WO2001034234A1 - Inhalateur de poudre seche - Google Patents

Inhalateur de poudre seche Download PDF

Info

Publication number
WO2001034234A1
WO2001034234A1 PCT/US2000/029392 US0029392W WO0134234A1 WO 2001034234 A1 WO2001034234 A1 WO 2001034234A1 US 0029392 W US0029392 W US 0029392W WO 0134234 A1 WO0134234 A1 WO 0134234A1
Authority
WO
WIPO (PCT)
Prior art keywords
dose
cassette
dose ring
seal disk
ring body
Prior art date
Application number
PCT/US2000/029392
Other languages
English (en)
Inventor
James Boyles
Charles Ganem
Daryl Woodworth
Chester Damecki
Clyde L. Witham
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 AU17526/01A priority Critical patent/AU1752601A/en
Publication of WO2001034234A1 publication Critical patent/WO2001034234A1/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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0048—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged in a plane, e.g. on diskettes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/04—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0445—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0454—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments the whole forming a circular container with rotating parts
    • 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 inhalers. More specifically, the invention relates to cassettes or containers for storing dry powder pharmaceuticals, for use with inhalers.
  • Inhalers are used to deliver drugs into a patient's lungs.
  • an inhaler typically contains or provides a mixture of drugs and air or propellants.
  • the mixture is delivered via the patient inhaling from a mouthpiece on the inhaler, for treatment of various conditions, for example, bronchial asthma.
  • delivery of drugs via inhalation can be used for many other treatments, including those unrelated to lung conditions.
  • Inhalers have used various techniques for storing drugs to be delivered. Some inhalers have used bulk drug storage reservoirs and mechanisms for dividing out individual doses with each use. Other inhalers have used separately contained drug doses, such as in U.S. Patent Nos. 4,778,054 and 5,327,883.
  • the inhaler described in U.S. Patent No. 5,327,883 uses individual medicine doses stored within a plurality of apertures in a dry powder pharmaceutical containing cassette.
  • the cassette is manually advanced to deliver successive doses.
  • disadvantages still remain in storing and delivering dry powder pharmaceuticals from a cassette, and in reliably delivering a precise quantity of drug from the cassette.
  • a multi-dosage powder containing cassette has individual powder pharmaceutical dosages radially spaced apart in a dose ring.
  • a seal disk has clamping arms which hold the dose ring and seal disk together. The seal disk seals the powder within the dose ring.
  • Fig. 1 is an exploded perspective view of the cassette of the invention
  • Fig. 2 is a section view thereof;
  • Fig. 3 is a perspective view of the bottom of the cap shown in Fig. 1;
  • Fig. 4 is a top perspective view thereof
  • Fig. 5 is a bottom perspective view of the dose ring shown in Fig. 1 ;
  • Fig. 6 is a top perspective view thereof;
  • Fig. 7 is a top perspective view of the seal disk shown in Fig. 1 ;
  • Fig. 8 is a bottom perspective view thereof
  • Fig. 9 is a section view of the dose ring shown in Fig. 1;
  • Fig. 10 is an enlarged detailed view of the dose container shown in Fig. 9;
  • Fig. 11 is a perspective view of a second cassette embodiment
  • Fig. 12 is a top view thereof
  • Fig. 13 is a partial section view taken along line 19-19 of Fig. 12;
  • Fig. 14 is a section view taken along line 20-20 of Fig. 12;
  • Fig. 15 is an enlarged detail of a section of Fig. 14.
  • Fig. 16 is a top view of a tool used to assemble the cassette shown in Fig. 1 ;
  • Fig 17 is a side view thereof;
  • Figs. 18-22 are enlarged partial section views showing the steps used to assemble the cassette shown in Fig. 1.
  • a cassette 220 has a dose ring 224 attached to a seal disk 226.
  • a cap 222 may optionally be provided on top of the dose ring 224, opposite from the seal disk 226.
  • the dose ring 224 has an inner flat surface 240.
  • An annular first top step 242 and an annular second top step 244, concentric to and within the first top step 242, are located on the top surface 235 of the dose ring 224.
  • a center bore 245 extends through the dose ring 224.
  • a plurality of radially spaced apart dose containers 248 are formed in the bottom surface 237 of the dose ring 224.
  • Each of the dose containers 248 has an open end 250 and a blind or closed bottom 252.
  • the open ends 250 of the dose containers 248 are located on a flat annular land area 258 formed between the bottom step 246 and a raised outer rim 256.
  • a plurality of saw teeth 264 are provided around the outer perimeter of the dose ring 224, with one saw tooth associated with each dose container 248.
  • 31 dose containers 248 are formed in the dose ring 224.
  • the dose ring 224 provides a one month supply.
  • the seal disk 226 has a top surface 280 and a bottom surface 282.
  • a smooth and flat annular seal ring 292 is formed around the outside of a center plate 278.
  • a single dose hole 295 extends through the seal ring 292.
  • Tubes 284 pass through the center plate 278, with tube extensions 296 extending slightly below the bottom surface of the center plate, as shown in Fig. 8.
  • a center pin 286 extends upperly from the center of the center plate 278.
  • a plurality of clamping arms 288 are radially spaced apart and extend upwardly from the top surface of the center plate 278.
  • An opening 290 is formed under each of the clamping arms 288, to simplify injection molding of the seal ring.
  • feet 294 extend downwardly between each of the clamp arm openings 290.
  • Bottom pins 298 extend downwardly from the bottom surface of the center plate 278.
  • the feet 294 and the pins 298 are provided so that the cassette 220 can be used interchangeably with the cassette 60, in the same inhaler.
  • the cap 222 has a cap post bore 234 adapted to fit over the center pin 286 on the seal disk 226.
  • the cap 222 also has cap holes 230 located and dimensioned to fit over the top end of the tubes 284.
  • the land area 258 of the dose ring 224 is clamped against the seal ring 292 of the seal disk 226, via the clamping arms 288 clamping down on the second top step 244 of the dose ring 224.
  • the clamping force exerted by the clamping arms 288 is sufficient to hold the dose containers 248 tightly against the seal ring 292, to largely prevent a dry pharmaceutical powder held in the dose containers 248 from leaking out.
  • the clamping force is advantageously applied by the clamping arms very close to the containers 248.
  • the clamping force still permits the dose ring 224 to be incrementally rotated or indexed, to bring each of the dose containers 248 sequentially into alignment with the dose hole 295, so that the dry pharmaceutical powder contents of each dose container 248 can be released into the inhaler.
  • the seal disk 226, dose ring 224 and cap 222 are preferably made from Lexan plastic.
  • the cassette 220 as shown in Fig. 1 is preferably assembled by first filling the dose containers 248 with pharmaceutical dry powder, with the dose ring 224 upside down.
  • the seal disk 226 is then pressed onto the dose ring 224.
  • the clamping arms 228 momentarily are deflected radially inwardly as they pass through the center bore 245 of the dose ring 224 and then flex back outwardly to engage the second top step 242.
  • the cap 222 is then pressed onto the center pin 286 of the seal disk 226.
  • the edges of the cap 222 are located on the first step 242 on the top of the dose ring.
  • the steps for assembling the seal disk 226 to the dose ring 224 are shown in sequence in Figs. 18-22.
  • the seal disk is placed upside down in a fixture or holder 410, as shown in Fig. 18.
  • a mandrel 400 is then brought down on top of the seal disk 226, as shown in Fig. 19.
  • the mandrel 400 as shown in Figs. 16 and 17, has legs 402 projecting from a disk section 406.
  • the mandrel 400 is oriented so that the legs 402 align with the openings 290 in the seal disk 226.
  • the assembly is performed in batches, with an array of e.g, 9 seal disks 226 positioned within an array of 9 holders 410.
  • An actuator or automation element 404 such as a robot arm, is attached to the disk section Referring to Figs. 19 and 20, the mandrel is pushed down onto the seal disk 226. As this occurs, a chamfered inner edge 408 on each leg of the mandrel engages an outer leg surface 291 at each of the clamping arms 288. In the embodiment shown, there are 8 clamping arms, and 8 legs on the mandrel, although other numbers may be used as well.
  • the outer leg surface 291 extends downwardly and outwardly (from the center of the seal disk) as shown in Figs. 7 and 19-22.
  • each clamping leg 288 As the mandrel 400 moves down, it pushes each clamping leg 288 down, displacing the outer edge 289 of each arm downwardly and inwardly, from the position A to position B as shown in Fig. 20.
  • the clamping legs are now in a temporarily retracted position.
  • the amount of displacement is relatively small, yet it is sufficient to allow the clamping legs to pass freely through the dose ring 224.
  • the arm edge 289 is displaced both vertically downwardly and inwardly by e.g., 0.25- 1.0 mm, and preferably by about 0.75 mm .
  • the clamping legs 288 are sufficiently resilient to allow this displacement without adverse effects.
  • the holder 410 supports the seal disk all around against the downward force of the mandrel.
  • the mandrel 400 stops moving relative to the seal disk when the chamfered inner edge 408 of each leg of the mandrel reaches the radius joining the arm edge 289 to the rest of the leg 288. Referring to Fig. 2 the mandrel 400 next retracts or lifts up, while still fully engaged onto the seal disk 226, lifting the seal disk up and off of the holder 410.
  • the mandrel 400, carrying the seal disk (or the array of mandrels and seal disks) then moves over, preferably via automation, into vertical alignment with a dose ring 224 supported on or in a second holder 412.
  • the dose ring 224 is filled with pharmaceutical powder.
  • the mandrel 400 is then moved down, with the seal disk 226 passing through the central bore or opening 245 in the dose ring 224. As shown in Fig. 21, the arms on the seal disk 226 pass freely through the dose ring, because they are deflected inwardly by the legs 402 of the mandrel 400.
  • the mandrel 400 lifts up, while the seal disk is held down onto the dose ring by a cylinder push rod 414, which extends down through the mandrel during this step.
  • the clamping arms 288 move back into their original positions. The edges of the clamping arms move up and clamp onto the second step 244 of the dose ring. This occurs smoothly and with no abrupt snapping movement, so that the powder pharmaceutical in the dose ring is not disturbed or scattered.
  • the clamping arms hold the seal disk 226 and the dose ring 224 together, into a cassette assembly, as described above. While the seal disk 226 does not provide a total, e.g., gas-tight or hermetic seal, it does efficiently keep the powder from escaping out of the dose ring.
  • a first cassette 302 has a first seal disk 306, and a second cassette 304 has a second seal disk 308.
  • the cassettes 302 and 304 are the same as the cassette 220, described above, except that the first cassette 302 has retainer spring fingers 310 extending upwardly from the center plate of the first seal disk 306. Hooks 312 extend radially outwardly on the retainer spring fingers 310.
  • the center plate of the second seal disk 308 of the second cassette 304 has hooks slots 314. The hooks 312 on the retainer spring fingers 310 engage the hook slots 314, to hold the second cassette 304 on top of the first cassette 302, providing a two layer cassette 300, having twice as many doses as the single cassette 320.
  • the cassettes 220 and 300 are installed and used with the inhaler in the same way as the cassette described in U.S. Patent No. 6,006,747.
  • the double cassette 300 With the double cassette 300, the saw teeth on the first cassette 302 and second cassette 304 are vertically spaced apart sufficiently so that the advancing mechanism of the inhaler advances only the bottom cassette (the dose ring on the top cassette remaining in a fixed position).
  • the double cassette 300 is removed from the inhaler, turned over, and reinstalled, so that the cassette on the bottom becomes the cassette on top, and vice versa. Accordingly, the double cassette 300 is able to deliver a larger number of doses.

Landscapes

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

Abstract

L"invention concerne un médicament sous forme de poudre sèche contenu dans une caissette (220) fixée à un inhalateur comprenant un anneau de dosage (224) présentant des ouvertures (248) permettant de contenir la poudre sèche. Un disque d"étanchéité (226) présente des bras de serrage (288) qui se referment sur l"anneau de dosage de manière à étanchéifier la poudre dans les ouvertures de l"anneau de dosage. Une double caissette (300) présente deux caissettes (302, 304) fixées ensemble dos à dos de manière à distribuer un grand nombre de doses.
PCT/US2000/029392 1999-11-11 2000-10-25 Inhalateur de poudre seche WO2001034234A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU17526/01A AU1752601A (en) 1999-11-11 2000-10-25 Dry powder inhaler

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43874699A 1999-11-11 1999-11-11
US09/438,746 1999-11-11

Publications (1)

Publication Number Publication Date
WO2001034234A1 true WO2001034234A1 (fr) 2001-05-17

Family

ID=23741847

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/029392 WO2001034234A1 (fr) 1999-11-11 2000-10-25 Inhalateur de poudre seche

Country Status (2)

Country Link
AU (1) AU1752601A (fr)
WO (1) WO2001034234A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6871647B2 (en) 2001-09-19 2005-03-29 Advent Pharmaceuticals Pty Ltd Inhaler
WO2010036839A2 (fr) * 2008-09-26 2010-04-01 Oriel Therapeutics, Inc. Inhaleurs avec disques de voie aérienne munis de canaux de voie aérienne discrets ainsi que disques et procédés associés
US8381721B2 (en) 2008-09-26 2013-02-26 Oriel Therapeutics, Inc. Dry powder inhalers with dual piercing members and related devices and methods
US8646446B2 (en) 2008-10-01 2014-02-11 Oriel Therapeutics, Inc. Dry powder inhalers with rotating piercing mechanisms and related devices and methods
US8887722B2 (en) 2008-09-26 2014-11-18 Oriel Therapeutics, Inc. Inhaler mechanisms with radially biased piercers and related methods
US9050427B2 (en) 2008-09-30 2015-06-09 Oriel Therapeutics, Inc. Dry powder inhalers with multi-facet surface deagglomeration chambers and related devices and methods
USD745660S1 (en) 2010-03-26 2015-12-15 Oriel Therapeutics, Inc. Dry powder inhaler

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3604559A (en) * 1969-10-15 1971-09-14 Lilly Co Eli Multilayer dispenser for pills
US3638830A (en) * 1969-10-06 1972-02-01 Paul Belokin Jr Pill dispenser with top rotatable relative to base
US5035237A (en) * 1985-07-30 1991-07-30 Newell Robert E Devices for administering medicaments to patients
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
US6116238A (en) * 1997-12-02 2000-09-12 Dura Pharmaceuticals, Inc. Dry powder inhaler

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3638830A (en) * 1969-10-06 1972-02-01 Paul Belokin Jr Pill dispenser with top rotatable relative to base
US3604559A (en) * 1969-10-15 1971-09-14 Lilly Co Eli Multilayer dispenser for pills
US5035237A (en) * 1985-07-30 1991-07-30 Newell Robert E Devices for administering medicaments to patients
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
US6116238A (en) * 1997-12-02 2000-09-12 Dura Pharmaceuticals, Inc. Dry powder inhaler

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6871647B2 (en) 2001-09-19 2005-03-29 Advent Pharmaceuticals Pty Ltd Inhaler
US8550071B2 (en) 2008-09-26 2013-10-08 Oriel Therapeutics, Inc. Inhalers with airway disks having discrete airway channels and related disks and methods
US8887722B2 (en) 2008-09-26 2014-11-18 Oriel Therapeutics, Inc. Inhaler mechanisms with radially biased piercers and related methods
CN102159270A (zh) * 2008-09-26 2011-08-17 奥里尔治疗公司 一种带有具有气道盘沟槽的气道盘的吸入器和相关的气道盘和方法
JP2012503531A (ja) * 2008-09-26 2012-02-09 オリエル・セラピューティクス，インコーポレイテッド 個別気道通路を有する吸入器ならびに関連するディスクおよび方法
US8381721B2 (en) 2008-09-26 2013-02-26 Oriel Therapeutics, Inc. Dry powder inhalers with dual piercing members and related devices and methods
WO2010036839A2 (fr) * 2008-09-26 2010-04-01 Oriel Therapeutics, Inc. Inhaleurs avec disques de voie aérienne munis de canaux de voie aérienne discrets ainsi que disques et procédés associés
US10493222B2 (en) 2008-09-26 2019-12-03 Oriel Therapeutics, Inc. Dry powder dose container assemblies and related inhalers
WO2010036839A3 (fr) * 2008-09-26 2010-06-03 Oriel Therapeutics, Inc. Inhaleurs avec disques de voie aérienne munis de canaux de voie aérienne discrets ainsi que disques et procédés associés
US8985103B2 (en) 2008-09-26 2015-03-24 Oriel Therapeutics, Inc. Dry powder inhalers with dual piercing members
US9795749B2 (en) 2008-09-26 2017-10-24 Oriel Therapeutics, Inc. Dry powder inhalers with dual piercing members and methods of operating same
US9597465B2 (en) 2008-09-26 2017-03-21 Oriel Therapeutics, Inc. Methods of operating and fabricating inhalers with airway disks having discrete airway channels
US9050427B2 (en) 2008-09-30 2015-06-09 Oriel Therapeutics, Inc. Dry powder inhalers with multi-facet surface deagglomeration chambers and related devices and methods
US8646446B2 (en) 2008-10-01 2014-02-11 Oriel Therapeutics, Inc. Dry powder inhalers with rotating piercing mechanisms and related devices and methods
USD745660S1 (en) 2010-03-26 2015-12-15 Oriel Therapeutics, Inc. Dry powder inhaler

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Publication number Publication date
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