RU2815222C2 - Device and method of delivery of medicinal product into patient's respiratory tract - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to variants of a device for delivering a medicinal composition into the patient’s respiratory tract and a method of introducing a medicinal composition into the patient’s respiratory tract. In the first embodiment, the device contains, in fluid communication: an inlet for a gas mixture; an outlet for gas mixture; a dispenser having an upper surface and a lower surface; a container for the medicinal composition adapted to accommodate the medicinal composition; and a dispersion chamber. The dispenser is configured to be positioned between: (a) a first arrangement, in which the lower surface of the dispenser is located at the inlet of the gas mixture to limit the flow of the gas mixture entering the device, and in which the upper surface of the dispenser is adjacent to the bottom of the medicinal product container composition to allow the medicinal composition to be contained in the container for the medicinal composition; and (b) a second arrangement, in which the lower surface of the dispenser is offset towards the gas mixture outlet compared to the first arrangement to open a path for the flow of the gas mixture into the device through the gas mixture inlet, and wherein the upper surface of the dispenser is adjacent to the top of the medicinal product composition container to transfer the medicinal product composition into the dispersion chamber. The dispenser is located between the first arrangement and the second arrangement as a result of: (i) creating excess pressure through the gas mixture inlet; and (ii) creating a vacuum through the outlet for the gas mixture. In the second version of the device, the dispenser is made with a floating piston and contains a dispersion chamber located between the container for the medicinal composition and the outlet for the gas mixture; and at least one opening in the chamber defining a passage for flow of the gas mixture between the gas mixture inlet and the dispersion chamber. In the third embodiment, the device contains an inlet for the gas mixture located at the second end of the device, opposite the first end. The dispenser is made with a floating piston. The method includes the following steps: placing the medicinal composition, connecting the outlet for the gas mixture to the patient's respiratory tract, and creating a flow of the gas mixture between the inlet for the gas mixture and the outlet for the gas mixture.

EFFECT: development of new devices for respiratory delivery of medicinal product compositions that have better versatility or flexibility during operation.

23 cl, 8 dwg

Description

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

The present invention relates to a device for delivering a drug into the respiratory tract of a patient. In particular, the invention relates, without limitation, to a device for delivering a drug in the form of microparticles into the respiratory tract of a patient under the influence of excess pressure and/or vacuum, and to an associated method of administration.

PREREQUISITES FOR CREATION OF THE INVENTION

For some medical conditions, it may be necessary to administer medication to the patient through the respiratory tract. For this purpose, you can use inhalers, for example, dry powder inhalers, as well as inhalers.

Existing dry powder inhalers are typically designed to operate under vacuum in response to the patient's inhalation. This typically limits the use of such inhalers to conscious and responsive patients, limiting the inhalers' utility in emergency medical settings.

Existing inhalers also typically have poor reliability and/or accuracy in dose delivery, with dosage typically dependent on changes in patient condition upon inhalation. This generally limits the use of inhalers to cases in which dosage changes are acceptable, eg where the effects of underdosing and/or overdosing are not life-threatening.

Accordingly, there is a need to develop new strategies for respiratory drug administration. In particular, there is a need to develop new devices for respiratory delivery of drug compositions that have better versatility or flexibility during operation.

BRIEF SUMMARY OF THE INVENTION

In a first aspect, a device is provided for delivering a medicinal composition to the respiratory tract of a patient; a fluid communicating device containing:

inlet for gas mixture;

outlet for gas mixture;

a dispenser having an upper surface and a lower surface;

a container for the medicinal composition adapted to accommodate the medicinal composition; And

dispersion chamber;

in this case, the dispenser is performed between:

(a) a first arrangement, in which the lower surface of the dispenser is located adjacent to the gas mixture inlet to restrict the flow of the gas mixture entering the device, and in which the upper surface of the dispenser is adjacent to the bottom of the drug composition container to allow the drug composition located in a container for the medicinal composition; And

(b) a second arrangement, in which the lower surface of the dispenser is offset towards the gas mixture outlet compared to the first arrangement so as to open a channel for the flow of the gas mixture into the device through the gas mixture inlet, and wherein the upper surface of the dispenser is adjacent to the top of the drug composition container to move the drug composition into the dispersion chamber; and wherein the dispenser is located between the first location option and the second location option as a result of:

(i) creating excess pressure through the gas mixture inlet; And

(ii) creating a vacuum through the outlet for the gas mixture.

Accordingly, an inlet for the gas mixture and an outlet for the gas mixture are located in the body of the device. The container for the medicinal composition may be located within the body of the device.

Accordingly, the flow of the gas mixture between the gas mixture inlet and the gas mixture outlet facilitates delivery of the drug composition into the respiratory tract of the patient through the gas mixture outlet.

In one embodiment, the device is sealed or substantially closed to the entry and/or exit of the gas mixture, except for the gas mixture inlet and the gas mixture outlet.

In other embodiments, the gas mixture inlet is configured to connect to respiratory equipment. Additionally or alternatively, the inlet for the gas mixture may be a mouthpiece. The inlet for the gas mixture may have a substantially cylindrical profile.

In some embodiments, the gas mixture outlet of the device is configured to connect to respiratory equipment. Additionally or alternatively, the outlet for the gas mixture may be a mouthpiece. The outlet for the gas mixture may have a substantially cylindrical profile.

It should be understood that the dispenser is configured to move between the first arrangement and the second arrangement.

A preferred movement of the dispenser is moving the dispenser from a position substantially outside the medicinal composition container to a position substantially inside the medicinal composition container. Typically, in the first arrangement, the dispenser is located substantially outside the medicinal composition container, and in the second arrangement, the dispenser is located substantially inside the medicinal composition container.

The dispenser usually contains a piston.

References to a dispenser located substantially inside or outside the drug composition container may refer to the surface of the dispenser adjacent to or directly facing the drug composition container when it is in the first arrangement. This surface may be the top surface of the piston closest to the drug composition container.

In this embodiment, the drug formulation container in the device will be adapted to accommodate the drug formulation for delivery to the patient's respiratory tract.

In some embodiments, the drug composition container is adapted to receive a container containing a drug composition for delivery. Typically the container is a capsule. The medicinal composition container can suitably accommodate the container. The fit may be a clearance fit.

According to this embodiment, if the dispenser of the device is in the first arrangement and the drug composition container is open, then the drug composition or a container containing the drug composition can be received in the drug composition container.

Accordingly, when the dispenser is moved from the first arrangement to the second arrangement with the medicinal composition container closed, the medicinal composition or container containing the medicinal composition located within the medicinal composition container is substantially displaced from the medicinal composition container.

In this embodiment, the dispersion chamber in the device may be adapted to disperse the drug composition in a gas mixture flow between the gas mixture inlet and the gas mixture outlet for delivery to the respiratory tract of the patient.

Accordingly, the dispersion chamber is in fluid communication with the inlet for the gas mixture, the outlet for the gas mixture, the dispenser and the container for the medicinal composition.

The dispersion chamber may be located substantially adjacent to the drug composition container.

Accordingly, the dispersion chamber is adapted to accommodate a medicinal composition for delivery to a patient. The dispersion chamber may be adapted to receive a container containing the medicinal composition.

When the dispenser is in the first arrangement and the medicinal composition or container containing the medicinal composition is located within the medicinal composition container, the medicinal composition or container may be located substantially outside the dispersion chamber.

When moving the dispenser from the first arrangement to the second arrangement, the medicinal composition or container containing the medicinal composition, which is located inside the medicinal composition container, can be moved from the medicinal composition container. When transferring the drug composition or container from the drug composition container, the drug composition or container may be placed in a dispersion chamber.

Moving the dispenser from the first arrangement to the second arrangement may involve moving the dispenser from an edge or flange adjacent to the gas mixture inlet to create a flow of the gas mixture.

In the second arrangement, the upper surface of the dispenser can be offset from the bottom of the dispersion chamber. The offset from the center can be up to 5 mm, 4 mm or 3 mm.

The dispersion chamber may be configured to move a container containing a medicinal composition within the dispersion chamber. In some embodiments, the dispersion chamber is adapted to allow rotational displacement or rotation of the container containing the drug composition.

When moving the dispenser from the first arrangement to the second arrangement, one or more openings in the chamber may be open to the flow of the gas mixture. The gas mixture flow may flow from the gas mixture inlet into one or more openings in the chamber.

One or more openings in the chamber may facilitate the flow of the gas mixture into the dispersion chamber. Each one or more openings in the chamber may constitute a chamber passageway for directing flow of the gas mixture into the dispersion chamber.

Moving the dispenser from the first arrangement to the second arrangement preferably opens a gas mixture flow path from the gas mixture inlet to one or more openings in the chamber and directly into the dispersion chamber. At this point, the flow of the gas mixture can interact with the drug composition.

One or more openings in the chamber facilitate the formation of a gas mixture flow between the gas mixture inlet and the gas mixture outlet.

Accordingly, the flow of a gas mixture into the dispersion chamber through one or more openings in the chamber helps disperse the drug composition for delivery to the patient's respiratory tract.

The flow of a gas mixture into the dispersion chamber through one or more openings in the chamber may promote movement of the container containing the drug composition within the dispersion chamber, thereby assisting in the dispersion of the drug composition.

The dispersion chamber may be a vortex chamber in which the flow of a gas mixture through one or more openings in the chamber creates a vortex within the vortex chamber.

Producing a vortex within the vortex chamber promotes rotational motion or rotation of the container containing the drug composition to be delivered to the patient within the dispersion chamber, thereby facilitating the dispersion of the drug composition.

The dispersion chamber may include one or more projections or protrusions to assist in dispersing the drug composition. The one or more projections may include one or more elongated projections, radially oriented projections, or protrusions on the surface of the dispersion chamber. It is preferable to use at least two projections, protrusions or protrusions. In some embodiments, projections, radially oriented projections, or protrusions protrude from the wall or top wall of the dispersion chamber or swirl chamber. Accordingly, the container containing the medicinal composition is displaced by one or more projections, protrusions or protrusions during its rotational movement, thereby helping to disperse the medicinal composition. Typically, the height of the radially oriented protrusions or protrusions above the surface from which they protrude is from about 0.1 mm to about 1 mm, including 0.2, 0.3, 0.4, 0.5, 0.6, 0 .7, 0.9 and 0.9 mm.

In accordance with this embodiment, the device typically includes a trigger for releasing the drug composition from the container containing the drug composition for delivery to the respiratory tract of the patient.

The trigger device may comprise at least one trigger device drive. Accordingly, the trigger mechanism can be actuated by the user to assist in the release of the drug composition from the container. The trigger drive may include a button or switch.

In some embodiments, activation of the trigger may occur automatically upon removal of the cap from the device.

The cap may have an elongate member extending from its underside. The elongate member may extend into the dispersion chamber when the cap is fully engaged with the device. This helps to hold the container containing the medicinal composition in place within the medicinal composition container.

The elongate member may be a plug or pin extending through the gas mixture outlet into the dispersion chamber when the cap is fully engaged with the device.

The trigger device may comprise at least one pin or blade capable of piercing or cutting a container containing a medicinal composition for delivery to the respiratory tract of a patient using a delivery device, or piercing or cutting a seal, membrane or shell. Accordingly, the at least one spoke or blade is capable of piercing or cutting the container in response to actuation of the trigger mechanism.

In this embodiment, the device may further comprise a degranulator adapted to further disperse and/or degranulate the drug composition for delivery to the patient's airway using the delivery device. Accordingly, the degranulator promotes the dispersion and/or degranulation of the drug composition in response to the formation of a gas mixture flow between the gas mixture inlet and the gas mixture outlet.

Accordingly, the degranulator is in fluid communication with an inlet for the gas mixture, an outlet for the gas mixture, a dispenser and a container for the medicinal composition. In some embodiments, the degranulator is located substantially adjacent to the dispersion chamber.

In some embodiments, the degranulator is or contains a screen or mesh. Accordingly, the sieve or mesh contains a plurality of holes or slits to create turbulence in the flow of the gas mixture. The degranulator additionally has the function of filtering the medicinal composition to remove residual organic substances from the container, including its fragments.

In some embodiments, the degranulator is or contains one or more elastic elements. Accordingly, the elastic elements are configured to vibrate in response to the formation of a gas mixture flow between the gas mixture inlet and the gas mixture outlet.

The second aspect proposes a system comprising:

(i) a device in fluid communication and comprising: an inlet for a gas mixture; outlet for gas mixture; dispenser; container for medicinal composition; and a dispersion chamber; wherein the dispenser may be located between the first arrangement in which the container for the medicinal composition is substantially open and the flow of the gas mixture between the inlet for the gas mixture and the outlet for the gas mixture is limited; and a second arrangement in which the drug composition container is substantially closed and the flow of the gas mixture between the gas mixture inlet and the gas mixture outlet is substantially unlimited; And

(ii) a medicinal composition or a container containing a medicinal composition located within the medicinal composition container.

In one embodiment, (i) is the apparatus of the first aspect.

In one embodiment, (ii) is a container containing a medicinal composition, where the container contains a cutable or pierceable seal, membrane or shell.

The system of the second aspect may further comprise respiratory equipment connected to the gas mixture inlet and/or gas mixture outlet.

A third aspect provides a method of administering a medicinal composition to a patient's respiratory tract using a fluid communicating device comprising: an inlet for a gas mixture; outlet for gas mixture; dispenser; container for medicinal composition; and a dispersion chamber; wherein the dispenser may be located between the first arrangement in which the container for the medicinal composition is substantially open and the flow of the gas mixture between the inlet for the gas mixture and the outlet for the gas mixture is limited; and a second arrangement in which the capacity for the medicinal composition is substantially limited and the flow of the gas mixture between the gas mixture inlet and the gas mixture outlet is substantially unlimited, comprising the steps of:

placing the medicinal composition or a container containing the medicinal composition substantially inside the container for the medicinal composition;

connecting the outlet for the gas mixture with the patient's respiratory tract; And

creating a flow of a gas mixture between the inlet for the gas mixture and the outlet for the gas mixture, wherein the medicinal composition is delivered by the flow of the gas mixture into the respiratory tract of the patient through the outlet for the gas mixture,

thereby introducing the medicinal composition into the patient's respiratory tract.

A fourth aspect provides a method of treating or preventing a condition in a patient by administering an effective amount of a drug composition to the patient's respiratory tract using a fluid communicating device comprising: an inlet for a gas mixture; outlet for gas mixture; dispenser; container for medicinal composition; and a dispersion chamber; wherein the dispenser may be between a first arrangement in which the drug composition container is substantially open and the flow of the gas mixture from the gas mixture inlet to the gas mixture outlet is restricted; and a second arrangement, in which the capacity for the medicinal composition is significantly limited, and the flow of the gas mixture from the inlet for the gas mixture to the outlet for the gas mixture is practically unlimited, including the stages:

placing the medicinal composition or a container containing the medicinal composition substantially inside the container for the medicinal composition;

connecting the outlet for the gas mixture with the patient's respiratory tract; And

creating a flow of the gas mixture from the inlet for the gas mixture to the outlet for the gas mixture,

in this case, the medicinal composition is delivered by a flow of gas mixture into the patient’s respiratory tract through the outlet for the gas mixture

to treat or prevent a condition in a patient.

In embodiments of the third or fourth aspect, the patient is conscious and/or responsive. In these embodiments, the patient may self-administer.

It should be understood that in embodiments of the third or fourth aspect, creating a flow of the gas mixture from the gas mixture inlet to the gas mixture outlet will cause the dispenser to move from the first arrangement to the second arrangement.

In embodiments of the fourth aspect, the patient's condition is critical. In these embodiments, the patient may be unconscious and/or unconscious.

In embodiments of the third or fourth aspect, the device is a device of the first aspect.

In embodiments of the third or fourth aspect, a flow of the gas mixture is generated and therefore the dispenser is moved from the first arrangement to the second arrangement as a result of creating a vacuum through the gas mixture outlet. Vacuum can be created as a result of the patient inhaling through the outlet for the gas mixture.

In embodiments of the third or fourth aspect, a flow of the gas mixture is generated and therefore the dispenser is moved from the first arrangement to the second arrangement as a result of pressurization through the gas mixture inlet. The excess pressure may be generated by a compressed gas source connected to the gas mixture inlet. In addition, excess pressure can be created as a result of the patient exhaling into the inlet for the gas mixture. It should be understood that in such embodiments, the operator will be different from the patient or subject who will receive the drug composition.

The method of the third or fourth aspect may include the step of displacing the drug composition or a container containing the drug composition from the drug composition container.

The method of the third or fourth aspect may include the step of placing a medicinal composition or a container containing a medicinal composition within a dispersion chamber of the device.

The drug composition may be dispersed within or at the outlet of the dispersion chamber in response to the flow of a gas mixture between the gas mixture inlet and the gas mixture outlet.

Dispersion of the drug composition within or at the outlet of the dispersion chamber may be aided by rotation of the drug composition or container within the dispersion chamber.

The method of the third or fourth aspect may include the step of cutting or piercing a container containing a medicinal composition using a trigger of the device to facilitate release of the medicinal composition from the container.

The method of the third or fourth aspect may include the step of further dispersing and/or degranulating the drug composition using a degranulator device.

As used herein, the terms “ comprises ,” “ containing ,” “ includes ,” “ including ,” or similar terms are intended to denote non-exclusive inclusion in which a method, system, or apparatus that contains a list of elements does not include only those elements, but may well include other elements not listed.

It should be understood that the indefinite articles "a" and "an" are not to be understood as singular indefinite articles or otherwise excluding more than one or more than a single thing to which the indefinite article refers. For example, a gas mixture inlet means one gas mixture inlet, one or more gas mixture inlets, or a plurality of gas mixture inlets.

BRIEF DESCRIPTION OF THE DRAWINGS

In FIG. 1A is a side view of an embodiment of the invention.

In FIG. 1B is a front cross-sectional view of the device shown in FIG. 1A.

In FIG. 2A is a front view of the device shown in FIG. 1A.

In FIG. 2B is a top cross-sectional view of the device shown in FIG. 1A.

In FIG. 3A is a cross-sectional perspective view of the device shown in FIG. 1A, where the piston is in the first arrangement.

In FIG. 3B is a cross-sectional perspective view of the device shown in FIG. 1A, where the piston is in the second arrangement.

In FIG. 4 is an exploded view of a preferred embodiment of a device in accordance with the present invention.

In FIG. 5A and 5B are a top cross-sectional view and a front cross-sectional view, respectively, of the device shown in FIG. 4 with the cap completely closed.

In FIG. 6A and 6B show a top cross-sectional view and a front cross-sectional view, respectively, of the device shown in FIG. 4 with the cap partially removed.

In FIG. 7 is a cross-sectional perspective view of the device shown in FIG. 5B and 6B with the cap completely removed.

In FIG. 8 is an enlarged view of a disassembled portion of the device shown in FIG. 4, with attention directed to certain channels of the gas mixture flow.

DETAILED DESCRIPTION OF THE DRAWINGS

Delivery of therapeutic agents through the respiratory tract can be used in a number of applications. These include applications in which the patient is typically conscious and responsive, such as the administration of powdered vaccines, antibiotics, and insulin; and applications in which the patient may be unconscious, such as when administering powdered epinephrine to treat critical illnesses such as anaphylaxis or cardiac arrest.

The present invention is based at least in part on the recognition of the need for a device that provides versatility for respiratory delivery of therapeutic agents. In particular, there is a need for devices that facilitate both respiratory delivery of therapeutic agents under vacuum, similar to inhaler-type devices, and respiratory delivery of therapeutic agents under positive pressure, similar to, but not limited to, inflator-type devices.

The medicinal formulations mentioned herein are, without limitation, usually in the form of a dry powder for delivery. As used herein and as will be apparent to one skilled in the art, the term " dry powder " generally refers to a particulate form of a drug for respiratory delivery that is typically delivered or is suitable for delivery in the absence of a propellant.

A drug formulation as described herein (eg, a dry powder or particulate drug) will suitably contain at least one " active ingredient ", ie a biologically active component. The dry powder or particulate drug may be in the form of one or more pure or substantially pure active ingredients. In addition, the dry powder or particulate drug may contain one or more pharmaceutically acceptable components in addition to one or more active ingredients, e.g., excipients, excipients or diluents well known to those skilled in the art to which this invention relates. . For a non-limiting overview of dry powder formulations, one skilled in the art may refer to Telko and Hickey (2005) "Dry Powder Inhaler Formulation" Respiratory Care, 50 (9), 1209-1227, the contents of which are incorporated herein by reference in their entirety. It should be understood that the active agent and/or dosage composition containing the active agent may also be referred to as a “ drug .”

In one embodiment of the invention, a device is provided for administering a medicinal composition into the respiratory tract of a patient. In fig. 1-3 illustrate a typical embodiment of a device in this aspect, device 10.

In fig. 1A and 1B, the device 10 includes: a body 50; inlet 100 for gas mixture; an outlet 200 for a gas mixture; capacity 300 for medicinal composition; dispenser 400; a dispersion chamber 500; and starting devices 600.

As shown in more detail in FIG. 1B and 2B, body 50 includes walls 51 surrounding a hollow interior region. The body 50 is made of plastic, but this can be changed if necessary. For example, body 50 may be made of metal or contain rubber. It is also possible to use combinations of suitable materials.

The gas mixture inlet 100 and the gas mixture outlet 200 may be through the wall 51 of the body 50, although they may also be provided separately.

The inlet 100 for the gas mixture is designed for use as a fitting for connecting respiratory equipment or as a mouthpiece. Likewise, the gas mixture outlet 200 is configured for use as a fitting for connecting respiratory equipment or as a mouthpiece.

As shown, the gas mixture inlet 100 and the gas mixture outlet 200 have a conical profile, which is necessary when used as a connection and/or a mouthpiece. However, the profile of the gas mixture inlet 100 and/or the gas mixture outlet 200 can be changed as necessary.

As shown in more detail in FIG. 1B, 3A and 3B, the drug composition container 300 is located within the body 50. The drug composition container 300 in the device 10 is configured as a pocket with walls 310. The drug composition container 300 is adapted to properly accommodate a container, such as a capsule, containing the drug composition (not shown) for administration to a patient using delivery device 10.

As shown in more detail in FIG. 1B, the dispenser 400 is located within the body 50. The dispenser 400 of the device 10 is configured as a piston including an inlet end 410 and an outlet end 420. The piston 400 is movable from a first location or position substantially outside the drug composition container 300, as shown. in fig. 1B and 3A, to a second arrangement or position substantially within the drug composition container 300, as shown in FIG. 3B, with the piston 400 adjacent or adjacent to the dispersion chamber 500. In particular, the outlet end 420 of the piston 400 in the second arrangement will be located closer to the dispersion chamber 500 than in the first arrangement.

The dispersion chamber 500 of the device 10 is designed as a vortex chamber. As shown in more detail in FIG. 2B, 3A and 3B, the swirl chamber 500 includes a chamber wall 510; 520 camera channels; and corresponding chamber openings 530 that allow the gas mixture to flow from the gas mixture inlet 100 to the gas mixture outlet 200 and create and maintain a vortex. In some embodiments, the swirl chamber 500 may include at least a partial top wall.

The vortex chamber 500 is configured to receive a container containing a drug formulation for delivery as the container is moved from the medicinal composition container 300 to the vortex chamber 500. The vortex chamber 500 is configured to rotate a container located therein relative to the chamber wall 510.

In some embodiments, the swirl chamber 500 may include one or more projections (shown in more detail in FIG. 7) to assist in dispersing the drug formulation for delivery from the container containing the drug formulation. In some embodiments, swirl chamber 500 includes one or more projections, radially oriented projections, or protrusions on chamber wall 510 or the top wall of the chamber (FIG. 7). Typically, the height of the projections, radially oriented projections or protrusions is from about 0.1 mm to about 1 mm, including 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.9 and 0.9 mm.

As shown, the device 10 includes two triggering devices 600 on the sides of the container 300 for the medicinal composition. It should be understood that a single trigger can also be used.

As shown in more detail in FIG. 1B, 3A, and 3B, the triggers 600 are supported within the walls 51 of the body 50. The triggers 600 include a button 610 and a spoke 620. The trigger buttons 610 of the device 10 may be resilient buttons, such as deformable buttons or spring-loaded buttons, but may change if necessary.

It should be understood that the device 10 is sealed or substantially sealed at the inlet or outlet (eg, leakage or leakage) of the gas mixture, except for the gas mixture inlet 100 and the gas mixture outlet 200. As described above, the gas mixture inlet 100 and the gas mixture outlet 200 are part of the body 50 of the device 10 or an extension thereof. In addition, the firing devices 600 are located within the walls 51 of the body 50 in an air-tight or substantially air-tight manner.

It will also be appreciated that devices of this aspect, such as device 10, may include a degranulator 700 capable of degranulating the drug composition for delivery to the respiratory tract of a patient using the delivery device.

In some embodiments of apparatus 10 including a degranulator 700, the degranulator 700 is typically adjacent to or located adjacent to the dispersion chamber 500, as shown in more detail in FIG. 3A and 3B.

In one exemplary embodiment, the degranulator is or contains a screen or mesh containing a plurality of holes or slits to create turbulence in the flow of the gas mixture.

In one exemplary embodiment, the degranulator is or includes one or more elastic elements that are configured to vibrate in response to the generation of a flow of gas mixture.

During operation, the device 10 is capable of entraining the medicinal composition in the gas mixture flow between the gas mixture inlet 100 and the gas mixture outlet 200 and delivering the medicinal composition carried by the gas mixture flow into the patient's respiratory tract through the gas mixture outlet 200.

In use, a container or capsule (not shown) is placed substantially within the drug composition container 300. Typically, the capsule is held in a drug formulation container 300. The container or capsule typically includes a seal, membrane, or the like, such as a foil-lined seal or plastic shell, that can be cut or pierced by the firing devices 600. The top surface of the piston 400 may form the base or bottom of the drug composition container 300.

In operation, the trigger 600 is pressed, which presses the spokes 610 of the trigger 600 against the container or capsule placed in the drug composition container 300, piercing or cutting the seal or membrane of the container or capsule.

During operation, the piston 400 is moved by the flow of the gas mixture: from the first arrangement, as shown in FIG. 3A, in which the drug composition container 300 is open and receives a container or capsule, and the inlet end 410 of the piston 400 prevents or at least substantially restricts the flow of a gas mixture from the gas mixture inlet 100 to the gas mixture outlet 200; in the second arrangement, as shown in Fig. 3B, wherein the outlet end 420 of the piston 400 displaces the container or capsule from the drug formulation container 300 and facilitates or does not substantially restrict flow of the gas mixture from the gas mixture inlet 100 to the gas mixture outlet 200 as a result of the displacement of the inlet end. 410 piston 400.

References herein to the phrase “substantially unrestricted” with respect to the movement of the piston 400 during flow of the gas mixture are to be understood as substantially unrestricted flow of the gas mixture with respect to the first arrangement or position of the piston 400. In the second arrangement or position, the flow gas mixture is somewhat limited by the paths and channels through which it must flow, but the degree of restriction will be significantly less than if the piston 400 is in the first arrangement or position. In some embodiments, the phrase “substantially unrestricted” should be understood to mean “enabling,” “open,” “free,” or “clean” flow of the gas mixture relative to the flow of the gas mixture when the piston 400 is in the first arrangement or position.

During operation, the piston 400 may move from the first location to the second location by creating a vacuum on the piston 400 through the gas mixture outlet 200 and by creating excess pressure through the gas mixture inlet 100.

In one exemplary embodiment, a vacuum is created at the outlet end 420 of the piston 400 as a result of the patient's inhalation through the gas mixture outlet 200, which moves the piston 400 from the first location to the second location.

In one exemplary embodiment, excess pressure is generated at the inlet end 410 of the piston 400 as a result of the patient exhaling into the gas mixture inlet 100, which moves the piston 400 from the first arrangement to the second arrangement.

In one exemplary embodiment, excess pressure is generated at the inlet end 410 of the piston 400 by a compressed gas source, such as a gas cylinder, connected to the gas mixture inlet 100, which causes the piston 400 to move from the first arrangement to the second arrangement.

In operation, when the piston 400 moves to the second location, displacement of the container or capsule from the drug composition container 300 moves the container or capsule substantially inside the swirl chamber 500.

In operation, when the container or capsule is located substantially within the swirl chamber 500, the flow of the gas mixture between the gas mixture inlet 100 and the gas mixture outlet 200 helps disperse the drug composition from the container or capsule.

Specifically, the flow of the gas mixture between the gas mixture inlet 100 and the gas mixture outlet 200 enters the swirl chamber 500 through the chamber channels 520 (which in turn are ducted with the chamber openings 530, as shown in more detail in FIG. 7), creating a vortex and causing the container or capsule to rotate within the swirl chamber 500. In some embodiments, the chamber channels 520 facilitate flow of a gas mixture into the swirl chamber 500 such that the flow path of the gas mixture becomes tangential to the wall of the swirl chamber 500 and essentially continuous.

In operation, rotation of the container or capsule within the vortex chamber 500 relative to or adjacent to the chamber wall 510 disperses the drug composition from the container or capsule through a seal or membrane pierced or cut by the operative trigger 600, which, in the embodiments shown in FIGS. 1B, 3A and 3B, drives the spokes 620. The projections on the chamber wall inhibit the rotation of the container due to high speed contact and thus facilitate the release of the drug composition.

In embodiments of devices in this aspect, such as device 10 further comprising a degranulator 700, the drug composition dispersed in the vortex chamber 500 is further dispersed and/or degranulated by the degranulator as a result of the flow of a gas mixture between the gas mixture inlet 100 and the outlet. 200 for a gas mixture.

In exemplary embodiments in which the degranulator 700 includes a screen or mesh, as shown in FIG. 3A and 3B, containing a plurality of holes or slits to create turbulence in the flow of the gas mixture, the passage of the medicinal composition entrained by the gas flow through the sieve or mesh promotes further dispersion and/or degranulation of the drug composition as a result of creating turbulence in the flow of the gas mixture.

In typical embodiments in which the degranulator contains one or more elastic elements that are configured to: vibrate in response to the formation of a flow of a gas mixture, the passage of a medicinal composition entrained by the flow of a gas mixture through or past the elastic elements, promoting further dispersion and/or degranulation of the medicinal composition as a result of vibration of the elastic element.

In operation, the medicinal composition dispersed by the flow of the gas mixture between the gas mixture inlet 100 and the gas mixture outlet 200 while passing through or past the vortex chamber 500 and, optionally, through the degranulator of the device, is delivered to the patient's respiratory tract, entrained by the gas flow. mixtures.

In one exemplary embodiment, the flow of the gas mixture between the gas mixture inlet 100 and the outlet 200 past or through the swirl chamber 500 and, optionally, through the degranulator of the device, delivers the drug composition entrained in the gas flow into the patient's respiratory tract as a result of the patient's inhalation through outlet 200 for gas mixture.

In one exemplary embodiment, the flow of the gas mixture between the gas mixture inlet 100 and the outlet 200 past or through the swirl chamber 500 and, optionally, through the degranulator of the device, delivers the drug composition entrained in the gas flow into the patient's respiratory tract as a result of the patient exhaling through inlet 100 for the gas mixture of device 10.

In one exemplary embodiment, the flow of the gas mixture between the gas mixture inlet 100 and the outlet 200 past or through the swirl chamber 500 and, optionally, through the degranulator of the device, delivers the drug composition entrained in the gas flow into the respiratory tract of the patient as a result of the delivery of the gas mixture from a compressed gas source, such as a gas cylinder, into the gas mixture inlet 100.

In fig. 4-8 depict a preferred embodiment of device 10, designated device 1000 in these figures. It should be understood that like parts are numbered the same in FIGS. 1-3 and fig. 4-8, and therefore, for example, the dispenser or piston 400 in FIG. 1-3 represents the dispenser or plunger 1400 of FIG. 4-8; the gas mixture inlet 100 is the gas mixture inlet 1100, etc. All comments made for the device 10 apply, mutatis mutandis, to the device 1000 and are deemed to be repeated in their entirety herein with respect to the device 1000.

In fig. 4 shows: the components of the device 1000 and the method of their connection with the dispenser or piston 1400, mounted on an internal surface, in particular on the edge or flange of the gas mixture inlet 1100; a body 1050 connected to the gas mixture inlet 1100 to form a gas-tight connection; firing devices 1600 located within the walls of the body 1050 with spokes 1620 protruding towards the container 1300 for the medicinal composition; an outlet 1200 for a gas mixture connected to the body 1050 to form a gas-tight connection; and, unlike device 10, a cap 1800 located above the gas mixture outlet 1200.

In fig. 5A-7 illustrates in more detail the design and arrangement of the various components depicted in FIGS. 4. Referring to the drawing, the cap 1800 has a pocket 1810 formed on its top surface 1820. On the underside of the cap 1800, below a portion of the pocket 1810, there is a downwardly extending elongated member 1830. In the embodiment shown, the elongated member 1830 has a pin or plug profile, but it is clear that a number of other profiles can be envisaged that give the same result. Airflow cannot pass through the pocket 1810 and therefore the cap 1800 must be removed from the device 1000 before use.

In fig. 5B is a cross-sectional view of the device 1000 when the cap 1800 is fully seated or engaged with the gas mixture outlet 1200. In this position, the lower surface of the cap 1800 substantially abuts the upper surface of the gas mixture outlet 1200. Obviously, in this embodiment, the pins 1830 extend through the degranulator or screen 1700 (shown in more detail in FIG. 7), and to do this, the degranulator 1700 has two holes formed therein to allow the pins 1830 to pass through them. The holes are sized such that the functionality of the degranulator 1700 is substantially unaffected by their presence once the cap 1800 is removed since the pins 1830 are no longer present therein. The pins 1830, once the cap 1800 is fully seated, extend into the dispersion chamber or swirl chamber 1500 such that when the drug formulation container is placed in the drug formulation container 1300, they hold the container in place. This prevents the container from shifting or moving and keeps it in an optimal position relative to the spokes 1620 for piercing the container when removing the cap.

From the drawing, it appears that the bottom of the walls of the cap 1800 has a chamfered or tapered portion 1840, which in the illustrated embodiment may be referred to as a curved slot(s) 1840. Buttons or cam followers 1610 of the triggers 1600 interact with the top of the chamfered sections/curved slot 1840 such that when the cap 1800 is displaced to remove it and use the device, the beveled portion causes increasing displacement of the button/cam follower 1610, thereby causing the spokes 1620 to advance further into the drug composition container 1300 and pierce the drug composition container that will be contained therein. be. The displacement may be caused by pressure exerted on the resilient material of the buttons/cam followers 1610. It is a distinct advantage of the present invention that there is no need to press individual buttons or switches to release the drug composition. Instead, removing the cap 1800 automatically pierces the container and releases the drug composition. In addition, piercing occurs only after the simultaneous lifting of the pins 1830, which ensures optimal placement of the container as the inward movement of the pins 1620 occurs.

The result of removing the cap 1800 can be seen in contrast to FIG. 5B from FIG. 6B, in which the cap 1800 is raised to the point of maximum displacement of the firing devices 1600 and thus advancing the spokes 1620 a maximum distance into the drug composition container 1300. From the drawing, it appears that the pins 1830 are raised and substantially released from the swirl chamber 1500.

In fig. 7 shows the complete removal of the cap 1800 and therefore the pins 1830 are also missing and the holes 1710 in the degranulator 1700 can be seen. In FIG. 7 also shows a more detailed view of a single projection 1540 extending from the top wall of the swirl chamber 1500 immediately adjacent to the edges of the degranulator 1700 that is formed therein. Preferably, there are at least two projections 1540 on the top wall of the swirl chamber 1500. It has been found that two such projections 1540, which are located at 90 degrees with respect to each other, provide optimal inhibition of rotation of the container during use and thus , optimal release of the drug composition. Thus, if one projection 1540 is considered to be located at 12 o'clock, then the preferred location of the other would be at 3 or 9 o'clock relative to the first. The projections 1540 in the illustrated embodiment provide elongated projections 1540.

As shown in FIG. 7, complete removal of the cap 1800 also allows the triggers 1600 to return to their original position and retract the spokes 1620 away from the formulation container 1300. It is important to note that it follows from Fig. 6B and 7, that once the cap 1800 is removed and the triggers 1600 are in their original position, it is not possible to simply reset the cap 1800 back into full engagement with the device 1000. This is because the chamfered portions/curved slots 1840 will engage in locking engagement with the device 1000. the top surface of the buttons/cam followers 1610. The chamfer angle this time prevents the buttons/cam followers 1610 from moving and therefore the cap 1800 cannot be lowered further. This is an advantage of the present device 1000 because it effectively becomes a disposable device. If a potential user possesses the device 1000 with the cap 1800 removed, the user will immediately recognize that the device 1000 has been used or the drug container has been otherwise punctured and is not suitable for administration. This provides quick and easy visibility for the user to see that the device 1000 they are carrying or using is fit for use. Given the, in many cases, critical nature of the medical end use, this represents an important safety feature.

It should be understood that the piston 1400 in FIG. 5-7 is stationary and the gas mixture cannot freely pass through the device 1000. However, in FIG. 5B represents a resting or non-use position, while FIG. 6B shows the position of the medicinal composition container being pierced, and FIG. 7 shows a ready-to-use position in which the container has been pierced, the cap 1800 has been removed, and the device 1000 is ready to apply positive pressure or vacuum to move the piston 1400 from the first location to the second location, as discussed previously, to promote flow of the gas mixture. from the gas mixture inlet 1100 to the gas mixture outlet 1200 at the point at which it will contain the entrained drug composition.

In fig. Figure 8 shows a more detailed illustration of the gas mixture flow path itself. From the drawing, it appears that the piston 1400 is typically located within the gas mixture inlet 1100 and its inlet end 1410 is in sealed engagement with a lip or flange. When the piston 1400 is actuated and moves upward, displacing the drug container, it should be understood that air may flow past the lip or flange. At this point, the flow of the gas mixture may pass through the chamber openings 1530 that extend through the body 1050 and are conducive to the interior of the gas mixture inlet 1100 as well as to the swirl chamber 1500. It should be understood that there can only be one hole 1530 chamber, but at least two holes would be best.

In fig. 8 shows that the upper end of the chamber openings 1530 is an extension of the chamber channels 1520, which essentially correspond to the walls of the body 1050, so that the incoming flow of the gas mixture follows a circular, circulation or vortex channel. The effect of this is that the drug container that has been moved into the swirl chamber 1500 by the movement of the piston or dispenser 1400 begins to rotate rapidly. At this stage, as a result of the gas mixture flow and turbulence, the drug composition will be released, however, it has been found that the release is significantly aided by the presence of one or more projections 1540 into which the container will continually strike, causing the drug composition to spill out of the container. The flow of the entrained drug gas mixture then passes through the degranulator 1700 to the gas mixture outlet 1200 as previously described for device 10.

Device 1000 may be connected to equipment or otherwise used as described for device 10.

Accordingly, in some embodiments, a device is provided for administering a medicinal composition to the respiratory tract of a patient; device containing:

a gas mixture inlet, a gas mixture outlet, a piston, a drug composition container and a dispersion chamber in fluid communication;

a container for the medicinal composition substantially adjacent to the upper surface of the piston;

a dispersion chamber located substantially adjacent to the drug composition container and comprising one or more openings in the chamber; And

a degranulator located substantially adjacent to the dispersion chamber;

wherein the piston may be between: a first arrangement in which the drug composition container is substantially open and the flow of the gas mixture between the gas mixture inlet and the gas mixture outlet is restricted; and a second arrangement wherein the flow of the gas mixture between the gas mixture inlet and the gas mixture outlet is not substantially limited, independently, by either (i) pressurizing the gas mixture inlet; or (ii) by creating a vacuum through the gas mixture outlet.

It should be understood that devices in this aspect, such as device 10 and device 1000, may have several important advantages.

Advantageous embodiments, for example, devices 10 and devices 1000, allow operation both in conditions of excess pressure of the gas mixture flow and in conditions of vacuum. Accordingly, the device 10 and the device 1000 can be used: both as an inhaler, for example, as an inhaler for self-administration of a medicinal composition to a patient by inhalation through the gas mixture outlet 200/1200; and as an insufflation device, for example, for administering a medicinal composition to a patient by supplying a gas mixture under excess pressure into the gas mixture inlet 100/1100 to an unconscious and/or unconscious patient.

The 100/1100 gas inlet and 200/1200 gas outlet provide flexibility and versatility in use as it can be used directly as a mouthpiece or as a connection or fitting for other respiratory equipment.

As an example, when the device 10 and the device 1000 are used as an inhaler, the patient can use the gas mixture outlet 200/1200 as a mouthpiece and inhale directly through the gas mixture outlet 200/1200. In addition, the 200/1200 gas mixture outlet can be used to connect suitable respiratory equipment, such as masks, including intraoral masks, nose-and-mouth masks, etc., and advanced breathing equipment, such as endotracheal tubes , supraglottic airways, laryngeal masks, etc., for example, when the device 10 and the device 1000 are used as an insufflation apparatus.

As a further example, device 10 or device 1000, through the gas mixture inlet 100/1100, can be used to connect suitable respiratory equipment, such as a ventilator, a compressed gas source, a manual respirator and an automatic respirator, and also a valve apparatus for artificial respiration, etc., for example, when the device 10 or the device 1000 is used as an insufflation apparatus. In addition, the gas mixture inlet 100/1100 can be used directly as a mouthpiece for exhalation into the device 10/1000 by a user or caregiver.

In view of the foregoing, it is apparent that devices in this aspect, such as device 10 or device 1000, provide flexibility and versatility in use. For example, device 10 or device 1000 may be used as an inhaler for self-administration of a medicinal composition to a patient. The device 10 or device 1000 can also be used in resuscitation, where the drug formulation is administered simultaneously with artificial respiration performed by a caregiver. The device 10 or device 1000 can also be used in hospitals where the drug formulation is administered by insufflation using a respirator mask or improved devices for delivering drug formulations into the respiratory tract.

Embodiments of the devices of this aspect, such as device 10 or device 1000, may be adjusted or modified to vary the dosage according to specific patient indications.

For example, the size and/or number of spokes 620/1620 and/or launcher blades 600/1600 can be changed or modified to adjust the rate of delivery of the drug formulation. It will be understood that a larger number or size of spokes or blades will generally provide a higher rate of release of the drug formulation from the dispersion chamber 500/1500 and subsequent delivery to the patient.

As a further example, the number, position and/or height of projections 540/1540, such as elongated projections, radially oriented projections or protrusions within the dispersion chamber 500/1500, such as on the wall 510/1510 or the top wall of the swirl chamber 500/ 1500 may be altered or modified to control the rate of delivery of the drug formulation. It should be understood that, at least where the arrangement of projections does not significantly impede or limit the rotation of the container or capsule in the dispersion chamber 500/1500, increasing the number and/or height of the projections will generally increase the release of the drug formulation from the chamber 500/1500 for dispersion and subsequent delivery to the patient.

Likewise, in embodiments of the device containing the degranulator 700/1700, the characteristics of the degranulator (eg, with respect to the properties of the elastic element or screen) can be changed or adjusted to control the rate of delivery of the drug composition.

Embodiments such as device 10 or device 1000 are generally reliable in use for delivery from containers or capsules.

For example, an arrangement in which the dispenser 400/1400 is positioned between the first arrangement and the second arrangement allows: (a) movement of a container or capsule from the drug composition container 300/1300 into the dispersion chamber 500/1500; and (b) promotes and maintains the flow of the gas mixture between the gas mixture inlet 100/1100 and the gas mixture outlet 200/1200, may be effective in eliminating or at least preventing unwanted displacement or lack of displacement, e.g. “sticking” of the container or capsule.

In addition, devices 10 or devices 1000, particularly those in which the drug formulation container 300/1300 is configured to properly accommodate a container or capsule, are typically refilled and used in any orientation, with limited or no change in properties.

As described above, device 10 or device 1000 typically has a substantially sealed or airtight gas mixture flow path through the body 50/1050 from gas mixture inlet 100/1100 to gas mixture outlet 200/1200. It should be understood that such a sealed flow path essentially prevents or at least limits unwanted leakage or leakage of the drug composition.

In some embodiments, device 10 or device 1000 including a dosage tracking device is capable of estimating the dosage of a drug formulation delivered to a patient. It should be understood that this promotes dosage reliability and may reduce the likelihood of under- or over-dosing and/or alert the user to the occurrence of under- or over-dosing.

In addition, the device 1000 has the distinct advantage of allowing the device 1000 to be easily refilled by simply removing the cap 1800.

The above advantages are a non-limiting list of some typical advantages of exemplary embodiments of the invention.

A further aspect of this invention provides a method of administering a medicinal composition to the respiratory tract of a patient using a device according to the previous aspect, for example, device 10 or device 1000.

In a further aspect of this invention, there is provided a method of treating or preventing a condition in a patient by administering an effective amount of a medicinal composition to the respiratory tract of the patient using a device of the previous aspect, for example, device 10 or device 1000. In accordance with this aspect, the patient is typically a human.

Thus, one skilled in the art will appreciate that, in accordance with these aspects, a suitable drug formulation may be selected for administration to a particular patient, including for a particular therapeutic purpose for a particular condition.

Typically, drug formulations administered as described herein can contain any suitable drug for administration into the patient's respiratory tract in accordance with the subject's condition and medical indications. As described above, typically the dosage composition may be a dry powder, and may be one or more pure or substantially pure active ingredients. In addition, the dosage composition may contain one or more pharmaceutically acceptable components in addition to one or more active ingredients, eg, excipients, excipients or diluents, well known to those skilled in the art to which this invention relates.

It will be apparent to one skilled in the art that the particle size of a drug formulation in the form of a dry powder administered into a patient's respiratory tract may influence the therapeutic effectiveness of the dry powder. Typically, the injected microparticles will have a d50 value or mass median aerodynamic diameter (MMAD) of less than 6 μm. It will be apparent to one skilled in the art that "d50" or "D50" refers to the value at which a diameter of 50 wt. % of particles from the particulate matter sample is less than this value. The particle MMAD d50 value is preferably from about 0.5 to about 20 μm, including about: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 , 17, 18 and 19 microns, more preferably from about 0.5 to 10 microns, and even more preferably from 1 to 6 microns, including about: 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 and 5.5 microns. It should be understood that in embodiments in which the device 10 includes a dispersing device 310 and/or a filter 330, the preceding values refer to the particle size after dispersion in the gas mixture stream and/or after passing through the filter 330.

Examples of active agents that can be delivered in accordance with the present invention are: beta-2 agonists, steroids, e.g. glucocorticosteroids (preferably anti-inflammatory), anticholinergics, leukotriene antagonists, leukotriene synthesis inhibitors, conventional pain relievers, e.g. analgesics and anti-inflammatory agents ( including both steroidal and non-steroidal anti-inflammatory drugs), cardiovascular drugs, e.g. cardiac glycosides, respiratory drugs, anti-asthma drugs, bronchodilators, anti-neoplastic drugs, alkaloids (e.g. ergot alkaloids) or triptans, e.g. for the treatment of migraine, drugs (eg, sulfonylureas) useful in the treatment of type I and II diabetes and related disorders, sleeping pills, including sedatives and hypnotics, antidepressants, appetite suppressants, antiarthritics, antimalarials, antiepileptics, antithrombotics, antihypertensives, antiarrhythmics, antioxidants, antidepressants, antipsychotics, tranquilizers, anticonvulsants, antiemetics, anti-infectives, antihistamines, antifungals and antivirals, drugs for the treatment of neurological disorders, e.g. Parkinson's disease (dopamine receptor antagonists), medications for the treatment of alcoholism and other forms of addiction, drugs such as venodilators for the treatment of erectile dysfunction, muscle relaxants, muscle contractants, opioids, stimulants, tranquilizers, antibiotics such as macrolides, aminoglycosides, fluoroquinolones and beta-lactams, vaccines, cytokines, growth enhancing agents, hormonal agents including contraceptives, sympathomimetics, diuretics, lipid-regulating agents, antiandrogenic agents, antiparasitics, anticoagulants, neoplastics, antineoplastic agents, hypoglycemic agents, nutritional agents and additives, growth enhancing additives, anti-enteritis agents, vaccines, antibodies , diagnostic agents, as well as contrast agents and mixtures of the above (for example, for the combination treatment of asthma containing both a steroid and a beta-agonist).

The active agent may belong to one of a number of structural classes, including, but not limited to, synthetic drugs (including insoluble synthetic drugs), peptides, polypeptides, proteins, polysaccharides, steroids, nucleotides, oligonucleotides, polynucleotides, fats, electrolytes, and the like. Specific examples are: beta-2 agonists: salbutamol (eg, salbutamol sulfate) and salmeterol (eg, salmeterol xinafoate); steroids: budesonide and fluticasone (eg fluticasone propionate), cardiac glycoside: digoxin; alkaloid drug against migraine; digidatroergotamine misylate and other alkaloid ergotamines; alkaloid bromocriptine, used in the treatment of Parkinson's disease, sumatriptan, rizatriptan, naratriptan, frovatriptan, almotriptan, zolmatriptan, morphine and morphine analog fentanyl (eg fentanyl citrate), glibenclamide (sulfonylurea), benzodiazepine such as Valium, triazolam, alprazolam, midazolam and clonazepam (commonly used as a sleep aid, such as to treat insomnia or panic attacks); neuroplegics: risperidone, apomorphine for the treatment of erectile dysfunction; anti-infective amphotericin B; antibiotics: tobramycin, ciprofloxacin and moxifloxacin, nicotine, testosterone; anticholinergic bronchodilator: ipratropium bromide; bronchodilator: formoterol; monoclonal antibodies and LHRH proteins, insulin, human growth hormone, calcitonin, interferon (eg, interferon beta or gamma), EPO and Factor VIII, and in each case their pharmaceutically acceptable salts, esters, analogs and derivatives (eg , prodrugs).

Additional examples of potentially suitable active agents include, but are not limited to: aspariginase, amdoxovir (DAPD), antid, becaplermin, calcitonins, cyanovirine, denileukindiftitox, erythropoietin (EPO), EPO agonists, dornase alpha, erythropoiesis-stimulating protein (NESP), clotting factors eg Factor VIIa, Factor VIII, Factor IX, von Willebrand Factor; ceredase, ceresyme, alpha-glucosidase, collagen, cyclosporine, alpha-defensins, beta-defensins, exdin-4, granulocyte colony-stimulating factor (GCSF), thrombopoietin (TPO), alpha-1 proteinase inhibitor, elcatonin, granulocyte-monocyte colony-stimulating factor ( GMCSF), fibrinogen, filgrastim, growth hormones, growth hormone releasing hormone (GHRH), GRO-beta, GRO-beta antibody, bone morphogenetic proteins, eg bone morphogenetic protein-2, bone morphogenetic protein-6, OP-1; acid fibroblast growth factor, basic fibroblast growth factor, CD-40 ligand, heparin, human serum albumin, low molecular weight heparin (LMWH), interferons, eg interferon alpha, interferon beta, interferon gamma, interferon omega, interferon tau; interleukins and interleukin receptors, for example: interleukin 1 receptor, interleukin 2 receptor, interleukin 2 receptor fusion proteins, interleukin 1 receptor antagonist, interleukin 3 receptor, interleukin 4 receptor, interleukin 6 receptor, interleukin 8 receptor, receptor 12 -interleukin, interleukin 13 receptor, interleukin 17 receptor; lactoferrin and lactoferrin fragments, luteinizing hormone release hormone (LHRH), insulin, proinsulin, insulin analogs, amylin, C-peptide, somatostatin, somatostatin analogs including octreotide, vasopressin, follicle stimulating hormone (FSH), influenza vaccine, insulin-like growth factor (IGF), insulintropin, macrophage colony-stimulating factor (M-CSF), plasminogen activators, for example, alteplase, urokinase, reteplase, streptokinase, pamiteplase, lanoteplase and teneteplase; Nerve growth factor (NGF), osteoprotegerin, platelet-derived growth factor, tissue growth factors, transforming growth factor-1, vascular endothelial growth factor, leukemia inhibitory factor, keratinocyte growth factor (KGF), glial growth factor (GGF), T cells receptors, CD molecules/antigens, tumor necrosis factor (TNF), endothelial growth factors monocyte chemoattractant protein-1, parathyroid hormone (PTH), glucagon-like peptide, somatotropin, thymosin alpha 1, thymosin alpha 1, IIb/IIIa inhibitor, thymosin beta 10, thymosin beta 9, thymosin beta 4, alpha-1 antitrypsin, phosphodiesterase (PDE) compounds, VLA-4 (very late antigen-4), VLA-4 inhibitors, bisphosphonates, respiratory syncytial virus antibody, cystic fibrosis transmembrane regulator gene (CFTR), deoxyribonuclease (DNAase), bactericidal permeabilization protein (BPI), and anti-CMV antibody. Typical monoclonal antibodies are: etanercept (a dimeric fusion protein consisting of the extracellular ligand-binding region of the human 75 kD TNF receptor linked to the Fc region of IgG1), abciximab, afeliomab, basiliximab, daclizumab, infliximab, ibritumomabtiuxetan, mitumobab, muromonab-CD3, tositumomab conjugate with iodine 131, olizumab, rituximab and trastuzumab (Herceptin), amifostine, amiodarone, aminoglutethimide, amsacrine, anagrelide, anastrozole, asparaginase, anthracyclines, bexarotene, bicalutamide, bleomycin, buserelin, busulfan, cabergoline, cap ecitabine, carboplatin, carmustine, chlorambucin , cisplatin, cladribine, clodronate, cyclophosphamide, cyproterone, cytarabine, camptothecins, 13-cis-retinoic acid, all trans-retinoic acids; dacarbazine, dactinomycin, daunorubicin, dexamethasone, diclofenac, diethylstilbestrol, docetaxel, doxorubicin, epirubicin, estramustine, etoposide, exemestane, fexofenadine, fludarabine, fludrocortisone, fluorouracil, fluoxymesterone, flutamide, gemcitabine, epinephrine, L-dopa, hydroxymo chevin, idarubicin, ifosfamide, imatinib, irinotecan, itraconazole, goserelin, letrozole, leucovorin, levamisole, lomustine, mechlorethamine, medroxyprogesterone, megestrol, melphalan, mercaptopurine, methotrexate, metoclopramide, mitomycin, mitotane, mitoxantrone, naloxone, nicotine, nilutamide, octreotide, oxaliplatin, pamidronate, pentostatin, pilcamycin, porfimer, prednisolone, procarbazine, prochlorperazine, ondansetron, raltitrexed, sirolimus, streptozocin, tacrolimus, tamoxifen, temozolomide, teniposide, testosterone, tetrahydrocannabinol, thalidomide, thioguanine, thiotepa, topotecan, tretinoin, valrubicin, vinblastine; vincristine, vindesine, vinorelbine, dolasetron, granisetron; formoterol, fluticasone, leuprolide, midazolam, alprazolam, amphotericin B, podophyllotoxins, nucleoside antivirals, aroylhydrazones, sumatriptan; macrolides, for example, erythromycin, oleandomycin, troleandomycin, roxithromycin, clarithromycin, davercin, azithromycin, flurithromycin, dirithromycin, josamycin, spiromycin, midecamycin, leukomycin, myocamycin, rokithromycin, andacitromycin zvinolide A; fluoroquinolones, e.g. ciprofloxacin, ofloxacin, levofloxacin, trovafloxacin, alatrofloxacin, moxifloxacin, norfloxacin, enoxacin, grepafloxacin, gatifloxacin, lomefloxacin, sparfloxacin, temafloxacin, pefloxacin, fleroxacin, amifloxacin, tosufloxacin sacin, prulifloxacin, irloxacin, pazufloxacin, clinafloxacin and sitafloxacin; aminoglycosides, for example, gentamicin, netilmicin, paramecin, tobramycin, amikacin, kanamycin, neomycin and streptomycin, vancomycin, teicoplanin, rampolanine, mideplanin, colistin, daptomycin, gramicidin, colistimethate; polymyxins, eg polymyxin B, capreomycin, bacitracin, penems; penicillins, including penicillinase-sensitive agents, eg penicillin G, penicillin V; penicillinase-resistant agents, eg methicillin, oxacillin, cloxacillin, dicloxacillin, floxacillin, nafcillin; active agents of gram-negative microorganisms, for example, ampicillin, amoxicillin and hetacillin, cillin and galampicillin; antipseudomonal penicillins, for example, carbenicillin, ticarcillin, azlocillin, mezlocillin and piperacillin; cephalosporins, for example, cefpodoxime, cefprozil, ceftibuten, ceftizoxite, ceftriaxone, cephalothin, cefapirin, cephalexin, cefradine, cefaxitin, cefamandole, cefazolin, cephaloridine, cefaclor, cefadroxil, cephaloglycine, cefuroxime, cepharanide, ceftaxit, ceftrizine, cefotrin, cefopite, cefoxit, cefoniside, cefoperazone, cefotetan, cefmetazole, ceftazidime, loracarbef and moxalactam, monobactams, for example, aztreonam; and carbapenems, for example, imipenem, meropenem, pentamidinesethiouate, albuterol sulfate; lidocaine, metaproterenol sulfate, beclomethasone diprepionate, triamcinolone acetamide, budesonide acetonide, fluticasone, ipratropium bromide, flunisolide, cromolyn sodium and ergotamine tartrate; taxanes, eg paclitaxel; CH-38; tyrphostins.

Other agents that can be used are: linezolid; treprostinol, optionally in combination with a PDE5 inhibitor; oxyntomodulin; and palonosetron, optionally in combination with an NK1 antagonist, preferably with high activity.

It should be understood that the above examples of active agents include, where applicable, analogs, agonists, antagonists, inhibitors, isomers and pharmaceutically acceptable salt forms thereof. With regard to peptides and proteins, the invention covers synthetic, recombinant, native, glycosylated, non-glycosylated and biologically active fragments and analogs thereof.

In some exemplary embodiments, the drug composition contains one or more active agents selected from epinephrine, glucose, glucagon, naloxone, insulin, and the like.

In some exemplary embodiments, the drug formulation contains microparticles, nanoparticles, microcapsules, nanocapsules, microspheres and/or nanospheres of epinephrine and/or atropine for the treatment of heart failure, cardiac dysfunction, cardiac arrest, anaphylaxis, drug overdose, and the like.

In some exemplary embodiments, the drug composition contains particulate glucose and/or glucagon for the treatment of hypoglycemia, coma caused by diabetes, etc. In some embodiments, the dry powder contains particulate benzodiazepine, phenytoin, or anticonvulsants for the treatment seizure.

In some exemplary embodiments, the drug composition contains one or more agents to elicit an immune response, such as one or more vaccines. In some embodiments, the dry powder contains a measles vaccine to induce an immune response or vaccination against measles. In some embodiments, the dry powder contains a hepatitis B vaccine to induce an immune response or vaccination against hepatitis B. In some embodiments, the dry powder contains an influenza vaccine to induce an immune response or vaccination against influenza.

The above description of various embodiments of the present invention is intended for one skilled in the relevant field of technology. It is not intended to be exhaustive or limiting the invention to the one disclosed embodiment. As mentioned above, numerous alternatives and variations of the present invention will be apparent to those skilled in the art. Accordingly, although some alternative embodiments have been discussed in detail, other embodiments will be obvious or relatively easy to develop by those skilled in the art. The invention covers all alternatives, modifications and variations of the present invention that are disclosed herein, as well as other embodiments that may be carried out within the spirit and scope of the disclosed invention.

Claims (60)

1. A device for delivering a medicinal composition into the patient’s respiratory tract, containing fluidly communicating: inlet for gas mixture; outlet for gas mixture; a dispenser having an upper surface and a lower surface; a container for the medicinal composition adapted to accommodate the medicinal composition; And dispersion chamber; wherein the dispenser is configured to be located between: (a) a first arrangement in which the lower surface of the dispenser is located at the gas mixture inlet to restrict the flow of the gas mixture entering the device, and in which the upper surface of the dispenser is adjacent to the bottom of the drug composition container to allow the drug composition to be in a container for a medicinal composition; And (b) a second arrangement, in which the lower surface of the dispenser is offset towards the gas mixture outlet compared to the first arrangement so as to open a channel for the flow of the gas mixture into the device through the gas mixture inlet, and wherein the upper surface of the dispenser is adjacent to the top of the drug composition container to move the drug composition into the dispersion chamber; And wherein the dispenser is located between the first location option and the second location option as a result of: (i) creating excess pressure through the gas mixture inlet; And (ii) creating a vacuum through the outlet for the gas mixture. 2. The device according to claim 1, characterized in that in the first arrangement, the dispenser is located outside the container for the medicinal composition, and in the second arrangement, at least part of the dispenser is located inside the container for the medicinal composition. 3. The device according to claim 1, characterized in that the container for the medicinal composition is adapted to accommodate a container containing the medicinal composition when the dispenser is in the first arrangement. 4. The device according to claim 1, characterized in that the dispersion chamber is adapted to: accommodate a container containing a medicinal composition; and disperse the medicinal composition in the gas mixture flow between the gas mixture inlet and the gas mixture outlet for delivery to the respiratory tract of the patient; and wherein the dispersion chamber is in fluid communication with an inlet for the gas mixture, an outlet for the gas mixture, a dispenser and a container for the medicinal composition. 5. The device according to claim 4, characterized in that the dispersion chamber is adapted to accommodate a container containing a medicinal composition when the dispenser is moved from the first location to the second location. 6. The device according to claim 1, characterized in that the dispersion chamber is a passage with at least one opening in the chamber for the flow of a gas mixture between the inlet for the gas mixture and the outlet for the gas mixture. 7. The device according to claim 6, characterized in that at least one opening of the chamber forms a flow channel in the second arrangement between the inlet for the gas mixture and the dispersion chamber. 8. The device according to claim 1, characterized in that the dispersion chamber contains at least one protrusion protruding from its surface. 9. The device according to claim 1, containing at least one trigger device for releasing the medicinal composition from the container containing the medicinal composition for delivery to the respiratory tract of the patient. 10. The device according to claim 9, characterized in that the at least one triggering device comprises at least one pin configured to pierce a container containing a medicinal composition for delivery into the respiratory tract of a patient using the delivery device, or to pierce a seal, membrane or shell. 11. The device according to claim 9, characterized in that the at least one triggering device comprises at least one blade configured to cut the container containing the medicinal composition for delivery into the respiratory tract of the patient using the delivery device, or to cut the seal, membrane or shell. 12. The device according to claim 9, containing a removable cap located above the outlet for the gas mixture, and at least one trigger device is configured to be activated when the removable cap is removed. 13. The device according to claim 1, containing a degranulator located at the dispersion chamber and in fluid communication with the inlet for the gas mixture, the outlet for the gas mixture, the dispenser, the container for the medicinal composition and the dispersion chamber. 14. A method of introducing a medicinal composition into the patient’s respiratory tract using a device according to claim 1, including the stages: placing the medicinal composition or a container containing the medicinal composition inside the container for the medicinal composition; connecting the outlet for the gas mixture with the patient's respiratory tract; And creating a flow of gas mixture between the gas mixture inlet and the gas mixture outlet, in this case, the medicinal composition is delivered by a flow of a gas mixture into the patient’s respiratory tract through the outlet for the gas mixture. 15. The method according to claim 14, characterized in that the patient is conscious and/or responsive, and the administration is self-administration. 16. The method according to claim 14, characterized in that the patient is unconscious and/or does not respond. 17. The method according to claim 14, characterized in that the movement of the dispenser from the first location option to the second location option is carried out as a result of (i) creating excess pressure through the inlet for the gas mixture. 18. The method according to claim 14, characterized in that the dispenser moves from the first location option to the second location option as a result of (ii) creating a vacuum through the outlet hole for the gas mixture. 19. A device for delivering a medicinal composition into the patient’s respiratory tract, containing fluidly communicating: inlet for gas mixture; outlet for gas mixture; a floating piston dispenser having an upper surface and a lower surface; a container for the medicinal composition adapted to accommodate the medicinal composition; a dispersion chamber located between the container for the medicinal composition and the outlet for the gas mixture; And at least one hole in the chamber defining a channel for flow of the gas mixture between the inlet for the gas mixture and the dispersion chamber; wherein the dispenser with a floating piston is configured to move between: (a) a first arrangement in which the lower surface of the floating piston dispenser is located at the gas mixture inlet to restrict the flow of the gas mixture into the at least one opening in the chamber, and in which the upper surface of the dispenser is adjacent to the bottom of the container for a medicinal composition to allow the medicinal composition to be contained in the medicinal composition container; And (b) a second arrangement, in which the lower surface of the floating piston dispenser is offset towards the outlet of the gas mixture compared to the first arrangement so as to open a channel for the flow of the gas mixture into the device through at least one opening in the chamber, and wherein wherein the upper surface of the dispenser is adjacent to the upper part of the medicinal composition container to transfer the medicinal composition into the dispersion chamber; and wherein the dispenser is configured to be located between the first location option and the second location option as a result of: (i) creating excess pressure through the gas mixture inlet; And (ii) creating a vacuum through the outlet for the gas mixture. 20. The device according to claim 19, characterized in that it is configured to position the dispenser inside the container for the medicinal composition when moving the dispenser with a floating piston to the second location option. 21. The device according to claim 19, characterized in that in the first arrangement, the lower surface of the dispenser with a floating piston is designed to fit hermetically on the edge of the inner surface of the inlet for the gas mixture. 22. The device according to claim 19, characterized in that in the first arrangement, the lower surface of the dispenser with a floating piston is designed to fit tightly onto the flange of the inner surface of the inlet for the gas mixture. 23. A device for delivering a medicinal composition into the patient’s respiratory tract, containing fluidly communicating: a gas mixture inlet located at the first end of the device, allowing the gas mixture to enter the device, and having an edge or flange on its inner surface; an outlet for the gas mixture located at the second end of the device, opposite the first end; a floating piston dispenser having an upper surface and a lower surface; a container for the medicinal composition adapted to accommodate the medicinal composition; a dispersion chamber located between the container for the medicinal composition and the outlet for the gas mixture; at least one hole in the chamber defining a nonlinear gas mixture flow channel between the gas mixture inlet and the dispersion chamber; And a degranulator located between the top of the dispersion chamber and the gas mixture outlet, the floating piston dispenser being movable between: (a) a first arrangement in which the lower surface of the floating piston dispenser is sealed against the edge or flange of the gas mixture inlet to restrict the flow of the gas mixture into the at least one opening in the chamber, and in which the upper surface of the dispenser is adjacent to the bottom of the medicinal composition container to allow the medicinal composition to be contained in the medicinal composition container; And (b) a second arrangement, in which the lower surface of the floating piston dispenser is offset towards the outlet of the gas mixture compared to the first arrangement so as to open a channel for the flow of the gas mixture into the device through at least one opening in the chamber, and wherein wherein the upper surface of the dispenser is adjacent to the upper part of the medicinal composition container to transfer the medicinal composition into the dispersion chamber; and wherein the dispenser is configured to be located between the first location option and the second location option as a result of: (i) creating excess pressure through the gas mixture inlet; And (ii) creating a vacuum through the outlet for the gas mixture.