US20030188747A1 - Inhalator, a powder composition and a process for administering the powder composition using inhalators - Google Patents

Abstract

An inhalator including an inhalator body including a powder receiving chamber for receiving a powder, an air-powder mixture reservoir for temporarily storing an air-powder mixture flowing from the powder receiving chamber, and a diluent air passage for introducing a diluent air into the air-powder mixture reservoir. The air-powder mixture is formed within the powder receiving chamber when an air is introduced into the powder receiving chamber. The air-powder mixture within the air-powder mixture reservoir is admixed with a diluent air introduced thereinto through the diluent air passage. The diluted air-powder mixture is discharged from an air-powder mixture outlet into a user's oral or nasal cavity. A powder composition for inhalators includes at least two kinds of fine particles different in particle diameter.

Description

BACKGROUND OF THE INVENTION
• The present invention relates to an inhalator suitable for administering a powder or powder composition, and a powder composition containing powders different in particle diameter from each other and a process for administering the powder composition using inhalators.[0001]
• Generally, a powder inhalator is used for inhaling a powder or powder composition such as a powdered medicine into a human body through the oral or nasal cavity. The inhalator includes an inhalator body having an air intake path for introducing an ambient air and a suction opening through which an air-powder mixture within the inhalator body is sucked into the oral or nasal cavity. A powder receiving chamber for receiving the powder is disposed within the inhalator body and communicated with the outside of the inhalator body via the air intake path. An air-powder mixture path extends from the powder receiving chamber to the suction opening. The air-powder mixture is formed when the air is introduced into the powder receiving chamber through the air intake path. The air-powder mixture is then transmitted from the powder receiving chamber to the suction opening via the air-powder mixture path.[0002]
• There are several types of powders different in aerodynamic mean particle diameter as follows: a powder having the aerodynamic mean particle diameter of not less than 7 μm and depositing in an oral cavity or hypoglottis, a powder having the aerodynamic mean particle diameter of 5-7 μm and depositing in a throat, a powder having the aerodynamic mean particle diameter of 3-5 μm and depositing in a trachea, a powder having the aerodynamic mean particle diameter of 1-3 μm and depositing in bronchi, and a powder having the aerodynamic mean particle diameter of not more than 1 μm and depositing into alveoli, and the like. The powder having the aerodynamic mean particle diameter of not more than 3 μm is required to surely reach affected areas of the human body. Also, the powder such as an acrid powder is preferably dosed in several parts upon being inhaled.[0003]
• In addition, there has been proposed powder tobacco for use with the inhalator. The powder tobacco can be substituted for a usual smoking tobacco because the powder tobacco provides a smoking feeling upon being inhaled. When the powder tobacco is used, one dose of the powder tobacco is dispensed in parts from the inhalator upon each inhalation.[0004]
• The human bronchi and alveoli exist in deeper portions of the human body. Therefore, in order to ensure stable deposit of the powder having the particle diameter of not more than 3 μm in the bronchi and alveoli, it is preferable to dose the powder in parts, i.e., dispense a small amount of the powder each inhalation.[0005]
• However, in the earlier technique, the whole amount of the powder received within the powder receiving chamber of the inhalator is dispensed from the inhalator by the inhalation substantially at one time. If a dose of the powder having the particle diameter of not more than 3 μm is inhaled through the inhalator upon inhalation, a large amount of the powder dosed will be deposited in the oral cavity or trachea before being deposited in the bronchi and alveoli.[0006]
• Further, there is known a process for administering a particulate medicament having a specific mean particle diameter into a patient's lungs upon the patient breathing. International Publication No. WO97/36574 discloses a process and device for inhalation of particulate medicament. The process includes (i) providing an inhalator which contains at least one dose of medicament particles comprising spherical hollow particulates of respirable particle size suitable for deposition in a human lungs, and (ii) removing the spherical hollow particulates from the inhalator. In the earlier technique, the particulate medicament having the specific particle diameter is used with the inhalator, but there is not described inhalation on multipurpose prescription, for instance, one-time inhalation of multiple particulate medicaments for the purpose of simultaneous deposition in different portions such as the trachea and the alveoli of the patient's body. In order to follow the multi-purpose prescription, it is required that the patient repeatedly inhales separate doses of particulate medicaments for different prescriptions, takes a specific particulate medicament formulated for the multi-purpose prescription, or is treated with the combination of various prescriptions including peroral medicament, injection, application of fomentation, and the like.[0007]
SUMMARY OF THE INVENTION
• It is an object of the present invention to provide an inhalator capable of dispensing one dose of a powder or powder composition in parts therefrom.[0008]
• It is another object of the present invention to provide a powder composition containing powders different in particle diameter from each other and a process for administering the powder composition using inhalators, which are suitable for simultaneous deposition in different portions of the human body by one-time inhalation.[0009]
• According to one aspect of the present invention, there is provided an inhalator for administering an air-powder mixture, comprising:[0010]
• an inhalator body including an air intake path for introducing air into the inhalator body, and an air-powder mixture outlet for discharging the air-powder mixture from the inhalator body;[0011]
• a powder receiving chamber adapted to receive a powder, the powder receiving chamber being disposed within the inhalator body and communicated with an outside of the inhalator body through the air intake path;[0012]
• an air-powder mixture path adapted to transmit the air-powder mixture flowing from the powder receiving chamber to the air-powder mixture outlet;[0013]
• an air-powder mixture reservoir adapted to temporarily store the air-powder mixture flowing from the powder receiving chamber, the air-powder mixture reservoir being disposed within the air-powder mixture path; and[0014]
• a diluent air passage adapted to introduce a diluent air into the air-powder mixture reservoir, the diluent air passage communicating the air-powder mixture reservoir with the outside of the inhalator body.[0015]
• According to a further aspect of the present invention, there is provided an inhalator for administering an air-powder mixture, comprising:[0016]
• a casing including an air intake inlet for introducing air into the casing, and an air-powder mixture outlet for discharging the air-powder mixture from the casing;[0017]
• powder receiving means for receiving a powder within the casing and permitting the powder to be admixed with the air introduced from the air intake inlet;[0018]
• air-powder mixture storing means for temporarily storing the air-powder mixture passing through the powder receiving means;[0019]
• diluent air passage means for permitting a diluent air to flow into the air-powder mixture storing means; and[0020]
• air-powder mixture path means for permitting the air-powder mixture to flow from the powder receiving means to the air-powder mixture outlet via the air-powder mixture storing means.[0021]
• According to another aspect of the present invention, there is provided a powder composition for use with an inhalator, comprising:[0022]
• at least two kinds of fine particles selected from a first kind of fine particles having an aerodynamic mean particle diameter of not less than 7 μm, a second kind of fine particles having an aerodynamic mean particle diameter of 5-7 μm, a third kind of fine particles having an aerodynamic mean particle diameter of 3-5 μm, a fourth kind of fine particles having an aerodynamic mean particle diameter of 1-3 μm, and a fifth kind of fine particles having an aerodynamic mean particle diameter of not more than 1 μm.[0023]
• According to a further aspect of the present invention, there is provided a process for administering a powder composition using an inhalator, comprising:[0024]
• preparing the powder composition containing at least two kinds of fine particles selected from a first kind of fine particles having an aerodynamic mean particle diameter of not less than 7 μm, a second kind of fine particles having an aerodynamic mean particle diameter of 5-7 μm, a third kind of fine particles having an aerodynamic mean particle diameter of 3-5 μm, a fourth kind of fine particles having an aerodynamic mean particle diameter of 1-3 μm, and a fifth kind of fine particles having an aerodynamic mean particle diameter of not more than 1 μm;[0025]
• supplying the powder composition to the inhalator; and[0026]
• discharging the powder composition from the inhalator.[0027]
• The other objects and features of this invention will become understood from the following description with reference to the accompanying drawings.[0028]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an elevation of an inhalator of a preferred embodiment, according to the present invention;[0029]
• FIG. 2 is a longitudinal section of the inhalator, taken along the line[0030]2-2 of FIG. 1, showing a rest position of the inhalator;
• FIG. 3 is an enlarged section of the inhalator, taken along the line[0031]3-3 of FIG. 2;
• FIG. 4 is an enlarged section of the inhalator, taken along the line[0032]4-4 of FIG. 2;
• FIG. 5 is an enlarged section of the inhalator, taken along the line[0033]5-5 of FIG. 2; and
• FIG. 6 is a view similar to FIG. 2, but showing a use position of the inhalator.[0034]
DETAILED DESCRIPTION OF THE INVENTION
• Referring to FIGS.[0035]1-6, an inhalator, according to the present invention, of a preferred embodiment is explained.
• As illustrated in FIG. 1, the inhalator includes an[0036]inhalator body1 as a casing which is formed into a cylindrical shape.Inhalator body1 is made of a suitable resin material such as polypropylene, polystyrene, ABS resin and the like.Inhalator body1 is constituted ofcap3,suction body4 andcapsule body2 interposed betweencap3 andsuction body4.Cap3 hasair intake inlet7A shown in FIG. 2, through which an ambient air is introduced intocap3 and flows towardcapsule body2 andsuction body4 as explained later.Cap3 has a length shorter than that ofcapsule body2 and is rotatably connected with an upstream side ofcapsule body2.Suction body4 has air-powder mixture outlet18 shown in FIG. 2, from which an air-powder mixture formed ininhalator body1 is discharged into a user's oral cavity.Suction body4 has a length longer than that ofcapsule body2 and is rotatably connected with a downstream side ofcapsule body2.
• As illustrated in FIG. 2,[0037]capsule body2 has engagingprojection2A and engaging groove2A1 on the upstream end portion.Engaging projection2A and engaging groove2A1 axially adjacent thereto are engaged withengaging tube portion3A and engaging projection3A1 ofcap3, respectively.Capsule body2 is coupled withcap3 by the engagement ofengaging projection2A and engaging groove2A1 withengaging tube portion3A and engaging projection3A1, respectively.Capsule body2 also has at the downstream end portion, engagingprojection2B and engaging groove2B1 axially adjacent thereto.Engaging projection2B and engaging groove2B1 are engaged withengaging tube portion4A and engaging projection4A1 ofsuction body4, respectively.Capsule body2 is coupled withsuction body4 by the engagement of engagingprojection2B and engaging groove2B1 with engagingtube portion4A and engaging projection4A1, respectively.
• Cocoon-shaped[0038]powder receiving chamber5 is substantially coaxially disposed withincapsule body2.Powder receiving chamber5 is provided for receiving a dose of a powder or powder composition such as particulate medicament, powder tobacco or the like.Powder receiving chamber5 is in communication with the outside ofinhalator body1 throughair intake path6, when the inhalator is in a use position as explained later by referring to FIG. 6. The air-powder mixture is formed withinpowder receiving chamber5 when the air flows intopowder receiving chamber5 viaair intake path6 in the use position of the inhalator.
• [0039]Air intake path6 is provided for introducing the air intopowder receiving chamber5.Air intake path6 includesupstream intake passage7 formed incap3 anddownstream intake passage8 formed incapsule body2.Upstream intake passage7 has an upstream end opening asair intake inlet7A which is open to a generally central portion of an axial end face ofcap3.Upstream intake passage7 has a downstream end opening that is open to a bottom of engagingtube portion3A which mates with an axial end face of engagingprojection2A, in an offset position relative to the center axis ofcap3.Downstream intake passage8 has an upstream end opening that is open to the axial end face of engagingprojection2A in an offset position relative to the center axis ofcapsule body2.Downstream intake passage8 has a downstream end opening that is open to an upstream end portion ofpowder receiving chamber5 and in substantially alignment with the center axis ofcapsule body2.
• [0040]Capsule body2 andcap3 are relatively rotatable to be placed in a non-communication position shown in FIG. 2 and a communication position shown in FIG. 6. In the non-communication position, the downstream end opening ofupstream intake passage7 and the upstream end opening ofdownstream intake passage8 are out of alignment with each other. Fluid communication betweenupstream intake passage7 anddownstream intake passage8 is blocked so thatpowder receiving chamber5 is prevented from being fluidly communicated with the outside of the inhalator. On the other hand, in the communication position, the downstream end opening ofupstream intake passage7 and the upstream end opening ofdownstream intake passage8 are in alignment with each other. The fluid communication betweenupstream intake passage7 anddownstream intake passage8 is established so thatpowder receiving chamber5 is fluidly communicated with the outside of the inhalator. The opening area at the connection ofupstream intake passage7 anddownstream intake passage8 may be desirably regulated by adjusting the alignment ofintake passages7 and8 to thereby control a flow amount of the air introduced intopowder receiving chamber5 and therefore control an amount of the powder in the air-powder mixture flowing frompowder receiving chamber5 toward air-powder mixture outlet18.
• Air-[0041]powder mixture path9 extends betweenpowder receiving chamber5 and air-powder mixture outlet18. Air-powder mixture path9 permits the air-powder mixture to flow frompowder receiving chamber5 to air-powder mixture outlet18 when the inhalator is in the use position.
• First air-[0042]powder mixture reservoir12 is disposed within air-powder mixture path9. Air-powder mixture reservoir12 is disposed in substantially coaxial withsuction body4. Air-powder mixture reservoir12 is adapted to be communicated withpowder receiving chamber5 throughdischarge passage10 and connectingpassage11 of air-powder mixture path9. Air-powder mixture reservoir12 has a cocoon shape having a volumetric capacity greater than a volumetric capacity of connectingpassage11. Air-powder mixture reservoir12 having the greater volumetric capacity allows the air-powder mixture flowing thereinto through connectingpassage11 to be temporarily stored.
• [0043]Discharge passage10 is formed incapsule body2 so as to be open topowder receiving chamber5 at the upstream end and to engagingprojection2B at the downstream end. An upstream end opening ofdischarge passage10 is open to a downstream end portion ofpowder receiving chamber5 and in substantially alignment with the center axis ofcapsule body2. A downstream end opening ofdischarge passage10 is open to an axial end face of engagingprojection2B in an offset position relative to the center axis ofcapsule body2. Connectingpassage11 is formed insuction body4 so as to be open to engagingtube portion4A at the upstream end and to air-powder mixture reservoir12 at the downstream end. An upstream end opening of connectingpassage11 is open to a bottom of engagingtube portion4A which mates with the axial end face of engagingprojection2B, in an offset position relative to the center axis ofsuction body4. A downstream end opening of connectingpassage11 is open to an upstream end portion of air-powder mixture reservoir12 and in substantially alignment with the center axis ofsuction body4.Capsule body2 andsuction body4 are relatively rotatable so as to be placed in a non-communication position shown in FIG. 2 and a communication position shown in FIG. 6. In the non-communication position, the downstream end opening ofdischarge passage10 and the upstream end opening of connectingpassage11 are out of alignment with each other so that fluid communication betweendischarge passage10 and connectingpassage11 is blocked.Powder receiving chamber5 is prevented from being fluidly communicated with air-powder mixture reservoir12. On the contrary, in the communication position, the downstream end opening ofdischarge passage10 and the upstream end opening of connectingpassage11 are in alignment with each other. The fluid communication betweendischarge passage10 and connectingpassage11 is established so thatpowder receiving chamber5 is fluidly communicated with the air-powder mixture reservoir12. The opening area at the connection ofdischarge passage10 and connectingpassage11 may be desirably regulated by adjusting the alignment ofdischarge passage10 and connectingpassage11 to thereby control an amount of the air-powder mixture flowing frompowder receiving chamber5 into air-powder mixture reservoir12.
• First[0044]diluent air passage19 is formed insuction body4 and communicated with air-powder mixture reservoir12.Diluent air passage19 introduces a diluent air into air-powder mixture reservoir12 when the air-powder mixture flows frompowder receiving chamber5 into air-powder mixture reservoir12. The diluent air introduced is merged in the air-powder mixture within air-powder mixture reservoir12 to thereby dilute the air-powder mixture. The diluted air-powder mixture flowing from air-powder mixture reservoir12 has a reduced flow rate and a decreased mixing ratio of the powder relative to the air which are present in the diluted air-powder mixture.Diluent air passage19 is constituted of four passages arranged in crossed manner in lateral section in this embodiment as shown in FIG. 3. As illustrated in FIG. 3, each of fourdiluent air passages19 has an inlet open to an outer circumferential surface ofsuction body4 and an outlet open to a circumferential surface of air-powder mixture reservoir12.
• Second air-[0045]powder mixture reservoir14 is disposed within air-powder mixture path9 downstream of first air-powder mixture reservoir12. Air-powder mixture reservoir14 is disposed in substantially coaxial relation tosuction body4. Air-powder mixture reservoir14 is communicated with air-powder mixture reservoir12 throughcommunication passage13 of connectingpassage11 which extends in the axial direction ofsuction body4. Air-powder mixture reservoir14 has a bell shape having a volumetric capacity greater than a volumetric capacity ofcommunication passage13 when viewed in axial cross-section. Air-powder mixture reservoir14 with the greater volumetric capacity allows the air-powder mixture flowing thereinto throughcommunication passage13 to be temporarily stored.
• Dispersion[0046]part15 is disposed within air-powder mixture path9 downstream of second air-powder mixture reservoir14.Dispersion part15 is adapted to prevent the powder in the air-powder mixture flowing from second air-powder mixture reservoir14 from aggregating together and intimately mix the powder and the air to form a uniform air-powder mixture.Dispersion part15 includesdispersion chamber17 and a plurality ofdispersion passages16 connected withdispersion chamber17.Dispersion passages16, four passages in this embodiment, connectdispersion chamber17 with air-powder mixture reservoir14. Each ofdispersion passages16 has an inlet open to air-powder mixture reservoir14 and an outlet open todispersion chamber17. Specifically,dispersion passage16 includes an inlet passage portion extending from an outer peripheral portion of air-powder mixture reservoir14 in the axial direction ofsuction body4.Dispersion passage16 also includesoutlet passage portion16A that radially inwardly extends from a downstream side of the inlet passage portion and is open to an upstream end portion ofdispersion chamber17. As illustrated in FIG. 4,dispersion chamber17 has a generally circular-shaped section andoutlet passage portion16A extends in a tangential direction ofdispersion chamber17. The air-powder mixture flowing intodispersion chamber17 throughdispersion passages16 forms a swirl flow withindispersion chamber17. The swirl flow of the air-powder mixture prevents the powder in the air-powder mixture from forming an aggregated mass of the powder.
• Second[0047]diluent air passage20 is formed withinsuction body4 in communication withdispersion chamber17. As seen from FIGS. 2 and 5, fourdiluent air passages20 radially extend fromgrooved portion4B on an outer surface ofsuction body4 todispersion chamber17.Grooved portion4B extends along the entire circumference of the outer surface ofsuction body4.Diluent air passages20 introduce the ambient air as a diluent air intodispersion chamber17 when the air-powder mixture withindispersion chamber17 is directed towardoutlet18 by the user's suction.
• [0048]Regulator21 for variably controlling a flow amount of the diluent air introduced intodispersion chamber17 viadiluent air passages20 is axially moveably disposed on groovedportion4B ofsuction body4.Regulator21 is in the form of a ring in this embodiment.Regulator21 has fourregulator holes21A coming into alignment withdiluent air passages20 by the axial movement of theregulator21.Regulator21 variably regulates an opening area of each ofdiluent air passages20 to thereby variably control the flow amount of the diluent air which is merged in the air-powder mixture withindispersion chamber17.
• The air-powder mixture passing through[0049]dispersion passages16 anddispersion chamber17 flows to air-powder mixture outlet18 from which the air-powder mixture is dispensed into the user's oral cavity. Air-powder mixture outlet18 is communicated withdispersion chamber17 and open to one axial end surface ofsuction body4. Air-powder mixture outlet18 is disposed substantially coaxially with the center axis ofsuction body4.
• Referring back to FIG. 1, counter or[0050]registration marks22,22,22 are formed on the upstream and downstream end portions of the outer circumferential surface ofcapsule body2, downstream engagingtube portion3A ofcap3, and upstream engagingtube portion4A ofsuction body4, respectively. Whencounter mark22 on the upstream-end side ofcapsule body2 is aligned withcounter mark22 on the downstream-end side ofcap3, upstream anddownstream intake passages7 and8 ofair intake path6 are communicated with each other. Whencounter mark22 on the downstream-end side ofcapsule body2 is aligned withcounter mark22 on the upstream-end side ofsuction body4,discharge passage10 and connectingpassage11 of air-powder mixture path9 are communicated with each other.
• An operation of the thus-constructed inhalator of the present invention will be explained hereinafter.[0051]
• When the inhalator is in a rest or nonuse position shown in FIG. 2, upstream and[0052]downstream intake passages7 and8 ofair intake path6 are fluidly disconnected from each other and dischargepassage10 and connectingpassage11 of air-powder mixture path9 are fluidly disconnected from each other. In this state,powder receiving chamber5 is prevented from being fluidly communicated with the outside ofinhalator body1 and air-powder mixture reservoir12. Thus, if the inhalator is in the rest position, the powder received withinpowder receiving chamber5 can be restrained from flowing therefrom andinhalator body1 when the user carries the inhalator.
• Next, upon using the inhalator,[0053]cap3 andsuction body4 are rotated relative tocapsule body2 to align respective counter marks22 with each other.Regulator21 is axially moved ingrooved portion4B so as to desirably adjust the opening area of seconddiluent air passage20. The inhalator is thus placed in a use position shown in FIG. 6. In the use position, upstream anddownstream intake passages7 and8 ofair intake path6 are fluidly connected with each other and dischargepassage10 and connectingpassage11 of air-powder mixture path9 are fluidly connected with each other.Powder receiving chamber5 is allowed to be in fluid communication with the outside ofinhalator body1 and air-powder mixture reservoir12. In this state, air-powder mixture outlet18 ofinhalator body1 is put into the user's oral cavity and the ambient air is sucked by the user. The air is introduced intoair intake path6 throughair intake inlet7A. The air then flows intopowder receiving chamber5 as indicated by arrows in FIG. 6. The introduced air is admixed with the dose of the powder withinpowder receiving chamber5, forming the air-powder mixture. The air-powder mixture flows into first air-powder mixture reservoir12 viadischarge passage10 and connectingpassage11 of air-powder mixture path9. The air-powder mixture is temporarily stored within air-powder mixture reservoir12 and admixed with the diluent air introduced throughdiluent air passage19. The thus diluted air-powder mixture has a decreased flow rate flowing intocommunication passage13, and a reduced mixing ratio of the powder in the diluted air-powder mixture to the air in the diluted air-powder mixture.
• The diluted air-powder mixture within first air-[0054]powder mixture reservoir12 flows into second air-powder mixture reservoir14 viacommunication passage13 and then enters intodispersion chamber17 viadispersion passages16. There occurs a swirl flow of the diluted air-powder mixture withindispersion chamber17. The swirl flow atomizes an aggregated mass of the powder which remains indispersion chamber17, to thereby assure the air-powder mixture containing fine particles of the powder in a suitably dispersed state. The air-powder mixture withindispersion chamber17 is diluted by the diluent air introduced thereinto through seconddiluent air passage20 andregulator holes21A ofregulator21. The thus diluted air-powder mixture then is discharged from air-powder mixture outlet18 into the user's oral cavity.
• As be appreciated from the above explanation, the air-powder mixture flowing from[0055]powder receiving chamber5 is diluted within air-powder mixture reservoir12 by the diluent air introduced into air-powder mixture reservoir12 throughdiluent air passage19. A flow rate of the air-powder mixture is reduced within air-powder mixture reservoir12 by the introduction of the diluent air. As a result, a part of the dose of the powder received withinpowder receiving chamber5 is sucked by one-time inhalation by the user. Therefore, the dose of the powder received withinpowder receiving chamber5 can be divided into a plurality of dose parts each being sucked by the user. Thus, the user can suck a small amount of the powder that forms each dose part, by one-time inhalation. If it is required to deposit fine particulate medicament having a small particle diameter in the bronchi or alveoli of a patient, a dose of the medicament can be dispensed in parts which are inhaled by multiple-time inhalation of the user through the inhalator of the invention. The fine particulate medicament can be prevented from being deposited in the trachea and be stably deposited in the bronchi or alveoli by multiple-time inhalation of the dose parts. The inhalator of the invention can be effectively used for dispensing a dose of a powder or powder composition such as particulate medicament and powder tobacco, in parts by multiple-time inhalation.
• Further, with the arrangement of second[0056]diluent air passage20 andregulator21 for regulating the opening area ofdiluent air passage20, an amount of the diluent air introduced intodispersion chamber17 can be desirably regulated by axially movingregulator21. A mixing ratio between the powder and the air present in the air-powder mixture withindispersion chamber17 can be readily controlled by the regulation of the diluent air to be introduced. Accordingly, an amount of the powder which is sucked by one-time inhalation by the user, can be desirably controlled usingregulator21 depending on the user's liking, kinds of particulate medicaments, or the like. This can improve a performance of the inhalator. The amount of the powder for one-time inhalation may be controlled by regulating the opening area at the connection of upstream anddownstream intake passages7 and8 ofair intake path6 or the opening area at the connection ofdischarge passage10 and connectingpassage11 of air-powder mixture path9.
• Furthermore, with the arrangement of[0057]dispersion passages16 anddispersion chamber17 atdispersion part15, the swirl flow of the air-powder mixture can be produced withindispersion chamber17, which atomizes an aggregated mass of the powder remaining indispersion chamber17 and forms the air-powder mixture containing the powder particles in a good dispersed state. This can improve a dispersion efficiency of the inhalator.
• Further, upstream and[0058]downstream intake passages7 and8 ofair intake path6 is arranged to establish and block the fluid communication betweenpowder receiving chamber5 and the outside ofinhalator body1. When the inhalator is in the nonuse position, upstream anddownstream intake passages7 and8 are disconnected from each other so that the fluid communication betweenpowder receiving chamber5 and the outside ofinhalator body1 is blocked. In addition,discharge passage10 and connectingpassage11 of air-powder mixture path9 is arranged to allow and block the fluid communication betweenpowder receiving chamber5 and first air-powder mixture reservoir12. In the nonuse position of the inhalator,discharge passage10 and connectingpassage11 are disconnected from each other so that the fluid communication betweenpowder receiving chamber5 and first air-powder mixture reservoir12 is blocked. With this arrangement ofintake passages7 and8 and dischargepassage10 and connectingpassage11, the powder received withinpowder receiving chamber5 can be prevented from flowing therefrom toward bothair intake inlet7A and air-powder mixture reservoir12 upon the user carrying the inhalator. This can improve reliability of the inhalator. Further, whenintake passages7 and8 are communicated with each other upon using the inhalator, the opening area of the connection ofintake passages7 and8 can be regulated to control the flow amount of the air flowing intopowder receiving chamber5. Therefore, the amount of the powder present in the air-powder mixture produced withinpowder receiving chamber5 can be adjusted. Similarly, upon communication ofdischarge passage10 and connectingpassage11, the opening area of the connection thereof can be regulated to control the flow amount of the air-powder mixture flowing frompowder receiving chamber5 into air-powder mixture reservoir12. The amount of the powder in the air-powder mixture flowing from air-powder mixture reservoir12 toward air-powder mixture outlet18 can be adjusted, and therefore, the amount of the powder to be sucked can be adjusted.
• Although two air-[0059]powder mixture reservoirs12 and14 are provided withinsuction body4 in this embodiment, a single air-powder mixture reservoir or three or more air-powder mixture reservoirs may be provided.
• In addition, a capsule chamber for storing a capsule having a dose of the powder may be substituted for[0060]powder receiving chamber5. In this case, the capsule within the capsule chamber may be pierced using a piercing device upon inhalation.
• Further, a shutter member may be provided for blocking and allowing the fluid communication between[0061]powder receiving chamber5 and the outside ofinhalator body1 and air-powder mixture reservoir12, instead of the arrangement of upstream anddownstream intake passages7 and8 ofair intake path6 and dischargepassage10 and connectingpassage11 of air-powder mixture path9. The shutter member may be rotatably or slidably disposed withinair intake path6 extending betweenpowder receiving chamber5 andair intake inlet7A and the portion of air-powder mixture path9 which extends betweenpowder receiving chamber5 and air-powder mixture reservoir12.
• Furthermore, either one of the upstream end portion of[0062]capsule body2 and engagingtube portion3A ofcap3 may have on the outer circumferential surface a groove circumferentially extending within a predetermined angular region. The other may have on the outer circumferential surface a projection engageable with the groove such that bothcapsule body2 andcap3 are rotatably moveable to each other in the predetermined angular region. A similar circumferentially extending groove may be formed on either one of the outer circumferential surface of the downstream end portion ofcapsule body2 and the outer circumferential surface of engagingtube portion4A ofsuction body4, and a similar projection may be formed on the other thereof. If the projections reach the respective ends of the grooves, the communication between upstream anddownstream intake passages7 and8 and the communication betweendischarge passage10 and connectingpassage11 will be established. In this case, counter marks22 can be omitted.
• Next, a powder composition for use with inhalators and a process for administering the powder composition using inhalators, according to the present invention, will be explained hereinafter.[0063]
• The powder composition is suitable to be administered from an oral or nasal cavity for deposition in inside parts of the human body. The powder composition includes at least two kinds of fine particles selected from a group consisting of a first kind of fine particle having an aerodynamic mean particle diameter of not less than 7 μm, a second kind of fine particle having an aerodynamic mean particle diameter of 5-7 μm, a third kind of fine particle having an aerodynamic mean particle diameter of 3-5 μm, a fourth kind of fine particle having an aerodynamic mean particle diameter of 1-3 μm, and a fifth kind of fine particle having an aerodynamic mean particle diameter of not more than 1 μm. The first kind of fine particle having the aerodynamic mean particle diameter of not less than 7 μm is deposited in an oral cavity or hypoglottis of a human body. The second kind of fine particle having the aerodynamic mean particle diameter of 5-7 μm is deposited in a throat of a human body. The third kind of fine particle having the aerodynamic mean particle diameter of 3-5 μm is deposited in a trachea of a human body. The fourth kind of fine particle having the aerodynamic mean particle diameter of 1-3 μm is deposited in bronchi of a human body. The fifth kind of fine particle having the aerodynamic mean particle diameter of not more than 1 μm is deposited in alveoli of a human body.[0064]
• Preferably, the fine particles of the powder composition of the present invention have a significantly narrow particle size distribution. More preferably, the fine particles have the particle size distribution consistent with a predetermined range of an aerodynamic mean particle diameter which is required for deposition in the respective parts of the human body.[0065]
• The powder composition may be powder tobacco and particulate medicament. The powder tobacco contains at least two kinds of fine particles selected from the first, third and fifth kinds of fine particles as described above. For instance, the powder tobacco may contain fine particles as a gustatory component which have the aerodynamic mean particle diameter of 45-55 μm for deposition in the oral cavity or hypoglottis, fine particles as a stimulatory component which have the aerodynamic mean particle diameter of 3-5 μm for deposition in the trachea or throat, and fine particles as an agent which have the aerodynamic mean particle diameter of 0.5-2 μm for deposition in the alveoli or bronchi. A coffee extract powder may be used for the fine particles as a gustatory component having the aerodynamic mean particle diameter of 45-55 μm. A menthol extract powder may be used for the fine particles as a stimulatory component having the aerodynamic mean particle diameter of 3-5 μm. A nicotine extract powder may be used for the fine particles as an agent having the aerodynamic mean particle diameter of 0.52 μm. If the powder tobacco is inhaled with the inhalator, the same taste, stimulus and nicotinic effect as those obtained by smoking can be obtained.[0066]
• The particulate medicament as the powder composition of the present invention contains at least two kinds of fine particles selected from the first through fifth kinds of fine particles as described above. The particulate medicament may contain fine particles as a gustatory component which have the aerodynamic mean particle diameter of 60-80 μm for deposition in the oral cavity or hypoglottis, fine particles as an antiphlogistic agent which have the aerodynamic mean particle diameter of 4-6 μm for deposition in the trachea or throat, and fine particles as an agent which have the aerodynamic mean particle diameter of 1-3 μm for deposition in the alveoli or bronchi. A powdered troche or candy may be used for the fine particles as a gustatory component having the aerodynamic mean particle diameter of 60-80 μm. An antiphlogistic powder may be used for the fine particles as an antiphlogistic agent having the aerodynamic mean particle diameter of 4-6 μm. An antibiotic powder may be used for the fine particles as an agent having the aerodynamic mean particle diameter of 1-3 μm.[0067]
• In addition, the particulate medicament as the powder composition of the present invention may be selected from an analgesic agent, an anginal preparation, an antiallergic agent, an anti-infective agent, an antihistaminic agent, an anti-inflammatory agent, an antitussive agent, a bronchodilator agent, a diuretic agent, an anticholinergic agent, and the like, depending on cure purposes. These powder agents may have various aerodynamic mean particle diameters suitable for deposition in different target parts of the human body.[0068]
• If required, the particulate medicament as the powder composition of the present invention may be used together with a known excipient acceptable for inhalation into the human body. The composition of the particulate medicament is prepared in accordance with the doctor's prescription given on the basis of the patient's symptom.[0069]
• In the administration process of the present invention, first the powder composition is prepared so as to contain at least two kinds of fine particles selected from the first to fifth kinds of fine particles as described above. The at least two kinds of fine particles of the powder composition may be blended together. The thus prepared powder composition is supplied to an inhalator suitable for dispensing a powder into the human body. The powder composition may be capsulated and then accommodated in the inhalator. Subsequently, the powder composition supplied is discharged from the inhalator. If the above-described inhalator of the present invention is used, the powder composition may be dispersed within the inhalator and then discharged therefrom without aggregation of the fine particles of the powder composition.[0070]
• The powder composition and administration process of the present invention can be suitably used for cure of multiple diseases using the particulate medicaments which have effects on the multiple diseases, respectively. Specially, the powder composition and administration process of the present invention is suitable for providing analgesia and curing inflammation in the oral cavity and/or throat, asthma, bronchitis, COPD (chronic obstructive pulmonary disease), respiratory disease such as thoracho-infection, and allergosis.[0071]
• The inhalators useable in this embodiment are described in Japanese Patent Applications First Publication Nos. 62-41668 and 9-47509, Japanese Patent Application Second Publication No. 63-6024, and U.S. Pat. No. 5,996,577.[0072]
EXAMPLES
• The present invention is described in more detail by way of examples. However, these examples are only illustrative and not intended to limit a scope of the present invention thereto.[0073]
Example 1
• A dose of a powder tobacco was prepared by blending 5 mg of coffee extract particulates having an aerodynamic mean particle diameter of 50 μm, 10 mg of menthol extract particulates having an aerodynamic mean particle diameter of 4 μm, and 1 mg of nicotine extract particulates having an aerodynamic mean particle diameter of 0.5-2 μm together. The thus prepared dose of a powder tobacco was supplied to a suitable inhalator as described above and then discharged from the inhalator.[0074]
Example 2
• A dose of a particulate medicament mixture was prepared by blending candy particles having an aerodynamic mean particle diameter of 70 μm, antiphlogistic agent particles having an aerodynamic mean particle diameter of 5 μm, antibiotic agent particles having an aerodynamic mean particle diameter of 2 μm together in accordance with a doctor's prescription. The thus prepared dose of a particulate medicament mixture was filled in a capsule. The thus capsulated dose of a particulate medicament mixture was accommodated in a suitable inhalator as described above and then discharged from the inhalator.[0075]
• Using the powder composition and the administration process of the present invention, a dose of the powder composition containing the at least two kinds of fine particulates different in mean particle diameter from each other can be selected depending on the target parts of the human body in which the powder composition is required to be deposited, and can be deposited in the target parts by one-time inhalation using the inhalator. Namely, multi-purpose dosage of particulate medicaments, for instance, deposition of the particulate medicaments in both of the trachea and the alveoli or all of the throat, the bronchi and the alveoli, can be achieved during the one-time inhalation.[0076]
• Further, using the powder composition and the administration process of the present invention, the patient can dispense with multiple times of inhalation for dosing a plurality of particulate medicaments required in different prescriptions. Also, any specific compound of particulate medicaments may not be required for multi-purpose prescription.[0077]
• Furthermore, in a case where the capsulated powder composition of particulate medicaments having different mean particle diameters is used, the patient can dispense with adjusting the amount of the powder composition required for each inhalation and the mixing ratio of the different kinds of particulate medicaments.[0078]
• The entire contents of basic Japanese Patent Applications Nos. 2000-363636 filed on Nov. 29, 2000, and 2000-359822 filed on Nov. 27, 2000, inclusive of the specification, claims and drawings, are herein incorporated by reference.[0079]
• Although the invention has been described above by reference to certain embodiments of the invention, the invention is not limited to the embodiments described above. Modifications and variations of the embodiment described above will occur to those skilled in the art, in light of the above teachings. The scope of the invention is defined with reference to the following claims.[0080]

Claims (27)

What is claimed is:

1. An inhalator for administering an air-powder mixture, comprising:

an inhalator body including an air intake path for introducing an air into the inhalator body, and an air-powder mixture outlet for discharging the air-powder mixture from the inhalator body;

a powder receiving chamber adapted to receive a powder, the powder receiving chamber being disposed within the inhalator body and communicated with an outside of the inhalator body through the air intake path;

an air-powder mixture path adapted to transmit the air-powder mixture flowing from the powder receiving chamber to the air-powder mixture outlet;

an air-powder mixture reservoir adapted to temporarily store the air-powder mixture flowing from the powder receiving chamber, the air-powder mixture reservoir being disposed within the air-powder mixture path; and

a diluent air passage adapted to introduce a diluent air into the air-powder mixture reservoir, the diluent air passage communicating the air-powder mixture reservoir with the outside of the inhalator body.

2. The inhalator as claimed inclaim 1, further comprising a second diluent air passage adapted to introduce a diluent air into the air-powder mixture path downstream of the air-powder mixture reservoir upon the air-powder mixture flowing from the air-powder mixture reservoir, and a regulator variably controlling an opening area of the second diluent air passage.

3. The inhalator as claimed inclaim 1, further comprising a dispersion part adapted to disperse the powder in the air-powder mixture passing through the air-powder mixture path downstream of the air-powder mixture reservoir.

4. The inhalator as claimed inclaim 3, wherein the dispersion part comprises a plurality of dispersion passages branched from the air-powder mixture path downstream of the air-powder mixture reservoir, and a dispersion chamber disposed within the air-powder mixture path downstream of the dispersion passages, each of the dispersion passages having an outlet passage portion that is open into the dispersion chamber and arranged to form a swirl flow of the air-powder mixture.

5. The inhalator as claimed inclaim 4, wherein the dispersion chamber has a generally circular-shaped section and the outlet passage portion of each of the dispersion passages extends in a tangential direction of the dispersion chamber.

6. The inhalator as claimed inclaim 1, wherein the air intake path is arranged to allow and block fluid communication between the powder receiving chamber and the outside of the inhalator body.

7. The inhalator as claimed inclaim 6, wherein the air intake path comprises at least two passages having an alignment position where the at least two passages are in alignment with each other and an offset position where the at least two passages are out of alignment with each other.

8. The inhalator as claimed inclaim 1, wherein the air-powder mixture path is arranged to allow and block fluid communication between the powder receiving chamber and the air-powder mixture reservoir.

9. The inhalator as claimed inclaim 8, wherein the air-powder mixture path comprises at least two passages disposed between the powder receiving chamber and the air-powder mixture reservoir, the plurality of passages having an alignment position where the at least two passages are aligned with each other and an offset position where the at least two passages are offset from each other.

10. The inhalator as claimed inclaim 4, further comprising a second air-powder mixture adapted to temporarily store the air-powder mixture flowing from the first air-powder mixture reservoir toward the dispersion passages of the dispersion part.

11. The inhalator as claimed inclaim 10, wherein each of the dispersion passages comprises an inlet open into the second air-powder mixture reservoir.

12. An inhalator for administering an air-powder mixture, comprising:

a casing including an air intake inlet for introducing an air into the casing, and an air-powder mixture outlet for discharging the air-powder mixture from the casing;

powder receiving means for receiving a powder within the casing and permitting the powder to be admixed with the air introduced from the air intake inlet;

air-powder mixture storing means for temporarily storing the air-powder mixture passing through the powder receiving means;

diluent air passage means for permitting a diluent air to flow into the air-powder mixture storing means; and

air-powder mixture path means for permitting the air-powder mixture to flow from the powder receiving means to the air-powder mixture outlet via the air-powder mixture storing means.

13. The inhalator as claimed inclaim 12, further comprising air intake path means for permitting the air to flow from the air intake inlet into the powder receiving means.

14. The inhalator as claimed inclaim 12, wherein the air-powder mixture path means allows and blocks fluid communication between the powder receiving means and the air-powder mixture storing means.

15. The inhalator as claimed inclaim 12, further comprising a second diluent air passage means for permitting a diluent air to flow into the air-powder mixture path means downstream of the air-powder mixture storing means upon the air-powder mixture flowing from the air-powder mixture storing means.

16. The inhalator as claimed inclaim 15, further comprising a regulator variably controlling an opening area of the second diluent air passage means.

17. The inhalator as claimed inclaim 12, further comprising dispersion means for preventing the powder in the air-powder mixture from being aggregated together.

18. The inhalator as claimed inclaim 17, wherein the dispersion means comprises passages means for forming a swirl flow of the air-powder mixture and chamber means for receiving the swirl flow of the air-powder mixture.

19. The inhalator as claimed inclaim 18, wherein the chamber means has a generally circular-shaped section and the passage means extends in a tangential direction of the chamber means.

20. A powder composition for use with an inhalator, comprising:

at least two kinds of fine particles selected from a first kind of fine particles having an aerodynamic mean particle diameter of not less than 7 μm, a second kind of fine particles having an aerodynamic mean particle diameter of 5-7 μm, a third kind of fine particles having an aerodynamic mean particle diameter of 3-5 μm, a fourth kind of fine particles having an aerodynamic mean particle diameter of 1-3 μm, and a fifth kind of fine particles having an aerodynamic mean particle diameter of not more than 1 μm.

21. The powder composition as claimed inclaim 20, wherein the powder composition comprises powder tobacco.

22. The powder composition as claimed inclaim 20, wherein the powder composition comprises particulate medicament.

23. A process for administering a powder composition using an inhalator, comprising:

preparing the powder composition containing at least two kinds of fine particles selected from a first kind of fine particles having an aerodynamic mean particle diameter of not less than 7 μm, a second kind of fine particles having an aerodynamic mean particle diameter of 5-7 μm, a third kind of fine particles having an aerodynamic mean particle diameter of 3-5 μm, a fourth kind of fine particles having an aerodynamic mean particle diameter of 1-3 μm, and a fifth kind of fine particles having an aerodynamic mean particle diameter of not more than 1 μm;

supplying the powder composition to the inhalator; and

discharging the powder composition from the inhalator.

24. The process as claimed inclaim 23, wherein the discharging comprises dispersing the powder composition within the inhalator.

25. The process as claimed inclaim 23, further comprising capsulating the powder composition.

26. The process as claimed inclaim 23, wherein the powder composition comprises powder tobacco.

27. The process as claimed inclaim 23, wherein the powder composition comprises particulate medicament.

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