The present invention relates to an inhaler suitable for administration of drugs in dry powder form used in the prophylaxis and the treatment of respiratory tract diseases by the inhalation route.

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, some properties they hold and the physical form of the medicament to be delivered.

In the inhalers used to deliver medicament in dry powder form, the medicament is carried in reservoirs, capsules or blisters packages. It is highly significant to deliver sufficient amounts of the medicament to the patient since the amount of dry powder medicament that is to be delivered to the patient for each inhalation is very low. In the inhalers comprising a reservoir, one dose of dry powder medicament is administered to the patient generally via a valve or a mechanical component in the device during each inhalation. In the inhalers comprising capsules, there is a metered dose of dry powder medicament in the capsule which is to be placed in the inhaler before each inhalation. In response to each actuation of the device, one capsule is pierced or opened by another method and the dry powder medicament contained in the capsule becomes ready for inhalation. In the inhalers comprising blister packs, at least one blister pocket is opened when the blister package is indexed and the dry powder medicament metered with high preciseness becomes ready for inhalation.

The inhalers in which the dry powder medicament is carried in blister packs or capsules can be multiple-dose or single-dose inhalers. The term "multiple-dose inhaler" refers to inhalers comprising more than one medicament dose. The term "single-dose inhaler", on the other hand, refers to inhalers comprising a single medicament dose.

The inhalers enabling the inhalation of dry powder medicament from capsules are commonly used. In general, one capsule is placed in the capsule chamber of the device before each inhalation in these devices; the capsule in the capsule chamber of the device is pierced, cut or opened by similar methods when the device is actuated, and the dry powder medicament contained in the capsule becomes ready for inhalation.

Since the active agents used in inhalation treatment induce rather strong effects, the amount of the active agent in one dose of dry powder medicament is quite low. Thus, absorption of a sufficient amount of the active agent in the patient's lung is essential in order to realize an effective inhalation. Absorption of less than the required amount of the active agent in the patient's lung remains insufficient for an effective treatment.

The inhaler marketed under the trade mark Spiriva® Handihaler® by Boehringer and Pfizer is one of the inhalers comprising capsules available on the market. However, there is still need for devices having different mechanisms and specifications so as to realize an effective inhalation.

In order to deliver sufficient dry powder medicament contained in the capsule to the lungs, it is essential to ensure a pressure decrease of 4 kPa in the inhaler during inhalation. Thus, analysis about inhalers are carried out on this basis. However, ensuring this pressure decrease in the inhaler during the inhalation depends on resistance of the inhaler and flow rate applied by the patient. Since there is an inverse proportion between the resistance of the inhaler and the flow rate as shown in the equation below;

the flow rate required to ensure a pressure decrease of 4 kPa during inhalation that the patient has to apply is high when the resistance of the inhaler is low. In the equation, "ΔΡ" represents the pressure decrease required to be ensured in the inhaler for an effective inhalation and it values 4kPa. "Rd" and "Q" in the equation represent the resistance of the inhaler and the flow rate that the patient has to apply during the inhalation respectively. The fact that the flow rate that the patient has to apply is high requires the patient to spend more effort during the inhalation to ensure the pressure decrease of 4 kPa in the inhaler. Since the maximum flow rate that each patient can apply varies, not all patients can achieve to use these inhalers having low resistance and the medicament cannot be delivered to the patients lungs in an effective amount for the treatment. The inventor has surprisingly found that the diameter of the air intake duct which ensures to deliver the dry powder medicament in the capsule to the patient via the inhaler during inhalation affects the resistance of the inhaler to a substantial extent.

In general, the present invention relates to an inhaler which comprises capsule and enables effective inhalation of dry powder medicament even at low flow rates during inhalation.

In detail, the inhaler of the present invention which comprises capsule containing dry powder medicament comprises a mouthpiece cover hiding the mouthpiece; a bottom casing where the device mechanism is situated; a movable mouthpiece communicating with the bottom casing; a middle casing situated between the bottom casing and the mouthpiece; a capsule chamber where the capsule is placed and an air intake duct which is inserted into the mouthpiece characterized in that the diameter of the air intake duct through which the air flow entraining the dry powder medicament from the capsule to the mouthpiece passes is in the range of 3 mm to 7 mm.

In another aspect, the inhaler of the present invention which comprises capsule containing the medicament in dry powder form described above characterized in that the diameter of the air intake duct through which the air flow entraining the dry powder from the capsule to the mouthpiece passes is preferably in the range of 3.5 mm to 6.5 mm, more preferably in the range of 4.0 mm to 5.5 mm.

The flow rate required to ensure the pressure decrease of 4 kPa in the inhaler for an effective inhalation must be applied by the patient. When the pressure decrease that has to be ensured in the inhaler is taken 4 kPa constant, there is an inverse proportion between the resistance of the inhaler and the flow rate according to the equation above. It has been found that increasing or decreasing the diameter of the air intake duct affects the rate of the air flow entraining the medicament in dry powder form which passes through it; therefore it conduces to increase and/or decrease the friction resulting from the air flow rate. The change of the friction in the air intake duct affects the resistance of the inhaler to a significant extent; thus the flow rate required for the pressure decrease of 4 kPa in the inhaler varies. The smaller the diameter of the air intake duct gets, the higher the flow rate of the air entraining the dry powder medicament gets and therefore the friction in the air intake duct increases. The increase of friction in the air intake duct results in an increase of the resistance of the inhaler hence the flow rate required to attain to the pressure decrease of 4 kPa in the inhaler decreases. In the inhaler designed by the inventor, the flow rate that must be applied by the patient is in the range of 20 L/min to 50 L/min when the diameter of the air intake duct is in the range of 3 mm to 7 mm; and flow rate values varying in this range can easily be applied by almost all patients at different ages and strength.

The term "effective inhalation" refers to an inhalation in which a sufficient amount of active agent required for an effective treatment is delivered to the patient's lungs.

The term "resistance of the inhaler" refers to resistance of the inhaler against air flow.

The term "flow rate" refers to volume of air flow that the patient must apply per minute during the inhalation of the medicament in dry powder form in the inhaler.

In another aspect, the present invention provides an inhaler which enables to deliver a sufficient amount of the dry powder medicament used in the treatment of respiratory diseases to the patient's lungs.

Since an increase of friction in the air intake duct causes increase of the resistance of the inhaler as mentioned above, the air intake duct is preferably made of a material having a sufficiently high friction coefficient and/or the inner surface of the air intake duct which is in contact with the air flow entraining dry powder medicament is coated with a material having a sufficiently high friction coefficient. The inner surface of the air intake duct is smooth so as to prevent dry powder particles to be confined to the air intake duct. The material used to produce the air intake duct or the coating material used to coat the inner surface of the air intake duct can be any material which has a sufficiently high friction coefficient though it is preferably selected from, but not limited to, a group comprising aluminum, steel, plastic, iron, copper, nickel, brass, zinc and/or a combination thereof. Friction coefficient of the materials used in production of said air intake duct and/or coating of inner surface of said air intake duct is in the range of 0.01 to 5, preferably in the range of 0.1 to 3, more preferably in the range of 0.1 to 2.5. Thickness of the coating on the inner surface of the air intake duct of the inhaler comprising capsule is preferably in the range of 1-40 μπι, more preferably in the range of 5- 30 μπι.

In the inhaler comprising capsule according to the present invention, the air intake duct inserted into the mouthpiece can be cylindrical or tapered. If the duct is tapered, the end of the duct through which the air flow entraining the dry powder medicament enters is preferably wide while the end of the duct which communicates with the patient's mouth is narrow. Thus, the air flow entraining medicament particles which exits the capsule, passes through the sieve and arrives in the air intake duct in the mouthpiece enters the wide end of the duct, pass through the duct that narrows through the other end and reaches the patient.

Agglomeration of particles of the dry powder medicament contained in capsules is probable due to the reasons such as moisture, electrostatic forces etc. This may result in failure to deliver the medicament in dry powder form to the patient's lungs and to absorb it the lungs. There are preferably protrusions on the inner surface of the air intake duct of the inhaler of the present invention. These protrusions are cylindrical or acicular. These protrusions provides to disaggregate the potential agglomerates of dry powder particles entrained in the air flow; therefore help to realize an effective inhalation.

In another aspect, there are preferably holes on the walls of the air intake duct in order to create turbulence in the air flow which passes through the air intake duct and entrains medicament in dry powder form. Number of these holes is at least two though they may have identical or different diameters. The holes are situated symmetrically or asymmetrically on the walls of the air intake duct.

The inhaler of the present invention comprises preferably a pierceable capsule containing medicament in dry powder form.

The inhaler of the present invention is composed of various components in order to ensure inhalation of the dry powder medicament contained in the capsule.

According to this, basic components of the inhaler are the mouthpiece cover, bottom casing, capsule chamber, mouthpiece and the middle chasing. The mouthpiece cover covers the mouthpiece and provides to keep it clean. The mouthpiece which is exposed when the mouthpiece cover is opened is joined with the middle casing and they synchronize. In the bottom casing, the capsule containing the medicament in dry powder form and the mechanism of the device are situated. On the sides of the middle casing, there are holes used as pin holders. The pins placed in these pin holders enable the mouthpiece cover, mouthpiece, middle casing with the mouthpiece, capsule chamber and the bottom casing to easily move around the pin they are attached to.

Mechanism of the device is situated in the bottom casing of the inhaler. The mechanism is composed of components which contribute to the inhaler of the present invention to work properly and the medicament in dry powder form contained in the capsule to be prepared for inhalation. The piercing needles which pierce the capsule; the needle carrier; the springs which enable the needle carrier to move towards and away from the capsule chamber and to be positioned correctly according to the needles are among components constituting the mechanism of the device.

There are holes on the capsule chamber in which the capsule containing dry powder medicament is placed in order to enable the needles to enter and exit the compartment where the capsule is placed. The connecting rod in the capsule chamber is inserted through the spring and the hole in the center of the needle carrier between the capsule chamber and the needle carrier and provides said spring to be positioned on it. According to this, said spring is situated between the capsule chamber and the needle carrier. The other spring in the mechanism of the device is on the other side of the needle carrier, between the needle carrier and the inner surface of the bottom casing. In other terms, the needle carrier is situated between the two springs.

At the outlet of the capsule chamber, there placed a sieve and a sieve holder above the sieve providing to keep it fixed. The air intake duct inserted into the mouthpiece is also fixed into this sieve. Therefore, the air exiting the capsule chamber passes through the sieve, the sieve holder and the air intake duct before being delivered to the patient as the air intake duct is on the same axis with the sieve and the sieve holder. In addition to these, the capsule chamber cover covering the capsule chamber provides to protect the capsule chamber and the mechanism of the device from external factors.

Prior to inhalation, the mouthpiece which synchronizes preferably with the middle casing has to be rotated outwards around the pin it is joined with in order to place the capsule containing the medicament in dry powder form in the capsule chamber. This movement of the mouthpiece is maintained until the capsule chamber gets to an available position for placing a capsule. For the capsule to be pierced after being placed in the capsule chamber, the mouthpiece has to be moved towards the capsule chamber. During the move of the mouthpiece towards the capsule chamber, while the pawls at the ends of the cogs reaching down under the mouthpiece are advancing on the rails in both sides of the needle carrier, the needle carrier compresses the spring and the piercing needles are moved towards the capsule. Furthermore, when each of the pawls at the ends of the cogs reaching down under the mouthpiece gets close to the corner of the rail it advances on, the spring approaches to maximum compression as the needle carrier is moved towards the capsule chamber and the needles pierce the capsule passing through the holes on the capsule chamber. While this movement of the mouthpiece is continuing, the pawls' passing the corner causes the spring to loosen and therefore the needle carrier to move away from the capsule chamber. When the mouthpiece is completely closed, the needle carrier is in the accurate and exact position between the two springs; and the needles are out of the capsule. In this position of the mouthpiece, the medicament in dry powder form contained in the pierced capsule is ready for inhalation.

The air flow entering the device upon inhalation of the patient flows through the holes of the capsule in the capsule chamber and entrains the dry powder medicament in the capsule out. Subsequently, the air flow entraining the dry powder medicament ensures the delivery of the medicament in dry powder form to the patient passing through the sieve, sieve holder and the air intake duct.

The mouthpiece is moved outwards after the dry powder medicament in the pierced capsule is inhaled by the patient and removed from the capsule chamber. In the case that the mouthpiece moves with the middle casing, the capsule chamber is exposed when the mouthpiece is moved outwards around the pin it is attached to. Thus, the discharged capsule is ejected from the capsule chamber after the inhalation and the capsule chamber is cleaned properly if required. The mouthpiece and the mouthpiece cover are kept close until the next inhalation.

The inhalation device of the present invention comprising capsule can be made of the same or different materials. According to this, each component of the inhaler can be made of a suitable material though it is preferably selected from a group comprising styrene- acrylonitrile, polyoxymethylene, acrylic polymethyl metacrylate, cellulose acetate, polyetheretherketone, polyvinyl chloride, polyethylene, polypropylene, acrylonitrile butadiene styrene, silicon, polycarbonate, polyamide, polystyrene, polyurethane or fluoropolymer types. Furthermore, each component of the device can be in any suitable color.

The capsule used in the inhaler comprising a capsule pertaining to the present invention can be made of any suitable substance though it is preferably made of a material selected from a group comprising gelatin, chitosan, starch and/or starch derivatives, cellulose and/or cellulose derivatives or synthetic polymers. In addition, the capsule of the present invention is composed of intertwining top and bottom compartments. The top and the bottom compartments of said capsule can be made of identical or different materials. According to this, in the case that the capsule used in the present invention is made of cellulose or its derivatives, the capsule material can be selected from, but not limited to, a group comprising hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose.

In the case that the capsule used in the present invention is synthetic polymer, the capsule material can be selected from, but not limited to, a group comprising polyethylene, polyetheleneteraphtalate, polycarbonate or polypropylene.

In the case that the capsule material used in the present invention is gelatine, additional agents such as polyethylene glycol, sorbitol, glycerol, propylene glycol, polyethylene oxide - polypropylene oxide block copolymers and/or other polyalcohols and polyethers at different molecular weights can be added into it.

The volume of the capsule containing the dry powder medicament in the inhaler of the present invention is in the range of 0.10 ml to 0.70 ml, preferably in the range of 0.10 ml to 0.52 ml and it is filled up to 0,01-30 %, preferably 0,01-25 % of said volume.

Moreover, the capsule pack containing the dry powder medicament and used in the inhaler of the present invention can be in any suitable shape and color on condition that it holds the specifications mentioned above.

The drawings given in the appendix in order to exemplify the present invention are explained with reference numbers below. The drawings aims to exemplify the invention, yet the invention cannot be limited to these drawings and descriptions below.

Figure 1 is a front view of the inhaler of the present invention.

Figure 2 is an exploded view of the inhaler of the present invention.

Figure 3 is a view of the communication of the main components of the device of the present invention.

Figures 4a and 4b are views of the capsule chamber together with the needle carrier of the inhaler of the present invention.

Figure 5 is a view of route that the mouthpiece of the inhaler of the present invention follows during its move towards the capsule chamber. Figure 6 is a view of the capsule chamber together with the mouthpiece when the mouthpiece of the inhaler of the present invention is entirely closed.

Figure 7 is a view of the capsule chamber together with the mouthpiece and the middle casing when the mouthpiece is entirely closed.

Figures 8 a- 8b are plan and bottom views of the mouthpiece of the inhaler of ht epresent invention respectively.

The preferred embodiment of the inhaler of the present invention is as in Figure 1 and Figure 2 in the appendix though the components of the inhaler of the present invention are illustrated in the figures 3 to 8.

The inhaler of the present invention illustrated in Figure 1 is in pre-use position. In pre-use position, only the mouthpiece cover (1) hiding the mouthpiece; the bottom casing (2) where the mechanism of the device is situated; and the middle casing (3) are visible. The mouthpiece cover (1) covers the movable mouthpiece (3') component which is connected with the bottom casing (2) of the inhaler in pre-use position. Therefore, the mouthpiece cover (1) enables to keep the mouthpiece (3') clean in pre-use position and carry it everywhere comfortably.

Each component of the inhaler and their communication with each other can clearly be seen in the exploded view of the inhaler of the present invention in Figure 2. The mechanism of the inhaler of the present invention and the capsule chamber (13) are situated in the bottom casing (2) of the device. The mechanism of the inhaler is composed of constituents which contribute to ensure proper operation of the inhaler of the present invention and prepare the medicament in dry powder form contained in the capsule of the inhaler for inhalation. The piercing needles (9a, 9b) that pierce the capsule, the needle carrier (8), the springs (10a, 10b) which enable the needle carrier to easily move towards and away from the capsule chamber and keep the needle carrier at the accurate position according to the positions of the needles are among the constituents composing the mechanism of the inhaler. According to figure 2, the mouthpiece (3') and the middle casing (3) are joined and they synchronize. The capsule chamber cover (13a) which covers the capsule chamber (13) ensures protection of the capsule chamber (13) and the mechanism of the inhaler from external factors. There is a sieve (6) at the outlet of the capsule chamber (13) and a sieve holder (7) which keeps this sieve fixed.

In figure 3; the mouthpiece cover (1), the bottom casing (2), the middle casing (3) and the mouthpiece (3') which are the main components of the inhaler and the positions of each around the pins (12a, 12b) they are attached to are illustrated. According to figure 3 and 8b, the upper pin (12a) and the lower pin (12b) are kept in a precise position by the pin holders (3a, 3b, 3c, 3d) on the middle casing (3). The upper pin (12a) is hold by the pin holders (3a, 3c) on the upper part of the middle casing; the lower pin (12b) is hold by the pin holders (3b, 3d) on the lower part of the middle casing. The mouthpiece cover (1) of the inhaler of the present invention is joined with the upper pin (12a); the bottom casing (2), the middle casing (3), the mouthpiece (3') and the capsule chamber (13) are joined with the lower pin (12b), and these components can be easily rotated around the pins they are joined. The mouthpiece cover (1) is joined with the upper pin (12a) via the mouthpiece pin hole (la); the bottom casing (2) and the capsule chamber (13) are joined with the lower pin (12b) via the bottom casing pin hole (2a) and the capsule chamber pin hole (13b) respectively.

In figures 4a-4b, the needle carrier (8) is illustrated with the capsule chamber (13). There are holes (15a, 15b) on the capsule chamber (13) where the capsule comprising the medicament in dry powder form is placed in order to enable the needles (9a, 9b) to go in and out of the compartment where the capsule is. The needles (9a, 9b) held by the needle carrier (8) go through these holes (15a, 15b) on the capsule chamber (13) and pierce the capsule. The connection rod (11) in the capsule chamber (13) goes into the hole (8a) in the center of the needle carrier (8) with the spring (10a) between the capsule chamber (13) and the needle carrier (8). The other spring (10b) in the mechanism of the inhaler is on the other side of the needle carrier (8), between the needle carrier (8) and the inner surface of the bottom casing (2). In other words, the needle carrier (8) is situated between the two springs (10a, 10b). This spring (10b) on the other side of the needle carrier (8) enables accurate and exact positioning of the needle carrier (8) when the mouthpiece (3') is completely closed.

Movement of the mouthpiece (3') towards the capsule chamber (13) after the capsule is placed in the capsule chamber (13) is illustrated in figures 5, 6 and 7. The mouthpiece (3') is advanced on the rails (14a, 14b) on both sides of the needle carrier (8) by means of the pawls (4c, 4d) at the end of the cogs (4a, 4b) reaching down under the mouthpiece (3'). In more detail, while one of the pawls (4c) at the ends of the cogs reaching down under the mouthpiece (3') is advancing on the path (14a) in its side, the pawl (4d) at the end of the other cog reaching down under the mouthpiece (3') advances on the rail (14b) in its side. The cogs (4a, 4b) reaching down under the mouthpiece and the pawl (4c, 4d) at the end of each cog are clearly illustrated in Figure 8a in detail. In order to place the capsule containing the medicament in dry powder form into the capsule chamber (13) before inhalation, the mouthpiece (3') which synchronizes with the middle casing (3) has to be moved outwards around the pin (12b) it is joined. This movement of the mouthpiece (3') has to be continued until the mouthpiece (3') gets to a position available to comfortably place the capsule into the capsule chamber (13). So as to pierce the capsule after the capsule is placed into the capsule chamber (13), the route illustrated in figure 5 should be followed while the mouthpiece (3') is being closed on the capsule chamber (13). During the movement of the mouthpiece (3^ onto the capsule chamber (13), while the pawls (4c, 4d) at the ends of the cogs (4a, 4b) reaching down under the mouthpiece are advancing on the rails (14a, 14b) on both sides of the needle carrier (8), the needle carrier (8) compresses the spring (10a) and the piercing needles (9a, 9b) move towards the capsule. Furthermore, when each of the pawls (4c, 4d) at the end of the cogs (4a, 4b) reaching down under the mouthpiece gets close to the corner of the rail (14a, 14b) it advances on, the spring (10a) approaches to maximum compression as the needle carrier (8) is moved towards the capsule chamber (13) and the needles (9a, 9b) pierce the capsule passing through the holes on the capsule chamber (15a, 15b). While this movement of the mouthpiece (3') is continuing, the pawls' (4c, 4d) passing the corner causes the spring (10a) to loosen and therefore the needle carrier (8) to move away from the capsule chamber (13). As shown in figure 6 and figure 7, when the mouthpiece (3') is completely closed, the needle carrier (8) is in the accurate and exact position between the two springs (10a, 10b); and the needles (9a, 9b) are out of the capsule. In this position of the mouthpiece (3 , medicament in dry powder form contained in the pierced capsule is ready for inhalation.

The mouthpiece of the inhaler of the present invention which is joined with the middle casing is shown from different perspectives in figure 8a and figure 8b. The air intake duct (5) which is inserted into the mouthpiece (3') ensures delivery of the air flow entraining the medicament in dry powder form to the patient. According to figure 2, there is a sieve (6) at the outlet of the capsule chamber (13) and a sieve holder (7) which keeps this sieve fixed. The air intake duct (5) which is inserted into the mouthpiece (3') also fits into this sieve holder (7). Thus, as the air intake duct (5) is on the same axis with the sieve (6) and the sieve holder (7), the air exiting the capsule chamber (13) passes through the sieve (6), the sieve holder (7) and the air intake duct (5) and reaches the patient.

External air entering the device upon inhalation of the patient flows into the holes on the capsule chamber (13) and entrains the medicament in dry powder form contained in the capsule out. Then, the air flow entraining the medicament in dry powder form ensures delivery of the dry powder medicament to the patient passing through the sieve (6), the sieve holder (7) and the air intake duct (5).

After the medicament in dry powder form in the pierced capsule is inhaled by the patient, the mouthpiece (3') is moved outwards and removed from the capsule chamber (13). The capsule chamber (13) is exposed when the mouthpiece (3') synchronizing with the middle casing (3) is moved outwards around the pin it is joined. Hence, the capsule discharged after inhalation is ejected from the capsule chamber (13) and the capsule chamber (13) is cleaned properly if required. The mouthpiece (3') and the mouthpiece cover (1) are kept close (figure 1) until the following inhalation.

The capsule containing the dry powder medicament in the inhaler of the present invention is produced according to the prior art. According to the present invention, the particle size of the active agents contained in the capsule is less than 20 μηι, preferably less than 10 μηι.

The inhaler of 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 used.

The dry powder medicament delivered via the device of 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 excipient 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 capsules used in the device of 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 derivatives thereof.

The active agent comprised in the medicament in dry powder form delivered via the inhaler of 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 of the present invention is used in the administration of the medicament in dry powder form which is utilized in the treatment of respiratory diseases, particularly in asthma, chronic obstructive pulmonary disease (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.

Analysis Results

Using DUSA device, tables 1-5 illustrate flow rate (Q) values required to be applied by the patient during inhalation at different diameter values (d) of air intake duct in order to ensure standard pressure decrease (ΔΡ) of 4 kPa in the inhaler of the present invention after the capsule is pierced. For each diameter value of the air intake duct, 10 measurements were conducted. Analysis results under given condition are as follows. As can be seen in the tables, in the case that the diameter of the duct fixed into the mouthpiece is in the range of 3 mm to 6 mm, the flow rate required to be applied by the patient in order to provide standard pressure decrease of 4 kPa is rather low.

Table 1: Q-ΔΡ values when diameter of air intake duct is 4.1 mm

Table 2: Q-ΔΡ values when diameter of air intake duct is 4.3 mm

Table 3: Q-ΔΡ values when diameter of air intake duct is 4.5 mm

Table 4: Q-ΔΡ values when diameter of air intake duct is 4.7 mm

Table 5: Q-ΔΡ values when diameter of air intake duct is 5.0 mm