Unit dose capsules and dry powder inhaler.

(54) Title: UNIT DOSE CAPSULES AND DRY POWDER INHALER.

(54) Title: UNIT DOSE CAPSULES AND DRY POWDER INHALER.

(57) Summary

The dry powder inhaler (10) comprises an inlet section (20); a mixing section (30), and a nozzle (40). The nozzle is connected by means of a rotary joint to the mixing section, and can rotate back towards the inlet section and be closed by a lid or cover (290). The inlet chamber comprises a piston with a tapered piston rod and spring, and one or more bleed holes to modulate air flow through the device. Optionally, it comprises a feedback module to generate a tone that indicates when the appropriate flow rate has been reached. The mixing section contains a capsule (300) with holes containing a drug in dry powder form and further opens and closes the capsule when the inlet section is at an angle to the nozzle. The mixing section is a Venturi chamber for imparting a cyclonic flow to the air passing through the mixing chamber.

(57) Abstract

The dry powder inhaler (10) comprises an intake section (20); a mixing section (30), and a mouthpiece (40). The mouthpiece is connected by a swivel joint to the mixing section, and may swivel back into the intake section and be enclosed by a cover (290). The intake chamber comprises a piston with a tapered piston rod and spring, and one or more bleed through orífices to modulate the flow of air through the device. It optionally comprises a feedback module to generate a tone indicating when the proper rafe of airflow has been achieved. The mixing section holds a capsule (300) with holes containing a dry powder medication, and further opens and closes the capsule when the intake section is at a certain angle to the mouthpiece. The mixing section is a Venturi chamber to impart a cyclonic flow to air passing through the mixing chamber.

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Institute

Mexican

IVICAUClf IU my | Property Q

Industrial □

PATENT TITLE NO. 347170

Headlines):

MANNKIND CORPORATION

Home

28903 North Avenue Paine, Valencia, California, 91355, USA

D nomination

UNIT DOSE CAPSULES AND DRY POWDER INHALER.

Classification:

lnt.CI.8: A61M15 / 00

Inventor (s):

SOLOMON S. STEINER; TRENT POOLE; ROBERT FELDSTEIN; PER B. FOG

REQUEST

Number:

International filing date:

PA / a / 2002/000812 July 2000

PRIORITY

Country:

Date:

Number:

US

US July 1999 May 2000

60/145,464

60/206,123

Validity: Twenty years

Expiration Date: July 21, 2020

The reference patent is granted based on articles 1, 2, fraction V, 6 useful fraction, and 58 of the Industrial Property Law.

In accordance with article 23 of the Industrial Property Law, this patent is valid for twenty years, non-extendable, counted from the filing date of the international application and will be subject to the payment of the fee to keep the rights in force. .

Whoever signs this title does so based on the provisions of articles 6 sections III and 7 bis 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 08/02 / 1994, 10/25/1996, 12/26/1997, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01/2010 , 06/18/2010, 06/28/2010, 01/27/2012 and 04/09/2012); Articles 1, 3^or section V subsection a), 4th and 12th sections I and III of the Regulation of the Mexican Institute of Industrial Property (DOF 12/14/1998, amended on 07/01/2002, 07/15/2004, 07/28/19 2004 and 9/7/2007); Articles 1, 3, 4, 5 * section V Subsection e), 16 sections I and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007) 1st, 3rd and 5th subsection a) of the Agreement that delegates powers to the Deputy General Directors. Coordinator, Divisional Directors, Heads of Regional Offices, DMsionalee Deputy Directors, Departmental Coordinators and other subsNems of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

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Issue Date: April 18, 2017

THE DIVISIONAL DIRECTOR OF PATENTS

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NAHANNY CANAL REYES

Arenal No 5; Col PiAájto Santa

-T a;

MX / 2017/32268

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INSTITUTO M1JUCANO

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INDUSTRIAL

UNIT DOSE CAPSULES AND DRY POWDER INHALER

FIELD OF THE INVENTION

The present invention is in the field of inhalers.

BACKGROUND OF THE INVENTION

In the early 1970s it was found that certain medicines could be administered in dry powder form directly to the lungs by inhalation through the mouth or inspiration through the nose. This process allows the medicine to bypass the digestive system, and may, in certain cases, use smaller doses to achieve the same results as medicines taken orally or injected. In some cases, it provides a delivery technique that reduces drug side effects produced by other drugs.

Inhaler devices typically deliver your medicine in a liquid mist or a powder mist. Liquid mist is typically created by a chlorofluorocarbon propellant. However, with the ban on dichlorofluorocarbons by the Montreal protocol, interest in dry powder inhalers has returned.

<img file="MX347170B_D0005.tif" />

IMPI

INSTITUTO MEXICANO DE LA non HMD INDUSTMAL

For a dry powder inhaler to work effectively, it must distribute fine particles of medicinal powder that do not agglomerate, and that do not end up hitting the back of the user's throat, and that are absorbed through the patient's mouth or oropharyngeal region higher. The flow air must therefore not be too fast. Furthermore, it should not be difficult for a patient to load it with medicine or to use it with proper technique. Today's dry particulate inhalers fall into one or more of those important criteria.

SUMMARY OF THE INVENTION

A dry powder inhaler is disclosed comprising an inlet section; a mixing section and a nozzle. The nozzle is connected by a swivel joint to the mixing section, and can be swiveled back over the inlet section and closed by a lid or cover. The inlet chamber comprises a special piston with a tapered piston rod and spring, and one or more bleeder through holes to modulate air flow through the device. The inlet chamber optionally further comprises a feedback module to generate a tone that indicates to the user when the flow rate of the flow has been reached.

<img file="MX347170B_D0006.tif" />

IMPI

INSTITUTO MEXICANO DCLANtOPIIDAD INDUSTklAL appropriate air. The mixing section contains a capsule with holes containing a drug in dry powder form, and the lid can only be opened when the nozzle is at an angle to the inlet section. The mixing section further closes and opens the capsule when the inlet section is at a certain angle to the nozzle. The mixing section is a Venturi chamber configured by projections or spirals to impart a cyclonic flow to the air passing through the mixing chamber. The mouthpiece includes a tongue blade, and a projection to come into contact with the user's lips to tell the user that the DPI is in the correct position. An optional storage section, with a lid or cover, contains additional capsules. The cap or cover of the mouthpiece, and the cover or cover of the storage section can both be transparent magnifying lenses.

Capsules can be two-part capsules where the portion layer has openings which correspond to openings in the other half when each half is partially attached to the other half, and fully attached to the other half. In all openings they can be closed when the two halves are made to rotate around their longitudinal axes one with

<img file="MX347170B_D0007.tif" />

IMPI

INTTTTUTO MEXICANO DI LA ΡΒΟΗΚΜΡ with respect to the other. Each capsule can have a unique key on each half so that it will only fit a particular inhaler.

Therefore an object of the invention is to provide a dry particle inhaler that can be folded into a compact shape.

Therefore an object of the present invention is to provide a dry particle inhaler that can be loaded with medication easily.

Therefore an object of the present invention is to provide a dry particle inhaler, where a small writing on a medicine capsule can be easily read.

Therefore an object of the invention is to provide a dry particle inhaler, where only a capsule containing medicament can be inserted when a person unfolds the inhaler for use.

Therefore an object of the invention is to provide a dry particle inhaler where the air flow through the device is regulated.

Therefore an object of the invention is to provide a dry particle inhaler to provide means to indicate to the user when the air flow is at the correct speed.

<img file="MX347170B_D0008.tif" />

IMPI

MEXICAN INSTITUTE

DC THE IMMISTUAL PNOHIOAD

Therefore an object of the invention is to provide a dry particle inhaler where the drug particles are finely dispersed.

Those and other objects of the invention will be readily apparent upon reading the present specification, claims and drawings.

BRIEF DESCRIPTION OF THE DIFFERENT VIEWS OF THE DRAWINGS

The Figure is a schematic view of the dry particle inhaler described herein.

Figure 2 is a schematic view of the nozzle cap or cover.

Figure 3 is a schematic showing the angle between the inlet section and the nozzle.

Figure 4 is a schematic view of the dry particle inhaler, showing the storage section.

Figure 5 is a schematic view of the inlet section of the dry particle inhaler, showing the flow regulator and the feedback module.

Figure 6 is a schematic view of the mixing section.

Figure 7 is a schematic view of a capsule for containing medicine.

<img file="MX347170B_D0009.tif" />

IMPI

MUUCANO INSTITUTE

OF THE NOLITY

INDUSTRIAL

Figure 8 is a schematic view of the nozzle.

Figure 9 is a perspective view of a specific embodiment of the dry particle inhaler in the closed position, with a capsule inserted in the mixing section, and dry capsules stored in the storage section.

Figure 10 is a perspective view of a specific embodiment of the dry particle inhaler showing a capsule being loaded into the mixing section.

Figure 11 is a perspective view of a specific embodiment of the dry particle inhaler showing a capsule inserted into the mixing section, and the mouthpiece extended for use.

Figures 12, 13, 14 and 15 follow each other in time sequence.

Figure 12 is a perspective view of a specific embodiment of the dry particle inhaler showing a closed mouthpiece cap.

Figure 13 is a perspective view of a specific embodiment of the dry particle inhaler showing an open mouthpiece cap or cover.

Figure 14 is a perspective view of a specific embodiment of the dry particle inhaler

<img file="MX347170B_D0010.tif" />

IMPI

INSTITUTO MUUCANO Df LA rworiOAD INDUSTUA1 showing an open spout cap, an open mixing section cap, and a capsule being inserted into the mixing section.

Figure 15 is a perspective view of a specific embodiment of the dry particle inhaler showing the mouthpiece extended for use.

Figure 16 is a view of the pneumatic circuit, where the air flows (fluid flows) are represented by their electrical equivalents.

Figure 17 is a schematic view of the dry particle inhaler.

Figure 18 is a sectional view of a capsule and a portion of the mixing section.

Figure 19 is a sectional view of the half of a capsule, showing a cone in the secondary and inner hole with a chamfered or chamfered edge.

TABLE OF REFERENCE NUMBERS dry powder inhaler device inlet section mixing section mouthpiece air passage through dry powder inhaler device

<img file="MX347170B_D0011.tif" />

IMPI

ΙΝΠΤΠΠΌ MEXICAN ix la raoninAD INDUST1UAL longitudinal axis of the inlet section longitudinal axis of the nozzle section rotating tip connecting the nozzle and the mixing section cap or nozzle cover

100 projections on the nozzle cap

110 depressions on the dry particulate inhaler cap to engage the projections on the mouthpiece cap

120 tongue depressor on the mouthpiece

130 projection on the surface of the mouthpiece to come into contact with the lips of the user of the device

135 mouthpiece opening to be placed in the user's mouth

140 inlet or feed hole

150 Flow regulator

160 bleed hole

170 piston

180 piston head

190 piston connecting rod

200 proximal portion of piston rod

210 distal portion of piston rod

220 spring

IMPI tm I l'I UIO MEXICANO M LAMONUMD INDUSTIUAl

230 inner walls of the inlet or feed section of the inner chamber

240 feedback module

250 mechanical fasteners in storage section

260 holder in mixing section for capsule

270 venturi chamber

280 spiral shape or projections to impart cyclonic flow to the air

290 lid or cover for mixing chamber

291 interior of mixing section

292 air flow inlet to mixing section

294 air flow outlet of mixing section

296 retention mechanism for mixing section lid

298 inner wall of mixing section

300 capsule

310 first tube

320 open end of first tube

330 closed end of first tube

340 longitudinal axis of the first tube

350 projection onto the first tube

<img file="MX347170B_D0012.tif" />

IMPI

INSTITUTO MUCAMO MiAmommo ΙΜΜΗΤΜΛ1.

360 clamping surface on the first tube

370 secondary holes in the first tube

372 chamfered or chamfered edge of secondary hole

375 cone inside the first tube

380 second tube

390 open end of second tube

400 closed end of second tube

410 longitudinal axis of the second tube

420 projection onto the second tube

430 clamping surface on the second tube

440 secondary holes in the second tube

445 cone inside the second tube

450 user hand

460 air flow direction

470 storage section

480 storage section lid

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 is a schematic drawing of the dry powder inhaler (10) described herein. This comprises a feed inlet section (20), a mixing section (30) and a nozzle (40). An air passage (50) travels through the section of

<img file="MX347170B_D0013.tif" />

IMPI

IHSTTTUTO MEXICANO

DBLAMONITY

INDUSTRIAL inlet (20), a mixing section (30) of a nozzle (40). A rotating tip (80) that connects the nozzle (40) to the mixing section (30). The mixing section (20) has a lid or cover (290) which may be a transparent magnifying lens. Arrow (460) shows the direction of air flow through air passage (50) through dry powder inhaler (10).

Figure 2 shows the mouthpiece cap (90) in the closed position on the dry particle inhaler (10). The projections (100) on the mouthpiece cover (90) engage with the grooves or depressions (110) on the dry particle inhaler (10), to join the mouthpiece cover (90) to the dry particle inhaler ( 10).

Figure 3 is a diagram showing the nozzle (40) and the inlet section (20) as represented by the longitudinal axis of the nozzle (70) and the longitudinal axis of the feed inlet section (60 ). The swivel joint (80) that connects the nozzle (40) to the inlet section (20) and the mixing section (30) can be considered as the apex of the angle. The importance of the angle (here called theta) between these two longitudinal axes will be explained later.

<img file="MX347170B_D0014.tif" />

IMPI

MEXICAN INSTITUTE

DEUPWnUM * IMMISTNAL

Figure 4 shows the dry particle inhaler (10) with a storage section (470). Indicated as shown within the storage section (470) are mechanical fasteners (250) which operate to hold medication capsules (300) (not shown in this figure) in the storage section. In this embodiment, the storage section (470) is shown attached to the inlet section to the feed section (20). The storage section has a cap (480) which may be a transparent magnifying lens to allow the user to easily read the writing on the medication capsules stored therein. The storage section lid 480 can be pivoted outwardly, or slid open on a slide (not shown), or opened by a variety of mechanisms known to those skilled in the art.

Figure 5 shows the inlet section (20) of the dry particle inhaler (10). The direction of the air flow is shown by arrow (460). Air is admitted through an inlet port (140) and one or more curved ports (160) [Bleed ports can also be designed as secondary ambient air inlet or intake ports]. The piston (170) normally covers the inlet port (140). When the

<img file="MX347170B_D0015.tif" />

IMPI

INJTTTUTO MJUUCANO MunomDA »UNBUSTUAL user (not shown) inhales, the piston head (180) is pulled back, at a constant speed modulated by the spring (220). The spring (220) is fixed to the piston (170) in the inner wall (230) of the chamber of the inlet or feed section. In this way the speed of the air flow is controlled. The air flow is further controlled by the taper of the piston rod (190), along which the air flows. For additional air flow control, a second spring (not shown) can also control the speed of movement of the piston (170).

The piston (170) and spring (220) in combination allow the user (not shown) to generate a vacuum in their lungs before the inlet port (140) opens. In this way, when enough vacuum is generated to open the inlet port (40), there will be enough air flow at a sufficient speed in the dry particle inhaler (10) to extract the majority of the medicine in the capsule (not shown) out of the inhaler to the appropriate location in the user's lungs.

A feedback module (240) generates a signal to the user (not shown), which tells the user if they are breathing in the correct rate. The signal may be an audible, in a one tone mode

<img file="MX347170B_D0016.tif" />

IMPI

INSTITUTO MEXICANO di la morapAD INDUSHUAL which is a constant tone when a certain constant speed.

the air flow is at

In one embodiment of dry particle bonding (10), the signal is generated mechanically, such as a musical reed. In another embodiment of the invention, the signal can be generated electronically, after electronic measurement of the speed of the air flow. The feedback module (240) would include means to increase or decrease the strength of the signal or completely interrupt the signal. If the signal were generated by a reed, the signal interruption mechanism can be by covering a curve hole which can admit the airflow that generates the signal. If the signal is generated electronically, a simple button or a graduated dial can activate or deactivate the signal.

Figure 6 shows a diagram of the mixing section (30) of the present invention. The mixing section has a cap (290) with a holder (260) for a capsule of medication (not shown). The holder (260) is a mechanism which holds and rotates the capsule (not shown) to open and close the capsule when the longitudinal axis (70) of the nozzle rotates around the rotary joint (80) in relation to the longitudinal axis ( 60) from the inlet section. Such a mechanism can be straight:

<img file="MX347170B_D0017.tif" />

IMPI

INSTITUTO MEXICANO os ΙΛ nortiMD INDUSTRIAL in a simpler modality, both the upper and lower halves (not shown) of the capsule could be attached to their respective fasteners (260).

The Venturi chamber (270) accelerates the flow of air near the capsule (not shown). Air flows in (292), and out through (294). In one embodiment, air flows both through and around a capsule (not shown) containing a medicament in dry powder form. The special shape of the Venturi chamber (270), further containing projections or spiral shapes (280) imparts a cyclonic flow to the air that passes through the mixing section (30). This helps to break down the dry powder particles. The spiral shape within the mixing section (291) can be two separate spirals, in one embodiment of the invention. A mixing section (30) therefore provides the means by which the air flow is accelerated to suspend the dry particles in the air and deagglomerate them, and then to decrease the air flow somewhat while the particles are still suspended in the air. the air. The lid 290 of the mixing section 30 can be a transparent magnifying lens, so that any writing on the capsule (not shown) can be easily read.

<img file="MX347170B_D0018.tif" />

IMPI

INSTITUTO MUUCANO de LA rwonuMD INDUSTRIA!

In one embodiment of the dry particle regulator (10), the lid (290) of the mixing section may not be opened unless the longitudinal axis (70) of the nozzle is at an angle with the longitudinal axis (60) of the inlet section, with the apex of the angle and forms the rotating joint (80) that connects the nozzle (40) and the mixing section (30). The retention mechanism 296 for the mixing section cover 290 can accomplish this, by any of the mechanical means known to those skilled in the art. In the simplest embodiment, a lid (not shown), a lid (290) of the mixing chamber could be engaged by a sliding spring (not shown) on the mixing section which has only a certain number of degrees of a circle. When the nozzle (40) is rotated sufficiently relative to the inlet section (20), the slide spring (not shown) would no longer engage the trap (not shown). In one embodiment, the user could open the lid 290 when the angle is between about ninety to one hundred and eighty degrees.

Figure 7 shows the medication capsule (300) for use with an inhaler, this being a dry powder inhaler (10), or a liquid mist inhaler. The capsule (300) has two halves which are

<img file="MX347170B_D0019.tif" />

IMPI / PUAFROFflDAC tMBUSTNAl place gaskets, here illustrated as a first tube (310) and a second tube (380). Each tube has an open end (320, 390), and a closed end (330, 400). Each tube has an open end (320,390), and a closed end (330, 400). Each tube has a longitudinal axis (340, 410). In addition, each tube has a number of secondary holes (370, 440). The first tube (310) is placed within the second tube (380) tightly. A projection (350) on the outer surface of the first tube (310) can slide along a corresponding path (420) on the inner surface of the second tube (380). This immobilizes the first tube (310) to the second tube (380). This locks the first tube (310) to the second tube (380). Therefore the first tube (310) and the second tube (380) both have a locked and an unlocked position. The unlocked position, at least one secondary hole (370) in the first tube aligns with at least one secondary hole (440) in the second tube. This allows the introduction of a drug (not shown) into the capsule through the aligned secondary ports (370, 440). The first tube (310) can then be locked to the second tube (380). When a user (not shown is ready to use a capsule (300), he simply places the capsule in the holder (260) in the mixing section (30) and closes

IMPI ικηττυτο Mexican

DELA industrial PROPERTY

<img file="MX347170B_D0020.tif" />

the cover (290). When the fastener (260) rotates the first tube (310) about its longitudinal axis (340) relative to the second tube (380) and its longitudinal axis (410) (the axes now coincide), it causes at least two holes secondary holes (370) in the first tube align with at least two secondary holes (440) in the second tube. Air can now pass in, through, and out of the capsule (300), releasing the drug contained therein. In one embodiment of the leveler, the capsule (300) can be covered with the angle of the longitudinal axis (70) of the nozzle section, the apex of the swivel joint (80), and the longitudinal axis (70) of the nozzle section. the nozzle are between 170 and 180 degrees. This rotation of the nozzle (40) relative to the inlet section (20) would produce a corresponding rotation of the first tube (310) about its longitudinal axis (340) relative to the second tube (380) and its longitudinal axis (410 ).

In one embodiment of the invention, various projections on the surfaces of the first tube or the second tube can provide a variety of etching or locking positions. Similarly, a variety of secondary holes in the first and second tubes can provide a variety of rotational positions with or without aligning holes.

<img file="MX347170B_D0021.tif" />

IMPI

MUUCANO INSTITUTE

Say THE FROHITY

INDUSTRIAL side alignment on the first and second tubes.

The capsules described here allow the introduction of liquid or gel medicine which can be dried in the capsule, creating powder. This allows the exact production of very small amounts of powdered medicine in a capsule, since they can be formed from a large volume of exactly metered or dosed liquid or gel medicine. This allows for very accurate microdosing. Additionally, chemical reactions or drug mixtures can be done directly in the capsules described herein, then resulting in a dry formulation.

In one embodiment of the capsule (300), one or more of the secondary ports (370, 440) used to admit air to the capsule is oval (elliptical) in shape. In one embodiment of the invention, the ratio of the longitudinal axis of the ellipse to the shortest axis can be between 1: 1 and 3: 1, and can be 2: 1. This relationship can be called vertical aspect. In one embodiment of the invention, the intersection in the surface that defines one or more of the secondary holes (370, 440) and the surface that defines the interior of the capsule (300) meet at a chamfered or beveled edge. This edge

<img file="MX347170B_D0022.tif" />

IMPI

ΙΝΤΤΤΠ1ΤΟ MEXICANO M LA nOKBAD INDUmiAl the air flows through

440) .

chamfered creates a vortex when of the secondary holes (370,

Each capsule (300) also has a fitting surface (or clamping mechanism) on the closed end (330) of the first tube and a closed end (400) of the second tube comprising the capsule. The clamping surface (360) on the first tube may be different from the clamping surface (430) on the second tube. This allows for easy visual and tactile identification of capsule orientation. It also allows a system where each drug formulation in a capsule (300) corresponds to a dry particle inhaler (10), so that users cannot mix drugs. In one embodiment of the invention, the clamping surface (360) of the first tube mates with a fitting surface (430) of a second different tube, or the mechanical fasteners (250) of the storage section (470). This allows for easy storage of the capsules (300) in the storage section (470).

Figure 18 shows a drug capsule (300), with a clamping surface (360) on the first tube and a fitting surface (430) on the second tube. It also shows a sectional view of the mixing section (30) and the air flow inlet (292) in the mixing section and the air flow outlet (294) to the Mexican institute DE LA rWDT! £ DAC&gt; INDUSTRIAL a spiral shape (280) a of the mixing section

IMPI the mixing section. The interior walls (298) are provided to impart a cyclonic flow to the air passing through. At the air flow inlet (292) and the air flow outlet (294) in this mode they are tangential to an imaginary tube which we can call the interior of the mixing section (291). That is, if we were to draw a radius perpendicular to the longitudinal axis of the tube, and if we were to draw a tangent line that circulates perpendicular to the radius, the air flow would leave the mixing section along that tangent line. The outgoing tangential airflow 394 increases the airflow velocity, and thus helps disperse the drug particles. As can be seen from Figure 18, the interior of mixing section (291) is dimensioned to accommodate a capsule of medication (300). Adjustment mechanisms (360, 430) are formed to engage clamp (260) in the mixing section. Capsules according to the present invention can have a number of shapes, including ovoid or rectangular shapes. A variety of projections and grooves can also be used as clamping surfaces. For example, a fitting surface can be a rectangular block and a capsule holder can have a rectangular hole. By way of

<img file="MX347170B_D0023.tif" />

IMPI

INSTITUTO MEXICANO M LA PWOMDAD INDUSTRIAL alternative, a clamping surface can be rectangular, hexagonal, Z-shaped, C-shaped, etc., and the fastener would have the opening along the corresponding height.

Figure 18 also shows an embodiment of the capsule (300) where a cone (375) is located inside the first tube, and a cone (445) is located inside the second tube. These cones (375, 445) make the airflow within the capsule cyclonic, helping the drug particles mix with the air. A cone is shown here, but other structures creating cyclones are contemplated by the present invention.

Figure 8 shows a mouthpiece (40) of the dry pack inhaler (10). This has a projection (130) on its surface to come into contact with the lips of a user (not shown). This helps the user to position the mouthpiece correctly in their mouth. The mouthpiece (40) also includes a tongue blade (120), which may be bulbous in shape. The mouthpiece (40) is long enough so that it is positioned approximately halfway towards the user's mouth (not shown). This allows more medication to be delivered to the lungs and less to the oral cavity. Nozzle (40)

<img file="MX347170B_D0024.tif" />

IMPI

MEXICAN INSTITUTE

M THE NORTHERN INDUST1UA1 has a particular aspect ratio of its internal channel (50) (see Figure 17). This slows the passage of air through the channel, so that it contains the particles and does not end up hitting the back of the user's throat. However, the air is not too lethargic, so that the particles settle out of the air flow.

Figure 9, Figure 10 and Figure 11 show a specific embodiment of the dry particle inhaler (10). In Figure 9, the nozzle layer (90) is closed, and several capsules (300) are in the storage section (470). In Figure 10, the nozzle (40) has been rotated relative to the inlet section (20). The longitudinal axis (60) [not shown] of the inlet section here makes an angle of approximately ninety degrees with the longitudinal axis (70) of the nozzle section. This allows the layer or cover (290) of the mixing section to be opened. A medicine capsule (300) taken from the storage section (470) is rotated to be inserted into the mixing section (30). In Figure 11, the nozzle (40) has been rotated to a fully extended position, the lid (290) for the mixing section has been closed, and the dry particle leveler (910) is ready for use. In a mode

<img file="MX347170B_D0025.tif" />

IMPI

INSIHU ΙΟ MEXICANO or the INWfnUAL name of the dry particle inhaler (10), when the dry particle inhaler is in the closed position (Figure 9), the interior of the inlet section (20) would be isolated from the outside air, but the The interior of the nozzle (40) and the interior of the mixing section (291) would be absent, allowing them to dry out after being exposed to a user's wet breath.

Figure 12, Figure 13, Figure 14 and Figure 15 show a time sequence where a capsule (300) of medication is loaded into the mixing section (30) of a dry particle inhaler (10), and the mouthpiece (40) is extended for use. The dry particle inhaler (10) described here can also be used for nasal delivery of medications. A small tube (not shown) can be placed at the end of the mouthpiece (40), and the left end of the tube inserted into the nostril. Alternatively, the mouthpiece (40) can be replaced by a nose piece (not shown) whose free end is sized to be inserted into the nostril of a user. In another embodiment, a device such as bellows or an outlet is used to force air through the dry particle inhaler (10) into the nosepiece inserted into the nostril of a user (not shown).

<img file="MX347170B_D0026.tif" />

IMPI institute maajca no

M LA FftOmlMP

INDUSTRIAL

Figure 16 shows the fluid (air) flow of the dry particle inhaler (10) molded as the equivalent electrical circuit. This is shown as a pneumatic resistance circuit.

Figure 17 shows a schematic view of the dry particle inhaler (10). The air passage (50) through the dry particle inhaler widens as it travels through the mouthpiece (40) along the direction of air flow (460). The mouthpiece opening (135) to be inserted into the user's mouth may be approximately ellipsoidal or oval and thus has a major axis and a minor axis. The ratio of those two can be called the horizontal aspect ratio. In one embodiment of the invention, the horizontal aspect ratio is between 2: 1 and 4: 1. In one embodiment of the dry particle inhaler (10), the horizontal aspect ratio is 3: 1. Deformation of the aperture (135) in this manner keeps the drug particles collimated, maintains the optimum velocity of the particles in the airflow, and is oriented toward the natural horizontal aspect ratio of the oropharyngeal region of the mouth. In one embodiment of the invention, the outline of the opening (135) resembles a bean.

<img file="MX347170B_D0027.tif" />

IMPI

INSTITUTO MUUCANO M la morniMD INDUSTRIAL

The dry particle inhaler described herein can be used with low, high and medium flow shear drug particles.

The dry particle inhaler and capsules 5 described herein can be made from a variety of suitable materials known to those skilled in the art, such as metal, glass, rubber, and plastic.

Although the invention has been described with reference to particular embodiments, those skilled in the art will be able to make various modifications without departing from the spirit and scope thereof.

It is stated that in relation to this date, the best method known to the applicant for putting the aforementioned invention into practice is the one that is clear from the present description of the invention.