WO2008139490A2

WO2008139490A2 - A multi dose dry powder inhaler

Info

Publication number: WO2008139490A2
Application number: PCT/IN2008/000286
Authority: WO
Inventors: Thirumalai Anandampillai Aparna; Thirumalai Anandampillai Anandvishnu; Thirumalai Anandampillai Vijayan
Original assignee: Thirumalai Anandampillai Aparna; Thirumalai Anandampillai Anandvishnu; Thirumalai Anandampillai Vijayan
Priority date: 2007-05-09
Filing date: 2008-05-08
Publication date: 2008-11-20
Also published as: WO2008139490A3

Abstract

A transparent pistol shaped inhaler has the body (1) and front mouthpiece (4) with a dust cap (12). Needed drug strip (3) is slid on channel (13) with a drug hole (18). A handle (5) with a sharp strong piercing rod (6) moves on a fulcrum (14) at the body top. The pierced powder falls into drug chamber (15) with a bottom hole (16) closed by a sliding trap plate (10), connected to a trigger (11) in the body. The body has side air hole (2) with a dust filter (7) leading inside to a cone shaped air chamber(8) with a front jet hole (9), just behind the drug hole (16). A baffle (19) below drug hole (16) breaks the falling powder into a spray. To use. drug strip (3) is pierced by handle(5), inhaler kept in mouth, trigger(11) pressed and inhaled, trap plate(10) opens drug hole(16), drug falls on baffle (19), air jet(9) breaks and forms drug spray for lung deposit.

Description

A MULTI DOSE DRY POWDER INHALER Technical Field 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. Existing 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.

Defects in the existing DPI inhaler devices are as follows:

1. Fast strong velocity inhalation, allowing short time for inhalation!

2. Wider drug spray coating the spray into mouth. 3. The larger, wider mouthpiece produces shallow, fast inhalation and allows little time and effective suction for drug deposition in the lungs.

4. Mouth wastage due to combination of above factors.

5. Dusty, polluted air is inhaled without a filter that may cause disease to users!

6. The formulation has to be 5 micron non aggregating powders with no moisture. 7. Uncomfortable to hold

8. The spray path, spray forming, spray inhalation are often angulated and not ideal for human inhalation.

An extensive search has been carried out using the Internet and related patent specifications were studied for low mouth coating multi dose inhalers. Since the present invention is radically different, the inventor is unable to site any patent specification out of the available databases except

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 6,427,688 of Ligotke is for single dose bead assisted deaggregation of powder spray formation

Us patent 6,142,146 of Abrams is for an electronic vibrator 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.

All existing dry powder inhalers have problems of keeping the powder as a 5 micron powder, preventing aggregation that decreases lung deposit. AU these inhalers are focused on powder, not the inhalation part. Humans have a complex anatomy & physiology of inhalation. We inhale 500cc in adults- this volume must be used to form a spray with effort of inhalation and send to air sacs for blood transfer. Ideal inhalation is by breathing through a small 3-5mm hole which creates high velocity jet that can be used for spray formation as in our device. No inhaler design & working uses the correct inhalation but is focused on the powder spray by complicated angles or vibrators, or electrical discharges. What ever spray produced if not properly inhaled will deposit in mouth only leading to failed low lung deposit, as in all devices.

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.

Further the invention is addressed to the process of using the new inhaler, which is unique in design and construction, working , use and different with a lower mouth coating mechanism which helps to deposit the drug only in the lungs correctly. Further objects of the invention will be clear from the ensuring description.

Summary of the invention:

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.

Statement of Drawings:

These and other objects and features of the invention will become more apparent upon perusal of following description taken in conjunction with accompanying drawings wherein:

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

DESCRIPTION OF PREFERRED EMBODIMENTS

The following specification describes salient features of invention, the method of construction, the method of use and the advantages of the novel invention.

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. As the powder falls, it is converted to a spray led by the longer mouthpiece beyond the tongue to wind pipes for lung deposit he needed drug is packed as a long strip of blister pack. 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 body on its inside has a capsule breaking lid (5). To use, 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. There is an air hole (2) with a dust filter (7) at the back or on the side of the body. The dust filter traps dust for clean air inhalation. Air hole leads to a narrowing cone shaped chamber (8) with a 2-3mm jet forming hole (9). This small hole generates a high velocity air flow that sprays the drug as a thin slow, low velocity uniform narrow spray. A baffle (19) placed below hole (16) to spread the falling powder for blowing away as a jet by the high velocity air jet escaping through the jet hole (9).The mouthpiece (4) is shaped as a long slightly divergent cone, at the front of the body for 2-5 cm. A dust cap (12) fits mouthpiece for clean storage. 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.

To use, the novel inhaler, 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 inhalation.

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.

The term "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. The term "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. For example, 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. beclomethasone, fluticasone propionate, flunisolide, budesonide, tipredane or triamcinolone acetonide; antitussives, e.g. noscapine; bronchodilators, e.g. salbutamol, salmeterol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, albuterol, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tulobuterol, orciprenaline,or(-)-4-amino-3,5- dichloro-.alpha.[[[6-[2-(2-pyridinyl) ethoxy] hexyl] amino] me thyl] benzenemethanol; diuretics, e.g. amilόride; 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 . It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts (e.g. as alkali metal or amine salts or as acid addition salts) or as esters (e.g. lower alkyl esters) or as solvates (e.g. hydrates) to optimise the activity and/or stability of the medicament and/or to minimize the solubility of the medicament in the propellant.

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. Combinations for the other diseases as sildenafil for pulmonary hypertension, insulin for diabetes, luprolide for prostrate cancer etc may be used for treatment. N2008/000286

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.

It will be apparent to those skilled in the art that modifications to the invention described herein can readily be made without departing from the spirit of the invention. Protection is sought for all the subject matter described herein including any such modifications. Advantages of the new invention:

1. Slow and deep inhalation, as air is drawn through a smaller air hole.

2. 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.

4. There is no mouth coating and waste of drug spray.

5. Useful for kids, old, who can now coordinate the spray mechanism easily.

6. The spray is released at the back of the mouth that easily goes into windpipes and lungs for good effect. 7. The filter removes all air polluting dust and germ particles for safe inhalation.

8. Transparent body reveals the dose used or available.

9. The air inlet, air chamber, spray jet are in line for easy soft inhalation.

Claims

We Claim:

(1) An improved dry powder inhaler comprising a transparent pistol shaped body(l) with a drug part and a mouthpiece, the said drug part having a channel (13)for the drug blister strip (3)on the top surface, a handle (5)with a short strong sharp piercing rod (6)to puncture the said drug blister, the said handle moving in a fulcrum(14) at the top of the said body, the said powder of the punctured drug blister falling through a hole(18) into an inside the body drug chamber(15), the said drug chamber has another bottom drop hole (16) with a sliding trap plate(lθ), the said body also having on one side an air hole(2) with a dust filter (7) leading to an inside the said body a narrowing cone air chamber (8) with a front smaller jet hole(9), the said jet hole has a baffle(19) before to break the powder as a spray that is sprayed through the mouth piece(4) into wind passages, such that the said drug spray with the inspired air flows into the lungs,

(2) An improved dry powder inhaler as claimed in claim 1, wherein the body (1) is a transparent plastic, the said body having on the top surface a handle (5) with a short sharp drug blister piercing rod (6), the said handle moving in a fulcrum (14) is pressed to pierce the drug blister strip (3) for effortless piercing and dropping the powder through the drug hole (18) into the said drug chamber (15) inside the said body.

(3) An improved dry powder inhaler as claimed in claim 1 wherein the said body(l) has inside the drug chamber (15)with a top drug hole(18) for the pierced powder, the said drug chamber of needed volume has at the bottom another hole (16)with a sliding trap plate(lθ), the said hole(16) is placed just in front of the said cone air chamber jet hole(9) and above a baffle (19)for immediate breaking and spraying of powder on contact with the air jet.

(4) An improved dry powder inhaler as claimed in claim 1 wherein the body(l) has on its side or back an air inlet(2) with a dust filter (7), the said air hole leading inside to a cone shaped air chamber (8)with a forward air jet hole(9), the air jet hole creating a high velocity flow for spraying the powder.

(5) An improved dry powder inhaler as claimed in claim 1 wherein the inhaler is made of transparent plastic for visual clue and is made as two halves joined air tight.

(6) An improved dry powder inhaler as claimed in claim 1 wherein the mouth piece(4) is a longer slightly diverging cone , the free front mouth end having a detachable dust cap(12) for storage, the said body end having the air jet, and powder hole (16) to deliver the spray.

(7) An improved dry powder inhaler as claimed in claim 1 wherein, the said body(l) has a trigger(l l) connected to the sliding trap plate(lθ), the trap plate having a spring(17) such that, pressing the trigger pulls the said trap plate(lθ) open for the powder to drop through bottom hole( 16) of the said drug chamber or released to block the said bottom hole (16) to stop the powder spray.

(8) An improved dry powder inhaler as claimed in claim 1 wherein, wherein the inhalation drug is the micronized single or combination of active pharmacological agents as described in the specification and packed as a blister strip...

(9) An improved dry powder inhaler as claimed in claim 1 wherein the drug is made as a multi dose film rolled on a knob fixed inside the hand holding part of the body with the knob outside and rotated to feed below the said piercing rod for drop into the drug chamber.

Dated this sixth day of May2008.

T.A. Aparna T.A.Anand Vishnu T.A. Vijayan