GB2488992A

GB2488992A - Medicament dispenser

Info

Publication number: GB2488992A
Application number: GB1104117.5A
Authority: GB
Inventors: Eliahu Eliacher; Eran Eilat; Joshua Altman; Moshe Tshuva
Original assignee: Advanced Ophthalmic Pharma Ltd
Current assignee: Advanced Ophthalmic Pharma Ltd
Priority date: 2011-03-10
Filing date: 2011-03-10
Publication date: 2012-09-19
Also published as: GB201104117D0; WO2012101634A3; WO2012101634A2

Abstract

A dispenser for delivering a medicated mist to the eye or nose separately contains a medicament fluid 1 in a chamber 10 and a carrier fluid in a bellows 21. The two fluids are mixed at a launching point 3 and expelled from the dispenser. Medicament is delivered to the launching point, preferably by a peristaltic pump, timed so that an early portion of the mist is rich in medicament whilst a final portion contains little medicament but is rich in carrier fluid. Pressurised carrier fluid enters the bellows through a oneâ way valve 70 and expands it against the compression force of a spring 22. Upon operation of a release valve the spring compresses the bellows to drive the carrier fluid through the launching point where it collects the medicament. Preferably, the mist comprises three phases with both the first and last phases containing little medicament (figure 2) to minimize residue accumulation.

Description

A TWO-STEPS MULTI-DOSE MEDICAMENT DISPENSER

FIELD OF THE INVENTION

The present invention relates to a device and method for multi-dose medicament dispensing.

BACKGROUND OF THE INVENTION

Medicament dispensers have been widely know in the art. For example, PCT publication no. W02007132446 discloses a device for applying an ophthalmic liquid to at least one eye of a subject, said device comprising: a flexible bag containing said ophthalmic liquid; an output valve assembly at one extremity of said bag; an outer container enclosing said flexible bag, said outer container containing a propellant gas under positive pressure, such that ophthalmic liquid is ejected from said flexible bag when said valve assembly is activated; at least one eye goggle having at least one opening in its rim, said outer container being disposed relative to said at least one goggle such that said ejected ophthalmic liquid is directed through said at least one opening into said at least one goggle; and a nebulizing element configured to disperse said ophthalmic liquid in the form of a mist within said at least one eye goggle.

Another example is US Patent No. 6,336,917 which provides an eye mist apparatus for treatment of an eye having an outer housing that contacts the bony orbit surrounding the eye. An inner housing, concentrically disposed within the outer housing contacts the eyelid, pushing the eyelid back, exposing the eye. One end of the inner housing is adapted to receive a dispenser for administering a metered spray of medicine, powdered or liquid, or lavage to the eye as it is held open by the ocular treatment apparatus. The dispenser nozzle is equipped with a contrasting mark, which provides a target for the eye to focus on ensuring the eye is optimally positioned to receive the metered spray. The spray is described as being directed straight onto the anterior surface of the eyeball, so that none of the medication is wasted. However, it is possible that delivery directly onto the eyeball surface may cause blinking reflex and discomfort to some users. US Patent Application Publication No. 2005/0255144 provides articles and methods for drug delivery by way of hydrogel for treatment of dry eye conditions. It allows for passive transference of drug from a dilute solution into the hydrogel. The hydrogel, when placed in contact with the eye, delivers the drug. The delivery of the drug is sustained over an extended period of time.

Yet another example is US Patent Application Publication No. 2006/0020253 which provides an implantable device including a body defining a reservoir, and a head provided at the end of the body and closing the reservoir. The head is made from a permeable material adapted to release the medication from the reservoir to an implant site at a determinable rate.

US Patent No. 5,893,515 provides a device for creating and applying mist, vapors or sprays from a liquid. The device contains a spinning rotor within a mist chamber. The rotor has inner walls that taper conically outwardly from the open bottom of the rotor to a hole near the top of the rotor. Liquid is pumped by a finger actuated pump from a cartridge module into a bowl surrounding the bottom end of the rotor.

A spray is created as the liquid is formed into droplets as it passes through the hole in the rotor under centrifugal force.

US Patent Application Publication No. 2002/0124843 provides an apparatus and a method for delivering medicine for one or more eyes.

The apparatus includes goggles worn around the eyes. An atomizer nebulizes medicine into a medicine carrying fog such that the fog discharges from the fog outlets to deliver medicine to one ore more eyes. However the apparatus requires a comparatively complex system for nebulization of the medicine, such as an ultrasonic atomizer.

Additionally, according to those embodiments of this invention where a propellant is used, the propellant does not appear to be separated from the medicine. Furthermore, it would appear from the embodiments shown that the medicament is stored in a freely fillable container, such that sterility may be difficult to maintain.

POT Published Application No. W02006/082588 describes a device for ophthalmic administration of pharmaceutical ingredients configured to direct a mist of the pharmaceutical composition at the eye. In this application, there is recognition of the need for maintaining sterility of the device. This is achieved by sterilizing the skin contact surface with the device between individual administrations, As stated therein, o device that is quick and easy to sterilize allows high throughput and safe ophthalmic administration of a pharmaceutical composition, for example in a hospital or clinic where many patients may be treated with one device, or in high-throughput situations, for example when desired to treat a population for an epidemic or endemic condition or to inoculate or immunize a population. One embodiment incorporates a self-sterilization device, in the form of an element radiating the contact surface of the device. However, in this application, other than by the assumed use of preservatives, no consideration appears to have been made for the need to ensure that the pharmaceutical composition ifself remains sterile, especially in the typical domestic setting of prolonged sequential use of the device by a single person.

Lastly, PCT publication no. WO 2007132446 discloses a dispenser for applying an ophthalmic liquid to at least one eye of a subject, said device comprising: a flexible bag containing said ophthalmic liquid; an output valve assembly at one extremity of said bag; an outer container enclosing said flexible bag, said outer container containing a propellant gas under positive pressure, such that ophthalmic liquid is ejected from said flexible bag when said valve assembly is activated; at least one eye goggle having at least one opening in its rim, said outer container being disposed relative to said at least one goggle such that said ejected ophthalmic liquid is directed through said at least one opening into said at least one goggle; and a nebulizing element configured to disperse said ophthalmic liquid in the form of a mist within said at least one eye goggle.

In all of the above mentioned devices the profile of medicament/carrier dispensing is as described in FIG. 1 B. Thus, there remains a substantially equal amount of medicament and carrier on the rims of the dispenser.

Such amount of a medicament might often lead to accumulation of bacteria, which eventually renders the use of the dispenser.

Thus, there remains a long felt, for a multi dose treatment dispenser that does not enable the accumulation of bacteria.

SUMMARY Of THE INVENTION

It is one object of the present invention to provide a two-steps operated multi-dose dispenser 100, comprising a. at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. a carrier fluid (2, not shown in the figures), flowable by means of an actuating mechanism (20); c. a nozzle (40) for dispensing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); and d. a two-steps dispensing mechanism adapted to sequentially disperse at least one first and at least one second fractions of said dose, wherein one of the following is held true: (I) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier; said dispensing mechanism comprising a launching point (3) adapted to accommodate the entire volume of said fraction of said medicament; said launching point (3) is in fluid connection with said medicament chamber (10), said carrier's actuating mechanism (20) and said nozzle (40) such that in a first step a predefined amount of medicament is provided within said launching point, and in a second step, by actuating said carrier by said actuating mechanism, said predefined amount of medicament within said launching point is dispersed by means of a predefined amount carrier in a manner that a fractionated dose of mist (3) is dispensed outwardly throughout said nozzle.

It is another object of the present invention to provide the dispenser as defined above, wherein at least one first fraction comprises a carrier to medicament ratio lower or equal 50%, and at least one second fraction comprising a medicament to carrier ratio lower or equal 50%.

It is another object of the present invention to provide the dispenser as defined above, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region Ocxcxl; M(x)=cx+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl <x<x2; Y(x)=cx3+dx2-i-ex-s-f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cxcx3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)ix3+jx2+kx+i where i is the triple coefficient; I is the square coefficient, Ic is the linear coefficient and / is the y intercept; wherein a to I are real numbers, and wherein the absolute value of c, ci or e is greater than the absolute value of a or g.

It is another object of the present invention to provide the dispenser as defined above, wherein said fraction of said medicament within said dispensed mist is time-resolved.

It is another object of the present invention to provide the dispenser as defined above, useful for dispensing a time-resolved medicament's fraction mist, wherein per each action of mist dispensing lasting a time period Tdisperisir-ig Tdispensing comprises early time (Ieariy) and late time (hate) phases, the amount of said medicament ([M]) within said mist is relatively higher in the early phases Tea than in the late phases hate, such that EM] heady >>[M] Tiate.

It is another object of the present invention to provide the dispenser as defined above, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (Tiate) is a medicament-drying phase.

It is another object of the present invention to provide the dispenser as defined above, wherein said medicament is a preservative-full, preservative-poor or a preservative-free product.

It is another object of the present invention to provide the dispenser as defined above, wherein said actuating mechanism (20) comprising at least one carrier fluid container 21 in communication with spring 22, such that (1) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.

It is another object of the present invention to provide the dispenser as defined above, additionally comprising metering dose mechanism (41) adapted to load a predetermined amount of medicament (1) within said launching point (3).

It is another object of the present invention to provide the dispenser as defined above, wherein said metering dose mechanism (41) is selected from a group consisting of a peristaltic pump (41), cogwheels mechanism duct-bile pumps, or a piston mechanism.

It is another object of the present invention to provide the dispenser as defined above, additionally comprising a meshed or porosive cover adapted to facilitate a unidirectional flow of the medicament from the medicament chamber (10) or the medicament metering dose mechanism (41) to the launching point (3).

It is another object of the present invention to provide the dispenser as defined above, wherein said carrier is selected from a group consisting of compressed air, nitrogen, carbon dioxide, butane, propane, a mixture of hydrocarbons or any combination thereof.

It is another object of the present invention to provide the dispenser as defined above, utilized as a nasal.

It is another object of the present invention to provide a two-steps method for dispensing a mist, said method comprising: a. providing a fluid communication between at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. providing a carrier fluid (2), flowable by means of an actuating mechanism (20); c. providing a nozzle (40) for dispersing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); d. providing a launching point (3); e. fluid connecting said launching point (3) with said medicament chamber (10), said carrier's actuating mechanism (20) and said nozzle (40); f. sequentially dispersing, from said launching point (3) at least one first and at least one second fractions of said dose, wherein one of the following is held true: (I) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier.

It is another object of the present invention to provide the method as defined above, wherein said step of sequentially dispensing additionally comprising steps of: a. accommodating within said launching point (3) a predefined amount of medicament; b. actuating said carrier fluid by means of said by said actuating mechanism; and, c. dispersing said predefined amount of medicament by means of a predefined amount carrier such that a fractionated dose of mist (3) is dispensed outwardly throughout said nozzle.

It is another object of the present invention to provide the method as defined above, wherein at least one first fraction comprises a carrier to medicament ratio lower or equal 50%, and at least one second fraction comprising a medicament to carrier ratio lower or equal 50%.

It is another object of the present invention to provide the method as defined above, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region Ocxcxl; M(x)ox+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl cx<x2; Y(x)=cx3+dx2+ex+f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cxcx3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)=ix3s-1x2+kx-i-! where i is the triple coefficient; I is the square coefficient, k is the linear coefficient and I is the y intercept; wherein a to I are real numbers, and wherein the absolute value of c, d or e is greater than the absolute value of a or g.

It is another object of the present invention to provide the method as defined above, wherein said fraction of said medicament within said dispensed mist is time-resolved.

It is another object of the present invention to provide the method as defined above, useful for dispensing a time-resolved medicament's fraction mist, wherein per each action of mist dispensing lasting a time period Idispensing, Idispensing comprises early time (Ieay) and late time (hate) phases, the amount of said medicament ([M}) within said mist is relatively higher in the early phases Ie than in the late phases Tiate, such that [M] Teariy >>[M] hate.

It is another object of the present invention to provide the method as defined above, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (late) is a medicament-drying phase.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said medicament as a preservative-full, preservative-poor or a preservative-free product.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said actuating mechanism (20) with at least one carrier fluid container 21 in communication with spring 22, such that (1) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing metering dose mechanism (41) adapted to load a predetermined amount of medicament (1) within said launching point (3).

it is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said metering dose mechanism (41) from a group consisting of a peristaltic pump (41), cogwheels mechanism, duct-bile pumps or a piston mechanism.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a meshed or porosive cover adapted to facilitate a unidirectional flow of the medicament from the medicament chamber (10) or the medicament metering dose mechanism (41) to the launching point (3).

It is still an object of the present invention to provide the method as defined above, additionally comprising step of selecting said carrier from a group consisting of compressed air, nitrogen, carbon dioxide, butane, propane, a mixture of hydrocarbons or any combination thereof.

It is lastly an object of the present invention to provide the method as defined above, utilized as a nasal.

BRIEF DESCRIPTION OF THE FIGURES

The preferred embodiments of the invention will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the invention, wherein like designations denote like elements, and in which:

FIG. la illustrates prior art dispenser.

FIG. 1 b illustrates prior art dispensing profile.

FIGs. 2-3 illustrate the medicament/carrier fluid dispensing profile according to the present invention.

FIGs. 4-8 illustrate the dispensing profile according to the present invention.

FIGs. 9A-9C illustrates another embodiment of the present invention, in which a peristaltic pump is utilized.

FIG. 10 illustrates another embodiment of the present invention, in which the two-steps operated multi-dose dispenser is utilized as a nasal FIGs. ila-lic illustrates the above mentioned iwo-steps multi-dose dispensing method as described above, utilized as a nasal FIG. 12 illustrates another embodiment of the present invention, in which the Iwo-steps operated multi-dose dispenser is provided with a meshed cover.

While the invention is susceptible to various modifications and alternative forms, specific embodiments of the invention are provided as examples in the drawings and detailed description. It should be understood that the drawings and detailed description are not intended to limit the invention to the particular form disclosed. Instead, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a two steps operated multi-dose dispenser, comprising a. at least one first medicament fluid 1 contained within at least one medicament chamber 10; b. a carrier fluid 2 (not shown in figures), flowable by means of an actuating mechanism 20; c. a nozzle 40 for dispensing a dose of said medicament 1 and said carrier 2 in the form of a mist 4; and d. a two-steps dispensing mechanism adapted to sequentially disperse at least one first and at least one second fractions of said dose, wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier; said dispensing mechanism comprising a launching point 3 adapted to accommodate the entire volume of said fraction of said medicament; said launching point 3 is in fluid connection with said medicament chamber 10, said carrier's actuating mechanism and said nozzle 40 such that in a first step a predefined amount of medicament is provided within said launching point, and in a second step, by actuating said carrier by said actuating mechanism, said predefined amount of medicament within said launching point is dispersed by means of a predefined amount carrier in a manner that a fractionated dose of mist {4) is dispensed outwardly throughout said nozzle The present invention also provides a two-steps method for dispensing a mist 4. The method comprises steps selected inter alia from: a. providing a fluid communication between at least one first medicament fluid 1 contained within at least one medicament chamber 10; b. providing a carrier fluid 2, flowable by means of an actuating mechanism 20; c. providing a nozzle 40 for dispersing a dose of said medicament 1 and said carrier 2 in the form of a mist 4; d. providing a launching point 3; e. fluid connecting said launching point 3 with said medicament chamber 10, said carrier's actuating mechanism 20 and said nozzle 40; f. sequentially dispersing, from said launching point 3 at least one first and at least one second fractions of said dose, g. wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicarnent is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier Reference is now made to FIGs. la-lb which illustrates a prior art dose

dispenser and a prior art dose dispensing profile.

The prior art dispenser usually comprises a flexible bag 15 containing a medicament; an output valve assembly 16 at one extremity of said bag; an outer container 12 enclosing said flexible bag 15, said outer container containing a propellant gas 18 under positive pressure, such that the medicament fluid is ejected from said flexible bag when said valve assembly is activated; and a nebulizing element configured to disperse said ophthalmic liquid in the form of a mist.

Such dispensers are usually accompanied by a medicament dispensing profile as described in figure lB.

As is seen in FIG. lB. the amount of medicament and the amount of the carrier is substantially equal through substantially the entire dose dispensing. Such medicament dispensing profile will result in the agglomeration of medicament on at least a portion the dispenser's rim.

Such vast accumulation of said medicament will inevitably least to the accumulation of bacteria on the same, which will eventually render the dispenser as useless. One of the main objects of the dispenser, as provided by the present invention is to prevent such bacteria accumulation by proving a dispensing profile, in which, the agglomeration of medicament is prevented.

Reference is now made to FIG. 2, which illustrate the medicament/carrier fluid dispensing profile according to the present invention.

As is seen in the figure, the dispensing profile (and the concept behind the same) are completely different than the prior art dispensing devices.

As seen in the figure, at the beginning the % of carrier (relatively to the % of medicament) is high.

Then, the amount of medicaments increases to a max after which it slowly decreases.

According to another embodiment of the present invention, the %w of medicament is represented by function M(x) characterized by at least 4 regions (see FIGs. 3A and 3B): a. first region Ocx<xl; M(x)=ax+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl<x<x2; Y(x)=cx3+dx2l-ex4-f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cxcx3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)=ix3-e-jx2+kx+! where i is the triple coefficient; I is the square coefficient, k is the linear coefficient and I is the y intercept; where a-I are real numbers. Furthermore, the absolute value of c, d or e is greater than the absolute value of a or g.

Reference is now made to FIGs. 4-8 illustrating the two-steps operated multi-dose dispenser 100 according to the present invention.

The two-steps operated multi-dose dispenser 100 comprises: a. at least one first medicament fluid 1 contained within at least one medicament chamber 10; b. a carrier fluid (2, not shown), flowable by means of an actuating mechanism 20; c. a nozzle 40 for dispensing a dose of said medicament 1 and said carrier 2 in the form of a mist 4; d. a two steps dispensing mechanism adapted to sequentially disperse at least two fractions of said dose, each of which comprises a predetermined amount of said medicament and said carrier, such that said two fractions are composed of substantially different amounts of said medicament and said carrier; comprising: I. a launching point 3 in fluid connection with said medicament chamber 10, said carrier's actuating mechanism 20 and said nozzle 40; said launching point 3 is adapted to accommodate each of said fractions; and, ii. at least one valve in connection with said launching point, adapted to dispense each of said fractions by means of said flowing carrier.

According to one embodiment of the present invention, the actuating mechanism 20 comprises a carrier fluid container 21 in physical communication with a spring 22.

A unidirectional valve 70 enables the entrance of said carrier fluid 2 into said container 22.

Once said container is filled with said carrier fluid, said spring is loaded, such that the same is activated, the spring applies pressure on the container so as to release predetermined amount of said carrier fluid into the launching point 3.

Reference is now made to FIGs. 5-8 illustrating the operation of the iwo-steps operated multi-dose dispenser 100.

Figure 5 schematically illustrates the first step in which the actuating mechanism is being loaded with the carrier fluid (see arrows 50).

As the carrier fluid container 21 is filled, spring 22 is loaded (see FIG. 6).

As will be described hereinafter, said carrier will be dispersed (along with predetermined amount of medicament 1 by the application of pressure, by means of said spring, on said fluid container 21. Due to the unidirectional valve 70, said fluid is not being extracted from the dispenser, upon activation, but rather being delivered to the launching point 3.

While the above mentioned actuating mechanism is being loaded, a predetermined amount of medicament 1 is dispensed from the medicament chamber 10.

Upon activation of the dispenser, the two steps dispensing mechanism sequentially disperses at least two fractions of a dose, each of which comprises a predetermined amount of the medicament 1 and the carrier 2, such that said two fractions are composed of substantially different amounts of said medicament and said carrier.

The two steps dispensing mechanism comprises (a) a launching point 3 in fluid connection with said medicament chamber 10, said carrier's actuating mechanism 20 and said nozzle 40. In said launching point 3 each of said fractions is accommodated; and, (b) at least one valve in connection with said launching point 3, adapted to dispense each of said fractions by means of said flowing carrier.

FIG. 7 illustrates the final step in which the dose of predetermined amount of medicament and carrier is dispersed in the form of mist 4.

As described above, the carrier 2 is dispersed (along with predetermined amount of medicament 1) by the application of pressure, by means of said spring (see FIG. 8, arrows 80), on said fluid container 21. The unidirectional valve 70, prevents the carrier from being extracted from the dispenser and enables the delivery of the same to the launching point 3 (to be dispersed).

According to another embodiment of the present invention, the two-steps operated multi-dose dispenser additionally comprising means 9 adapted to metered dose provide said amount of said medicament.

According to another embodiment of the present invention, the above mentioned means 9 are peristaltic pump (see FIGs. 9A, 96 and 9C).

Reference is now made to FIG. 10, illustrating another embodiment of the present invention, in which the two-steps operated multi-dose dispenser is utilized as a nasal.

As illustrated in the figure, the application of force (see arrow 90), activates the two-steps multi-dose dispenser and a dose of said medicament 1 and said carrier 2 in the form of a mist is dispensed.

FIGs. ila-lic illustrates the above mentioned two-steps multi-dose dispensing method as described above, utilized as a nasal.

According to another embodiment of the present invention, the two-steps operated multi-dose dispenser as described above, additionally comprising a meshed cover 91 adapted to prevent any unwanted leakage of said medicament.

Reference is now made to FIG. 12, illustrating such meshed cover embodiment.

According to another embodiment of the present invention, the carrier is selected from a group consisting of compressed air, nitrogen, carbon dioxide, butane, propane, a mixture of hydrocarbons or any combination thereof.

According to another embodiment of the present invention, the medicament is preservative free.

Thus, it is one object of the present invention to provide a two-steps operated multi-dose dispenser 100, comprising a. at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. a carrier fluid (2), flowable by means of an actuating mechanism (20); c. a nozzle (40) for dispensing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); and d. a two-steps dispensing mechanism adapted to sequentially disperse at least one first and at least one second fractions of said dose, wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier; said dispensing mechanism comprising a launching point (3) adapted to accommodate the entire voJume of said fraction of said medicament; said launching point (3) is in fluid connection with said medicament chamber (10), said carrier's actuating mechanism (20) and said nozzle (40) such that in a first step a predefined amount of medicament is provided within said launching point, and in a second step, by actuating said carrier by said actuating mechanism, said predefined amount of medicament within said launching point is dispersed by means of a predefined amount carrier in a manner that a fractionated dose of mist (4) is dispensed outwardly throughout said nozzle.

It is another object of the present invention to provide the dispenser as defined above, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region Ocxcxl; M(x)=ax+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl <x<x2; Y(x)=cx3+dx2+ex+t; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2<x<x3; {(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)=1x3+jx2-Fkx+/ where i is the triple coefficient; j is the square coefficient, k is the linear coefficient and / is the y intercept; wherein a to 1 are real numbers, and wherein the absolute value of c, d or e is greater than the absolute value of a or g.

It is another object of the present invention to provide the dispenser as defined above, useful for dispensing a time-resolved medicament's fraction mist, wherein per each action of mist dispensing lasting a time period Tdispensing, Idispensing comprises early time (Ieay) and late time (hate) phases, the amount of said medicament ([M]) within said mist is relatively higher in the early phases Tearn, than in the late phases Tiate, such that EM] Teariy >>[M] blate.

It is another object of the present invention to provide the dispenser as defined above, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (hale) is a medicament-drying phase.

It is another object of the present invention to provide the dispenser as defined above, wherein said actuating mechanism (20) comprising at least one carrier fluid container 21 in communication with spring 22, such that (I) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.

It is another object of the present invention to provide the dispenser as defined above, wherein said metering dose mechanism (41) is selected from a group consisting of a peristaltic pump (41), cogwheels mechanism, duct-bile pumps or a piston mechanism.

It is another object of the present invention to provide a two-steps method for dispensing a mist, said method comprising: a. providing a fluid communication between at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. providing a carrier fluid (2), flowable by means of an actuating mechanism (20); c. providing a nozzle (40) for dispersing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); d. providing a launching point (3); e. fluid connecting said launching point (3) with said medicament chamber (10), said carrier's actuating mechanism (20) and said nozzle (40); f. sequentially dispersing, from said launching point (3) at least one first and at least one second fractions of said dose, wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier.

if is another object of the present invention to provide the method as defined above, wherein said step of sequentially dispensing additionally comprising steps of: a. accommodating within said launching point (3) a predefined amount of medicament; b. actuating said carrier fluid by means of said by said actuating mechanism; and, c. dispersing said predefined amount of medicament by means of a predefined amount carrier such that a fractionated dose of mist (3) is dispensed outwardly throughout said nozzle.

It is another object of the present invention to provide the method as defined above, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region Ocxcxl; M(x)ox+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl cxcx2; Y(x)=cx3÷dx2+ex+f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cxcx3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)ix3+jx2+kx+/ where I is the triple coefficient; j is the square coefficient, k is the linear coefficient and / is the y intercept; wherein a to / are real numbers, and wherein the absolute value of c, d or e is greater than the absolute value of a or g.

It is another object of the present invention to provide the method as defined above, useful for dispensing a time-resolved medicamentts fraction mist, wherein per each action of mist dispensing lasting a time period Tdispensing, Idispensing comprises early time (Ieay) and late time (hate) phases, the amount of said medicament ([M]) within said mist is relatively higher in the early phases Tea than in the late phases Tiate, such that [M] T90 >>[M] Tiate.

It is another object of the present invention to provide the method as defined above, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (hate) is a medicament-drying phase.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said actuating mechanism (20) with at least one carrier fluid container 21 in communication with spring 22, such that (I) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing metering dose mechanism (41) adapted to load a predetermined amount of medicament(1) within said launching point (3).

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a meshed or porosive cover adapted to facilitate a unidirectional flow of the medicament from the medicamenf chamber (10) or the medicament metering dose mechanism (41) to the launching point (3).

Claims

Claims 1. A two-steps operated multi-dose dispenser 100, comprising a. at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. a carrier fluid (2), flowable by means of an actuating mechanism (20); c. a nozzle (40) for dispensing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); and d. a two-steps dispensing mechanism adapted to sequentially disperse at least one first and at least one second fractions of said dose, wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier; said dispensing mechanism comprising a launching point (3) adapted to accommodate the entire volume of said fraction of said medicament; said launching point (3) is in fluid connection with said medicament chamber (10), said carrier's actuating mechanism (20) and said nozzle (40) such that in a first step a predefined amount of medicament is provided within said launching point, and in a second step, by actuating said carrier by said actuating mechanism, said predefined omount of medicament within said launching point is dispersed by means of a predefined amount carrier in a manner that a fractionated dose of mist (3) is dispensed outwardly throughout said nozzle.
2. The dispenser of claim 1, wherein at least one first fraction comprises a carrier to medicament ratio lower or equal 50%, and at least one second fraction comprising a medicament to carrier ratio lower or equal 50%.
3. The dispenser of claim 1, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region Ocx<xl; M(x)=ax+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xlcxcx2; Y(x)=cx3+dx2÷ex4-f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cxcx3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)4x3+jx2+kx+I where i is the triple coefficient; I is the square coefficient, k is the linear coefficient and I is the y intercept; wherein a to I are real numbers, and wherein the absolute value of c, d or e is greater than the absolute value of a or g.5. The dispenser of claim 1, wherein said fraction of said medicament within said dispensed mist is time-resolved.6. The dispenser of claim 4, useful for dispensing a time-resolved medicament's fraction mist, wherein per each action of mist dispensing lasting a time period Iciispensing Tciispersing comprises early time (Tea) and late time (Tiate) phases, the amount of said medicament ([MJ) within said mist is relatively higher in the early phases learly than in the late phases Tiate, such that [M] Tearty >>[M] Tiate.7. The dispenser according to claim 5, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (Tiate) is a medicament-drying phase.8. The dispenser of claim I wherein said medicament is a preservative-fuU, preservative-poor or a preservative-free product.9. The dispenser of claim 1, wherein said actuating mechanism (20) comprising at least one carrier fluid container 21 in communication with spring 22, such that (I) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.10. The dispenser of claim 1, additionally comprising metering dose mechanism (41) adapted to load a predetermined amount of medicament (])within said launching point (3).11. The dispenser of claim 9, wherein said metering dose mechanism (41) is selected from a group consisting of a peristaltic pump (41), cogwheels mechanism, duct-bile pumps or a piston mechanism.12. The dispenser of claim 1, additionally comprising a meshed or porosive cover adapted to facilitate a unidirectional flow of the medicament from the medicament chamber (10) or the medicament metering dose mechanism (41) to the launching point (3).13. The dispenser of claim 1, wherein said carrier is selected from a group consisting of compressed air, nitrogen, carbon dioxide, butane, propane, a mixture of hydrocarbons or any combination thereof.14. The two-steps operated multi-dose dispenser of claim 1, utilized as a nasal.15. A two-steps method for dispensing a mist, said method comprising: a. providing a fluid communication between at least one first medicament fluid (1) contained within at least one medicament chamber (10); b. providing a carrier fluid (2), flowable by means of an actuating mechanism (20); c. providing a nozzle (40) for dispersing a dose of said medicament (1) and said carrier (2) in the form of a mist (4); d. providing a launching point (3); e. fluid connecting said launching point (3) with said medicament chamber (10), said corner's actuating mechanism (20) and said nozzle (40); f. sequentially dispersing, from said launching point (3) at least one first and at least one second fractions of said dose, wherein one of the following is held true: (1) said first and second fractions are substantially similar; or (ii) said first fraction is characterized by that the amount of said medicament is equal or greater than the amount of said carrier; and said second fraction is characterized by that the amount of said medicament is equal or lower than the amount of said carrier.16. The method of claim 15, wherein said step of sequentially dispensing additionally comprising steps of: a. accommodating within said launching point (3) a predefined amount of medicament; b. actuating said carrier fluid by means of said by said actuating mechanism; and, c. dispersing said predefined amount of medicament by means of a predefined amount carrier such that a fractionated dose of mist (3) is dispensed outwardly throughout said nozzle.17. The method of claim 15, wherein at least one first fraction comprises a carrier to medicament ratio lower or equal 50%, and at least one second fraction comprising a medicament to carrier ratio lower or equal 50%.18. The method of claim 15, wherein said fraction of said medicament within said dispensed mist is represented by function M(x) characterized by at least one of a group consisting of four regions: a. first region 0cxcxl; M(x)ax+b; where a is the linear coefficient; and, b is the y intercept and x is the time; b. second region xl cxcx2; Y(x)cx3+dx2+ex+f; where c is the triple coefficient; d is the square coefficient, e is the linear coefficient and f is the y intercept; c. third region x2cx<x3; Y(x)=gx+h; where g is the linear coefficient; and, h is the y intercept; and, d. fourth region x3cxcx4; Y(x)=ix3+jx2+kx+/ where i is the triple coefficient; 3 is the square coefficient, k is the linear coefficient and I is the y intercept; wherein a to I are real numbers, and wherein the absolute value of c, d or e is greater than the absolute value of a or g.19. The method of claim 15, wherein said fraction of said medicament within said dispensed mist is time-resolved.20. The method of claim 15, useful for dispensing a time-resolved medicament's fraction mist, wherein per each action of mist dispensing lasting a time period Tdispensing, Tdispensing comprises early time (leady) and late time (Tiate) phases, the amount of said medicament ([M]) within said mist is relatively higher in the early phases Teariy than in the late phases Tiate, such that [M] Tea,iy >>[M] Tiate.21. The method of claim 17, wherein per each action of mist dispensing, said carrier-rich medicament-poor fraction along the late time phase (Tiate) is a medicament-drying phase.22. The method of claim 15, additionally comprising step of providing said medicament as a preservative-full, preservative-poor or a preservative-free product.23. The method of claim 15, additionally comprising step of providing said actuating mechanism (20) with at least one carrier fluid container 21 in communication with spring 22, such that (I) as said container is filled with said carrier, said spring is loaded; and, (ii) the dispensing of said carrier from said container is provided by the application of force upon said container, by means of said spring.24. The method of claim 15, additionally comprising step of providing metering dose mechanism (41) adapted to load a predetermined amount of medicament (1) within said launching point (3).25. The method of claim 22, additionally comprising step of selecting said metering dose mechanism (41) from a group consisting of a peristaltic pump (41), cogwheels mechanism, duct-bile pumps or a piston mechanism.26. The method of claim 15, additionally comprising step of providing a meshed or porosive cover adapted to facilitate a unidirectional flow of the medicament from the medicament chamber (10) or the medicament metering dose mechanism (41) to the launching point (3).27. The method of claim 15, additionally comprising step of selecting said carrier from a group consisting of compressed air, nitrogen, carbon dioxide, butane, propane, a mixture of hydrocarbons or any combination thereof.28. The method of claim 15, utilized as a nasal.