gear 76.
  • the slide button 92 is attached to, or formed with, the leg 86 having the rack gear 88.
  • the powder cartridge 50 is filled with a pharmaceutical powder composition.
  • the powder cartridge 50 is sealed within a pouch or other enclosure, until ready for use.
  • the powder cartridge 50 is then removed from its package, the lid 24 of the housing 22 is opened, and the powder cartridge 50 is installed in the cartridge slot 40.
  • the cartridge slot 40 locates the powder cartridge 50 so that the fill hole 80 and drop hole 66 align over the mixing chamber 38.
  • the lid 24 is closed.
  • the slide button 92 is moved out (from right to left in Fig. 1 ) via the patient's thumb or fingers As this occurs, the rack gear 88 turns the spur gear 76, causing the shaft 72 to rotate 180 degrees.
  • the dose cup 74 which initially is facing upwardly towards the powder storage chamber 66, and is filled with powder, moves to a downward facing position, in alignment with the drop hole 66.
  • the shaft 72 turns, the powder in the dose cup 74 is leveled as the cup moves away from the drop hole 66 and into the bore 78.
  • the pharmaceutical powder in the dose cup 74 then drops into the mixing chamber 36.
  • the motor 34 is then turned on when the patient inhales, as described in U.S. Patent No. 5,577,497.
  • the storage chamber 60 is preferably large enough to store at least 1.6 grams of powder, which is about the equivalent of 200 doses, of a unit dose of 8 mg.
  • the size of the dose cup 74 which controls the volume of powder dispensed, can be varied to suit different pharmaceutical preparations.
  • the diameter of the dose cup 74 is greater than the depth of the dose cup, so that all of the powder will tend to fall into the drop hole 66, with little or no powder remaining the upside down dose cup.
  • the fill hole 80 is larger in diameter than the dose cup 74, so that the dose cup 75 is completely filled with powder when facing the fill hole 80.
  • the drop hole 66 is larger in diameter than the dose cup 74 to avoid the hold up or accumulation of powder above the drop hole 66.
  • the shaft 72 is provided within an interference fit in the bore 78, i.e., with the shaft diameter preferably about .02-.3 mm larger than the bore diameter.
  • the shaft 72 is preferably hollow, allowing it compress within the bore 78, and creating an outward spring force, to assist in sealing the shaft in the bore 78.
  • the interference fit between the shaft 72 and the bore 78 minimizes powder leakage through the bore 78, and also minimizes moisture penetration into the storage chamber 60. For us with powder formulations which are not largely affected by ingress of moisture, less of an interference fit may be used.
  • the dosator 70 and cartridge housing 52 are preferably made of two different plastic materials, to avoid binding between the shaft 72 and bore 78.
  • the shaft 72 may be made of polypropylene, while the cartridge housing 52 is Delrin or Nylon.
  • an alternate powder cartridge embodiment 100 is the same in design and operation as the powder cartridge 50 described above, with the following differences.
  • the dosator 104 in the powder cartridge 100 has a knob 106 attached to shaft
  • the dosator 104 is pivotably installed at the lower end the cartridge housing 102 of the powder cartridge 100.
  • a spring 1 14 is attached to the cap 1 12 and extends down through the powder storage chamber 128 within the cartridge housing 102.
  • the bottom end or tip 1 16 of the spring 114 projects into the dose cup 110.
  • the cartridge housing 102 has a fill hole 122 above a shaft bore 120, and a drop hole 124, aligned with the fill hole 122, below the shaft bore 120, similar to the arrange of the fill hole 80, drop hole 66, and shaft bore 78 shown in Figs. 2 and 3.
  • the lower end of the cartridge housing 102 includes a conical section 126 terminating in a round fill hole 122.
  • the powder cartridge 100 operates in a manner similar to the powder cartridge 50, except that the dosator is manually operated by turning the knob 106, in contrast to the automatic operation of the dosator 70 with movement of the slide button 92, in the inhaler shown in Fig. 1.
  • the spring member moves within the storage chamber 128, to agitate the powder and better facilitate free flow of powder into the cup 112.
  • Figs. 12-14 illustrate alternative cartridge housing or storage chamber geometries.
  • the sidewalls of the chamber are straight, and meet the circumference of the shaft 72 perpendicularly to a horizontal line H passing through the shaft.
  • Fig. 13 shows the embodiments of Figs. 2 and 6, in a simplified form, for better comparison to the embodiments in Figs. 12 and 14.
  • Fig. 14 shows an alternative storage chamber embodiment 150 having a cylindrical upper section 152, a conical section 154, and a smaller diameter cylindrical section 156 engaging the shaft 72, also with straight walls, as in Fig. 12 but with a reduced diameter.
  • Table 1 below shows data from testing run on the designs shown in Figs. 12-14. As shown, the "straight walls to funner embodiment of I ig. 1 provides the best precision in dose delivery.
  • the leveling angle is the angle formed by the walls W of the powder storage chamber engaging the shaft, and a tangent T to the circumference of the shaft, at the point that the walls W intersect the shaft (forming the angle LA in Fig. 15).
  • leveling angles of from about 30-80 degrees, and more preferably from about 50-70 degrees, provide improved dose delivery precision.
  • a knob or gear 172 is attached to a shaft 175.
  • a cup 176 is provided in a cylindrical central cup section 174 on the shaft 175.
  • the central cup section 174 is spaced apart from shoulders 178 by gaps 180.
  • the shoulders 178 have narrow seal surfaces 182, of width W, which allows the dosator 170 to be installed within a bore of a storage chamber, with greater interference fit, for improved sealing.
  • the width W of the seal surfaces 182 on the shoulders 178 is substantially less than the length S of the central cup section 174.
  • a central bore 184 ma ⁇ optionally be provided through the shaft 175, so that the shaft 175 can be more easiK compressed to provide an interference fit when installed in a storage chamber

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un inhalateur de poudre sèche doté d'une cartouche de poudre (50) placée dans un emplacement de cartouche dans un logement d'inhalateur. La cartouche de poudre présente une extrémité inférieure recouverte débouchant sur un orifice de remplissage (80). Un arbre (72) doté d'une cuvette à dose (74) peut pivoter et passer d'une première position dans laquelle la cuvette à dose fait face à l'orifice de remplissage à une seconde position où la cuvette à dose regarde vers le bas. L'extrémité inférieure recouverte du logement de la cartouche forme un angle de nivellement compris entre 30 et 80 degrés par rapport à l'arbre afin d'obtenir une augmentation de l'uniformité de dosage.
PCT/US2001/005797 2000-02-25 2001-02-21 Systeme de dosage pour un inhalateur de poudre seche WO2001078817A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001241697A AU2001241697A1 (en) 2000-02-25 2001-02-21 Dosing system for a dry powder inhaler

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US51361900A 2000-02-25 2000-02-25
US09/513,619 2000-02-25

Publications (1)

Publication Number Publication Date
WO2001078817A1 true WO2001078817A1 (fr) 2001-10-25

Family

ID=24044000

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/005797 WO2001078817A1 (fr) 2000-02-25 2001-02-21 Systeme de dosage pour un inhalateur de poudre seche

Country Status (2)

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AU (1) AU2001241697A1 (fr)
WO (1) WO2001078817A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003020197A1 (fr) * 2001-09-05 2003-03-13 Vectura Limited Perfectionnements dans ou ayant trait a l'administration orale de medicaments
WO2003092774A1 (fr) * 2002-04-29 2003-11-13 Chervinskaya Alina Viacheslavo Dispositif de generation d'un aerosol sec et cartouche de rechange associee
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
WO2020148633A1 (fr) * 2019-01-14 2020-07-23 Philip Morris Products S.A. Inhalateur de poudre sèche

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5033463A (en) * 1989-10-27 1991-07-23 Miat S.P.A. Multi-dose inhaler for medicaments in powder form
US5327883A (en) * 1991-05-20 1994-07-12 Dura Pharmaceuticals, Inc. Apparatus for aerosolizing powdered medicine and process and using
US5575280A (en) * 1990-11-29 1996-11-19 Boehringer Ingelheim Kg Powder inhalation device having nozzle to empty dosing chamber
US5645051A (en) * 1995-04-21 1997-07-08 Dura Pharmaceuticals, Inc. Unit dose dry powder inhaler
US5740794A (en) * 1994-09-21 1998-04-21 Inhale Therapeutic Systems Apparatus and methods for dispersing dry powder medicaments
US5765552A (en) * 1990-09-26 1998-06-16 Pharmachemie B.V. Inhaler devices provided with a reservoir for several doses of medium for inhaling, transporting device, whirl chamber
US5921237A (en) * 1995-04-24 1999-07-13 Dura Pharmaceuticals, Inc. Dry powder inhaler
US6006747A (en) * 1997-03-20 1999-12-28 Dura Pharmaceuticals, Inc. Dry powder inhaler

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5033463A (en) * 1989-10-27 1991-07-23 Miat S.P.A. Multi-dose inhaler for medicaments in powder form
US5765552A (en) * 1990-09-26 1998-06-16 Pharmachemie B.V. Inhaler devices provided with a reservoir for several doses of medium for inhaling, transporting device, whirl chamber
US5575280A (en) * 1990-11-29 1996-11-19 Boehringer Ingelheim Kg Powder inhalation device having nozzle to empty dosing chamber
US5327883A (en) * 1991-05-20 1994-07-12 Dura Pharmaceuticals, Inc. Apparatus for aerosolizing powdered medicine and process and using
US5740794A (en) * 1994-09-21 1998-04-21 Inhale Therapeutic Systems Apparatus and methods for dispersing dry powder medicaments
US5645051A (en) * 1995-04-21 1997-07-08 Dura Pharmaceuticals, Inc. Unit dose dry powder inhaler
US5921237A (en) * 1995-04-24 1999-07-13 Dura Pharmaceuticals, Inc. Dry powder inhaler
US6006747A (en) * 1997-03-20 1999-12-28 Dura Pharmaceuticals, Inc. Dry powder inhaler

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003020197A1 (fr) * 2001-09-05 2003-03-13 Vectura Limited Perfectionnements dans ou ayant trait a l'administration orale de medicaments
WO2003092774A1 (fr) * 2002-04-29 2003-11-13 Chervinskaya Alina Viacheslavo Dispositif de generation d'un aerosol sec et cartouche de rechange associee
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
WO2020148633A1 (fr) * 2019-01-14 2020-07-23 Philip Morris Products S.A. Inhalateur de poudre sèche

Also Published As

Publication number Publication date
AU2001241697A1 (en) 2001-10-30

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