Patent Publication Number: US-2023144040-A1

Title: Nasal delivery device for a powder

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is continuation of U.S. application Ser. No. 16/067,862, filed Sep. 20, 2018, which is a National Stage of International Application No. PCT/FR2017/050040 filed Jan. 6, 2017, claiming priority based on French Patent Application No. 1650118 filed Jan. 7, 2016. 
    
    
     FIELD OF INVENTION 
     The present invention relates to a nasal powder dispenser device. 
     BACKGROUND 
     Nasal powder dispenser devices are well known. They generally comprise: a reservoir containing one or more doses of powder; dispenser means; and a nasal dispenser head for inserting into a user&#39;s nostril, said nasal dispenser head including a dispenser orifice. The dispenser means generally include an air expeller. When the dispenser device is actuated, a dose of powder is dispensed into a user&#39;s nostril. 
     A drawback with those prior-art devices relates to dispensing the dose of powder into the nostril. 
       FIG.  1    is a diagram showing such a nostril. The nostril comprises: the nostril orifice  1  (sometimes known as the naris); the nasal valve  2 ; the inferior concha (or turbinate)  3 , the middle concha (or turbinate)  4 , and the superior concha (or turbinate)  5 ; the frontal sinus  6 ; the ethmoid sinuses  7 ; the sphenoidal sinus  8 , the sella turcica  9 , the choana  10 , the cavum (or nasopharynx)  11 , the Eustachian tube  12 , the uvula  13 , the soft palate  14 , and the hard palate  15 . 
     The nasal valve has a particular shape. It extends over about 1 centimeter (cm) in depth, has a vertical longitudinal section of about 3 cm to 4 cm, and a width of about 1 millimeter (mm) to 3 mm. Beyond the nasal valve, the nasal cavity includes a larger cavity (about 7 cm in height by 2 cm to 3 cm in width). The conchae face the nasal valve. The roof of the nasal cavity is situated above the conchae, which roof includes the ethmoid sinuses, the olfactory bulb, and the olfactory nerve. 
     Since nasal dispenser devices are non-invasive, or only minimally invasive, the dispensed powder generally does not pass through the nasal valve  2 . Thus, as a result of the anatomy of the nasal valve  2  and of the protective location of the conchae  3 ,  4 ,  5 , the axial or rectilinear path of the powder spray particles does not make it possible to reach the roof of the nasal cavity, and in particular the ethmoid sinuses  7 . 
     Documents WO 99/46055, WO 02/45866, and WO 2015/001281 describe prior-art devices. 
     CERTAIN OBJECT OF THE INVENTION 
     An object of the present invention is to provide a nasal powder dispenser device that does not have the above-mentioned drawbacks. 
     Another object of the present invention is to provide a nasal powder dispenser device that improves the percentage of dose that reaches the ethmoid sinuses. 
     Another object of the present invention is to provide a nasal powder dispenser device that is simple and inexpensive to manufacture and to assemble. 
     The present thus provides a nasal powder dispenser device comprising: a reservoir containing at least one dose of powder; a nasal dispenser head for inserting into a user&#39;s nostril, said nasal dispenser head including a dispenser orifice; and an air expeller that, during actuation of said nasal powder dispenser device, generates a flow of compressed air so as to dispense a dose of powder into said nostril through said dispenser orifice, said air expeller comprising an air chamber and a piston that slides in airtight manner in said air chamber so as to compress the air contained in said air chamber; said nasal powder dispenser device presenting the following properties:
         a pressure, of said flow of compressed air generated by said air expeller, that is higher than 0.7 bar; and   a volume, of said air chamber, that is greater than 1700 cubic millimeters (mm 3 ).       

     Advantageously, said pressure is lower than 2 bar, in particular lying in the range 1 bar to 1.5 bar, preferably about 1.3 bar. 
     Advantageously, said volume is smaller than 3000 mm 3 , in particular lying in the range 2000 mm 3  to 2700 mm 3 , preferably about 2600 mm 3 . 
     Advantageously, said dose of powder is 10 milligrams (mg). 
     Advantageously, the average size of particles of the dose of powder is greater than 5 micrometers (μm). 
     Advantageously, said reservoir contains a single dose of powder for dispensing during a single actuation of said nasal powder dispenser device. 
     Advantageously, said nasal powder dispenser device includes a plurality of reservoirs, each containing a single dose of powder. 
    
    
     
       BRIEF DESCRIPTION OF FIGURES 
       These characteristics and advantages and others appear more clearly from the following detailed description, given by way of non-limiting examples, and with reference to the accompanying drawings, and in which: 
         FIG.  1    is a diagrammatic view of a nostril; 
         FIG.  2    is a diagrammatic view of a nasal powder dispenser device adapted for the present invention; and 
         FIG.  3    is a chart showing percentage powder deposition in the various zones of the nostril depending on the volume of the air expeller and on the pressure generated by said air expeller. 
     
    
    
     DETAIL DESCRIPTION OF NON-LIMITING EMBODIMENTS 
     In the description, the terms “axial” and “radial” are relative in particular to the longitudinal direction of the device shown in  FIG.  2   . The terms “proximal” and “distal” are relative to the dispenser orifice of said device. 
     The invention applies more particularly to devices of the single-powder-dose type, as shown in  FIG.  2   . Naturally, other types of nasal powder dispenser devices can also be envisaged. 
     The device  100  shown in  FIG.  2    includes a reservoir  110  containing a dose of powder. Devices with a reservoir containing more than one dose are possible. Likewise, devices including a plurality of reservoirs, each containing a single dose are also possible. 
     A nasal dispenser head  120  is assembled on said reservoir  110 , said head being for inserting into a user&#39;s nostril. Said nasal dispenser head includes a dispenser orifice  121 . 
     The device  100  further includes an air expeller  130  that, during actuation of said device  100 , generates a flow of compressed air so as to dispense a dose of powder into said nostril through said dispenser orifice  121 . Said air expeller comprises an air chamber  131  and a piston  132  that slides in airtight manner in said air chamber  131  so as to compress the air contained in said air chamber  131  and thus generate said flow of compressed air. 
     In the embodiment shown in  FIG.  2   , the reservoir  110  is formed by a hollow tube  111  that is open at both of its axial ends, and that is closed at its proximal end by a closure element  112 , such as a ball, and that is closed at its distal end by an insert  115 . The insert  115  includes a rod-forming axial extension, and, during actuation, it can slide in said hollow tube  111  so as to expel said closure element  112  out from its closed position. In this embodiment, the piston  132  of the air expeller  130  is secured to an axial projection  135  that extends in the proximal direction, and that, during actuation, moves together with the piston  132  while the air contained in the air chamber  131  is being compressed. When said projection  135  of the piston  132  comes into contact with said insert  115  of the reservoir  110 , a continuation of the movement of the piston  132  causes said insert  115  to slide in said hollow tube  111  out from its closed position. Said insert  115  firstly opens the passage between the air expeller  130  and the reservoir  110 , and secondly causes the closure element  112  to be expelled. Thus, the compressed air in the air chamber  131  flows into said reservoir and drives the dose of powder out from said reservoir towards said dispenser orifice  121 . Documents WO 99/46055, WO 02/45866, and WO 2015/001281 describe devices of this type. Naturally, other types of dispenser can also be envisaged. 
     In the invention, the nasal powder dispenser device  100  presents the following properties:
         a pressure, of said flow of compressed air generated by said air expeller  130 , that is higher than 0.7 bar, advantageously lower than 2 bar, advantageously lying in the range 1 bar to 1.5 bar, preferably about 1.3 bar; and   a volume, of said air chamber  131 , that is greater than 1700 mm 3 , advantageously smaller than 3000 mm 3 , advantageously lying in the range 2000 mm 3  to 2700 mm 3 , preferably about 2600 mm 3 .       

     This combination of pressure and volume of the air expeller makes it possible to optimize the percentage of powder that is deposited on the ethmoid sinuses. 
       FIG.  3    shows comparative tests demonstrating, for a single dispenser device and for a single dose of powder of 10 mg, that:
         with an identical pressure of 0.7 bar, a volume of 2000 mm 3  provides better deposition at the ethmoid sinuses compared to volumes of 1300 mm 3  and 1700 mm 3 ;   with an identical volume of 2000 mm 3 , a pressure of 1 bar provides better deposition at the ethmoid sinuses compared to a pressure of 0.7 bar;   with an identical volume of 2600 mm 3 , a pressure of 1.3 bar provides better deposition at the ethmoid sinuses compared to a pressure of 1 bar; and   the best deposition at the ethmoid sinuses, approximately 35%, is obtained with a volume of 2600 mm 3  and a pressure de 1.3 bar.       

     It should be observed that the pressure and volume values of the air expeller may depend on the dose of powder to be dispensed, and that the maximum values may be limited by the difficulty caused to the user and by the need for actuation of the dispenser device not to be too difficult. 
     In known manner for nasal powder dispensing, it is desirable for the average size of the particles of the dose of powder to be greater than 5 μm. 
     The present invention is described with reference to an advantageous implementation, however it should be understood that a person skilled in the art can apply any modification without going beyond the ambit of the present invention as defined by the accompanying claims.