Patent Application
20240001054
The invention relates to the field of devices for dispensing product in powder form, in particular by inhalation.
The state of the art, in particular document EP1270034B1 already describes a dispensing device by inhalation of a product comprising a mouthpiece to dispense by inhalation a product in powder form, during an inspiration phase of a user, for example for a nasopharynx or pulmonary application. The product in dry powder form is contained initially in a capsule and is for example composed of an active product and lactose, to keep the product in powder form. The capsule is arranged in a housing, which communicates with the outside via holes, then a user perforates the capsule with needles, allowing the product in powder form to be released from the capsule. Once the capsule has been perforated, the user makes an inspiration. An air flow is thus created, which passes in the housing, around the capsule to move it and expel the powder. The air flow mixes with the powder generating the aerosol of medication. The aerosol then passes through the nozzle and is routed towards the user's airways. Thus, the product in powder form is dispensed by means of the air flow created by the user's inspiration. However, in some cases, the user's inspiration may not be very efficient, especially when the air flow is too weak.
When the air flow is too weak, the dry powder particles are not correctly deagglomerated. In fact, the air plays a role of deagglomerating or dispersing the powder particles, whether via the direct interaction of the air with the powder or indirectly via the rotation or the movement of the capsule containing the powder. When the particles are not correctly deagglomerated, they may be deposited in an unwanted area, for example the inner wall of the nozzle, the mouth or the throat, thereby reducing the effective amount of product inhaled.
Consequently, the dispensing quality provided by the device disclosed in this document largely depends on the inspiration quality, which means that it does not guarantee that the product in powder form is always dispensed efficiently.
To overcome this disadvantage, the invention aims in particular to propose a nozzle for a dispensing device of a product in powder form, which ensures that the product in powder form is dispensed more efficiently irrespective of the air flow generated.
The invention therefore relates to a nozzle for a dispensing device of a product in powder form, comprising:
This dispensing restriction thus corresponds to the smallest flow section of the entire dispensing duct, in other words to the smallest flow section of an air flow crossing the dispensing duct.
Thus, due to the dispensing restriction, in other words the restriction of the flow section of the air flow entraining the product, turbulences are generated in the air flow which combine with those generated by the holes in the grid and which improve the deagglomeration of the product. Consequently, the dispensing of product is improved. It is observed that by using the invention, there are fewer variations in the doses dispensed depending on the users. Such repeatability is particularly interesting since the inspirations may be quite different depending on the users, for example in the case of an athlete or a user suffering from respiratory difficulties. In addition, the invention thus proposes dispensing a more homogeneous quantity of product correctly deagglomerated and relatively independent of the inspiration quality, but also a dispensing that is more targeted towards the required area, in other words generally the lungs.
A transverse section or transverse arrangement designates a section or an arrangement along a plane arranged perpendicular to the longitudinal axis of the dispensing duct.
The words transverse, longitudinal, perpendicular, parallel, tangential or coplanar used in this document must be understood as including a certain tolerance, at least equal to the manufacturing variability, for example 10 degrees.
The nozzle may have the following characteristics, either alone or in combination:
Since these surfaces are coplanar, there is a sudden increase in the flow section of the air flow at the grid outlet, which is different from the case, for example, where the solid wall would not be flat and would have a transverse section that increases or decreases progressively towards the dispensing opening, forming a funnel around the grid. The sudden discontinuity generated by the planar wall of the solid wall maximizes the generation of turbulences in the air flow, said turbulences combining with those generated by the holes in the grid since the grid and the solid wall lie in the same plane. This increase in the generation of turbulences further improves the deagglomeration of the product, therefore efficient dispensing of the product, irrespective of the air flow generated, in other words irrespective of the user's inspiration.
The invention also relates to a dispensing device by inhalation of a product in powder form comprising a nozzle as described previously.
According to other optional characteristics of the dispensing device taken alone or in combination:
The invention will be better understood on reading the following description, given solely by way of example and with reference to the accompanying drawings in which:
On all the figures, the same references refer to the same elements. The following embodiments are examples. Although the description refers to one or more embodiments, this does not necessarily mean that each reference concerns the same embodiment, or that the characteristics apply only to a single embodiment. Simple characteristics of different embodiments may also be combined to provide other embodiments.
The products, in particular pharmaceutical products, likely to be used in the dispensing device include for example formulations containing at least one active ingredient such as corticoids, glucocorticoids, peptides, proteins, hormones, active ingredients of biological origin, nucleotide-based active ingredients, such as for example DNAs, RNAs or oligonucleotides, active ingredients of molecular weight up to 1500 Da, polysaccharides, vaccines, enzymes, antibodies, antivirals, or nutritional formulations or a mixture thereof.
The products, in particular pharmaceutical products, likely to be used in the dispensing device can be used for the treatment and/or prevention of asthmas, chronic obstructive pulmonary diseases (COPD), cardiovascular diseases such as angina pectoris, heart attacks, influenzas A and influenzas B.
The products, in particular pharmaceutical products, likely to be used in the dispensing device are for example formulations containing at least one active substance such as salbutamol, fluticasone, salmeterol, budesonide, formoterol, tiotropium, beclomethasone, vilanterol, laninamivir, levosalbutamol, ipratropium, fenoterol, their salts, hydrates, solvates, stereoisomers and/or derivatives such as for example fluticasone propionate, tiotropium bromide, beclomethasone dipropionate, fluticasone fuorate, fluticasone propionate or ipratropium bromide. The formulations may also contain a combination of two or more active substances such as for example fluticasone with salmeterol, budesonide with formoterol, fluticasone fuorate with vilanterol, beclomethasone with levosalbutamol, fluticasone with formoterol, ipratropium bromide with salbutamol or ipratropium bromide with levosalbutamol.
As shown on
In this example, the nozzle 3 is a mouthpiece. It comprises a dispensing duct 9 extending longitudinally. The dispensing duct 9 comprises a dispensing opening 11 configured to open freely into an airway of a user, for example the mouth. The nozzle 3 also comprises a grid 13 arranged transversally across the dispensing duct 9. The nozzle 3 further comprises a solid wall 15 arranged in the dispensing duct 9 around the grid 13 so as to form a dispensing restriction 17, the dispensing restriction 17 having a flow section smaller than the minimum flow section of the dispensing duct 9. The space extending longitudinally from the grid 13 up to the dispensing opening 11 is free. In this example, the nozzle 3 is entirely made in one piece. The nozzle 3 is made of a thermoplastic material. As shown on
The dispensing duct 9 comprises a flow section that is constant or increasing from the grid 13 up to the dispensing opening 11. In this example, the dispensing duct 9 comprises a flow section that is constant from the grid 13 up to the dispensing opening 11. According to a variant not shown, the dispensing duct comprises a flow section of elliptical shape.
The dispensing duct 9 has a minimum inner dimension in transverse section which is between 15 and 30 millimetres, preferably between 20 and 25 millimetres, more preferably is equal to about 22.5 millimetres. More precisely in this example, the dispensing duct 9 is tubular and the minimum inner dimension in transverse section corresponds to its diameter D1.
As shown on
The solid wall 15 is made in one piece with the dispensing duct 9 and with the grid 13. As shown on
The dosing chamber 5 is configured to contain product in powder form, said chamber comprising an air inlet 21 and an outlet 23, the nozzle 3 being connected directly to the outlet 23 of the dosing chamber 5. For example, the nozzle 3 is attached to the dosing chamber 5 by clipping. The air inlet 21 is arranged tangentially in the dosing chamber 5, the outlet 23 being arranged longitudinally on the side of the nozzle 3. Thus, an air flow entering via the air inlet 21 is swirling in the dosing chamber 5.
The dispensing device 1 further comprises means 25 that can be actuated by a user and configured to break the integrity of a capsule 26 containing product P in powder form arranged in the dosing chamber 5. The capsule 26 is arranged transversally in the dosing chamber 5. Thus, the capsule 26 is not arranged longitudinally in the dosing chamber 5. In this example, the means 25 are perforation means comprising two sliding buttons 27 arranged on each side of the dosing chamber 5, each supporting at least one needle 29 configured to perforate the capsule 26 and release the product P in powder form when an air flow passes in the dosing chamber 5. Each sliding button 27 comprises for example a return element, such as a spring 31. Thus, each return element is configured to return the respective sliding button 27 from a perforation position to a rest position.
Alternatively, according to a variant not shown, the perforation means are spikes.
The storage chamber 7 has the shape of a container. The storage chamber 7 is configured to store a plurality of capsules containing product in powder form. As shown on
In this example, it has been observed that the variability of the product dose dispensed efficiently depending on the air flow generated is much less compared with that of an existing commercial dispensing device of the above-mentioned type. Thus, for an air flow between 30 L/min and 100 L/min, the variability of the dose of product deagglomerated in the form of particles of size less than 5 μm and dispensed efficiently in the lungs of a user is approximately 15.6% whereas the commercial device has a variability of 28% under the same conditions.
The invention is not limited to the embodiments described and other embodiments will be clearly apparent to those skilled in the art. The nozzle 3 can have any outer shape, since this outer shape has no effect on the air flow passing inside the nozzle 3, in the dispensing duct 9.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2011946 | Nov 2020 | FR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/082372 | 11/19/2021 | WO |
