WO2025229550A1

WO2025229550A1 - A novel impeller-based dry powder inhaler (dpi)

Info

Publication number: WO2025229550A1
Application number: PCT/IB2025/054487
Authority: WO
Inventors: Vijaya VITTAL; Akash Mulemajalu Dinesh
Original assignee: ITC Ltd
Current assignee: ITC Ltd
Priority date: 2024-05-03
Filing date: 2025-04-30
Publication date: 2025-11-06
Anticipated expiration: 2026-11-03

Abstract

The present invention discloses Dry Powder Inhaler (DPI) technology, aiming to enhance the delivery efficiency of powdered formulation. The present invention includes a rotating pod (112) based delivery mechanism housed within a durable and lightweight housing (110). Key components include an upper housing (102) with an impeller (108) and a lower housing (104) with a rotating pod (112) in the mixing chamber (114) to deliver the powdered formulation to the user upon inhalation. This impeller (108), driven by breath actuation, rapidly rotates the rotating pod (112) upon inhalation, generating centrifugal forces upon the powdered formulation. An optimized release mechanism ensures precise delivery angles, 0 to ±85 degrees relative to the horizontal plane. The present invention represents a significant advancement in DPI technology, prioritizing usability, and dosage consistency.

Description

TITLE OF THE INVENTION

A NOVEL IMPELLER-BASED DRY POWDER INHALER (DPI)

FIELD OF INVENTION

[0001] The present invention relates to a breath-actuated device. More particularly, the present invention relates to a Dry Powder Inhaler (DPI) device for delivering powdered formulation to a user.

CROSS REFERENCE TO RELATED APPLICATIONS

[0002] Applicant claims priority and the benefit of Indian Provisional Patent application 202411035117, filed 03 May 2024 (03-05-2024), said application being hereby incorporated herein in its entirety by reference

BACKGROUND OF INVENTION

[0003] The use of Dry Powder Inhalers (DPIs) is one of the well-known methods to deliver powdered formulation effectively to a user. These are breath-actuated devices that aerosolize a set dose of micronized actives in the solid state on an airstream. Still there are certain challenges associated with the existing systems. Limitations with the presently available devices with respect to dry powder inhalers in general are:

• In Capsule-based design: Many DPIs rely on capsules to contain the powdered medication, which can be cumbersome and may lead to issues like dosage inconsistency and mishandling.

• Complexity: Existing DPIs often require multiple operations before inhalation, which can be inconvenient and confusing for users.

• Powder deposition: A significant amount of the powdered medication (40- 50%) often deposits on the walls of the mouthpiece instead of being effectively delivered to the user's lungs.

• Bulky and unattractive design: The form factor of existing DPIs is often bulky and may not be aesthetically appealing to consumers, potentially impacting their willingness to use the device regularly. [0004] WO 1995028192A1 describes a dry powder medicine inhaler with housing and a mouthpiece. An aerosolizing chamber is formed between a front wall and a rear wall of the housing. An impeller is rotatably mounted on a pin, to rotate within the aerosolizing chamber. Radial inlets pass through the housing and enter substantially tangentially into the aerosolizing chamber.

[0005] WO 1996032978 Al describes a dry powder inhaler which has a front section holding a unit dose cartridge over a mixing chamber. An impeller is rotatably mounted within the mixing chamber. A rear section of the inhaler includes a motor, a breath actuated switch, and pins for positioning the unit dose cartridge in the front section and driving a plunger through the unit dose cartridge, to deposit a powdered drug into the mixing chamber, as the front and rear sections are brought together

[0006] WO1998041265A1 describes an inhaler comprising: a housing; a mixing chamber in said housing; a pressure switch within said housing; a venturi air passageway within said housing; and a pressure tap on the venturi connecting to the pressure switch. The inhaler further comprising an impeller fixedly attached to a shaft of the electric motor, wherein the impeller is located within said mixing chamber.

[0007] However, none of the prior arts is using an impeller to push out the dry powder from the pod. All the round components in the above stated prior arts are for changing the positions in case of multi dose inhalers.

OBJECT OF INVENTION

[0008] It is an object of the present invention to improve the efficiency of powdered formulation delivery.

[0009] It is another object of the present invention to optimize the dispersion of powdered formulation within the inhaler device and enhance the mechanisms that facilitate the release of dry powder upon inhalation.

[0010] It is yet another object of the present invention to eliminate the reliance on capsule-based delivery systems commonly used in traditional DPIs. [0011] It is yet another object of the present invention to minimize the deposition of powdered formulation on the walls of the inhaler's mouthpiece.

[0012] It is yet another object of the present invention to optimize the release mechanism for powdered formulation.

[0013] It is yet another object of the present invention to enhance user experience.

SUMMARY OF THE INVENTION

[0014] The present invention discloses a Dry Powder Inhaler (DPI) by optimizing the delivery of powdered formulation to the user. Departing from conventional capsule-based systems, the present invention utilizes a pod-based delivery mechanism coupled with an impeller. By harnessing centrifugal forces and optimizing the release angle, the present invention ensures efficient and targeted delivery of powdered formulation with a focus on simplicity, usability, and enhanced sensory.

[0015] The present invention is a novel Dry Powder Inhaler (DPI) designed to optimize the delivery of powdered formulation to the users. The present invention utilizes a pod-based system, which eliminates the drawbacks associated with capsule-based DPI, thereby offering improved dosage consistency and ease of handling. The device of the present invention features an impeller mechanism that generates centrifugal forces to aerosolize the powdered formulation within an inhaler chamber. By releasing the powdered formulation at a specific angle (0 to +85 degrees) relative to the horizontal plane, the present invention targets delivery to specific areas.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0016] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which: [0017] Figure 1 is a schematic representation illustrating a DPI having an angle of the mouthpiece positioned at about 0 to +85 degrees with respect to the impeller, according to an embodiment of the present invention.

[0018] Figure 2 is a schematic representation illustrating the working of DPI with a rotating pod and device engagement along with the impeller setup, according to an embodiment of the present invention.

[0019] Figure 3 is a schematic representation illustrating the working of DPI with a rotating pod, in which the angle of the mouthpiece is in line with the axis of the impeller, according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The present invention may be embodied in several forms, and the details of embodiments of the present invention will be described in the following content with figures. The embodiments described below with reference to the drawings are merely illustrative of the technical solutions of the present disclosure but are not to be construed as limited to the technical solutions of the present disclosure.

[0021] The terms and words used in the following description and claims are not limited to the bibliographical meanings but are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of the present invention is provided for illustration purposes only and not for the purpose of limiting the invention as defined by the appended claims. As used in the description of the invention and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0022] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0023] The term “Pod” refers to but is not limited to a container used to hold powdered formulation for delivery through the dry powder inhaler (DPI).

[0024] The term “Impeller” refers to but is not limited to components that rotate rapidly upon inhalation, generating centrifugal forces that aerosolize the powdered formulation, facilitating its dispersion into the airflow.

[0025] The term “Dry Powder Inhaler (DPI)” refers to “inhaler” and can be used interchangeably. It may be noted that the terms such as Dry Powder Inhaler (DPI) and inhaler may be referred to as synonyms to each other and are represented as well understood concepts or the conventional terminologies used in the present art of the invention. It may further be noted that the interchangeable use of the terms does not limit the scope of the present invention in any way.

[0026] In a preferred embodiment, the present invention discloses a Dry Powder Inhaler (DPI) device to deliver powdered formulation effectively to the user. The DPI device comprises a housing and a pod insertion mechanism/loading mechanism. The housing is constructed from durable and lightweight materials, providing structural support, and housing the internal components. The powdered formulation is inserted in a rotating pod. The pod insertion /loading mechanism is designed to securely hold and align the rotating pod. The rotating pod is inserted in the housing of the DPI device, which enables the user to access the powdered formulation by inhalation. The pod insertion /loading mechanism includes a locking mechanism for ensuring proper alignment and secure placement of the rotating pod within the DPI device. The pod insertion /loading mechanism facilitates smooth and effortless powdered formulation administration to the user. The housing further includes an impeller. The impeller is coupled to the rotating pod. The impeller is driven by a means of breath actuation, and rotates rapidly upon inhalation by the user, generating centrifugal forces that facilitate the powdered formulation contained within the rotating pod to the user’s buccal cavity. The DPI device includes an optimized release mechanism that ensures the release of the powdered formulation at a specific angle within the range of 0 to +85 degrees, relative to the horizontal plane. This optimized release angle enhances the targeted delivery of the powdered formulation to the user. The DPI device includes features designed to minimize the deposition of powdered formulation on the walls of the DPI device mouthpiece. This mechanism ensures efficient delivery of powdered formulation to the user.

[0027] In another embodiment of the present invention, the present invention discloses a device for optimizing the delivery of powdered formulation to the user. The present invention comprises an upper housing with an impeller assembly and a lower housing with a mixing chamber and a mouthpiece. The mouthpiece design includes coatings to prevent adhesion of the powdered formulation and minimize deposition losses. The mixing chamber is adapted to hold the powdered formulation in a rotating pod. The rotating pod is coupled to an impeller present in the upper housing. The mixing chamber facilitates the efficient mixing and aerosolization of the powdered formulation. The impeller rotates rapidly which rotates the rotating pod within the mixing chamber, generating centrifugal forces that aid in the delivery of the powdered formulation to the user. The mouthpiece includes an orifice, providing an exit point for the delivery of powdered formulation to the user. The impeller is operatively coupled to the rotating pod, is breath-actuated, and initiates rotation upon user inhalation to generate centrifugal forces for aerosolizing and propelling the powdered formulation. The design of impeller is aerodynamically optimized to facilitate efficient aerosolization and dispersion of the powdered formulation.

[0028] In another embodiment of the present invention, the present invention discloses a device for optimizing the delivery of powdered formulation to the user. Better dose optimization is accomplished through a preferred rotating pod design and its volume, impeller design, preferred orifice/exit channel size, and the angle between the upper and lower housing. The present invention comprises at least one upper housing with at least one impeller and at least one lower housing with at least one mixing chamber and at least one mouthpiece/orifice/exit channel. The mouthpiece design includes coatings to prevent adhesion of the powdered formulation and minimize deposition losses. At least one mixing chamber includes at least one rotating pod. At least one mixing chamber is adapted to hold the powdered formulation within a rotating pod to be delivered to the user. At least one mixing chamber facilitates the mixing and aerosolization of the powdered formulation upon inhalation from the user.

[0029] In an embodiment, the pod can be rotated by means of any suitable mechanism including combinations of electrical or mechanical units. The electrical actuator/unit or electromechanical actuator/unit can be used to rotate the pod. In a preferred embodiment the pod can be rotated using a motor which draws power from a power source by pressing (or by pressing and holding) a switch by the user.

[0030] In another embodiment, a sensor (such as mike sensor, pressure sensor, etc.) can be used to detect the inhalation from the user, and a signal can be sent to control circuit to drive a motor to rotate the pod.

[0031] In another embodiment, the electro mechanical unit includes motor, power source, mechanical linkages such as lever, gear, gear assembly or any combination thereof.

[0032] Figure 1 of the present invention illustrates a device (100), according to an embodiment of the present invention, wherein the device (100) is a Dry Powder Inhaler (DPI) with an angle of a mouthpiece positioned within the range of 0 to +85 degrees with respect to an impeller (108). The device (100) includes a housing (110) and a mouthpiece (106). The housing (110) further comprises two sections, an upper housing (102), and a lower housing (104). The upper housing (102) consists of the impeller (108) and the lower housing (104) consists of a rotating pod (112) and a mixing chamber (114). A powdered formulation is inserted in the rotating pod (112) and the rotating pod (112) is subsequently inserted in a mixing chamber (114) of the lower housing (104), which enables the user to get access to the powdered formulation. A loading mechanism is provided to ensure proper alignment and accurate placement of the rotating pod (112) in the lower housing (104) within the device (100). The loading mechanism is configured to facilitate smooth and effortless administration of powdered formulation to the user. The mixing chamber (114) may be adapted to holding the rotating pod (112) with the powdered formulation. The rotating pod (112) is coupled to the impeller (108). The impeller (108) present in the upper housing (102), driven by means of breath actuation through the mouthpiece (106), rotates rapidly upon inhalation, generating centrifugal forces that facilitate the delivery of powdered formulation contained within the rotating pod (112) to the user’s buccal cavity. The impeller design is aerodynamically optimized to enhance the efficient aerosolization and dispersion of the powdered formulation. The mixing chamber (114) is configured to provide efficient mixing and aerosolization of the powdered formulation in the rotating pod (112) when the impeller (108) is activated by the user's breath inhalation. The mouthpiece (106) includes an orifice, providing an exit point for the delivery of powdered formulation. The device (100) includes an optimized release mechanism that ensures the powdered formulation to be released at a specific angle within the range of 0 to + 85 degrees, relative to the horizontal plane. This optimized release angle enhances the targeted delivery of the powdered formulation to the user. The device (100) includes features designed to minimize the deposition of powdered formulation on the walls of the device’s mouthpiece (106). This mechanism ensures efficient delivery of powdered formulation.

[0033] Figures 2 and 3 of the present invention illustrate the working of a device (100) with a rotating pod (112), according to an embodiment of the present invention. The device (100) comprises a housing (110) and a mouthpiece (106). The housing (110) includes two sections: an upper housing (102) and a lower housing (104). The upper housing (102) includes an impeller (108), while the lower housing (104) contains the rotating pod (112) and a mixing chamber (114). The rotating pod (112) contains the powdered formulation. The rotating pod (112) is inserted into the lower housing (104) for delivery of the powdered formulation to the user. A loading mechanism ensures secure placement of the rotating pod (112) within the lower housing (104) of the device (100), facilitating the smooth administration of powdered formulation to the user. The impeller (108) is coupled with the rotating pod (112). The impeller (108) placed within the upper housing (102), driven by breath actuation through the mouthpiece (106), rapidly rotates upon inhalation, generating centrifugal forces. This action aerosolizes the powdered formulation contained within the rotating pod (112) for delivery to the user's buccal cavity. The mouthpiece (106) includes an orifice for delivering the powdered formulation to the user. The device (100) includes an optimized release mechanism that ensures the powdered formulation is released at a specific angle within the range of 0 to +85 degrees, relative to the horizontal plane, thereby enhancing the targeted delivery of the powdered formulation. Additionally, features are integrated to minimize the deposition of powdered formulation on the mouthpiece (106) walls, ensuring efficient powdered formulation delivery.

ADVANTAGES OF THE INVENTION

[0034] Providing efficient dispersion of powdered formulation, enhancing delivery.

[0035] The optimized release mechanism of the present invention ensures that powdered formulation is released within a specific angle range of 0 to +85 degrees, relative to the horizontal plane.

[0036] The present invention's pod insertion mechanism and simplified loading process make it user-friendly.

[0037] By minimizing the deposition of powdered formulation on the walls of the DPI mouthpiece, the present invention reduces wastage and ensures more efficient delivery of powdered formulation.

[0038] Any combination of the above features and functionalities may be used in accordance with one or more embodiments. In the foregoing specification, embodiments have been described with reference to numerous specific details that may vary from implementation to implementation. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. The sole and exclusive indicator of the scope of the invention, and what is intended by the applicants to be the scope of the invention, is the literal and equivalent scope of the set as claimed in claims that issue from this application, in the specific form in which such claims issue, including any subsequent correction.

[0039] In the above description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present systems and methods. It will be apparent the systems and methods may be practiced without these specific details. Reference in the specification to “an example” or similar language means that a particular feature, structure, or characteristic described in connection with that example is included as described, but may not be included in other examples.

[0040] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily configure and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Claims

1. An inhaler (100) comprising: a housing (110) including a rotating pod (112) configured to hold the powdered formulation; a mixing chamber (114) with in the housing (110) in fluid communication with the rotating pod (112); a mouthpiece (106) having an opening for directing the aerosolized powdered formulation to a user.

2. The inhaler (100) as claimed in claim 1, where in the rotating pod (112) will release the powdered formulation at an angle ranging from 0 to +85 degrees relative to the horizontal plane to enhance targeted delivery.

3. The inhaler (100) as claimed in claim 1, wherein an impeller (108) is operatively coupled to the rotating pod (112).

4. The inhaler (100) as claimed in claim 3, wherein an impeller (108) is breath-actuated, and initiates rotation upon user inhalation.

5. The inhaler (100) as claimed in claim 3, wherein the impeller (108) generates centrifugal forces for aerosolizing and propelling the powdered formulation.

6. The inhaler (100) as claimed in claim 3, wherein the design of impeller (108) is aerodynamically optimized to facilitate efficient aerosolization and dispersion of the powdered formulation.

7. The inhaler (100) as claimed in claim 1, wherein the rotating pod (112) is removably inserted into the mixing chamber, and a pod loading mechanism ensures secure placement and alignment within the lower housing.

8. The inhaler (100) as claimed in claim 1, wherein the pod loading mechanism includes a locking mechanism that ensures proper alignment and prevents accidental displacement of the rotating pod (112).

9. An inhaler (100) comprising: a housing (110) including a rotating pod (112) configured to hold the powdered formulation; a mixing chamber (114) with in the housing (110) in fluid communication with the rotating pod (112); a mouthpiece (106) having an opening for directing the aerosolized powdered formulation to the user; wherein, the rotating pod (112) can be rotated using series of electro mechanical unit;

10. The inhaler (100) as claimed in claim 9, wherein the electro mechanical unit includes motor, power source, mechanical linkages such as lever, gear, gear assembly or any combination thereof.

11. The inhaler (100) as claimed in claim 1, wherein the mouthpiece design includes coatings to prevent adhesion of the powdered formulation and minimize deposition losses.