WO2011129788A1

WO2011129788A1 - User-friendly dry powder inhaler

Info

Publication number: WO2011129788A1
Application number: PCT/TR2011/000088
Authority: WO
Inventors: Mahmut Bilgic
Original assignee: Mahmut Bilgic
Priority date: 2010-04-13
Filing date: 2011-04-13
Publication date: 2011-10-20
Also published as: IN2012DN04987A

Abstract

The present invention relates to a user-friendly and rapid inhaler comprising blister package which is appropriate for delivering the medicament in dry powder form used in the treatment of respiratory diseases, particularly in asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis.

Description

USER-FRIENDLY DRY POWDER INHALER

Field of the Invention

The present invention relates to an inhaler appropriate for delivering the medicament in dry powder form used in the treatment of respiratory diseases, particularly in asthma and chronic obstructive pulmonary disease (COPD). In addition, the present invention relates to a user- friendly inhaler which is actuated by the rotation of the mouthpiece.

Description of the Prior Art

It is rather common to use inhalers for delivering medicaments utilized in the treatment and prophylaxis of respiratory diseases. Inhalation treatment is the most commonly preferred treatment method in these diseases as the inhalers provide ease of use; the medicaments have rapider onset of time resulting from local administration and they have fewer side effects. Various inhalers have been designed in order to provide effective and sufficient delivery of the medicaments used in the treatment of respiratory diseases, particularly in asthma and chronic obstructive pulmonary disease. These inhalers vary according to their operating mechanisms and the physical form of the medicament to be delivered.

In the inhalers used to deliver the medicaments in dry powder form, the medicament is carried in reservoirs, capsules or blisters packages. It is highly significant to provide the delivery of sufficient amounts of the medicament to the patient since the required amount of the dry powder medicament to be delivered to the patient for each inhalation is very low. In the prior art, most inhalers used for delivering dry powder medicament comprise mouthpiece cover component. This mouthpiece cover component can be used to preserve the mouthpiece, to actuate the device mechanism or for both purposes.

In the inhalers actuated by the mouthpiece cover, the cover has to be rotated as required and manually for the device mechanism to operate properly. The fact that the required force, skill and attention to rotate the mouthpiece cover cannot be provided in all cases results in improper operation of the inhaler and failure in the inhalation of the dry powder medicament on a sufficient amount. In addition, the mouthpiece cover has to be rotated rapidly for the dry powder medicament to be prepared for inhalation in a short time particularly in the course of a crisis. So as to meet all these requirements, the mouthpiece cover should hold the necessary specifications to be rotated easily. In the case that the mouthpiece cover cannot be rotated comfortably, the patient is distressed as the required active agent cannot be inhaled and the inhalation takes long. Furthermore, when the inhalation is distressfully experienced resulting from uneasy and uncomfortable actuation of the mouthpiece cover, the patient's state of mind may be influenced negatively and the treatment may be prolonged. Additionally, in some inhalers which are not actuated by the mouthpiece cover, one of the most significant factors for easy and rapid inhalation is easy rotation of the mouthpiece cover due to the necessity of moving the cover hiding the mouthpiece in order to expose the mouthpiece for the purpose of realizing the inhalation.

The inhaler disclosed in patent numbered WO 2007/012871 (Al) is actuated by the rotation of the mouthpiece cover. With the rotation of the cover, both the mouthpiece of the inhaler is exposed and the dry powder medicament to be inhaled becomes ready for inhalation. Therefore, it is essential to move the cover as required for the device mechanism to operate properly. However, it is probable that the cover movement which the patient performs to actuate the inhaler is not efficient enough to enable proper actuation of the inhaler in all cases as the cover does not hold any specifications providing the cover to be easily moved.

The inventor has surprisingly found that the cover can be moved easily at all events in the case that one end of the cover which enables the actuation of the inhaler and/or hiding the mouthpiece is carved in an appropriate shape and size. When the cover can be easily moved, it becomes possible to execute an effective movement of the cover enough to enable the device to work properly. In this way, an effective inhalation is realized as a result of the inhalation of sufficient amounts of the active agents in each actuation of the device.

Therefore the present invention relates to an inhaler having an easily rotatable cover which is used for delivery of medicament in dry powder form.

Summary of the Invention An inhaler suitable for delivery of the medicament in dry powder form according to the present invention is characterized in that the front and/or back end of the mouthpiece cover hiding the mouthpiece, which is in contact with the finger while being rotated manually, is carved in the shape of an arc of a circle.

According to another aspect, the inhaler pertaining to the present invention that is suitable for delivering dry powder medicament is characterized in that the front and/or back end of the mouthpiece cover hiding the mouthpiece, which is in contact with the finger while being rotated manually, is carved in the shape of an arc of a circle of at least 30°. In more detail, the carved part in the front and/or back end of the mouthpiece cover, which is in contact with the finger while being manually rotated, is in the shape of an arc of 30° of a circle which has a radius in the range of 30 mm to 40 mm, preferably in the range of 32.5 mm to 37.5 mm. In addition, one end or both ends of the mouthpiece cover of the inhaler pertaining to the present invention can be carved in the specified sizes and structures.

The inventor has found that the mouthpiece cover matches with the shape of any human finger, and therefore any patient can easily and rapidly rotate the mouthpiece cover hiding the mouthpiece of the inhaler as a result of the fact that the front and/or back end of the rotatable mouthpiece cove, which is in contact with the finger while being manually rotated, is carved in the shape of an arc of at least 30°, preferably in the range of 30° to 120°, most preferably in the range of 30° to 100°.

It is because of the fact that the carved part in the front and/or back end of the mouthpiece cover is in a size to match with the shape of the thumb which is generally used to rotate the mouthpiece cover. Thus, the thumb can be placed in this carved part; the cover can be tightly gripped and rotated properly and rapidly.

As the said carved part in the front and/or back end of the mouthpiece cover is in a size to match with the thumb of any patient, the possibility of accidental backward slip of the mouthpiece cover while being rotated is eliminated. Otherwise, it may take long to rotate the mouthpiece cover as required since it requires skill and attention.

The width of the mouthpiece cover and at the same time the width of the carved part in the front and/or back end of the mouthpiece cover is in the range of 10 mm to 20 mm, preferably in the range of 11 mm to 16 mm and this helps the mouthpiece cover be easily rotatable. However, the carved part in the front and/or back end of the mouthpiece cover enables the inhaler to be actuated rapidly by any patient at any case as its being in a shape and size that matches with the shape of any person's thumb brings the mouthpiece cover ergonomic specifications. Therefore, the movement of the cover required for the device mechanism to operate properly is executed easily and rapidly as required and the sufficient amount of the active agent becomes ready for inhalation in response to each actuation of the device in the inhalers that are actuated by the mouthpiece cover. When the inhalation is performed effectively in a short time, the patient is provided with a sense of well being both psychologically and physiologically.

The mouthpiece cover having a carved part of said sizes and specifications in its front and/or back end is preferably utilized in inhalers that are actuated by mouthpiece covers. To this respect, the inhaler pertaining to the present invention is preferably actuated by the cover and it is appropriate for delivering medicament in dry powder form. The inhaler according to the present invention is an easy-grip manual device which is appropriate for delivering medicament in dry powder form. In addition, the inhaler pertaining to the present invention preferably comprises peelable blister package. According to this, there is a gear mechanism actuated by the mouthpiece cover in the inhaler pertaining to the present invention. The gear mechanism actuated by the rotation of the mouthpiece cover provides the blister package to be indexed and the blister pocket containing one dose of dry powder medicament to be opened. The components comprising the inhaler pertaining to the present invention enables the inhaler to work properly. The housing of the device pertaining to the present invention has been designed such that each component of the blister package and the gear mechanism is situated accurately and works harmoniously. Furthermore, the housing also comprise the beak which enables the blister package to be peeled and the manifold through which the dry powder medicament in the open blister passes before reaching the mouthpiece during the inhalation. In addition, the housing can be in any appropriate shape while it is preferably elliptic or circular.

The upper and the lower housing members interlock with each other and enclose the housing in order to keep the housing and the gear mechanism fixed together. The mouthpiece cover hiding the mouthpiece is rotated by being slid on the upper and lower housing members. The upper and the lower housing members can be in any appropriate shape or size which provides ease of use.

On each connection point of the mouthpiece cover, there is a stabilizing resilient cover. The extensions under the stabilizing resilient covers pass through the holes on the upper or the lower housing member according to the position of the connection point and provide the stabilizing resilient covers that they connect with to remain stable. The rotation of the mouthpiece cover is prevented from both sides as the pawl under each of the stabilizing resilient covers in both sides of the device interlocks with the mouthpiece cover. Before the inhalation, the resilient parts of each stabilizing resilient cover which matches with the shape of the fingers are pressed on for raising the pawls and releasing the mouthpiece cover in order to move the mouthpiece cover which actuates the device. Thus, the mouthpiece cover can easily be rotated when the resilient parts of each stabilizing resilient cover on both sides of the device which match with the shape of the fingers are pressed on. When the resilient parts of the stabilizing resilient covers are not pressed on, the pawls under the stabilizing resilient covers do not allow the mouthpiece cover to move in any circumstances.

The mouthpiece cover that actuates the device can solely be in two positions. For the gear mechanism that indexes the blister package to be triggered, the mouthpiece cover should be moved from the first position to the second position. When the mouthpiece cover is in the first position, it leans on the protruding part in one end of the rotational path. The mouthpiece is completely hidden when the mouthpiece cover is in the first position and the device is on standby mode. When the mouthpiece cover is in the second position, it leans on the protruding part on the other end of the rotational path and one dose of the medicament in dry powder form is prepared for inhalation upon the actuation of the device.

Each gear of the gear mechanism in the device according to the present invention is directly or indirectly engages with each other. In each actuation of the device, the constant-angle rotational movement of the mouthpiece cover is transmitted to the indexing ratchet wheel which engages with the drive gear owing to the connection made via the side covers between the mouthpiece cover of the inhaler and the drive gear. The indexing ratchet gear which interlocks with the indexing wheel from inside thanks to its arms cause the indexing wheel to rotate. Upon the rotation of the indexing wheel, the blister package is indexed and it is peeled by the beak comprised in the housing. As the indexing wheel engages with the winding wheel gear and the pinion gear, these gears rotate as well upon the rotation of the indexing wheel. Since the mechanism gear engages both with the winding wheel gear and the winding wheel, the rotation of the winding wheel gear causes the winding wheel to move and lid sheet of the blister package coils on the winding wheel tightly. Pinion gear engages with the base gear while the small gear under the base gear engages with the counter gear. The rotation of the indexing wheel is transmitted to the base gear via the pinion gear. The rotation of the base gear causes the counter gear to move as the small gear under the base gear synchronizes with the base gear. The counter gear which rotates in each actuation of the inhaler causes the number of the unused blister pockets that can be seen through the display aperture on an appropriate spot of the inhaler pertaining to the present invention to be incremented. The blister package carries the medicament in dry powder form in one-dose portions and it is preferably a blister strip and it is preferably peelable. The blister pockets comprised in the blister package are spaced in equal intervals and each of them carries one dose of the medicament in dry powder form. While the blister package is indexed on the indexing wheel, the beak on the housing peels the blister. Therefore, one dose dry powder medicament becomes ready for inhalation after the blister package is peeled to be opened in each actuation of the device.

The blister is opened as a result of the actuation of the device after the mouthpiece is moved with the help of the carved part in its front and/or back end and the opened blister is situated immediately under the manifold. One end of the manifold communicates with the opened blister while its other end communicates with the mouthpiece. Upon the inhalation of the patient, the airflow that preferably enters the device through the air inlet reaches the opened blister via the manifold and entrains the dry powder medicament there to the manifold. The dry powder medicament entering the manifold with the air flow is delivered to the patient via the mouthpiece.

The mouthpiece is designed to fit the mouth for the patient to comfortably inhale the medicament in dry powder form. According to the shape of the device, the mouthpiece can be in any suitable shape and size as well as being fixed or movable. Furthermore, it could be attached or unattached to the upper and/or the lower cover. Each component of the device pertaining to the present invention can be made of any appropriate substance while it is preferably made of plastics. These plastic substances are selected from a group comprising styrene-acrylonitrile, polyoxymethylene (it is generally named as POM and it is also known as polyacetal or polyformaldehyde), acrylic- polymethylmetacrylate, cellulose acetate, polyetheretherketone, polyvinyl choloride, polyethylene, polypropylene, acrylonitrile butadiene styrene, polycarbonate, polyamide, polystyrene, polyurathane or fluoropolymer types while it is more preferably polyoxymethylene. The components made of plastics can be produced by methods such as injection molding. Furthermore, each component of the device can be in any appropriate color. The lid and the base sheets constituting the blister package preferably consist of a plurality of layers. Each of these layers are preferably chosen from a group comprising polymeric layers that are made of various polymeric substances; aluminum foil and fluoropolymer film.

According to the present invention, the lid and base sheets composing the blister package are sealed very tightly by at least one of the methods comprising cold formed bonding, hot metal bonding, hot metal welding, radio frequency welding, laser welding or ultrasonic welding in order to provide impermeability, more preferably by cold formed bonding method. Since these cold formed bonding methods can be carried out at lower temperatures than hot sealing methods, they are the most appropriate methods to use in the case that the medicament carried in the blister is heat sensitive.

Fluoropolymer film is a polymeric film which is used in blister packs and provides excellent moisture barrier. This chemically inert polymeric film does not cause any change in the taste of the formulation when it is in contact with the dry powder formulation. In addition, it easily constitutes a layered structure with the other polymeric layers which are composed of various polymers. It is appropriate to be transacted with heat.

For preserving the stability of the dry powder formulation stored in the blister package, preferably at least one of the polymeric layers comprises at least one desiccant agent including silica gel, zeolite, alumina, bauxite, anhydrous calcium sulfate, activated carbon and clay which has the property of water absorption in order to decrease gas and moisture permeability of the layer.

According to the invention, the thickness of the aluminum foil in the lid and the base sheets of the blister package are preferably chosen to be in the range of 5 to 80 μπι, more preferably in the range of 15 to 65 μπι.

According to the invention, the polymeric layers in the lid and the base sheets of the blister pack are made of the same or different polymers. The thickness of these polymeric layers varies according to the type of the polymeric substance used and its properties while they are preferably in the range of 5 to 100 μπι, more preferably in the range of 15 to 60 μπι. The polymers composing the polymeric layer are preferably selected from thermoplastics such as polyethylene, polypropylene, polystyrene, polyolefin, polyamide, polyvinyl chloride, polyurethane or synthetic polymers.

The blister pockets in the blister package can be in any appropriate shape. The plurality of blister pockets spaced at equal intervals on the base sheet of the blister package can be in the same or different shape, structure and volume.

The reference numbers of the drawings added to exemplify the present invention and the detailed description of the invention according to these drawings are given below but the scope of the invention should not be limited to these drawings. Brief Description of the Drawings

Figure 1 is a perspective view of an inhaler according to the inhaler described in the present invention;

Figure 2 is an exploded view of the inhaler pertaining to the invention;

Figure 3 is a perspective view of the blister pack for use with the inhaler pertaining to the invention;

Figure 4a is a perspective view of the mouthpiece cover of the inhaler pertaining to the present invention;

Figure 4b is an exploded view of the communication between the mouthpiece cover, the drive gear and the stabilizing resilient covers in the inhaler pertaining to the invention; Figure 4c is a cross-sectional view of the communication between the mouthpiece cover, the drive gear and the stabilizing resilient covers in the inhaler pertaining to the invention;

Figure 4d is a cross-sectional view of the communication between the mouthpiece cover, the drive gear and the stabilizing resilient covers in the inhaler pertaining to the invention;

Figure 5a is front view of the inhaler pertaining to the present invention; Figure 5b is a lateral view of the inhaler pertaining to the present invention; Figure 6 is a cross-sectional view of the engagement of the gears composing the gear mechanism with each other in the inhaler pertaining to the present invention;

Figure 7 is a cross-sectional view of the engagement of the gears composing the gear mechanism with each other in the inhaler pertaining to the present invention; Figure 8 is a cross-sectional view of the blister package delaminating in course of operation of the inhaler pertaining to the present invention.

Detailed Description of the Drawings

The inhaler (1) pertaining to the present invention comprises a gear mechanism situated in the housing (10) between the upper housing member (4a) and the lower housing member (4b) in order to enable the inhalation of the dry powder medicament carried in a blister package (15) as displayed in figures 1 and 2. Each component of the inhaler (1) is positioned at appropriate spots of the device to guarantee their working properly and accurately.

The inhaler (1) pertaining to the present invention shown in Figure 1 is ready for inhalation. In this case, the mouthpiece cover (2) is in the second position and the mouthpiece (14) is entirely exposed. The mouthpiece cover (2) has to be rotated by holding on the carved part (2a) on one end of the mouthpiece cover (2) in order to switch to the second position from the first position wherein the mouthpiece is completely covered. In this way, the mouthpiece (14) is completely exposed when the mouthpiece cover (2) is switched to the second position from the first position and the gear mechanism is triggered by the drive gear (12). The drive gear (12) precisely transmits the movement of the mouthpiece cover (2) to the indexing ratchet wheel (3).

The indexing wheel (8) which engages with the indexing ratchet wheel (3) enables the blister package (15) shown in figure 3 to be indexed. The blister pockets (15a) composing the blister package are received in the recesses (8a) on the indexing wheel and the blister package (15) is indexed when the indexing wheel (8) rotates. In the inhaler pertaining to the present invention, shapes of the recesses (8a) on the indexing wheel (8) have been designed to match the shapes of the blister pockets (15) composing the blister package (15) for the blister package to be indexed properly.

The blister package (15) shown in figure 3 is composed of the lid sheet (15b) which provides impermeability and the base sheet (15c) on which the blister pockets (15a) are spaced at equal intervals. Each blister pocket contains medicament in dry powder form comprising one or more active agents.

The rotational movement that the mouthpiece cover (2) of the device executes while switching from the first position to the second is transmitted to the indexing ratchet wheel (3) via the drive gear (12) that the mouthpiece cover (2) engages with. As displayed in figure 2, arms (3 a) of the indexing ratchet wheel interlocks with protrusions inside the indexing wheel (8) and rotates the indexing wheel (8) unidirectionally. Therefore, the blister package (15) is indexed forward while the indexing wheel (8a) rotates as the blister pockets (15a) composing the blister package (15) are received in the recesses (8a) of the indexing wheel. The beak (16) in the housing (10) provides the blister package (15) to be peeled while the blister package (15) is indexed and provides one blister pocket (15a) to be opened in response to each actuation of the device (1).

The winding wheel gear (6), which is another component of the gear mechanism, engages with the indexing wheel (8) as displayed in figure 2. The mechanism gear (5) that interlocks the winding wheel (13) from inside has arms (5a) to interlock with the interior teeth of the winding wheel gear (6). When the indexing wheel (12) rotates the winding wheel gear (6), the winding wheel rotates unidirectionally owing to the arms of the mechanism gear (5 a) which interlock with the interior teeth of the winding wheel gear (6) and the lid sheet (15b) which is peeled away while the blister package is indexed is tightly coiled on the wings (13a) of the winding wheel. The base sheet (15c) of the blister package (15) where the blister pockets are spaced is accumulated in a separate part (18a) of the device.

The mouthpiece cover (2) that engages with the gear mechanism of the inhaler and provides to actuate the device is illustrated in figure 4a. One end (2a) of the mouthpiece cover is carved such that it can easily be rotated. The mouthpiece cover (2) is connected with the gear mechanism in both sides of the device (1) via the connection points (29, 30).

The drive gear (12) interconnects with the connection points (30, 29) of the mouthpiece cover via the side covers (31a, 31c), as it can clearly be seen in figures 4b, 4c and 4d illustrating the communication between the mouthpiece cover (2), the drive gear (12), the side covers (31a, 31c) and the stabilizing resilient covers (32, 33). Both ends (12a; 12b) of the drive gear are carved such that the end of the side cover that engages with it can interlock. Each end (3 Id; 3 lb) of the side covers passes through one of the connection points (29; 30) of the mouthpiece cover and it is fixed in the carved part (12b; 12a) in one end of the drive gear (12b; 12a). Therefore, the mouthpiece cover (2) and the drive gear (12) synchronize.

The mouthpiece cover (2) can be rotated by holding from the front end (2a) or back end (2b) of its with the help of the thumb. Therefore, the front end (2a) or the back end (2b) of the mouthpiece cover (2) is in contact with the patient's finger while it is moved manually. According to figure 5a, only the front end (2a) of the mouthpiece cover (2) of the inhaler is carved such that it matches with the shape of the thumb so as to provide the mouthpiece cover (2) to be rotated easily and rapidly while the back end (2b) of the mouthpiece cover is not carved. However, it is probable that both the front end (2a) and the back end (2b) of the mouthpiece cover are carved. The shape of the carved part in the front end (2a) of the mouthpiece cover resembles to the shape of the thumb for the thumb to be placed in this carved part exactly in order to rotate the mouthpiece cover. Thus, the carved part of the front end (2a) of the mouthpiece cover illustrated in figure 5a is in the shape of the arc of the circle which has a radius (R) in the range of 30 mm to 40 mm, preferably in the range of 32.5 mm to 37.5 mm. In more detail, the carved part (2a) in the front end of the mouthpiece of the device shown in figure 5a is in the shape of the arc of 45° of said circle.

In addition, another variable contributing to the carved part in the front end (2a) of the mouthpiece cover to match with the shape of the thumb is the width of the mouthpiece cover (2) illustrated as Dl in figure 5b. For the thumb to be able to grip the cover and impose force, a particular part has to be in contact with the carved part in the front end (2a) and the back end (2b) of the mouthpiece cover. To this end, Dl distance is in the range of 10 mm to 20 mm, preferably in the range of 11 mm to 16 mm.

There is one stabilizing resilient cover (33; 32) on each connection point (29; 30) of the mouthpiece and on each side cover (31c; 31a) as displayed in figures 4b-4d. These pawls (32a, 33a) under the stabilizing resilient covers interlock with the mouthpiece cover (2) and hinder its movement.

The extensions under the stabilizing resilient covers pass through the apertures on the upper and the lower housing members and provide the stabilizing resilient covers to remain stable. Before the inhalation, the resilient parts (32d, 33 d) of each stabilizing resilient cover illustrated in figures 4b-4d are pressed on for raising the pawls (32a, 33a) and releasing the mouthpiece cover (2) in order to actuate the gear mechanism of the device to prepare one dose of dry powder medicament before inhalation. Therefore, the gear mechanism of the device is actuated and one blister pocket (15a) is opened for one dose of the dry powder medicament to be ready for inhalation when the resilient parts (32d, 33 d) of the stabilizing resilient covers are pressed on and the mouthpiece cover (2) is switched from the first position to the second position simultaneously. The air entering the device upon the inhalation of the device passes through the manifold (20) and reaches the opened blister pocket; entrains one dose of dry powder medicament in the opened blister pocket to the manifold (20); passes the dry powder medicament through the manifold (20) and the mouthpiece (14) respectively, then provides the medicament to be delivered to the patient.

As it can clearly be seen in figures 6 and 7, the indexing wheel (8) which synchronizes with the indexing ratchet wheel (3) is engaged with the winding wheel gear (6) and the pinion gear (11) and the rotation of the indexing wheel (8) causes the pimon gear (1 1) and the winding wheel gear (6) to rotate. Thus, both the peeled lid sheet (15b) of the blister package (15) which is indexed by the rotation of the indexing wheel (8) is tightly coiled on the winding wheel (13) engaging with the winding wheel gear (6) and also the counter wheel (9) is provided to be moved by the pinion gear (11) and the base gear (7) as a result of the rotation of the indexing wheel (8). The gear which directly engages with the counter gear (9) is the small gear (7a) that is under the base gear (7) as attached. Therefore, the movement transmitted to the base gear (7) via the pinion gear (11) is transmitted to the counter gear (9) by the small gear (7a) and the counter gear (9) is rotated. As is seen in figure 8, the lid sheet (15b) of the blister package (15) which is peeled away by the beak (16) and the base sheet (15c) are enclosed in separate compartments. The lid sheet (15b) that provides impermeability is indexed over the beak (16) and tightly coiled on the wings (13a) of the winding wheel. The base sheet (15c) of the blister package (15) where the blister pockets (15a) each of which carries one dose of the dry powder medicament are spaced is accumulated in the partitioned compartment (18a) of the housing (10). In response to each actuation of the device (1), one dose of the dry powder medicament which is prepared for inhalation after one blister pocket (15a) is opened and the air entering the device through the air inlet (22) upon the inhalation of the patient provides to deliver one dose of the dry powder medicament to the patient by entraining it from the blister pocket (15a) to the mouthpiece (14).

The medicament in dry powder form which is stored in blister cavities is manufactured according to the prior art. According to the present invention, the particle sizes of the active agents comprised in the dry powder medicament are smaller than 20 μπι, preferably smaller than 10 μηι.

The inhaler pertaining to the present invention has been designed so as to deliver the dry powder medicament used in monotherapy or combined therapy. The term "monotherapy" refers to inhalation treatments in which dry powder medicaments comprising a single active ' agent are used whereas the term "combined therapy" refers to inhalation treatments in which dry powder medicaments comprising more than one active agents are use used.

The dry powder medicament delivered via the device pertaining to the present invention comprises at least one excipient in addition to the active agent or agents. These excipients are generally chosen from a group comprising monosaccharides (glucose, arabinose, etc.), disaccharides (lactose, saccharose, maltose, etc.), oligo- and polysaccharides (dextran, etc.), polyalcohols (sorbite, mannite, xylite), salts (sodium chloride, calcium carbonate, etc.) or combinations thereof. According to the present invention, the medicament in dry powder form comprises lactose as the excipient. The medicament in dry powder form comprises fine or coarse excipients particles preferably having various particle size ranges in order to deliver the required amount to the lungs.

The active agent or the active agents comprised in the dry powder medicament which is stored in blister packages used in the device pertaining to the present invention can be selected from a group comprising cromolyns, anti-infectives, antihistamines, steroids, anti- inflammatories, bronchodilators, leukotirene inhibitors, PDE IV inhibitors, antitussives, diuretics, anticholinergics, hormones, xanthines and pharmaceutically acceptable combinations thereof.

The active agent comprised in the medicament in dry powder form delivered via the inhaler pertaining to the present invention is preferably selected from a group comprising tiotropium, oxitropium, flutropium, ipratropium, glicopironium, flunisolid, beclomethasone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, montelukast, methylcyclopropane acetic acid, sodium cromoglicat, nedocromil sodium, Npropylene, teophylline, roflumilast, ariflo (cilomilast), salmeterol, salbutamol, formoterol, terbutaline, carmoterol, indacaterol, cetirizine, levocetirizine, efletirizine, fexofenadine and their racemates, free base, enantiomers or diastereomers and their pharmaceutically acceptable salts, solvates and/or hydrates or a combination of said active agents. The device pertaining to the present invention is used in the administration of the medicament in dry powder form which is utilized in the treatment of many respiratory diseases, particularly in asthma, chronic obstructive pulmonary disorder (COPD) and allergic rhinitis. Accordingly, the respiratory diseases include, but not restricted to, allergic or non-allergic asthma at any phases, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), exacerbation of airways hyperactivity, bronchiectasis, chronic obstructive pulmonary including emphysema and chronic bronchitis, airways or lung diseases (COPD, COAD or COLD), pneumoconiosis, aluminosis, anthracosis, asbestosis, chalicosis, ptilosis, siderosis, silicosis, tabacosis and byssinosis. The device pertaining to the invention can be used in prophylactic or symptomatic treatment. In addition, the medicament in dry powder form which is preferably used in the symptomatic treatment of allergic asthma and COPD is administered to the patient via the device pertaining to the present invention.

Claims

I. The inhaler (1) appropriate for delivering medicament in dry powder form characterized in that the front and/or back end of the mouthpiece cover (2) which is in contact with the finger while the mouthpiece cover is being rotated is in the shape of an arch of a circle.

2. The inhaler (1) according to claim 1, wherein the front (2a) and/or back end (2b) of the mouthpiece cover (2) which is in contact with the finger while the mouthpiece cover hiding the mouthpiece (14) is being rotated is carved as an arch of a circle of at least 30°.

3. The inhaler (1) according to claim 1, wherein the front (2a) and/or back end (2b) of the mouthpiece cover (2) which is in contact with the finger while the mouthpiece cover hiding the mouthpiece (14) is carved as an arch of at least 30° of a circle with a radius (R) in the range of 30 mm to 40 mm.

4. The inhaler (1) according to claim 1, wherein the front (2a) and/or back end (2b) of the mouthpiece cover (2) which is in contact with the finger while the mouthpiece cover hiding the mouthpiece (14) is carved as an arch of at least 30° of a circle with a radius (R) preferably in the range of 32.5 mm to 37.5 mm.

5. The inhaler (1) according to claim 1 or 2, wherein the width (Dl) of the mouthpiece cover (2) hiding the mouthpiece (14) is in the range of 10 mm to 20 mm.

6. The inhaler (1) according to claim 1 or 2, wherein the width (Dl) of the mouthpiece cover (2) hiding the mouthpiece (14) is preferably in the range of 11 mm to 16 mm.

7. The inhaler (1) according to any one of the preceding claims, wherein said inhalation device (1) is preferably actuated by the rotation of the mouthpiece cover.

8. The inhaler (1) according to claim 1, wherein the mouthpiece cover (2) is rotationally moved by being slid on the upper (4a) and the lower (4b) housing member.

9. The inhaler (1) according to any one of the preceding claims, wherein the mouthpiece cover (2) can solely be in two positions:

the mouthpiece (14) is completely covered and the device (1) is on standby mode when the mouthpiece cover (2) is in the first position,

one dose of the medicament in dry powder form is ready for inhalation upon the actuation of the device (1) when the mouthpiece cover (2) is in the second position.

10. The inhaler (1) according to claim 1, wherein all components of the gear mechanism is directly or indirectly engages with each other.

I I. The inhaler (1) according to either one of claim 1 or 10, wherein said gear mechanism is composed of; the drive gear (12) which provides to actuate the device (1) by transmitting the constant- angle movement of the mouthpiece cover (2) to the indexing ratchet wheel (3);

the indexing wheel (8) which synchronizes with the indexing ratchet wheel (3) and enables the blister package (15) to be indexed;

- the winding wheel gear (6) which moves the winding wheel (13) via the mechanism wheel (5) upon the rotation of the indexing wheel (8);

the pinion gear (11) and the base gear (7) that provide to transmit the movement of the indexing wheel (8) to the counter wheel (9);

the counter wheel (9) which displays the number of the unused blister pockets (15a) remained in the device ( 1 ).

12. The inhaler according to any of the proceeding claims, further comprising a blister package (15) composed of a plurality of blister pockets (15a) each of which comprises medicament in dry powder form and which are spaced at equal intervals.

13. The inhaler (1) according to claim 1, wherein the blister package (15) it comprises is preferably a blister strip.

14. The inhaler (1) according to claim 1 or 13, wherein the blister package (15) it comprises is preferably peelable.

15. The inhaler (1) according to claim 14, wherein the lid (15b) and the base (15c) sheets composing the blister package (15) preferably comprises a plurality of layers.

16. The inhaler (1) according to claim 15, wherein the layers constituting the lid (15b) and the base (15b) sheets of the blister package are chosen from a group comprising polymeric layers preferably made of various polymeric substances, aluminum foil and fluoropoylmer film.

17. The inhaler (1) according to claim 16, wherein at least one of the layers constituting the lid (15b) and the base (15b) sheets of the blister package comprise at least one of the desiccant agents preferably including silica gel, zeolite, alumina, bauxite, anhydrous calcium sulfate, activated carbon and clay which has the property of water absorption.

18. The inhaler (1) according to claim 16, wherein the thickness of the aluminum foil comprised in the lid (15b) or the base sheet (15c) of the blister package is preferably in the range of 5 to 80 μηι, more preferably in the range of 15 to 65 μπι.

19. The inhaler (1) according to claim 16, wherein the thickness of the polymeric layer comprised in the lid (15b) or the base sheet (15c) of the blister package is preferably in the range of 5 to 100 μπι, more preferably in the range of 15 to 60 μπι.

20. The inhaler (1) appropriate for delivery of the medicament in dry powder form according to any one of the preceding claims, wherein said medicament in dry powder form comprises at least one active agent selected from a group comprising cromolyns, anti-infectives, antihistamines, steroids, anti-inflammatories, bronchodilators, leukotirene inhibitors, PDE IV inhibitors, antitussives, diuretics, anticholinergics, hormones, xanthines and pharmaceutically acceptable combinations thereof.

21. The inhaler (1) appropriate for delivery of the medicament in dry powder form according to any one of the preceding claims, wherein said medicament in dry powder form is used in monotherapy or combined therapy.

22. The inhaler (1) appropriate for delivery of the medicament in dry powder form according to any one of the preceding claims, wherein said medicament comprises at least one excipient along with the active agent or agents it comprises.

23. The inhaler (1) appropriate for delivery of the medicament in dry powder form according to claim 22, wherein the excipients comprised by said dry powder medicament can be selected from a group comprising monosaccharides (glucose, arabinose, etc.), disaccharides (lactose, saccharose, maltose, etc.), oligo- and polysaccharides (dextran, etc.), polyalcohols (sorbite, mannite, xylite), salts (sodium chloride, calcium carbonate, etc.) or combinations thereof.

24. The inhaler appropriate for delivery of the medicament in dry powder form according to claim 22 or 23, wherein the excipient comprised in the dry powder medicament is preferably lactose.