Aerosol inhalation device

a technology of aerosol particles and inhalation chambers, which is applied in the direction of inhalators, medical devices, other medical devices, etc., can solve the problems of reduced patient compliance, oral candidiasis and dysphonia and systemic side effects, and aerosol particles that are not easily absorbed and deposited in the mouth, throat and pharynx walls,

Inactive Publication Date: 2014-03-06
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0051]An actuator according to the present invention, retaining the coarse dose on the tubular element wall via inertial impaction, may remove the requirement for add-on devices, spacers or holding chambers such as the Volumatic™ and AeroChamber Plus™, which prevent a large proportion of the coarse particles from the dose reaching the patient, but produce dramatically changes in the PSD with respect to “actuator only” products. This reduces the need to carry such add-on devices which are cumbersome and is an additional factor considering patient compliance.
[0052]The so called “cold Freon effect”, in which high-velocity aerosol hits the back of the throat, causing hiccup and patients to stop inhaling prematurely, is minimized.

Problems solved by technology

As inhalers of this type are normally designed to be as small as practical for the convenience of users, the distance between the point at which the medicament is fired into the airflow and the patient's mouth is usually quite small so that there is little distance to reduce the inertia of the particles of medicament, with the result that coarse, non-respirable (>9 μm aerodynamic diameter) aerosol particles may impact and deposit in the mouth, throat and pharynx walls.
This is normally undesirable, since the medicaments were designed for delivery to the respiratory system and may not have an appropriate effect when deposited in the mouth and throat potentially causing oral candidiasis and dysphonia and systemic side effects, when allowed to enter the digestive tract by swallowing.
However, in these cases the drug delivery characteristics are not considered identical to a conventional pMDI product; and some of these devices are also bulky and inconvenient for the patients to carry with them, often leading to a reduction in patient compliance.
However, the correct use of this actuator depends on the inspiratory effort and timing of the patient, moreover the manufacture of such a device is more complex and expensive than a conventional pMDI.
But these devices are not intended for oral inhalation of drugs for the treatment of lung or pulmonary diseases but simply consist in spray applicator devices for local treatment of conditions of the nose, mouth or throat.
In fact their shape, wherein the angle between the longitudinal axis of the orifice (aerosol outlet) and the longitudinal axis of the valve stem of the canister is lower than 90°, makes these devices unsuitable for the administration to the lungs of a product by oral inhalation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1a

[0132]A range of tubular elements of predetermined dimensions were designed and manufactured. These were designed to allow them to be easily fitted to a conventional actuator block, thus converting the actuator into an actuator according to the present invention with a recessed orifice aperture design. FIGS. 3b and 4 show the basic premise of the design and the respective diameter D and length L of the geometries tested. The smallest internal diameter of 3 mm is less than the diameter of the orifice cone therefore was chamfered to prevent an impact surface and potential dead space from being created. The largest tube diameters required a step detail to enable the extra width to be catered for, as the internal diameter was wider than the nozzle block of the actuator (FIG. 5).

[0133]The tubular elements were manufactured in UV Curable Acrylic Plastic. All prototype tubes were fitted on actuators with 0.30 mm orifice diameter.

[0134]The actuator prototypes based on FIGS. 2 to 5 were prod...

example 1b

[0145]A range of single molded actuators plus tubular elements of 10 mm length and 6 mm diameter with smoothed or stepped nozzle tube features as shown in FIGS. 16A-B and in FIGS. 17A-C were manufactured and tested in their performances. The seven variants produced, depending also from the orifice diameters and the material types: Polypropylene (PP: Ineos 100-GA3), polymethylmetacrylate (PMMA: Aultglas V825T), Polycarbonate (PC: Makrolon 2405, are shown in Table 5

TABLE 5Single moulded actuators plus tubular elementsmanufactured according to Example 1B.SteppedOrifice DiameterPrototype N.FeatureMaterial(mm)269YesPolypropylene0.32270YesPolypropylene0.30271NoPolycarbonate0.30272NoPolycarbonate0.32273YesPolycarbonate0.30274YesPolycarbonate0.32275NoPolymethylmetacrylate0.32

example 2

[0146]An actuator fitted with one of the preferred tube element (i.e. Prototype 204 of Example 1A) with a 10 mm length (L) and 6 mm internal diameter (D) was tested to challenge the robustness of the concept. Through-can-life testing was carried out to assess the drug delivery performance of the prototype, in particular when no patient washing is performed, i.e. a “worst case” scenario. The plume temperature profile was also measured, to determine whether the presence of the nozzle tube could potentially reduce the “cold-freon” effect.

Through-Life-Testing.

[0147]Prototype 204 was coupled with a new, un-primed can containing the solution formulation of beclometasone dipropionate 250 μg / dose (BDP 250 of Table 1). Four doses were delivered to a waste Dose Unit Sampling Apparatus (DUSA; Copley Instruments, UK) every five minutes and all shot weights recorded. The five minute period allowed the ethanol to evaporate and the area around the orifice and nozzle tube to dry; this could be expe...

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Abstract

Actuators for an aerosol inhalation device containing a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, a mouthpiece portion through which the user inhales, a nozzle block and an orifice and a tubular element extending in the mouthpiece portion from the orifice aperture in a longitudinal axis substantially aligned with a longitudinal axis of the mouthpiece portion provide a significant reduction in the non-respirable, coarse fraction of the emitted aerosol medicament via inertial impaction and retention in the actuator than in the oro-pharynx, with consequent less associated side effects and oral candidiasis in the patient. In addition the presence of the tubular element has minimal, negligible impact on the fine particle dose and on the particle size distribution (PSD) of the delivered particles having aerodynamic diameter lower than 9 μm.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority to European Patent Application No. 12182122.7 filed on Aug. 29, 2012, which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to the field of inhalers for medicaments and in particular to an improvement of aerosol devices for transferring to the respiratory system of a patient and in particular to the lungs, by oral inhalation, a metered dose of a medicament contained in a pressurised dispensing container.[0004]2. Discussion of the Background[0005]The use of aerosol inhalation devices for the administration by inhalation of medicaments in form of aerosol is well known. Among the devices available to deliver medicaments to the lungs, pressurised metered-dose inhalers (pMDIs) are widely used.[0006]pMDIs are aerosol delivery systems designed to deliver a medicament formulated with a pressure liquefied propellant g...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M15/00A61M11/02
CPCA61M15/009A61M15/0065A61M11/02A61M15/0021A61M2205/0233A61M2205/0238A61M2209/06
Inventor BRAMBILLA, GAETANOJOHNSON, ROBERTLEWIS, DAIVD ANDREW
Owner CHIESI FARM SPA
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