Patent Publication Number: US-2012031398-A1

Title: Nasal spray device

Description:
FIELD OF THE INVENTION 
     This invention relates to devices for delivering at least one dose of a composition to the nasal cavity. 
     BACKGROUND 
     Nasal spray inhalers are known in the prior art. A nasal spray inhaler may include an elongated discharge member formed for insertion into a nasal cavity. A reservoir is coupled to the discharge member with spray actuation being achieved by squeezing the discharge member towards the reservoir. Such devices suffer from several deficiencies. First, the discharge member has a substantially long length due to the necessity for sufficient insertion into the nasal cavity and accommodation of a user&#39;s fingers thereabout. In addition, it is difficult to consistently locate the tip of the discharge member, having the spray orifice, at a position within the nostril where it is at an appropriate distance and is in axial alignment with the nasal valve to ensure delivery of the drug to the posterior nasal cavity when a patients fingers are placed atop of the gripping surface of the discharge member and beneath their nose. During squeezing motion necessary to actuate the device, the tip of the discharge member may move in reaction to the patient input motion which can result in misalignment and less efficient dose administration. Additionally, these designs can be difficult and unsanitary to use when administering a drug to others, such as in the case when a parent administers a spray to a child. 
     Thus, there is a need for a new nasal spray device that overcomes these shortcomings. 
     SUMMARY OF THE INVENTION 
     Several embodiments of the present invention provide for a delivery device for the delivery of at least one dose of a composition into a nasal cavity. The composition may be a liquid or powder composition. The delivery device includes a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough. The delivery device may further include a body containing a reservoir of at least one dose of a composition, such as a liquid or powder composition. The body is elongated and generally extending along a longitudinal axis. Further, the discharge member extends along a secondary axis. The secondary axis intersects with, and is disposed transversely to, the longitudinal axis. 
     Advantageously, a delivery device is provided having a discharge member which is not axially aligned with the body of the delivery device. In this manner, the body may be maintained away from the face of a user during dose administration. In addition, a relatively short discharge member may be provided. 
     Other embodiments provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; a stop surface defined at least partially about the discharge member, the stop surface extending radially outwardly from the discharge member, the stop surface limiting the extent the discharge member may be inserted into a nasal cavity; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis, wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis. 
     Various embodiments of the present invention provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis, wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis; wherein the reservoir is elongated and extends along the longitudinal axis, and; wherein a portion of the reservoir extends transversely away from the longitudinal axis to define a well for collecting a liquid or powder composition gravitationally below the longitudinal axis, during use of the delivery device. 
     Other embodiments of the present invention provide for a drug product comprising a delivery device and a composition comprising at least one active pharmaceutical agent. Suitable active pharmaceutical agents include but are not limited to mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, fluticasone furoate, fluticasone propionate, budesonide, triamcinolone, ciclesonide, oxymetazoline, azelastine, olopatadine, montelukast and combinations thereof or pharmaceutically acceptable salts thereof. 
     Various embodiments of the present invention provide a delivery device for the delivery of at least one dose of a composition into a nasal cavity, the device including a discharge member formed for insertion into a nasal cavity, a discharge aperture being formed therethrough; and, a body containing a reservoir of at least one dose, the body being elongated and generally extending along a longitudinal axis; a trigger for causing delivery of at least one dose from the reservoir through the discharge aperture, the trigger being located on the body and spaced from the discharge member; wherein the discharge member extends along a secondary axis, the secondary axis intersecting with, and being disposed transversely to, the longitudinal axis; and wherein the trigger is configured to have a force applied thereto for actuation, the force being applied in a direction generally oblique to the longitudinal axis. The secondary axis may subtend an acute angle with the longitudinal axis. The acute angle may be in the range from about 15° to about 45°. The force for actuation may be applied to the trigger in a direction generally parallel to the secondary axis. The discharge member may terminate at a free end with the discharge aperture being formed through the free end. The discharge aperture may be formed at the furthest most location on the discharge member from the body. A pump for delivering the at least one dose from the reservoir and through the discharge aperture may be included. The trigger may be pivotally attached to the body. The trigger may extend along a central axis, the central axis subtends an acute angle with the longitudinal axis. The acute angle may be in the range from about 15° to about 45°. The force for actuation may be applied to the trigger in a direction generally perpendicular to the central axis. Other embodiments provide a drug product with the device and a composition comprising at least one active pharmaceutical agent. Suitable at least active pharmaceutical agents include mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous. 
     These and other features of the invention will be better understood through a study of the following detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1-4  depict a delivery device formed in accordance with the various embodiments of the present invention; 
         FIG. 5  shows schematically use of a delivery device formed in accordance with the various embodiments of the present invention; 
         FIG. 5A  is a schematic showing application of force to actuate a delivery device formed in accordance with the various embodiments of the present invention; 
         FIGS. 6 and 7  are partial views of a delivery device formed in accordance with the various embodiments of the present invention; 
         FIG. 8  is an exploded view of a delivery device formed in accordance with the various embodiments of the present invention; 
         FIGS. 9-11  show different stages of actuation of a delivery device formed in accordance with the various embodiments of the present invention; and, 
         FIGS. 12 and 13  depict a reservoir usable with the various embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     As shown generally in the figures, several embodiments of the present invention provide a delivery device  10  for the delivery of at least one dose of a composition, such as a liquid or powder composition, into a nasal cavity of a user. The delivery device  10  generally includes a discharge member  12  and a body  14 . With reference to  FIG. 2 , the body  14  is elongated and extends along a longitudinal axis  16 . The discharge member  12  extends along a secondary axis  18 . The secondary axis  18  intersects with, and is disposed transversely to, the longitudinal axis  16 . With this arrangement, the discharge member  12  is not axially aligned with the longitudinal axis  16 . As shown in  FIG. 2 , an angle α may be subtended by the longitudinal axis  16  and the secondary axis  18 . The angle α may be 90° or an acute angle, such as in the range from about 15° to about 45°, or about 30°. 
     The discharge member  12  is formed for insertion into a nasal cavity. In several embodiments, the discharge member  12  is generally bullet-shaped. The discharge member  12  may have a maximum length of 0.75″ and a maximum diameter of 0.5″. A discharge aperture  20  is formed through the discharge member  12  to permit at least one dose of a composition, such as a liquid or powder composition, to be administered from the delivery device  10 . The discharge member  12  extends from the body  14  to have a free end  22 . The discharge aperture  20  may be formed through the free end  22  (e.g., centrally through the free end  22 ), or the discharge aperture  20  may be formed at the furthestmost location on the discharge member  12  from the body  14 . The discharge member  12  may be formed of various materials suitable for insertion into a nasal cavity. 
     The discharge member  12  may be immovably fixed to the body  14 . The discharge member  12  may be unitarily formed with the body  14  or attached thereto using any known technique. 
     The body  14  contains a reservoir  24  (best shown in  FIGS. 6 and 7 ) which houses a at least one dose to be administered by the delivery device  10 . In addition, a trigger  26  may be provided on the body  14  formed to cause delivery of at least one dose of a composition from the reservoir  24  through the discharge aperture  20 . The trigger  26  may be located on the body  14  and spaced from the discharge member  12 . The trigger  26  may be adapted to be actuated with force being applied thereto in a direction transverse to the longitudinal axis  16 , as shown schematically by arrow F in  FIG. 2 . With this arrangement, as shown in  FIG. 5 , the delivery device  10  may be pressed against the upper lip  28  of a user&#39;s face with the discharge member  12  being nested in the user&#39;s nasal cavity  30 . With the trigger  26  being spaced from the discharge member  12 , operation of the delivery device  10  may be achieved without interference of the person&#39;s face and may be one-handed. The trigger  26  may be located on an upper side of the body  14  so as to face upwardly during use, as shown in  FIG. 5 . In addition, a front end  32  of the delivery device  10 , as pressed up against the upper lip  28 , acts as a resting surface during actuation. With this arrangement, the subject invention provides for a stable positioning of the delivery device  10  during actuation and an effective alignment of the discharge aperture  20  within the nasal cavity  30 . 
     With reference to  FIG. 5 , the delivery device  10  may be formed such that a thumb T of a user may be located to counteract any movement to the discharge member  12  in reaction to the force or movement of trigger  26  in causing activation thereof. To facilitate proper location of the thumb T, an identifiable area  25  may be defined on the body  14  located so as to counteract any force or moment applied to the trigger  26 . The identifiable area  25  may be: of a different material from the body  14 ; and/or, a contoured, textured and/or colored area on the body  14 . Instructions corresponding to the delivery device  10  may also be relied upon in showing desired placement of the thumb T. 
     With reference to  FIG. 4 , a continuous or discontinuous stop surface  33  may be defined at least partially about the base of the discharge member  12 . The stop surface  33  may be annular and encircles the discharge member  12 . As shown in  FIG. 4 , the stop surface  33  extends radially outwardly from the discharge member  12 . With reference to  FIG. 5 , the stop surface  33  acts to press against a user&#39;s nose  34  in limiting the depth of insertion of the discharge member  12 . The ability to limit depth insertion allows for the positioning of the discharge aperture  20  relative to the user&#39;s anatomy. The extent of insertion of a nasal delivery device into a user&#39;s nose affects deposition of the delivered dose due to the distance a dose is delivered within the nasal cavity. The stop surface  33  provides for more accurate placement of the discharge aperture  20 . 
     In addition, the front end  32 , may be flattened or truncated or provided with little curvature adjacent to the stop surface  33  to provide a stable alignment surface for acting against the upper lip  28  in angularly aligning the nasal valve of device  10  with the nose  34  of the user. The front end  32  minimizes rocking or other angular or rotational variation, including during application of actuation force to the trigger  26 . 
     The angled discharge member  12  relative to the body  14  of the delivery device  10  locates a patient&#39;s hands, during placement and actuation, away from their face. This locates a patient&#39;s hands away from their nose where it can come into contact with nasal discharge. The discharge member  12  is designed to be placed against the face above the upper lip  28  and beneath the nasal cavity  30 , with the nose as a reference surface to assist in axially locating the spray orifice of the discharge member with the nasal valve when placed within the nasal cavity  30 . Accordingly, the underside of the nose provides a depth locator when the discharge member  12  is placed upward within the nasal cavity  30 . The length of the discharge member  12  is short as compared to the prior art, to place the discharge aperture  20  at a proper distance from the nasal valve when placed within the nasal cavity  30 . Furthermore, the trigger  26  and the body  14  of the device  10  have been designed to generally align the forces and reaction forces in opposing fashion during actuation, minimizing any reaction moments moving the discharge member  12  during actuation. The combination of these three features (hands-away actuation; depth location; general orientation of actuation and counter forces) increases the likelihood of proper placement during administration and allows for easier administration to users. 
     With reference to  FIG. 5A , the force F may be applied to the trigger  26  in a direction oblique to the longitudinal axis  16 . An acute angle β may be subtended between a central axis C of the trigger  26  and the longitudinal axis  16  with the trigger  26  being in a ready state for actuation. As discussed below, the trigger  26  may be a lever-type actuator, with the force F generating moment to cause actuation of the trigger  26 . Taking force F being applied generally perpendicularly to the trigger  26 , as taken relative to the central axis C, the force F is disposed obliquely relative to the longitudinal axis  16 . In addition, the angles α and β may be equal. With this arrangement, the force F may be parallel to the secondary axis  18 . The secondary axis  18  may coincide with the path of fluid delivered by the delivery device  10 . Accordingly, the force F may be parallel to the path of fluid delivery. The angle β may be in the range from about 15° to about 45°, or about 30°. With the parallel arrangement of the force F and the path of fluid delivery, moment created by the application of the force F is counteracted by the force created by delivery of the fluid. In addition, as discussed above, the thumb T provides a counteracting force to offset the force F applied to the trigger  26 . With reference to  FIG. 5A , force F T  generated by the thumb T is shown. As shown in  FIG. 5A , the trigger  26  pivots about axis A. The forces F and F T  may be applied generally at equal distances from the axis A so as to generate counteracting movements thereabout. 
     As will be recognized by those skilled in the art, the delivery device  10  may be self-administered or administered by a third party to a user. For example, a parent or medical practitioner may administer at least one dose of a composition by the delivery device  10  to a child or elderly patient. 
     Any configuration for delivering a dose of a composition from the reservoir  24  through the discharge aperture  20  may be utilized, particularly a trigger-activated configuration. By way of non-limiting example, a pump  36  may be provided to deliver a dose of a composition from the reservoir  24  through the discharge aperture  20 . The pump  36  may be provided with a discharge tube  38 , as best shown in  FIGS. 7 and 13 . The pump  36  may be configured in the same manner as any pump provided with a metered dose nasal spray, where compression of the discharge tube  38  into the reservoir  24  results in a dose of composition being discharged through the discharge tube  38 . The reservoir  24  may be the canister of a metered dose nasal spray. With respect to the subject invention, the discharge tube  38  may be fixed to a stop block  40  disposed in the body  14 . The discharge tube  38  may include a thinned region  42  formed to be received within a corresponding aperture  44  in the stop block  40 . A shoulder  46  is defined on the discharge tube  38  about the thinned region  42  which is formed larger than the aperture  44 . With the stop block  40  being fixed within the body  14 , forward translation of the reservoir  24  causes interengagement between the shoulder  46  and the stop block  40 . With further forward translation of the reservoir  24 , the shoulder  46  restricts movement of the discharge tube  38 . As the reservoir  24  is further translated, and the discharge tube  38  is restricted from forward movement, the discharge tube  38  is compressed into the pump  36  resulting in the pump  36  being actuated. 
     To permit delivery of at least one dose of a composition from the discharge tube  38  through the discharge aperture  20 , a change of direction element  48  is provided having a channel  50  formed therethrough to register with the aperture  44 . The channel  50 , in turn, is in registration with the discharge aperture  20  to permit delivery of the fluid. The channel  50  includes first and second sections  50 A,  50 B angularly off-set from one another. The sections  50 A,  50 B may be angularly off-set the angle α as described above. The stop block  40  and the change of direction element  48  may be formed separately and joined or formed unitarily as a single component. A nozzle  52  may be disposed along the fluid path between the stop block  40  and the discharge aperture  20  to control the resulting spray pattern of the administered dose. The nozzle  52  may be disposed to define the discharge aperture  20 . 
     With the arrangement described above, the trigger  26  may be coupled to the reservoir  24  to cause forward translation thereof upon the trigger  26  being actuated as shown in  FIG. 2 . After dose administration, and as known in the prior art, with force being removed from the trigger  26 , the pump  36  may be provided with a return mechanism, such as a return spring, to urge the reservoir  24  to a ready position for further dose administration. 
     With reference to  FIG. 8 , a configuration usable with the subject invention is shown for actuating the pump  36 . As shown in  FIG. 8 , the body  14  may be formed from first and second components  54 ,  56  which may constitute upper and lower housing components, respectively. The trigger  26  may be provided in the form of a lever which is pivotally mounted to the body  14 , such as to the first component  54 . The pivotal mounting may be defined by a pin  58  held on the body  14  by end pin holders  60 ,  62 . The trigger  26  may include passage  64  which is formed to receive the pin  58  with the trigger  26  being configured to rotate about the pin  58  relative to the body  14 . The pin  58  may define the axis A discussed above. 
     An actuator  66  is provided to transmit force from the trigger  26  to the reservoir  24  to cause forward translation thereof. The actuator  66  includes at least one mounting block  68  or two of the mounting blocks  68 , each having an aperture  70  formed therethrough. The aperture(s)  70  are formed to receive the pin  58 . The actuator  66  is mounted into the body  14  with the one or more mounting blocks  68  extending through an opening  72  formed in the body  14  with the pin  58  passing through the one or more apertures  70 . The passage  64  of the trigger  26  is defined in an end member  74 . The one or more mounting blocks  68  are positioned to be adjacent to one or both ends of the end member  74 . 
     The actuator  66  also includes one or more actuating arms  76  formed and positioned to engage against corresponding actuating surfaces  78  on the reservoir  24 . The actuator may  66  have a yoke shape with two of the actuating arms  76  being provided, the actuating arms  76  being spaced apart to straddle the reservoir  24 . With the actuating arm(s)  76  being forced forwardly, force is applied against the actuating surface(s)  78  resulting in forward translation of the reservoir  24 . 
     To transmit force from the trigger  26  to the actuator  66 , one or both ends of the end member  74  is provided with a protrusion  80  of limited circumferential length. Also, a notch  82  is formed in each of the mounting blocks  68  configured to be engaged by one of the protrusions  80 . 
     With reference to  FIGS. 9-11 , an actuation of the delivery device  10  is shown in different phases.  FIG. 9  shows the delivery device in an inactive state. In this state, return force generated by the pump  36  maintains the reservoir  24  in a rearmost state relative to the body  14 . 
     With reference to  FIG. 10 , the trigger  26  is shown in a ready-to-use state, where the protrusions  80  are in contact with the notches  82 . As shown in  FIG. 9 , in an inactive state, the protrusions  80  are spaced from the notches  82 . The trigger  26  is rotated from the inactive to ready-to-use states. Rotation of the trigger  26  to the ready-to-use state is done freely without any contact between the protrusions  80  and the notches  82 . The circumferential length of the protrusions  80  and the shape and positioning of the notches  82  defines the radial position of the trigger  26  for the ready-to-use state. More specifically, the circumferential length of the protrusions  80  and the shape and positioning of the notches  82  defines the angle β. 
     To cause actuation, force is applied, to the trigger  26 , as shown in  FIG. 2 , resulting in depression of the trigger  26  as shown in  FIG. 11 . Under force, the trigger  26  further rotates with rotation of the trigger  26  from the position shown in  FIG. 10  to the position shown in  FIG. 11  causing the protrusions  80  to urge the notches  82  forwardly. With the actuator  66  being pivotally mounted to the pin  58 , the protrusions  80  cause the notches  82  to rotate about the pin  58 . Rotation of the notches  82  results in pivotal movement of the one or more of the actuating arm(s)  86 . As a result, the actuating arms  86  press against the actuating surfaces  78  and cause forward translation of the reservoir  24 . The reservoir  24  will be urged sufficiently forwardly to cause proper actuation of the pump  36  and administration of a dose of a composition. The discharge tube  38  is visible in the states shown in  FIGS. 9 and 10 , but not visible in the state shown in  FIG. 11 . In an actuated state, the discharge tube  38  is compressed into the pump  36  for actuation. 
     With force being removed from the trigger  26  after dose administration, return force from the pump  36  urges the reservoir  24  rearwardly to the inactive state, such as that shown in  FIG. 9 . In addition, the trigger  26  is returned to the ready-to-use state as shown in  FIG. 10 . Any force of actuation required to actuate the trigger  26  must be sufficiently great to overcome the bias return force of the pump  36 . 
     A cap  84  may be provided to cover the discharge aperture  20  ( FIGS. 3 and 9 ). A releasable locking arrangement between the discharge member  12  and the cap  84  may be provided. As shown in  FIG. 4 , the releasable locking arrangement may be a cooperating locking detent  86  and locking aperture  88  formed on the discharge member  12  and the cap  84 .  FIG. 4  shows the locking detent  86  being formed on the discharge member  12 , with the locking aperture  88  being formed on the cap  84 . The reverse configuration may also be provided. The cap  84  may also be provided on the trigger  26  or at the end of the trigger  26 . In an inactive state, as shown in  FIG. 9 , the trigger  26  may be folded down with the cap  84  covering the discharge aperture  20 . 
     With reference to  FIGS. 12 and 13 , the reservoir  24  may be elongated and formed to extend along the longitudinal axis  16 . With the delivery device  10  being generally in a horizontal position during actuation, efficient consumption of the fluid stored within the reservoir  24  may be of concern. As shown in  FIGS. 12 and 13 , a portion  90  of the reservoir  24  may extend transversely away from the longitudinal axis  16 . The portion  90  may define a well  92  for collecting a liquid or powder composition gravitationally below the longitudinal axis  16 . With this arrangement, low levels of a liquid or powder composition in the reservoir  24  may be collected within the well  92 . A dip tube  94  may be further provided having first and second ends  96 ,  98  and a lumen  100  extending therebetween. The first end  96  may be positioned in the well  92 , or at a bottom-most section of the well  92  (furthermost section from the longitudinal axis  16 ), with the second end  98  of the dip tube  94  being in communication with the pump  36 . As arranged, the lumen  100  communicates the well  92  with the pump  36 . Low levels of a liquid or powder composition may thus be extracted from the well  92  for delivery to a user. 
     The descriptions of the embodiments of the invention have been presented for purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching.