MXPA97004489A - Inhalation device, method for dispersing a pharmaceutically active substance and method for administering a dose of a pharmaceutically acting substance - Google Patents

Abstract

The present invention relates to an inhalation device for connection to an inhaler having a pharmaceutically active substance in a reservoir of the inhaler when it is connected to the inhalation device, the device is characterized in that it comprises: a first element having an adapted connecting structure to be connected to the inhaler, so that air is extracted from the air outlet of the inhaler and passes through the first element, a second element slidably connected to the first element, a supply chamber, defined by the first element and the second element, and having an outlet with a valve element that allows the flow of air and substance out of the chamber to a patient, but which prevents a flow of air into the chamber, the relative movement of the first element and the second element is able to increase the volume of the supply chamber and decreases the pressure when closing the v-element valve in the same way that it draws air through and from the inhaler with the substance dragged into it, inside the supply chamber

Description

INHALATION DEVICE, METHOD FOR DISPERSING A PHARMACEUTICALLY ACTIVE SUBSTANCE AND METHOD FOR ADMINISTERING A DOSAGE OF A PHARMACEUTICALLY ACTIVE SUBSTANCE. DESCRIPTION OF THE INVENTION The present invention relates to an inhalation device for the inhalation of a pharmaceutically active substance, from a reservoir in an inhaler, comprising an inhalation channel with an air inlet and an air outlet, said The device comprises a separating chamber having an air inlet and an air outlet into which the active substance can be sucked from said reservoir, through the air outlet and the means for allowing a user to inhale the active substance from said dispensing chamber, the dispensing chamber is defined by at least a first non-movable element and a second movable element, the second element is substantially cylindrical in shape, said first element being accommodated in the second element, thereby creating a vacuum or negative pressure in the supply chamber, when the first and second elements are moved relative to each other, as described in the preamble of claim 1. REF: 24890 The inhalation device according to the invention is preferably a dry powder inhaler, operated by breathing, containing multiple doses of a medicament containing an active substance, the inhaler has a maneuvering unit comprising a maneuvering unit for loading a dose of medicament into a dosage unit, and providing said dosage in a position for inhalation. An inhaler of the type prescribed in European patent EP-A-0 069 715 and European patent EP-A-0 237 507 is described. The device according to the invention is specially designed for patients who are not able to actively inhale or those who are not able to create the inhalation flow necessary to release and raise the dose of the substance to the inhalation channel and to the lungs when an inhaler operated by breathing is used.

BACKGROUND OF THE INVENTION The pharmaceutically active, inhalable substances are generally used for the treatment of diseases in the bronchial and pulmonary area such as asthma and chronic bronchitis. Various modalities of inhalation devices or devices are used for that purpose. The function of these known devices depends on the creation of an air flow through the inhalation device, caused by an inhalation by the patient. The air flow causes the active substance to be movable from a release position to the air flow in which it is dispensed. A particularly advantageous inhaler of the aforementioned type is the multi-dose inhaled, dry powder inhaler, Turbuhaler®, schematically described in the aforementioned European patents. Some patients, such as young children and elderly people with diseases in the bronchial area, are not able to use a breathing-powered inhaler, since it may be difficult or even impossible for these patients to achieve the necessary inhalation flow, and these patients they are nowadays reduced to the use of inhalers that use pressurized gas, for example, Freon. Such inhalers suffer from many known disadvantages such as unwanted side effects. In addition, currently it is a problem to administer an inhalable substance to a patient with asthma, who is anesthetized during an operation, and the patient can not inhale actively. For many asthmatic patients it is vital to administer pharmaceutical products against asthma, during an operation.

COMPENDIUM OF THE INVENTION In order to facilitate the inhalation of pharmaceutically active substances that are administered through the use of pressurized metered dose inhalers, called pMDIs, it is known to provide expansion chambers within which the substance is dispensed, with the pressurized gas. These devices are generally referred to as spacers and a typical spacer is known from British Patent GB 1 565 029. In addition, inhalation devices including dispensing chambers have been developed for breath-operated dry bottom inhalers, of the aforementioned type. Such an inhalation device is described in European Patent EP-A-0 548 152. This device is nevertheless bulky and contains several mechanical parts that make the device complicated to produce and use. The reliability is not very high due to the complexity of the device. The present invention relates to an inhalation device of the aforementioned type, which can be used by patients having reduced ability to create an inhalation flow necessary to lift the dose from the release position towards the inhalation channel, when an inhaled breathing device is used, and which can be used to deliver inhaled substances to a patient who is anesthetized. The invention provides a device that facilitates the use especially of a Turbuhaler® for patients who are currently reduced to the use of pressurized metered dose inhalers. The inhalation device according to the invention has an uncomplicated construction with few mechanical parts, is simple and inexpensive to produce, and is easy to use by the patient. The device according to the invention a first non-movable element is fixed on the inhaler, so that a second element will move relative to the first element and to the inhaler, when the device is activated for inhalation, as described in the part of characterization of claim 1. Additional advantages with the present invention are clear from dependent claims 2 to 16. The present invention also includes a method for dispensing a pharmaceutically active substance, into a dispensing chamber by creating a negative pressure or vacuum in said dispensing chamber, by the use of a device according to the invention. The assorted substance could thereby be inhaled using an ordinary inhalation flow, or it could be pressed out from the inhalation device, as described in claims 17 to 19.

BRIEF DESCRIPTION OF THE DRAWINGS The inhalation device according to the present invention will now be described by way of example, with reference to the accompanying drawings, in which: Figure 1 shows a schematic view of a section of the inhalation device according to a first embodiment of the invention; Y Figure 2 shows a schematic view of a section of the second embodiment of the inhalation device according to the invention.

Detailed description of the drawings The device according to the invention is designed to be used in conjunction with an inhaler for the inhalation of a pharmaceutically active substance, for example, the multi-dose inhaler 12 for dry powder, powered by respiration, sold under the trademark Turbuhaler. ®. The inhalation device according to the invention can be modified within the scope of the appended claims, for use with any dry powder inhaler, which when activated will place a dose of medicament in a release position in the inhalation channel. . The preferred inhaler 12 is provided with a reservoir for storing the substance, a metering or dosing unit, an air flow path having an air inlet and an air outlet. The inhaler is also provided with the operating means comprising a maneuvering unit 13 for moving a measuring device by a loading position in which a predetermined dose of the substance to be inhaled is measured within the measuring device, and a release position where the dose is placed in the inhalation channel, released and carried by the inhalation air through the channel to the air outlet or mouth piece 15 of the inhaler. As can be observed in the drawings, the inhalation device according to the invention comprises a first element 10 substantially not mobile, which is provided on the air outlet or the mouth piece 15 of the inhaler. The first element 10 is formed as a piston having an opening 26 which, when the piston is accommodated on the air outlet of the inhaler, coincides with the opening 11 of the air outlet. The connection between the air outlet or mouth piece 15 of the inhaler and the piston is air tight through a seal, or as the preferred embodiment the piston is rigidly mounted on the outer walls of the air outlet or the mouthpiece 15 of the inhaler, in order to prevent air from entering between the two parts. The piston could be rubberized welded or rigidly attached in any other way to the inhaler. Around the first substantially non-movable element, for example, the piston 10, a second movable member 6 is provided. Said second element 6 is hollow and substantially formed as a cylinder. In the upper part of the cylinder the walls fuse and define a cone-shaped part 28. Above this cone-shaped portion 28 is accommodated an additional cylinder 22 having a diameter smaller than the cylinder 6 defining the second element. Said cylinder 22 defines the air outlet of the dispensing chamber 20 and the inhalation device, and is formed as a buccal part or nose adapter part. The piston 10 is accommodated inside the cylinder 6. With this the piston defines the bottom of the second element 6. A dispensing chamber 20 is defined in the cylinder 6 above the piston 10. Sealing means 8 are provided between the first and second elements in their mutual connection area. The sealing means 8 is preferably provided as an O-ring sealing member, and could be accommodated in a groove or notch provided on the outer surface of the piston. As mentioned above, the piston is formed with an opening 26 which coincides with the opening 11 of the air outlet or the mouthpiece of the inhaler. The first valve means 18 are provided which regulate the flow of air through the air outlet and the opening of the piston towards the dispensing chamber. The valve means is provided as a one-way valve only accommodated to open when air flows from the inhaler into the dispensing chamber. The valve could be of any known type, and in the preferred embodiment is formed as a thin membrane of which one part is fixed to the wall of the piston, and the other end is free moving. The cylinder 6 is formed with a limiting wall member 14 having an outlet opening which coincides with the air outlet of the inhaler. The wall member 14 defines the upper restriction of the dispensing chamber 20, and is provided with holding means 30 for holding the inhaler in a fixed position relative to the rotation, when the maneuvering unit 13 is rotated. These means could be provided as a ratchet mechanism, as toothed rings or have any other construction. The second valve means 16 is provided in the opening for regulation of the air flow out of the dispensing chamber after inhalation by a user. A buccal part 22 or nasal adapter is provided at the end of the cylinder 6. The first and second valves 18 and 16 are preferably of similar construction, and must be sensitive and easy to operate in order to minimize the resistance of the inhalation flow. and the retention of the substance within the inhalation device. For this purpose, the valve could preferably be processed as thin membranes of plastic or the like. The membranes could be fixed at one end in the opening of the piston 10 and the wall member 14 respectively, as can be seen in the figure. The wall member 14 acts as a seat for the valve 18. In a first preferred embodiment, an additional hollow cylindrical element 4 is provided. The cylinder is defined by a part of the bottom and wall parts, and is open in its interior region. The bottom of said additional cylinder is provided with openings 5 for air inlet communicating with the internal part of the additional cylindrical element 4. A mounting element 24 for the inhaler is provided inside the additional cylinder, and fixed to the bottom of the cylinder. The mounting element 24 comprises a portion 33 adapted to the shape of the operating unit 13 of the inhaler, so that it is fixedly mounted on the mounting means 24. Due to this fixed and rigid assembly of the maneuvering unit 13 of the inhaler 12 in the mounting part 23, the unit 13 is rotated at an angle proportional to the rotation of the outer element 4 in cylindrical form. The rotation of the outer element 4 of cylindrical shape and with this the maneuvering unit 13 activates the inhaler 12 for inhalation, as the maneuvering unit places the dosing unit, and with this a dose in the release position within the channel of inhalation. The function of this mode will now be described. In the inactive position, which is shown in Figure 1, the internal element 6 of cylindrical shape is completely interposed within the outer element 4 of cylindrical shape. When the outer element 4 is rotated, the maneuvering unit 13 and the dosage unit of the inhaler is rotated, and a dose is placed in the release position in the inhalation channel. The two cylindrically shaped elements 4 and 6 are thereafter moved axially relative to one another so that the inhaler 12 with the piston 10 is pressed downwardly along the internal wall of the internal element 6. It is created a low pressure or vacuum in the internal chamber 20, which is created when the elements are moved away from each other. The second valve 16 is closed. The valve 18 is opened and the air is pulled towards the inhalation device through the air inlets 5 in the lower part of the outer element 4. When the air passes in the inhaler, the dose placed in the inhalation channel is released and supplied to the internal chamber 20. The dispersed substance could now be actively inhaled by the patient, a method that could also be used by young children, by elderly people or other people with of reduced inhalation. Alternatively, the substance can be forced out of the inner chamber by oppressing the piston 10 and the second element 6 together, again after the activation and dispersion of the dose has taken place. The volume of the dispersion chamber will decrease and an overpressure or positive pressure will be created. The valve 18 will open and the air / substance contents of the dispersion chamber or dispenser will be forced out through the buccal part 22 of the device. In this way the substance can be forced down into the patient's lungs. This active outward pressure of the substance is specially designed to be used when treating an anesthetized patient, but it could also be used under other circumstances, for example, by small children or elderly people who refuse to inhale. The inhalation device can also be constructed without the outer cylinder 4. A deflection element 32 is thereby provided between the piston 10, which is mounted on the mouthpiece and the upper part of the inhaler, and the cylinder 6. The Cylinder 6 is provided with stop means 35 provided at the open end of the cylinder, preventing the cylinder from coming apart from piston 10. Additional sealing means 36 are provided between piston 10 and cylinder 6. In this embodiment , in the inactivated position of the device the piston 10 is arranged in relation to the cylinder, in such a way that the dispensing chamber has its largest volume, for example, the piston and the cylinder is in the retracted position, one relative to the other. When the device is activated for inhalation, a dose is co-located in the inhalation channel by the rotation movement of the maneuver unit 13, which in this mode is handled directly by the user. The piston 10 is then moved inside the cylinder 6, for example, the piston is pushed towards the outlet of the cylinder 6, against the force of the deflection element 32. The volume of the dispensing chamber is decreased. The piston 10 is then released and due to the force of the deflection element, it will instantaneously travel towards the bottom of the cylinder, whereby a negative or empty pressure is created in the dispensing or dispersing chamber, as the volume increases. The dose will be suctioned by the air that enters the air inlets in the inhaler, the inhalation channel and also to the supply chamber. When the pressure has been compensated, the valve 18 will close and the user can inhale through the mouthpiece as described above.

Additional sealing means could be provided in order to ensure an air tight seal between the inhaler 12, the piston 10 and the cylinder 6.

The steering element is preferably a spiral spring but any other type of elastic element could be used.

The use of the device to force the dose to be inhaled into the lungs of a patient as described above, could of course also be used with a device constructed in accordance with the second embodiment of the invention.

The volume of the spacer could be varied due to the requirements of the needs, and a preferred maximum volume of the dispensing chamber is between 50 - 250 ni.

The different parts of the inhalation device are preferably made of plastic, plastics or metal, but other materials are also possible.

The present invention is preferably directed to the use of a pharmaceutically active substance in powder form, and wherein the powder is delivered to the inner chamber of the inhalation device in a finely divided form, and wherein the particles are smaller than 10 μm , preferably smaller than 3 μm.

Possible modifications of the invention The inhalation device according to the present invention could of course be modified within the scope of the appended claims.

In the preferred embodiments, the means for generating the negative pressure or vacuum are two cylindrically shaped elements telescopically provided relative to one another. In the preferred embodiment, the elements have a circular cross section but any other shape such as a square shape is possible.

In the second embodiment, an additional cylinder could be provided in the second element 6. Said additional cylinder is arranged to be separately movable relative to the second element 6, whereby the deviation means are provided in a space between the two cylinders.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Having described the invention as above, property is claimed as contained in the following:

Claims (21)

1. An inhalation device for the inhalation of a pharmaceutically active substance, designed to be mounted on an inhaler, the inhalation device is characterized in that it comprises: a first non-mobile element and a second mobile element, the first mobile element is accommodated in the second element, defining a dispersion chamber between them; and the valve means provided in the first non-movable member - the first non-movable member is rigidly mounted on the air outlet of the inhaler whereby the second element will move relative to the first non-movable member and to the inhaler, when the device it is activated for inhalation, whereby a vacuum or negative pressure is created in the dispersion chamber, and with this the valve means regulates the flow of air through the inhalation device during inhalation.

2. The inhalation device according to claim 1, characterized in that the first non-mobile element is fixed on the air outlet adjacent to the air outlet of the inhaler.

3. The inhalation device according to claim 1 or 2, characterized in that the first and second elements are substantially cylindrical in shape, whereby the first non-mobile element is formed as a piston.

4. The inhalation device according to claim 1, 2 or 3, characterized in that an air tight seal is provided between the outer surface and the piston and the inner surface of the second element.

5. The inhalation device according to any of claims 1 to 4, characterized in that the first element is formed as a piston having an opening, and is provided on and surrounding the air outlet of the inhaler whereby a seal is provided air tight between the piston and the air outlet of the inhaler.

6. The inhalation device according to claim 5, characterized in that the opening of the piston is provided in direct alignment with the opening of the air outlet of the inhaler.

7. The inhalation device according to claim 5 or 6, characterized in that the valve means comprises the first valve means provided for closing the opening of the piston, the first valve means being provided to open when negative pressure or vacuum is created in the dispersion chamber, and the air is sucked through the inhaler into the chamber.

8. The inhalation device according to any of the preceding claims, characterized in that the valve means further comprises the second valve means provided for closing the air opening or outlet of the second element, the second valve means being provided for opening when a user inhales through the air outlet.

9. The inhalation device according to claim 7 or 8, characterized in that the valve means are formed as thin membranes rigidly coupled at their end to the walls of the first and second elements respectively, and freely movable at their other end.

The inhalation device according to any of the preceding claims, characterized in that the inhaler is a conventional inhaler for dry powder.

11. The inhalation device according to claim 10, characterized in that the inhaler comprises the maneuvering means, said means comprising a dosage unit and a dosing disc for feeding a dose of the pharmaceutically active powder substance from a loading position towards a position for inhalation in the inhalation channel of the inhaler.

12. The inhalation device according to claim 11, characterized in that the inhaler is a dry powder inhaler operated by breathing, preferably a respiratory-powered dry powder inhaler sold under the name Turbuhaler®.

13. The inhalation device according to any of the preceding claims, characterized in that the piston is rigidly mounted on the air outlet or mouth piece of the inhaler.

14. The inhalation device according to the preceding claims, characterized in that a substantially cylindrical-shaped element is provided, around the outer surface of the first cylindrical cylinder, and which is rotatable relative to the second element, the additional element having Cylindrical form the mounting means in its lower part for mounting the inhaler of said element.

15. The inhalation device according to claim 14, characterized in that the maneuvering means of the inhaler are fixedly provided in the mounting means of the element of additional cylindrical shape, so that a rotation of the additional element of cylindrical shape in relation to the second element, will rotate the maneuvering means of the inhaler, and activate the inhaler for inhalation.

16. The inhalation device according to claims 1 to 12, characterized in that the deflection means are provided between the piston and the second element, forcing the second element to move relative to the piston from a retracted position to an expanded position.

17. The inhalation device according to claim 16, characterized in that the deflection means is a spiral spring.

18. The method for dispersing a pharmaceutically active substance activates a dispersion chamber, by creating a negative pressure or vacuum in said dispersion chamber, by the use of an inhalation device as described in accordance with claims 1 to 15.

19. The method according to claim 18, characterized in that the active substance can be sucked through the air outlet of the inhaler, through the dispersion chamber, whereby the flow of inhalation air is regulated by the means of valve.

20. The method of administering a dose of a substance the pharmaceutically active powder, by using an inhalation device according to claims 1 to 16, characterized the method because the device is also used to force the dose into the chamber of spread out through the air outlet / mouth piece of the device.

21. The method according to claim 20, characterized in that the piston and the second element are forced to move in a direction opposite to the creation direction of the negative pressure or vacuum in the dispersion chamber, whereby an overpressure will be created. or positive pressure in the dispersion chamber, forcing the dose out of the device.