WO2008139490A2 - Inhalateur de poudre sèche à multiples doses - Google Patents

Inhalateur de poudre sèche à multiples doses Download PDF

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Publication number
WO2008139490A2
WO2008139490A2 PCT/IN2008/000286 IN2008000286W WO2008139490A2 WO 2008139490 A2 WO2008139490 A2 WO 2008139490A2 IN 2008000286 W IN2008000286 W IN 2008000286W WO 2008139490 A2 WO2008139490 A2 WO 2008139490A2
Authority
WO
WIPO (PCT)
Prior art keywords
drug
hole
air
powder
spray
Prior art date
Application number
PCT/IN2008/000286
Other languages
English (en)
Other versions
WO2008139490A3 (fr
Inventor
Thirumalai Anandampillai Aparna
Thirumalai Anandampillai Anandvishnu
Thirumalai Anandampillai Vijayan
Original Assignee
Thirumalai Anandampillai Aparna
Thirumalai Anandampillai Anandvishnu
Thirumalai Anandampillai Vijayan
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 Thirumalai Anandampillai Aparna, Thirumalai Anandampillai Anandvishnu, Thirumalai Anandampillai Vijayan filed Critical Thirumalai Anandampillai Aparna
Publication of WO2008139490A2 publication Critical patent/WO2008139490A2/fr
Publication of WO2008139490A3 publication Critical patent/WO2008139490A3/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
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0035—Piercing means
    • 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
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0041—Details of the piercing or cutting means with movable piercing or cutting means
    • 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
    • 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
    • A61M15/0051—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 on a tape, e.g. strips
    • 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

  • This invention in general relates to medical equipments, specifically a novel kind of multi dose, deep inhaling, low mouth coating dry powder inhaler State of Art
  • Existing Inhalers used by Asthmatics are metered dose pressure inhalers [called MDI] that send a spray of drug with evaporating propellant and a dry powder inhaler that has no propellant.
  • This device belongs to dry powder inhaler (DPI) type.
  • DPI inhalers are single dose (rotahalers) or a multidose (Turbuhalers, disc inhalers) with drugs as powders inhaled in a plastic body with a short and wide mouthpiece.
  • the drug spray coats the mouth and only 10-15% is sucked into the lungs.
  • the sucking of drug is difficult and wastes the drug, as mouth coating 85% with only 15% drug deposit in lungs.
  • Dry powder inhalers in existing inhalers are also inefficient as drug particles stick together as large poorly absorbed masses with oral deposit that needs water to swallow with 10%deposit in lungs.
  • the following description gives critical examination of the inhalers known in the art with its shortcomings. Further in order to overcome the problem associated with prior art inhalers, the invention offers the solution to overcome the impediments in the construction and the process of using the inhaler.
  • the formulation has to be 5 micron non aggregating powders with no moisture. 7. Uncomfortable to hold
  • US patent 2002170560 of YOUNG MATTHEW is a blister disc with a complicated dispersion mechanism and a short mouth piece
  • US patent 2004069303of BROWN DAVID is a multi dose powder chamber with a rotating disc feed. The angled air flow jet is after the feed, a poor spray forming mechanism in a short mouth piece. The jet is not at powder feed area but down stream.
  • US patent 2004163644 of GIESCHEN ANDREW W has a chamber with beads for deagglomeration of powder WO02053215 of GENOVA PERRY is for a single dose inhaler with a complicated seal plate that vibrates for spray formation.
  • Us patent 6,116,238 of Jackson is a slider mechanism to unseal the blister pack
  • US patent 6,029,663 of Eisele has a carrier disk with a blister shell sealed by a shear layer. A tab is adhered to the shear layer, underneath the blister shell. An actuator pushes against the tab, causing the shear layer to tear away, releasing the powder drug contents from the blister into the dry powder inhaler.
  • US patent 5,921,237 of Eisele is an inhaler with a blister disc with an actuator.
  • a switch senses pressure in the mouthpiece and switches on a motor spinning an impeller within the aerosolizing chamber .
  • the impellor also is coated with the powder in use decreasing dose.
  • Us patent 5,921,237 of Vaghefi uses pressurised gas to burst the powder pack. An electrostatic charge for spray formation in a nonstick lining chamber is costly too.
  • Patent MXPA05005402 of RAO ASHWIN BHUJANGA is a 30 multi dose blister disk with a short mouth piece & poor spray formation
  • US patent 5,577,497 of Mecikalski has a motor spinning the impeller at high speed & sprays powder ( released by a plunger into the chamber so that all powder particles are aerosolized to form a fine, low-density, low velocity, dry mist.
  • US patent 5,694,920 of Ab rams has a piezoelectric vibrator 54 for vibrating a diaphragm to a powder, and a controller 70 for controlling vibration so as to suspend a portion of powder in a fluidized state.
  • An electrostatic charge plate 32 draws powder of selected particle size into the inhalation stream.
  • Ideal inhaler must release a drug spray with low coating in the mouth. Spray must be of low velocity with longer duration of spray for easy inhalation into lungs.
  • the inhaler comprises of an easy holding pistol shape transparent plastic body with a front narrow longer mouth piece.
  • the needed powder is packed as multi dose blister strip and held in strip channel of the body.
  • a sharp pointed piercing rod of a handle pierces the strip to deposit the dry powder in a drug chamber in the body.
  • This chamber has a small hole to drop the powder in a spray zone.
  • the outside air is pulled through a hole with dust filter in the body for clean air inhalation.
  • the air is channeled as a cone for spray of powder.
  • the spray zone has baffle for the dropping powder and is blown as a mist.
  • the longer mouth piece leads straight to back of throat for lung deposit.
  • Figure 1 shows the novel inhaler.
  • Figure 2 shows the view of the novel inhaler: A closed B open. drug hole 16
  • Figure 3 shows the mechanism and spread of the drug mist deep in throat.
  • Figure 4 shows the conventional inhaler, (a) single dose, (b) multi dose
  • the novel inhaler has a pistol shaped plastic body for easy holding with a drug part and a mouthpiece ⁇
  • the body has an air hole with a dust filter.
  • a narrowing cone shaped air chamber with a small hole generates high velocity air.
  • Two or three baffles are placed across this hole and receive the micronized powder.
  • the strip is fitted to a strip channel in the body.
  • the body has a sharp piercing handle to release the powder in to the drug chamber.
  • the mouthpiece is a longer divergent cone that releases the drug spray at the back of mouth without mouth coating.
  • the small jet hole helps to develop deep, long slow inhalation that deposits the drug into the lungs without mouth coating.
  • the mouthpiece directs the spray into wind passages and lungs for good effect.
  • the novel inhaler according to the invention is loaded with drug strip, punctured and kept in mouth, air is sucked in through the mouthpiece, and Drug is now released as a soft spray at the back of mouthpiece, which travels to lungs for better effect.
  • the novel inhaler according to invention is better because of deeper inhalation.
  • the long mouth piece releases drug spray into wind passages without mouth coating unlike the short mouth pieces of existing inhalers, which spray the mouth and need larger suction effort as the drug is sucked from a wider mouth piece(difficult for kids and aged) and do not facilitate deep inspiration.
  • the conventional single dose existing powder inhaler fig.4 (a) consists of a transparent body (1) with an air inlet (2) at the top in which the drug capsule (3) is placed.
  • the body has at the other end has a wide short [1.5 cms], tapering mouthpiece (4).
  • the drug capsule is fitted and twisted to break the capsule.
  • the mouth piece (4) is kept in mouth. Air is inhaled. Inhalation is shallow and fast as the mouthpiece area is large with large mouth coating.
  • the device has not been improved for decades.
  • In fig 4 b is a multi dose inhaler. With a box having the disc (6) with many doses. The disc is pierced by a handle (7) to fall on an area near the short mouth piece (4) for a poor fast inhalation. None has the air dust filter
  • the new inhaler has a plastic transparent body made of two joined parts.
  • the drug in multi dose strip is pierced and falls into a drug chamber. Outside air passing through a dust filter is channeled to a cone with a narrow opening for high velocity spray of powder.
  • the mouth piece is a longer slight diverging to release spray at throat.
  • the clean air entry, air path, spray path are in a line for lowest suction effort and optimal spray formation.
  • the new inhaler fig 1-3 comprises of a pistol shaped body (1) preferably of plastic or metal. It has a drug strip (3) with needed drugs in a channel (13). The drug strip is pierced by short sturdy sharp rod (6) that is fitted in a pressing handle (5) working on a fulcrum (14) for easy pressing. The drug falls, through a hole (18)) to a drug chamber (15)of adequate powder volume and with a bottom hole for drug (16).
  • the Body is made as two halves screwed together.
  • This small hole generates a high velocity air flow that sprays the drug as a thin slow, low velocity uniform narrow spray.
  • the mouthpiece (4) is shaped as a long slightly divergent cone, at the front of the body for 2-5 cm.
  • a sliding trap plate (10) is pulled by trigger (11) in the hand part of body releases the powder in inhalation at the jet area.
  • a spring (17) keeps the trap plate closed, the trigger 11 presses the spring to pull the trap plate for free fall of powder from drug chamber (15) to meet the air jet at hole (9) for effective spray.
  • the device gives longer inhalation, does not spray into mouth, directs flow of mist maximally to air passages delivering correct doses, and is safe for children, aged, even- in disorientation fig 3.
  • the drug blister pack is mounted in the body drug channel .
  • the blister is pierced by the rod by pressing the handle.
  • the powder falls into the drug chamber through hole (18). Mouthpiece is kept between the lips.
  • the air hole (2) with the dust filter allows clean air to be sucked in inhalation!
  • the trigger 11 is pressed, compressing spring (17) which moves the trap plate (10), allowing the fall of drug through hole (16) of drug chamber.
  • Drug powder is sprayed as it falls on the baffle (19) by air passing through the jet hole (9).
  • the mouthpiece is longer and projects into the mouth longer as in Figure 3 producing a mist directed to the windpipe and not into mouth.
  • the drug is carried to distal air passages uniformly, because of deep and slow inhalation.
  • the increased duration and depth of inhalation due to smaller jet hole also helps in spread of mist.
  • the drug is delivered better maximally, without mouth coating. Releasing the trigger slides the trap and stops the spray. The remaining powder can be inhaled in next in
  • the inhaler is made of plastic with the orifices, mouth piece, air & drug chambers > incorporated as a unit or as separate segments easily assembled.
  • the device can be modified.
  • the mouthpiece tube is made as two pieces adjusted on a screw or sliding mechanism for varying the length. Electronic sensing spraying and counting are possible, but will make the device costly and heavy. A tiny rotating wheel instead of baffle can spray the powder.
  • the body may be a transparent plastic with the long piercing handle (5) for easy pressing of the drug blister. Various shapes for body [e.g. oval] and divergent mouthpiece [hexagonal] may be used. Any other design for holding and easy pressing can be used.
  • Air hole (2) may be on the side or back of the body. Dose available or used is indicated by printing the blister pack and transparent body.
  • the drug strip may be folded on a ring and rotated by a knob for feeding the drug channel.
  • the drug strip may be made as a cassette and fitted to channel (13) or fed as short strip.
  • drug formulation means active drug (or a physiologically acceptable salt thereof) optionally in combination with one or more other pharmacologically active agents such as anti-inflammatory agents, analgesic agents or other respiratory drugs and optionally containing one or more excipients.
  • excipients as used herein means chemical agents having little or no pharmacological activity (for the quantities used) but which enhance the drug formulation or the performance of the system.
  • excipients include but are not limited to surfactants, preservatives, flavorings, antioxidants, and antiaggregating agents.
  • Drug formulation for use in the invention may, if desired, contain one or more other pharmacologically active agents, selected from any suitable drug useful in inhalation therapy.
  • Medicaments may be selected from, for example, sildenafil for pulmonary hypertension, analgesics, e.g. codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g. diltiazem; antiallergics, e.g. cromoglycate, ketotifen or nedocromil; antiinfectives e.g. cephalosporins, pentamidine; antihistamines, e.g. methapyrilene; anti-inflammatories, e.g.
  • analgesics e.g. codeine, dihydromorphine, ergotamine, fentanyl or morphine
  • anginal preparations e.g. diltiazem
  • antiallergics e.g. cromoglycate, ketotifen or nedocromil
  • antiinfectives e.g. cephalo
  • amil ⁇ ride anticholinergics e.g. ipratropium, atropine or oxitropium; hormones, e.g. cortisone, hydrocortisone or prednisolone; xanthines e.g. aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; and therapeutic proteins and peptides, e.g. insulin or glucagon and genetic fragments or anti cancer drugs or any such lung absorbable drugs .
  • the medicaments may be used in the form of salts (e.g.
  • esters e.g. lower alkyl esters
  • solvates e.g. hydrates
  • Drug formulations for Asthma may contain fluticasone propionate in combination with a bronchodilator such as salbutamol (e.g. as the free base or the sulphate salt) or salmeterol (e.g. as the xinafoate salt) as a 5 micron powder.
  • a bronchodilator such as salbutamol (e.g. as the free base or the sulphate salt) or salmeterol (e.g. as the xinafoate salt) as a 5 micron powder.
  • a bronchodilator such as salbutamol (e.g. as the free base or the sulphate salt) or salmeterol (e.g. as the xinafoate salt) as a 5 micron powder.
  • the other diseases as sildenafil for pulmonary hypertension, insulin for diabetes, luprolide for prostrate cancer etc may be used for treatment.
  • the particle size of the particular (e.g., micronised) drug should be less than 20 microns, and, in particular, in the range of 1-10 microns, e.g., 1-5 microns.
  • the device gives more time to inhale the spray as the inhalation is slow and long. 3. There is an alerting sound to help time the trigger in early inhalation.
  • the spray is released at the back of the mouth that easily goes into windpipes and lungs for good effect.
  • the filter removes all air polluting dust and germ particles for safe inhalation.
  • the air inlet, air chamber, spray jet are in line for easy soft inhalation.

Abstract

Un inhalateur en forme de pistolet transparent a un corps (1) et une embouchure avant (4) avec un capuchon anti-poussière (12). Une bande de médicament nécessaire (3) est glissée sur un canal (13) avec un trou de médicament (18). Un manche (5) avec une tige (6) de perforation forte pointue se déplace sur un point d'appui (14) au niveau du dessus du corps. La poudre perforée tombe à l'intérieur d'une chambre de médicament (15) avec un trou inférieur (16) fermé par une plaque de piégeage coulissante (10), reliée à un déclencheur (11) dans le corps. Le corps a un trou d'air latéral (2) avec un filtre anti-poussière (7) conduisant à l'intérieur à une chambre à air en forme de cône (8) avec un trou de jet avant (9), juste derrière le trou de médicament (16). Une cloison (19) au-dessous du trou de médicament (16) disperse la poudre tombante en une pulvérisation. Utilisation. La bande de médicament (3) est perforée par le manche (5), l'inhalateur maintenu en bouche, le déclencheur (11) pressé et inhalé, la plaque de piégeage (10) ouvre le trou de médicament (16), le médicament tombe sur la cloison (19), le jet d'air (9) disperse et forme une pulvérisation de médicament pour un dépôt sur les poumons.
PCT/IN2008/000286 2007-05-09 2008-05-08 Inhalateur de poudre sèche à multiples doses WO2008139490A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN986CH2007 2007-05-09
IN986/CHE/2007 2007-05-09

Publications (2)

Publication Number Publication Date
WO2008139490A2 true WO2008139490A2 (fr) 2008-11-20
WO2008139490A3 WO2008139490A3 (fr) 2009-04-30

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PCT/IN2008/000286 WO2008139490A2 (fr) 2007-05-09 2008-05-08 Inhalateur de poudre sèche à multiples doses

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Country Link
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011080761A1 (fr) 2009-12-30 2011-07-07 Thirumalai Anadampillai Aparna Inhalateur de poudre sèche amélioré
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
CN105664347A (zh) * 2016-03-10 2016-06-15 刘洪飞 一种麻醉喷药辅助器
CN107405462A (zh) * 2015-03-27 2017-11-28 菲利普莫里斯生产公司 包括破裂部分的气溶胶生成系统

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0129985A1 (fr) * 1983-05-24 1985-01-02 Glaxo Group Limited Inhalateur
EP0633792B1 (fr) * 1992-03-19 2000-01-26 BOEHRINGER INGELHEIM INTERNATIONAL GmbH Separateur pour inhalateur a poudre
WO2001026720A1 (fr) * 1999-10-12 2001-04-19 Shl Medical Ab Inhalateur

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0129985A1 (fr) * 1983-05-24 1985-01-02 Glaxo Group Limited Inhalateur
EP0633792B1 (fr) * 1992-03-19 2000-01-26 BOEHRINGER INGELHEIM INTERNATIONAL GmbH Separateur pour inhalateur a poudre
WO2001026720A1 (fr) * 1999-10-12 2001-04-19 Shl Medical Ab Inhalateur

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
WO2011080761A1 (fr) 2009-12-30 2011-07-07 Thirumalai Anadampillai Aparna Inhalateur de poudre sèche amélioré
GB2489383A (en) * 2009-12-30 2012-09-26 Vijayan Thirumalai Anandampillai An improved dry powder inhaler
US20130025593A1 (en) * 2009-12-30 2013-01-31 Aparna Thirumalai Anandampillai Dry powder inhaler
CN107405462A (zh) * 2015-03-27 2017-11-28 菲利普莫里斯生产公司 包括破裂部分的气溶胶生成系统
US10850051B2 (en) 2015-03-27 2020-12-01 Philip Morris Products S.A. Aerosol-generating system comprising a rupturing portion
US11805809B2 (en) 2015-03-27 2023-11-07 Philip Morris Products S.A. Aerosol-generating system comprising a rupturing portion
CN105664347A (zh) * 2016-03-10 2016-06-15 刘洪飞 一种麻醉喷药辅助器

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