WO1993002804A1

WO1993002804A1 - Atomizing dispenser for endonasal drug spray administration

Info

Publication number: WO1993002804A1
Application number: PCT/IT1992/000090
Authority: WO
Inventors: Rosaria Galli
Original assignee: Rg S.A.S. Di Rosaria Galli & C.
Priority date: 1991-08-02
Filing date: 1992-07-30
Publication date: 1993-02-18
Also published as: US5501373A; IT1253173B; DE69206621T2; DE69206621D1; ITGE910102A1; ITGE910102A0; EP0597023A1; EP0597023B1

Abstract

Atomizing dispenser for endonasal spray administration of drug solutions, comprising a main body or slider (1), a piston/pump (12) axially slidable into a drug container (5) and a housing/button (3), characterized in that as a specific feature of the invention, the piston/pump (12) is provided on its stem (4) with two grooves/seats (6) and (7) each retaining the resilient detent rings (8) and (9), which oppose and control the piston/pump (12) run. Said control being exerted by obliging to accumulate enough energy in the user's hand to force the resilient detent rings (8) and (9) to expand and to snap out from their grooves/seats (6) and (7), one after the other one, thus fractioning the piston (12) run and the consequent atomized delivery into two separate deliveries which can be administered one for each user's nostril, said snap allowing an instant release of the accumulated energy on the piston/pump (5) with the consequent servo-assisted perfect atomization of the drug solution.

Description

Atomizing dispenser for endonasal drug spray administration.

DISCLOSURE In the pharmaceutical field specific packs , for emdonasal atomized administration of drugs, have been developed either for single use, or multi-use utilization. These container/dispenser packs are all to be manually actuated, by means of the user's depression of the slider, which requires a rapid an strong action, otherwise the spray jet is not properly atomized.

This rapid and strong action is not achievable by certain patients and therefore the drug is not properly delivered and looses its effectiveness. Furthermore in the use of single-use packs, which is now very popular due to the easier calculation of the number of administration in a given time period, it has become impossible to spread the delivery into two administrations, one for each nostril. This subdivided delivery being the most effective and therefore the most advisable.

Therefore the administration requirements of these drugs are: the calculation of the deliveries in a time period, the delivery of each administration subdivided into the two nostrils and a perfect atomization independent from the speed and the strength of actuation of the dispenser.

The known multi-use devices solve the twin deliverly problem, the single-use the calculation one and none of the two solve the atomization problem. It _# has therefore appeared necessary to facilitate the dispenser use and to avoid uncorrect delivery, by making available a spray dispenser able to provide a drug administration subdivided into two half deliveries, one for each nostril, combined to an easier activation of the atomizing device. This means a partially servo-assisted atomization not completely dependant from the speed and the strength of action applied by the user. This need has suggested a study of the problem having the target to develop a twin-dose dispenser or better a dispenser able to fraction the dose into two half doses for a subdivided administration, first into one nostril and then into the other one with the added aid to improve and make sure the atomization.

This study has been completed and, being the result very satisfactory, both on the use and production cost point of view, it is the intention of the inventor to fix the features and the details by means of the present patent application.

Container/dispenser pack for specific drugs for atomized endonasal administration comprising a main body, acting as usual as a slider, provided with grip radial . planar extensions for two finger tips of the user's hand, slider whith incorporates in its upper part the atomizing nozzle and in its lower part a protruding cylindrical neck within which is axially slidable a cup shaped housing which also act as control button to be pressed by the user's thumb tip. Said cup shaped housing enclosing the cylindrical drug solution container incorporating an axially slidable piston/pump comprising as specific feature, a stem provided with two separated slotted grooves with concave bottom, said grooves both being a seat , each retaining a resilient detent ring provided with radial cut.

These two resilient detent rings, which can, under the force exerted by the user's fingers, snap out from their retaining grooves, one after the other one, control the piston run by fractioning it into two half runs in the case of the twin use version.

Furthermore the slight effort required to make each of the two resilient detent rings to snap out from their seats, accumulates the correct energy in the user s fingers which is instantly released, due to the same snapping out of each of the ring, to provide the right speed of activation, necessary to obtain the best atomization in any condition. The accompanying drawings show in different scales, by way of non limiting examples, a basic embodiment of the article of the invention, with some possible modifications. In the drawings:

Fig. 1 is a fragmentary side elevational and partly axial sectional view, of the lower part of the container/dispenser assembly ^' being concerned, prior to the first actuating stroke with the upper resilient detent ring abutting against the cylindrical neck of the drug container and still into its seat. Fig. 2 is a plan view of one of the resilient detent ring provided with the elasticity aid radial cut.

Fig. 3 is a view similar to Fig. 1, after the first actuation stroke has occurred where the upper resilient detent ring has snapped out from its seat and now rests against the lower one, which now acts as an end stop to the first half-run of the piston/pump.

Fig. 4 is a view similar to Fig. 1 and 3, after the second and last actuation stroke has occurred, where the second and lower ring also snapped out from its seat allowing the second half-run to be performed with the proper servo-assisted speed.

Fig. 5 is a view similar to Fig. 1 of a slightly modified embodiment comprising the housing/button and the slider provided with auxiliary stop elements. Fig. 6 is a plan view of the bottom of the embodiment shown in Fig. 5.

Fig. 7 is a view similar to Fig. 3 of the embodiment shown in Fig. 5 with the parts in the condition at the end of the first actuating stroke. Fig. 8 is a view similar to Fig. 4 of the embodiment shown in Fig. 5 after the second and last actuation stroke is occurred.

As clearly shown in Fig. 1, the container/dispenser for endo-nasal atomized administration proposed by the invention, substantially comprises a main body or slider 1 provided with depression and grip radial planar extensions for the finger actuation and with an upper protruding tubular cylinder having the atomizing nozzle (not represented) on the top thereof.

Said slider 1 having, protruding from its lower part, a cylindrical neck 2 within which is axially slidable the cup shaped button/housing element 3 bearing against its bottom the lower end of the ste 4 of the piston/pump 12 which is axially slidable into the liquid drug container 5. The stem 4 of the piston/pump 12, has two different diameters, the larger being the upper one and the smaller the lower one.

The stem 4 is provided on each of the two diameters with concave bottom circular grooves 6 and 7 which retain, as seats the two resilient detent rings 8 and 9. The bottom of the upper groove 6 and therefore the hole in the upper resilient detent ring 8 have a diameter which is larger than the corresponding one of the groove 7 and the ring 9, and is also slightly larger than the one of the lower part of the stem 4 of the piston/pump 12. The two diameters of the stem 4 are blended by the bevel 10 which allows better snapping out of the resilient detent ring 8 and an easier assembling of the same into the groove 6 during the manufacturing process.

The two resilient detent rings 8 and 9 are both provided with an elasticity aid radial cut 11 as shown in Fig. 2. The unit comprising the piston/pump 12 and its stem 4, provided with the grooves 6 and 7 bearing the resilient detent rings 8 and 9, and the edge 13 of the container 5 constitutes the servo-assisting device to grant a safer and a perfect atomization and the control system to provide the availability of two deliveries or one divided into two halves.

The operation of the system will be described hereinafter with particular reference to Figs. 1, 3 and 4. In the position shown in Fig. 1 the upper resilient detent ring 8 abuts against the lower edge 13 of the container 5. When the butto /housing 3 is pressed, to obtain the first drug delivery, towards the indicated arrow, the pressure is transmitted to the piston/pump 12 resting, with the end of its stem 4, against the bottom of the button/housing 3. In this condition the movement of the piston/pump 12 is opposed by the resilient detent ring 8 abutting against the edge 13 of the container 5.

In order to obtain the first delivery of drug it is necessary to exert enough pressure to make the resilient detent ring 8 to expand and therefore to snap out from the groove 6 and to slide downward untill it is stopped by the resilient detent ring 9 still into the groove 7, thus allowing the piston/pump 12 to make the first half run inside the container 5 - as shown in Fig. 3.- said pressure being preset and dependant on the elasticity of the resilient detent ring 8, and producing an accumulation of energy in the user's hand, which is instantly released when the resilient detent ring 8 snaps out from the groove 6. To obtain the second delivery it is enough to repeat the same operation.

The resilient detent ring 9 opposes the same resistance as previously opposed by the ring 8 and requires again enough energy accumulated in the user's hand to snap out from the groove/seat 7 -as shown in fig. 4 -.

The instant release of the accumulated energy will again produce the best atomization independently from the speed of depression exerted by the user on the slider 1 and the housing/container 3.

Figs. 5, 6, 7 and 8 show a modification wherein the housing/container 103 is provided with two stop protrusions 114 and the protruding neck 102 of the slider 101 is provided with two vertical slots 115 each comprising a stop shoulder 116 - as shown in Fig. 5 and 6 -.

All the other parts and functions remain unchanged on respect to the basic embodiment.

As shown in Fig. 7 at the end of the first stroke, the run of the housing/container 113 and therefore of the piston/pump 12 is stopped, further than by detent action of the resilient detent ring 9 against the ring 8, also by the detent action exerted by the shoulders 116 against the protrusions 114 of the housing/container 113. To allow the second stroke it is necessary at first to turn the housing/container 113 - as indicated by the arrows in Fig. 6 and 7 - in order to remove the obstacle created by the shoulder 116 against the protrusion 114, and then apply the depression as previously described.

The modifications described herein improve the safety in the control of the first stroke run and avoid any accidental possibility to delivery the two doses within the same activation stroke.

Obviously, still within the basic principle of the invention further modifications are possible such as the grooves/seats retaining the resilient detent rings made on the inner walls of the housing/button 3 with the same functions and working principle of those made on the stem 4 of the piston/pump 12. Furthermore the basic principle of the invention does not exclude the possibility to replace the grooves/seats, and the resilient detent rings, with suitable ledges protruding from the outer walls of the housing/button 3, said protrusions abutting against the edge of the neck 2 of the slider 1 and being properly preconditioned with notches to self-shear and detach with a preset force of activation of the dispenser, allowing therefore also in this case the energy accumulation and the subsequent snap necessary to a correct atomization.In the same way said abutting protrusions could be replaced by elastic elements, able to bend, obtained,by means of suitable slits, in one piece with the housing/button 3 or with the neck 2 of the slider 1. It is finally to be noted that the described device and its possible modifications can be used also in a single-use version, that means with only one resilient detent ring or element, in order to obtain in any case a servo-assisted and perfect atomization. As to the remainder, all as described and shown, made of any suitable material, liable to modifications and improvements, still within the basic principle of the invention.

Claims

1 - Atomizing dispenser for endonasal drug spray administraion comprising a main body (1), operating as usaul as a slider, provided with depression and grip radial planar extensions, characterized in that it is formed by an upper protruding tubular cylinder, having the atomizing nozzle on the top thereof, and by a lower protruding neck (2) within which is axially slidable a housing (3) operating as control button. Said housing/button (3) containing the cyclindrical drug solution container (5) within which is axially slidable the pistoή/pump (12), characterized in that it is provided with a two diameters stem (4). Said stem (4) being provided, on each of the two diameters, with concave bottom circular grooves (6) and (7) serving as seats for the resilient detent rings (8) and (9), provided with elasticity aid radial cut (11). Said resilient detent rings controlling the piston/pump (12) run to obtain a delivery in two steps one for each user's nostril.

2 - Atomizing dispenser according to claim 1, characterized in that the upper resilient detent ring (8) abuts against the edge (13) of the drug solution container (5), within which the piston/pump (12) is axially slidable, said piston (12) resting with the end of its stem (4) against the bottom of the housing/button (3), said resilient detent ring (8) opposing therefore the movement of the piston/pump (12) and of the housing/button (3) when the latter is pressed to obtain the delivery of drug. Said resilient detent ring (8) being obliged to expand to get out from the groove/seat (6) and opposing therefore resistance to the actuation force, thus requiring such an energy accumulation in the user's hand to win said resistance, causing the resilient detent ring (8) to snap out from the groove/seat (6) and the piston/pump (12) to instantly move forward into the drug solution conatiner (5) for the first half run or half servo-assisted delivery, until the second resilient detent ring (9) is stopped by the first ring (8) now acting as a shoulder. 3 - Atomizing dispenser according to claims 1 and 2, characterized in that when the housing/button (3) is pressed again to obtain the second atomized drug delivery, the lower/second resilient detent ring (9), as it happened to the first one, is obliged to expand, opposing therefore resistance, up to the point to snap out from the groove/seat (7) allowing again to the piston/pump (12) to instantly move forward into the drug solution container with the consequent high speed to grant the servo-assisted delivery of the second dose or half-dose of drug.

4 - Atomizing dispenser according to claims 1 to 3 characterized in that in a detail modification the housing/container (103) is provided with two stop protrusions (114) and the protruding neck (102) of the slider (101) is provided with two vertical slots (115) each comprising a stop shoulder (116), wherein said stop protrusions (114) slide, during the first activation stroke, into the slots (115) until they reach the stop shoulders (116), with the consequent safety stop of the housing/button (103) and therefore of the piston/pump (12), this obliging the user to intentionally rotate the housing/button (103) to disengage the protrusion (114) from the shoulders (116), to perform the second stroke and to obtain the second drug delivery. 5 - Atomizing dispenser according to claims 1 to 3, characterized in that, as a detail modification, the grooves/seats (6) and (7) bearing the resilient detent rings (8) and (9) can be made on the inside walls of the housing/button (103) instead of on the piston/pump stem (4) without changing the working principle of the system.

6 - Atomizing dispenser according to claims 1 to 3, characterized in that as a detail modification, the grooves/seats (6) and (7) and the resilient detent rings (8) and (9) can be replaced by suitable positioned ledges protruding from the outer walls of the housing/button (3) that, being preconditioned to breakage, self sheare when a preset actuating energy is reached, thus suddenly breaking off and causing the same servo-assistance to the drug solution compression and atomization.

7 - Atomizing dispenser according to claims 1 to 6, characterized in that it can be used, by changing the number of resilient detent rings or elements and of the corresponding grooves/seats, in different configuration starting from a single dose up to a multi-dose version.