LOW-COST SINGLE USE POWDER INHALER

Abstract

The present invention relates to a low-cost single-use disposable breath actuated dry powder inhaler, its method of use, and method of manufacture. The inhaler comprises a bottom layer and a top layer. The inhaler comprises a medicament compartment and an air passageway. Furthermore, the medicament compartment is sealed by a flexible pull tab that is easily removed before use, and the air passageway comprises a mouthpiece port, a Venturi section, and an air inlet port.

Claims

1. A dry powder inhaler for administration of a unit dose of a medicament comprising a top layer, a bottom layer, a flexible pull tab, and powdered medicament, wherein the top layer and the bottom layer are sealed together and define structures comprising a mouthpiece port connected via an air passageway to an air inlet port, a medicament compartment adjacent to the air inlet port, the air passageway passing over the medicament compartment, and the pull tab coveting the medicament compartment and retaining the powdered medicament therein.

2. An inhaler according to claim 1, wherein the air passageway comprises a Venturi section.

3. An inhaler according to claim 2, wherein the top layer is comprised of foil and the bottom layer is comprised of foil.

4. The inhaler according to claim 1, wherein each of the top and bottom layers comprise laminated, extrusion-coated aluminum foil.

5. A method of operating an inhaler according to claim 1, comprising removing the pull tab from the inhaler, and inhaling through the mouthpiece port.

6. A method of manufacturing a continuous sheet of inhalers according to claim 1, wherein the top layer and the bottom layer are provided in continuous sheets; the mouthpiece port, the air passageway comprising a Venturi section, and the air inlet port are continuously formed in the top layer; the medicament compartment is continuously formed in the bottom layer; a machine incorporating a filling system continuously fills the medicament compartments; the medicament compartments are continuously sealed by a flexible foil with a pull tab; and the top layer and the bottom layer are continuously sealed together.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0022] The present invention provides an improved device, method of use, and method of manufacture for dry powder low-cost single-use disposable inhalers. As will be described in more detail below, a device of the present invention is an inhaler having a compact and convenient shape. This inhaler contains a single dose of dry powder medicament, and may be disposed of following use by a patient. The inhaler includes features for allowing air to pass into and through the device as a patient inhales. In proper use, air will exit the inhaler carrying a full dose of medicament in the form of a fine, dry, de-aggregated powder, with little risk of spillage. Following use, the patient may dispose of the inhaler.

[0023] In an exemplary embodiment, the dry powder inhaler for administration of a unit dose of a medicament comprises a top layer comprising a mouthpiece port connected via an air passageway to an air inlet port, a bottom layer comprising a medicament compartment sealed by a flexible pull tab; wherein the top layer and bottom layer are sealed together and the medicament compartment is adjacent to the air inlet port and the pull tab extends out of the air inlet port. Alternatively, any or all of the mouthpiece port, air passageway or air inlet port could be formed in the bottom layer while the medicament compartment could be formed in the top layer. Further, any of these structures may comprise portions defined in both the bottom and top layers and fully realized once the layers are sealed together. In addition, the flexible pull tab may extend out of the mouthpiece port.

[0024] Furthermore, the inhaler includes an air inlet port to allow a stream of ambient air to enter as the user draws air from the inhaler through the mouthpiece port. The air passageway connecting the air inlet port to the mouthpiece port may include a Venturi section. The purpose of the Venturi section is to de-aggregate the dry powder medicament. Adjacent to the air inlet port is a medicament compartment. A dry powder medicament is stored in the medicament compartment, and the medicament compartment is sealed by a flexible pull tab extending out of the air inlet port or mouthpiece port when the top layer and bottom layer are sealed together.

[0025] Supplemental to of in place of the Venturi section, a swirl chamber may be formed between the medicament compartment and the mouthpiece port. The action of the swirl chamber may be effectuated by the inclusion of a secondary air passageway having an air introduction portion separate from the air inlet portion of the primary air passageway with the other end thereof positioned to fluidly communicate with the swirl chamber and to enter at an angle oblique to the primary airflow carrying the medicament powder.

[0026] A number of materials for the top and bottom layer may be appropriate for achieving the goals of the presently described inhaler. One preferred embodiment of the present invention utilizes a foil material; more particularly, a laminated, extrusion-coated aluminum foil. One side is pre-lacquered and over-lacquered whilst the other side has a primer and polyethylene coating. The polyethylene coating provides the sealing interface for joining the top and bottom layers together. The thickness of the aluminium layer is chosen to give the appropriate mechanical and barrier properties. Thickness needs to be sufficient to provide sufficient rigidity to the inhaler but should be limited to ease formation of the various structures and to keep material costs down.

[0027] A preferred embodiment of the flexible pull tab may also comprise a laminated and/or extrusion-coated aluminium foil. The thickness of the aluminium foil used for the pull tab would likely be much less than for the top and bottom layers, given the greater need for flexibility when it comes to the pull tab.

[0028] The method of using the present invention utilizes an inhaler to administer a single dose of dry powder medicament. A user utilizes the method of the present invention by removing the pull tab from the inhaler. The fine powder medicament contained therein is exposed to air flowing through the inhaler and, thus, inhaled by the user. The user may dispose of the inhaler after use.

[0029] When provided to a user, such as a patient, the inhaler will be provided with a proper dosage of medicament in the medicament compartment. As noted, the inhaler medicament compartment is sealed, preventing moisture in the ambient air from reaching the dry powder medicament housed therein, reducing clumping and thereby facilitating inhalation when a dose is administered. Multiple inhalers may be provided in a continuous strip. Before administration, the user may preferably tear one inhaler off the continuous strip along a perforated line in-between consecutive inhalers.

[0030] When a patient is prepared to administer a dose of medicament, the patient then preferably holds the inhaler substantially parallel to the ground and gently removes the pull tab protruding from the air inlet or mouthpiece port. Removing the pull tab serves to remove the seal from the medicament compartment, and to expose the medicament to the air passageway. Preferably, the pull tab is completely removed from the inhaler by the patient prior to inhalation.

[0031] The inhaler is now ready for use in administering a dosage of medicament. The patient's lips form an airtight seal about the mouthpiece port. At this time, a relatively forceful inhalation action by the patient will draw air in through the air inlet port. The incoming air is forced over the dosage of medicament contained in the medicament chamber. Preferably, the powder medicament used will consist of independent particles. Such particles are highly susceptible to aerolization, i.e. they readily mix with ambient air. The stream of air passing through the air passageway causes the fine particles of medicament to become airborne. As the airborne medicament passes through the Venturi section, any remaining clumps of medicament are de-aggregated. Breaking up the medicament is another way of recognizing the relative independence of particles, one from another appropriate for effective respiration into the patient's respiratory tract, coating of respiratory tract tissues and ultimate absorption thereof, where appropriate. De-aggregation also makes inhalation more comfortable for the patient.

[0032] Preferably, a full dose of medicament will be administered by a single inhalation action by a patient. However, depending on a size of the dose, a patient's lung capacity generally, and a particular inhalation specifically, further inhalations may be necessary. The inhaler may be in part or completely formed of a translucent or transparent material, revealing to a user whether a full dosage of medicament has been properly administered. Alternatively, a patient may have to learn through experience how to best self-administer a full dosage. Preferably, the inhaler is disposed of after use.

[0033] The method of manufacture of the present invention uses a continuous manufacturing process to produce low-cost single-use disposable dry powder inhalers. Two strips of material are provided, one strip designated the top layer and the other strip designated the bottom layer. The mouthpiece port, air passageway comprising a Venturi section, medicament compartment and air inlet port are continuously formed in the top and bottom layers. A machine incorporating a filling system then continuously fills the medicament compartments. Next, the medicament compartment is sealed by a flexible pull tab. Finally, the top layer and the bottom layer are sealed together. A perforated line is placed in-between each consecutive inhaler allowing easy separation of an inhaler from the sheet of inhalers. Further, various cutting and forming steps may be applied to the strip of inhalers. One such cutting and forming steps includes the formation of a comfortable shape whereby the user engages the inhaler with their lips.