MX2008005432A - Dispenser for a liquid - Google Patents

Abstract

A dispenser (1) for a liquid is provided which is particularly, though not exclusively, useful for dispensing liquid medical compositions such as nasal sprays. The dispenser employs at least one, though preferably two, semi-rigid casing halves (2,3), defining a liquid reservoir (12), within which is mounted a bridge member (21) which performs the functions of dip tube, dose metering pump, and outlet orifice. An air inlet (8) may be provided into the reservoir, to allow air to enter as liquid leaves, in which case it may be provided with a liquid- impermeable, and preferably bacteria- impermeable, cover (9). Other constructions are described in which no such cover need be provided, or in which the need for an air inlet can be avoided altogether.

Description

DOSER FOR LIQUIDS This invention relates to a dispenser for liquids and, preferably, to a device for dosing liquids in the form of a spray. The dispenser of the present invention can be used, for example, for dosing liquids, such as medicaments, which includes sprays for nose and throat, optical and ophthalmic compositions, for example, eye drops, ear drops and sprays for the ears; perfumes; cosmetics; cleaning products, and the like. In the following description, specific reference will be made to the use of the dispenser in relation to medications, although it should be understood that the dispenser has many uses, including those already mentioned above. Specifically in the field of dispensers for medicaments, there is a significant amount of requirements that must be satisfied in order for a dispenser to be adequately effective. These include: (a) the need to maintain the sterility of the contents of the dispenser throughout its useful life; (b) the ability to dose a dose to the degree of accuracy appropriate to the use in question and maintain this not only when the dispenser is used for the first time, but in all subsequent uses; (c) the ability to avoid obstruction of the output of the dispenser (this is not only convenient for the dispenser itself, but is also related to the achievement of (a) and (b) already mentioned); (d) the ease and economy of costs in terms of manufacturing, at least to the extent permitted by the need to achieve the foregoing objectives; (e) a small size, at least in the case of dispensers that the user may have to carry with them to use during the day. There are numerous proposals in the industry for dispensers that are intended to satisfy at least some of the foregoing objectives and, by way of example, patents WO03 / 097250 (Genosar), US Pat. no. 6,460,781 (Garcia et al.) And U.S. Pat. no. 6,769,579 (Milian et al.). However, although benefits can be obtained with the use of dispensers manufactured in accordance with these and other proposals, it is believed that none is completely satisfactory in all respects, and the present invention is directed, in its various aspects, to achieving some or all of the previous objectives and to achieve other objectives that will be evident from the description that follows. In accordance with a first aspect of the invention, a dispenser for a respiratory tract treatment composition is provided; the dispenser comprises: a) a receptacle containing a fluid, which is a treatment composition for the respiratory tract; and b) a pump in continuous communication with the receptacle; the pump comprises a dose chamber and a pump actuator; and c) an outlet hole in continuous communication with the receptacle and the pump so that the drive of the pump can effect the supply of fluid from the dispenser through the outlet orifice, characterized in that the receptacle comprises a laminated container that is adapted for delaminate when the fluid is dosed from there. In another aspect, the invention provides a dispenser for liquids; The dispenser comprises: a) a receptacle suitable for containing the liquid; the receptacle comprises a laminated container comprising an outer layer comprising a rigid material and at least one other layer therein, which can be delaminated from the outer layer; and b) a pump in continuous communication with the receptacle and with an outlet hole; the pump comprises an upper pump half comprising a flexible actuator connected to the upper half of the pump, and a lower pump half, wherein a pressure on the flexible actuator is effective to dose a dose of fluid by means of the pump , and where each of the upper and lower halves of the pump are made with unitary molds. In another aspect, the invention provides a dispenser for liquids comprising: a) a pump body including two main separated surfaces having peripheral edges interconnected to define between them a substantially closed receptacle for containing a liquid to be dosed therefrom, and most of that body is practically rigid; b) a pumping chamber having an inlet valve communicating with the receptacle and an outlet valve communicating with an outlet orifice; the chamber is operated by means of a pumping button provided along one of the main surfaces, where the pumping button defines a part of one of the main surfaces and serves as the wall of the pumping chamber, and the action pressing the pumping button to its displaced position is adapted to make the liquid contained in the pumping chamber expelled by the outlet valve, and the return of the button to its first normal position causes the liquid to enter the chamber of the pump. pumping through the inlet valve; wherein the dispenser further comprises an opening for air intake, in continuous communication with the receptacle, which allows ambient air to enter the receptacle while the button returns to its first normal position and, after dosing the fluid, the opening for air intake is occluded by a cover that is gas permeable to let the gas flow in the receptacle, but impermeable to the liquid contained within the receptacle; preferably, the gas permeable cover is impermeable to microorganisms that might otherwise enter the receptacle. In yet another aspect, the invention provides a dispenser for liquids comprising a) a body including two main spaced apart surfaces having peripheral edges interconnected to enclose a closed receptacle capable of containing a liquid to be dosed therebetween, and most of which that body is practically rigid; b) a pump operated with a pumping button provided along one of the main surfaces, wherein the pumping button is formed as part of one of the main surfaces; wherein the dispenser further comprises a dosing nozzle in continuous communication with the pump and comprising an outlet orifice for dosing the fluid; the nozzle is provided with an expulsion channel and with a closure member fixedly disposed in the expulsion channel upstream of the outlet orifice; the closure member comprises a fixed portion fixed in relation to the outlet orifice and an elastically deformable portion supporting a closure element which, in a rest position, closes the outlet orifice and which, when the elastically deformable portion is deformed, open the exit hole. In a preferred form of the first described aspect, the pump comprises a pumping chamber having an inlet valve and being actuated by the pumping button, which is provided along one of the main surfaces, wherein the pumping button is formed as part of one of the main surfaces and serves as the wall of the pumping chamber and the action of pressing the pumping button to its displaced position causes the liquid contained in the pumping chamber to expel, and the return of the button to its first normal position causes the liquid to enter the pumping chamber by means of the inlet valve; The dosing nozzle is in continuous communication with the pumping chamber. In any of its aspects, the two described above and those described below, the dispenser according to the invention preferably comprises a cover that is attached to the body of the doser to cover and protect, from the external environment, at least the exit hole; the cover comprises a closing element which, when the cover is adjusted in the closed position, is coupled to the outlet or to a surface surrounding the outlet orifice to produce a seal.

In another aspect, the invention also provides a pump for dosing a fluid from a receptacle; the pump comprises a pump chamber comprising a lower plate, inlet and outlet ports, an actuator forming at least part of at least one of the walls of the pump chamber, and a deformable resistance device within the pump chamber, sandwiched between the lower plate and the actuator, so that the deformable resistance device does not significantly interfere with the initial deformation of the actuator during actuation, but that resists the final deformation of the actuator; the deformation of the deformable resistance device will not occur until a threshold force is overcome, which will provide a response signal to the user in order to determine a complete actuation. In yet another aspect, the invention provides a dispenser for liquids comprising a receptacle containing the liquid substance to be dosed and an outlet orifice; the receptacle includes at least one wall or actuating wall portion that can be deformed by applying a pressing force to reduce the internal volume of the receptacle and thereby exert pressure on the liquid substance in order to supply it through the outlet orifice; at least one of the actuator walls has a predetermined threshold of resistance to deformation which must be overcome in order to deform it; wherein the predetermined threshold of resistance to deformation of the actuator wall is generated by a threshold resistance means located immediately below the wall or actuator wall portion; the threshold resistance means exerts virtually no pressure on the fluid contained within the receptacle once the predetermined threshold of resistance to deformation is overcome. In any of these aspects, the output of the dispenser according to the invention preferably defines a fluid supply shaft, and the pump is driven with a force that is applied directly to the dispenser at an angle of at least 60 ° with with respect to the axis of fluid supply. In another aspect, the invention provides a dispenser for liquids comprising: a) a body comprising an upper half comprising a main surface and a lower half comprising a main surface; most of the body is practically rigid; the two main surfaces are opposite each other and have peripheral edges that are interconnected to define between them a substantially closed receptacle to contain therein a liquid to be dosed; the peripheral edges of the two halves comprise connecting means to allow the hermetic sealing of the fluid of the two halves, wherein the peripheral edges of the two halves define an opening for the exit of the fluid when they are interconnected; and b) a bridge piece defining at least part of a fluid inlet channel and interposed between the upper and lower halves; the bridge piece further comprises a fluid outlet channel body emerging from the liquid dispenser by means of the fluid outlet opening defined by the upper and lower halves; the fluid outlet channel body comprises a sealing means that engages the edges of the fluid outlet opening to produce a fluid tight seal. In yet another aspect, the invention provides a dispenser for liquids comprising: a) a body comprising an upper half comprising a main surface and a lower half comprising a main surface; most of the body is practically rigid; the two main surfaces are opposite each other and have peripheral edges that are interconnected to define between them a substantially closed receptacle to contain therein a liquid to be dosed; the peripheral edges of the two halves comprise connecting means to allow the hermetic sealing of the fluid of the two halves, wherein the peripheral edges of the two halves define an opening for the exit of the fluid when they are interconnected, wherein one of the halves it is formed with a material that is practically absorbing laser radiation of a wavelength capable of welding the two halves together, and the other half is practically transmitting that radiation; and b) a bridge piece comprising a pump means and defining at least part of a fluid metering channel which is located between the upper and lower halves; The bridge piece further defines a fluid outlet channel body emerging from the liquid dispenser by means of the fluid outlet opening defined by the upper and lower halves. In still another aspect, the invention provides a dispenser for liquids comprising: a) an upper half of dispenser comprising a main surface; most of the upper half of the dispenser is practically rigid; the peripheral edges of the upper half extend in a generally perpendicular direction from the plane of the main surface; the upper half further comprises a pumping button formed as part of the main surface and serving as a wall of a pumping chamber; b) a bridge piece comprising a lower pump chamber plate; the lower plate of the pump chamber comprises an inlet port and an outlet port in continuous communication with the pump chamber, where the lower plate of the pump chamber is coupled with the pumping button of the upper half of the dispenser for making a seal so as to form a sealed pumping chamber; c) an input valve in continuous communication with the input port; d) an outlet valve in continuous communication with the outlet port; and e) a lower half of the dispenser comprising a flexible material attached to the perpendicular peripheral edges of the rigid upper half of the dispenser to produce a seal and define a flexible receptacle wall and so that the return of the pumping button after dosing makes that the liquid is brought to the pumping chamber by means of the inlet valve and the inlet port and generate a reduced pressure in the receptacle that causes the deformation of the flexible lower half of the doser to adapt to the reduced volume therein. In another aspect, the invention provides a bridge piece for a dispenser and pump for liquids of modular design; The bridge piece is a unitary structure comprising: a) an inlet channel wall defining at least part of an inlet fluid channel; b) a lower surface of the pump chamber defining at least one wall of the pump chamber; c) an inlet port that communicates the inlet fluid channel with the pump chamber; d) an output port in continuous communication with the pump chamber; and e) a fluid outlet channel body in continuous communication with the outlet port; the fluid outlet channel body defines a fluid outlet channel therein. As already indicated, a dispenser in accordance with the present invention can be used, and in some aspects of the invention is used, for dosing a liquid composition comprising a medicament, for example, for dosing compositions for the treatment of the human respiratory tract . These will be described in more detail below by way of example. Respiratory tract treatment compositions Preferably, the fluid is a pharmaceutically acceptable composition comprising a pharmaceutically acceptable treatment agent selected from medicaments, flavors, salts, surfactants and mixtures thereof. The fluid comprises, optionally, other adjuvants dissolved or dispersed therein. The fluid can be aqueous or non-aqueous. Suitable aqueous fluids include water and mixtures of water with water miscible solvents, such as glycerol, propylene glycol, or alcohols, such as ethanol or isopropyl alcohol. Aqueous emulsions, either water-in-oil or oil-in-water emulsions, can also be used. Preferably, the fluid is an aqueous solution, an oil-in-water dispersion or emulsion. Suitable non-aqueous fluids comprise polyethylene glycols, glycerol, propylene glycol, dimethyl isosorbide, silicone oils, ketones, ethers, and mixtures thereof. In preferred embodiments, the fluid is a pharmaceutically acceptable and preferably isotonic intranasal carrier, ie, it has the same osmotic pressure as blood and tear fluid. The desired isotonicity of the liquid composition can be obtained, for example, by the use of sodium chloride or other pharmaceutically acceptable agents, such as dextrose, boric acid, citric acid, sodium tartrate, sodium citrate, sodium phosphate, phosphate of potassium, propylene glycol or other organic or inorganic solutes. Sodium chloride is especially preferred for buffers containing sodium ions. Other examples of sodium chloride equivalents are described in "Pharmaceutical Sciences" by Remington, pgs. 1491-1497 (Alfonso Gennaro, 18th edition 1990). The fluid of the present, which is preferably a nasal treatment composition, preferably has a viscosity of less than about 1000 mPa.s, but, generally, of at least 10 mPa.s. The most preferred viscosity values are from 20 to about 500 mPa.s and from about 50 to 500 mPa.s.

Medications The liquid composition may comprise a wide variety of medications. By "drug" is meant a drug or other substance intended to have a therapeutic effect on the body. Suitable levels of the medicament are from 0.001 to 20%, preferably from 0.01 to 5%, more preferably from 0.1 to 5%. It will be understood that the levels of specific drugs will depend on many factors, including their potency, safety profile, solubility / ease of dispersion and expected effect. The medicament, when used, may be a medicament that is intended to have an effect at the site of application, such as a decongestant, antihistamine, analgesic or antiinflammatory drug, or may be intended to be absorbed systemically, such as an antiviral drug, antidepressant, antiemetic, antipyretic or a hormone or similar. The drug may be soluble in the fluid or it may be a finely divided insoluble particulate liquid or solid dispersed within the fluid. Suitable decongestants include oxymetazoline, tramazoline, xylometazoline, naphazoline, tetrahydrozoline, pseudoephedrine, ephedrine, phenylephrine, their pharmaceutically acceptable salts, such as the hydrochlorides, and mixtures thereof. Preferred decongestants are selected from oxymetazoline, xylometazoline, their pharmaceutically acceptable salts, and mixtures thereof. Suitably, a decongestant is present in a concentration of from about 0.01% to about 3.0%, more preferably, from about 0.01% to about 1%.

Useful antihistamines include fast-acting H 1 histamine receptor antagonists. The antihistamines of H-1 receptors can be selected from the following antihistamine groups: alkylamines, ethanolamines, ethylenediamines, piperazines, phenothiazines, piperidines. Examples of useful fast-acting antihistamines include acrivastine, carbinoxamine, diphenhydramine, chlorpheniramine, brompheniramine, dexchlorpheniramine, doxylamine, clemastine, promethazine, trimeprazine, metdilazine, hydroxyzine, pyrilamine, tripelenamine, meclizine, triprolidine, azatadine, cyproheptadine, rocastin, phenindamine. or pharmaceutically acceptable salts and mixtures thereof. Other useful antihistamines include terfenadine, azelastine, cetirizine, astemizole, ebastine, ketotifen, lodoxamide, loratadine, levocabastine, mequitazine, oxatomide, setastine, taziphiline, temelastin or pharmaceutically acceptable salts and mixtures thereof. When used, preferably the antihistamine component is present in the nasal treatment fluid in a concentration of from about 0.01% to about 3.0%, more preferably, from about 0.01% to about 1%. The medication can also be an anti-inflammatory agent, such as a corticosteroid. Especially preferred agents within this category are glucocorticoids selected from the group comprising beclomethasone, flunisolide, fluticasone, mometasone, budesonide, pharmaceutically acceptable salts thereof and mixtures thereof. Preferably, an anti-inflammatory agent is present in the fluid in a concentration of from about 0.001% to about 0.1%, more preferably, from about 0.01% to about 0.1%. Also useful herein are xanthine derivatives, such as caffeine and methylxanthine and the like; antiallergic; mucolytics; anticholinergic; non-opiate analgesics, such as acetaminophen, acetylsalicylic acid, ibuprofen, etodolac, fenbuprofen, fenoprofen, ketorolac, flurbiprofen, indomethacin, ketoprofen, naproxen, pharmaceutically acceptable salts thereof and mixtures thereof; opioid analgesics, such as butorphanol; leukotriene receptor antagonists; mast cell stabilizers, such as cromolyn sodium, nedocromil and lodoxamide; and inhibitory compounds of lipoxygenase. Other examples of suitable medicaments can be found in patents W097 / 46243, EP-A-780127, U.S. Pat. num. -A-5, 24,315, -A-5,622,724, -A-5,656,255 and-A-5,705,490 Flavorings Various aromatic or flavoring components (eg, aldehydes and esters) may be used in the fluids for nasal treatment herein. These include, for example, menthol, camphor, eucalyptol, benzaldehyde (cherries, almonds); citral (lemons, limes); neral decanal (oranges, lemons); aldehyde C-8, aldehyde C-9 and aldehyde C-12 (citrus fruits); tolyl aldehyde (cherries, almonds); 2,6-dimethyloctanal (green fruits); 2-dodecenal (citrus, tangerines); and herbal components, such as thyme, rosemary and sage oils. Additional aromatic components suitable for use in the present invention include those described in U.S. Pat. num. 4,136,163, issued to Watson et al; 4,459,425, issued to Amano et al .; and 4,230,688, issued to Rowsell et al. Mixtures of these aromatics can also be used. Surfactants The treatment fluid may also comprise one or more pharmaceutically acceptable surfactants. The surfactants may be useful for dispersing or emulsifying drugs or flavors, for increasing absorption through the mucous or nasal membranes or as treatment agents by themselves. The surfactants can be anionic, nonionic, cationic or amphoteric; preferably, they are non-ionic. Typical nonionic surfactants useful herein include: polyoxyethylene derivatives of partial esters of fatty acids with sorbitol anhydrides, such as polysorbate 80; polyoxyethylene derivatives of fatty acids, such as polyoxyethylene stearate 50, as well as oxyethylated octyl phenol formaldehyde tertiary polymers (distributed by Sterling Organics as Tyloxapol), or mixtures of these. The normal concentration of surfactant is from about 0.1% to about 3% by weight. Salts The fluid may also comprise one or more pharmaceutically acceptable salts. The salt may be a mineral salt, such as, for example, sodium chloride, or salts of organic acids, such as sodium citrate.

Other adjuvants The fluid herein may further comprise other ingredients, such as thickeners, humectants, suspension aids, encapsulation aids, chelating agents and preservatives. The viscosity of the compositions can be maintained at the selected level by the use of a pharmaceutically acceptable thickening agent. Suitable thickening agents include, for example, xanthan gum, methylcellulose, microcrystalline cellulose, carboxymethylcellulose, chitosan, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, carboxyvinyl polymers, carbomers, and the like or pharmaceutically acceptable salts thereof. Mixtures of these thickening agents can also be used. The preferred concentration of the thickening agent will depend on the agent that is selected. The most important thing is to use an amount capable of achieving the selected viscosity. Typically, viscous compositions are prepared from solutions by the addition of these thickening agents. The fluids useful in the present invention may also comprise from about 0.01% to about 5% of a humectant to inhibit drying of the mucous membrane and prevent irritation. Any of a variety of pharmaceutically acceptable humectants may be employed, including, for example, sorbitol, propylene glycol, polyethylene glycol, glycerol or mixtures thereof. As with thickeners, the concentration will vary according to the agent selected, although the presence or absence of these agents, or their concentration, is not an essential feature of the invention. A pharmaceutically acceptable preservative may be employed to increase the shelf life of the compositions herein. A variety of preservatives can be used, which include, for example, benzyl alcohol, parabens, phenylethyl alcohol, thimerosal, chlorobutanol, chlorhexidine gluconate, or benzalkonium chloride. A suitable concentration of the preservative is from 0.001% to 2%, based on the total weight, although there may be appreciable variations depending on the agent selected. However, the provision, in some aspects of the invention, of an air inlet in the receptacle that is impermeable to potentially contaminating microorganisms, or the use of a closure member in the outlet orifice that closes the orifice to the outside except when dosing a dose, or the use of a laminated container, in which the air entering the dispenser during use can not come into contact with the liquid to be dosed, may make the use of a preservative unnecessary. Definitions Unless otherwise specified, the percentages and ratios herein are expressed by weight and all measurements are made at 25 ° C. All viscosity measurements herein are made, unless otherwise specified, at 25 ° C and at a shear rate of 1 s' using a steady state regime flow method.

In preferred embodiments, the dispensers and pumps of the present comprise upper and lower halves. The terms "half" and "halves" herein are meant to indicate only the corresponding parts and are not intended to mean any equality in size, structure or function. The terms "upper" and "lower" with respect to the pump or the dispenser are used only to differentiate the two halves and do not intend to mean any specific orientation of the parts during use. As used herein, a "semi-rigid" thermoplastic material refers to a thermoplastic material having a flexural modulus of at least about 300, preferably, at least about 500 MPa measured according to ASTM D790 standards. "Unitary mold" means a mold formed in one piece or completely formed within a single mold. The unitary mold can comprise only one material, but the term "unitary mold" also comprises the work pieces formed of two or more materials in a regular molding operation, such as a two shot injection molding, wherein different materials are co-injected or injected sequentially in a common mold. A "liquid" refers herein to a flowing liquid or gel. "Fluid supply axis" is related to the line in which most of the fluid moves when it leaves the dosing orifice, where the fluid disintegrates to form a spray; Usually, this axis represents the line from the dosing outlet that points towards the center of the atomization pattern. The invention is described in more detail below with reference to the accompanying figures, in which: Figure 1 is a side view of one embodiment of the invention; Figure 2 is a similar view, but the cover that is part of the modality has been removed to be able to see the underlying parts of the device; Figure 3 is a perspective view of what can be seen in Figure 2; Figure 4 is a cross section taken on line IV-IV of Figure 1; Figure 5 is a longitudinal section of the embodiment of Figure 1, and where the lid was completely removed; Figure 6 is an exploded perspective view showing certain components of the device of Figure 1; Figure 7 shows one of the components of Figure 6 from a direction at 180 ° with respect to that shown in Figure 6; Figure 8 is a view taken along the arrow "A" of the Figure 7; Figure 9 is a longitudinal section, on an enlarged scale, of a modified version of the output end of the devices; Figure 10 shows another embodiment of the invention; Figure 1 1 shows the two parts of Figure 10 assembled to form a pump; Figure 12 is a cross section of a receptacle according to an embodiment of the present invention comprising a rigid outer wall and an inner layer that delaminates; Figure 13 is an alternative embodiment of the present invention combining the pump of Figure 11 with the receptacle of Figure 12. The embodiment shown by way of example in Figures 1 to 9 is intended as a dispenser for a treatment composition. of the respiratory tract and, more specifically, for such a composition when administered as a nasal spray. The dispenser 1 comprises a housing formed by two housing parts, the parts 2 and 3, which are referred to by convenience below as upper half 2 and lower half 3; the terms "upper half" and "lower half" shall be understood as defined above. The halves 2 and 3 of the housing are made of a material that is, at least, semi-rigid. The halves 2 and 3 of the housing have the corresponding main surfaces 2a and 3a and peripheral walls 2b and 3b transverse to the main surfaces 2a and 3a and integral with the peripheral edges of the corresponding major surfaces. The peripheral walls 2b and 3b terminate at the peripheral edges 2c and 3c which are configured to mate with each other. In the illustrated embodiment, the peripheral edge 2c has a downwardly directed wall 2d, and the peripheral edge 3c has an upwardly directed slot, whereby the wall 2d engages with the 3d slot. However, it will be understood that the locations of the wall and the slot could be reversed, or that a completely different arrangement could also be provided. The upper half 2 of the casing has, on its main surface, an inward portion 4 which forms a shallow concavity and inside the concavity 4 a dome-shaped rising portion with thinner walls is formed defining a button 5. The button 5 can be completely integral with the rest of the upper half 2 of the casing, that is to say, be formed with the upper half of the casing and of the same material as the upper half of the casing, or it can be partially integral with this , that is to say formed jointly therefrom (preferably molded together), but of a material different from that of the upper half of the housing, or it may be a component other than an identical or different material. The configuration that is partially integral is preferred, since it can be easily manufactured, but allows the use of different materials for the button (preferably, a plastic elastomer) and the middle of the housing (preferably, a semi-rigid plastic material). The purpose of this is explained in more detail below. At the end that lies rearward in the dispenser, each half of the housing has a semicircular cut-out, so that, when the two halves are joined, they define a circular opening 6. The opening 6 receives a cylindrical plug 7 having a inner diameter 8 within which there is a filter member 9. Although shown as an elongated cylinder, the filter member 9 is preferably a disc of a filter material. The filter 9 is made of a material whose pore size is such that it allows air to pass through it, but also prevents the passage of liquids and bacteria. For this purpose, none of the pores of the filter material should have a diameter greater than 0.2 μ. Preferably, the filter member 9 is a fibrous material and, at least, where the dispenser is provided for dosing a water-based liquid, the fibers are preferably of a material that is inherently hydrophobic or that becomes hydrophobic. More preferably, the filter member is a membrane formed by PTFE fibers, distributed under the tradename GORE-TEX by W. L. Gore Associates, Inc., of Newark, Delaware, USA. The ends facing forward in the halves 2 and 3 of the housing end in the plane indicated by the reference number 10 in Figure 5, where they define a circular opening 11. The halves 2 and 3 of the housing define between they a cavity whose rear portion 12 forms a receptacle for the liquid to be dosed. A component 20 is mounted within the cavity which serves to allow a metered dose of the liquid to be dosed. The main part of the component 20 is provided with an element 21 that is of unitary structure and is called "bridge" in the present. The bridge comprises an elongated channel member 22 which, in the embodiment illustrated, includes a cross section defining three sides of a rectangle, and the channel member is secured to the lower half 3 of the housing, with the open side of the housing. cross section oriented towards the middle 3 of the channel. As shown in Figure 4, the channel member 22 has a central rib 22a running parallel to its side walls 22b, and the lower half 3 of the housing has four ribs 3e parallel to each other. The side walls 22b are press fit into the slots defined by the pairs of adjacent ribs 3e (the connection can be made with ultrasonic welding, laser welding or an adhesive that is of an acceptable type in relation to the liquid that the device is intended for. contain). The central rib 22a is coupled between two of the ribs 3e, but so as to leave a space that provides an inlet channel 23. As can be seen in Figure 6, the upstream portion of the rib 22a is reduced in height preferably from Progressively towards the end located upstream. Therefore, the cross section of the channel 23 decreases progressively from its inlet end. This allows the channel 23 to have an inlet portion having a relatively large cross section, followed by a portion having a cross section small enough to exert a capillary effect on the liquid therein. The end located downstream of the channel 23 communicates with a pump chamber 30 by means of an inlet chamber 24, which has an inlet valve 25 mounted therein. The inlet valve 25 may be one of a variety of types , but in the illustrated embodiment is made of a flexible material, for example, a synthetic rubber, and comprises a flange 26, a substantially cylindrical body 27 and a pair of surfaces 28 that converge towards each other and that meet to make a Seal along the line 29. Further, it is referred to as the unidirectional valve 25. The valve 25 acts as a non-return valve which allows the liquid to flow from its flange end to its opposite end and to exit between the surfaces 28., but prevents the flow of fluid in the opposite direction. The outlet end of the inlet chamber 24 is communicated, as mentioned above, with a pump chamber 30, which is defined on its underside by a lower surface of pump chamber 40, and which is defined on its side top by the button 5. A member with an ascending dome 31 is located on its edges on the surface 40 and is arranged parallel to the button 5. The member 31, which in this embodiment has the shape of a square with cut corners (see Figures 7 and 8), allows the fluid to pass freely so that the upper limit of the chamber is defined by the button 5, not by the member 31. The member 31 may be configured to perform one of two distinct functions, but related to each other. In one configuration, the member 31 is immediately below the button, i.e. the spacing shown between the button and the member 31 is negligible. In this configuration, the member is designed to provide significant resistance to downward movement of the button which prevents movement of the button, until reaching a point whereby a threshold resistance to deformation is exceeded and button 5 and member 31 they deform suddenly to provide a rapid reduction in the volume of the chamber for the dose. The effect of this is to allow an important pressure to build up on the button that is then exerted on the fluid to force it out of the dispenser at a higher speed. A member of this type sandwiched below the button is convenient to provide an increased threshold force compared to that available only by means of the materials and the structure of the button. In the other configuration, there is a significant separation between the button 5 and the member 31, so that during the first part of the button travel (the part during which the required volume of liquid to provide a dose is ejected from the chamber), the member 31 does not interfere significantly in the deformation of the button and, therefore, does not offer resistance. However, a point is then reached during the travel of the button in which it comes into contact with the member (31) and the resistance for the travel of the button is increased. The user must overcome this resistance, which will provide a response signal that a full dose has been obtained. The pump chamber 30 communicates with an intermediate chamber 32 which, in turn, communicates with an outlet chamber 33. A volume reducing element 33a occupies a considerable proportion of the chamber 33 for a purpose described below. The outlet chamber 33 communicates with the upstream end of an outlet duct 34 defined by an outlet duct 35. The outlet duct is provided, between the ends thereof, with an outwardly extending flange 36, which preferably forms an integral part of the main portion of the outlet duct 35 and which, as can be seen in Figures 6 and 7, preferably has a diamond shape with rounded corners. The flange 36 enters a pair of spacings, one defined between the two ribs 37 extending downwardly from the upper half 2 of the housing and the other defined by a pair of ribs 38 extending upwardly from the lower half 3 of the housing, and is sealed therein, for example, with ultrasonic spot welding, to thereby form a sealing means which prevents the liquid from escaping beyond the outside of the outlet duct 35 and the ingress of air into the housing. opposite direction. The connection between the flange 36 and the ribs 37 and 38 forms part of the medium through which the bridge is fixedly connected to the halves 2 and 3 of the housing. The rest of the connection means is provided by joining the channel member 22 to the lower half 3 of the housing and an annular rib 39a which is raised around the pump chamber and which meshes between a pair of ribs directed downwards formed in the lower part of the inward portion 4 and surrounding the button 5. Mounted within the outlet duct 34, there is another volume reducing element 50. The elements 33a and 50 act together to reduce the volume of dead space between the pump chamber and the dispenser outlet. This conveniently reduces the necessary priming before the device expels a dose of liquid through the outlet, in case the volume mentioned above is without liquid before the first use. The subject of priming is discussed below with respect to the operation of the device. In this regard, it is necessary to keep in mind that a typical liquid medication dose is in the order of 50 pL, so even a relatively small volume of dead space inside the dispenser can represent a large amount of dose and, therefore, a lot of volumes of the pump chamber. This comprises a rod 51 at its end located upstream, and the rod has a plurality of ribs 52 extending radially outwards. In the illustrated embodiment four of these ribs are shown, but it should be understood that less, or more, of four can be provided. The downstream end portion of the shank 51 is surrounded by an upstream end portion of a cylindrical member 53, such that the gaps between the downstream ends of the ribs 52 communicate with the interior of the member 53. The duct 35 is provided with an enlarged portion 35a located downstream, within which the cylindrical member 53 has a sliding fit. The member 53 has an outwardly extending flange 54 that bears against the downstream end of the portion 35a to hold the member 50 in its correct longitudinal position. The portion 35a is provided with an outwardly extending flange 55, the purpose of which is described below. The downstream end of the dispenser comprises a cap 60. The cap comprises a generally cylindrical wall 61 and an end wall 62, and has an aperture 63, which narrows in a downstream direction, which is defined in the end wall 62 for provide a spray nozzle. The cylindrical wall 61 is provided, near its end located upstream, of an inwardly directed circumferential groove, which snaps onto the flange 55 to hold the lid in place. A unidirectional valve 65 is secured to the downstream end of the cylindrical member 53 by a flange 60a extending inwardly from the interior surface of the cap 60 so that its interior is in continuous communication with the interior of the member 53. As shown in Figure 5, the downstream end of the unidirectional valve 65 is very close to the outlet nozzle 63, and this is the operating state for the dispenser. The operation of the dispenser will now be described, and will begin with a state in which the receptacle 12 is at least partially filled with liquid, and the entire liquid circulation path from the receptacle to the downstream end of the unidirectional valve 65 It is completely full of liquid. This will be the status of the doser after the user has used it to dose a dose. It can be a status of the dispenser when initially supplied to the user. However, before its first use, the pump chamber may require priming with the fluid to be dosed to replace the air inside the pump without priming with the fluid absorbed from the receptacle. The preferred number of priming strokes is three or less than three. The user presses the button 5 when exerting a force on it in the direction of arrow X. This direction is 90 ° from the direction Y in which the fluid leaves the dispenser (the fluid supply axis). Specifically in the case of a device for dosing a nasal or oral spray, this is advantageous in terms of ease of use. When, in a modification of the illustrated device, it is not possible or not convenient that the X direction is 90 ° from the Y direction, preferably it should be at an angle with it of at least 60 °, more preferably, so minus 75 °. Since the liquid in the chamber 24 can not escape through the unidirectional valve 25, the action of pressing the button 5 causes the liquid to pass through the intermediate chamber 32 towards the conduit 34 through the separations between the ribs 52, through the interior of the cylindrical member 53, through the interior of the unidirectional valve 65 and out of the dispenser, like a spray, through the outlet orifice 63. The atomization may be an atomized spray or not, depending on the viscosity of the liquid and the size and shape of the exit orifice. When the user stops pressing the button 5, it returns to the illustrated position and, in doing so, causes the liquid to be drawn into the chamber 24 from the receptacle 12 by means of the conduit 23 and the unidirectional valve 25. The device it will then be available to dose the next dose when necessary. As shown in Figure 1, the dispenser is protected against accidental actuation by means of a cover 70. The cover has a main portion 71 extending about one third of the length of the dispenser, viewed from the outlet end , and further comprises an integral extension 72 that is present only on the side of the dispenser where the button 5 is located. Preferably, the cover is press fit on the parts that are below it in the dispenser. The cover 70 may be provided with stop means inside its upper end to rest on the upper end of the cover 6. In one form, the stop means comprise a sealing ring, preferably a flexible material, which is it rests on the surface of the cap around the outlet orifice 63. In another form, the stop means comprises a pad of flexible material that abuts the end surface of the cap, which includes the exit orifice itself. In both forms, the effect is to isolate the outlet orifice, and therefore the liquid upstream of that orifice, from the ambient air. The dispenser shown in Figures 1 to 8 is preferably assembled using ultrasonic or laser welding to join the peripheral edges of the two housing halves together. Ultrasonic welding is conveniently used for these purposes, since the same welding apparatus as used to connect the flange 36 to the ribs 37 can be used, as mentioned above. When the halves of the housing are connected with laser welding, one of the two halves of the housing must be made of a material that is practically absorbing laser radiation of a wavelength capable of welding the two halves together, and the other The halves of the housing must be made of a material that is practically transmitter of that radiation. It is convenient, although not essential, that half of the housing (in this example, the lower half of the housing) having the 3d slot is transmitter and half of the housing (in this case, the upper half of the housing) having the wall 2d be absorbent so that welding can be performed with the radiation directed to the edge of the housing along lines that are generally horizontal, as shown in the view of Figure 4. Many alternative embodiments can be devised which they also exemplify some or all aspects of the present invention, and some of these will be described below. Figure 9 shows a modification in which the unidirectional valve 65 is replaced by a hollow sealing member 165 made of a flexible material mounted on a tubular stem 153. The sealing member 165 has a tapered tip seal 170 formed on the end of the member 165 adjacent the outlet orifice 63. In the position shown in Figure 9, the pointed seal 170 engages with the hole 63 to form a seal. The tubular stem 153 has an inner diameter 171 which extends through the wall of the stem and is in communication with the conduit 34. When the user presses the button 5, the pressure in the conduit 34 increases and, therefore, in the inner diameter 171, which causes the part of member 165 adjacent to the inner diameter to bend outwards. The fluid may then escape by passing the bent portion of the member 165 to move along the gap defined between the member 165 and the cap 62 until it reaches the portion of the member 165 bearing the pointed seal 170. The fluid pressure can make then that part of the member 165 is deflected to the left (as seen in Figure 9), separating the pointed seal 170 from the outlet hole 63 to thereby allow the liquid to pass through the orifice. The tip seal 170 prevents liquid outflow and air ingress when no dosage is dosed and helps to avoid obstruction of the outlet orifice 63. The embodiment shown in Figures 10a to 13 differs mainly from those already described in FIG. that the pump unit is on the outside of the receptacle. Figures 10a and 10b schematically show two pump halves 201 and 202, each made with a unitary mold, and the halves are connected together, as shown in Figure 11, to form a pump unit complete The pump unit has an outlet hole at one end, which can be seen in part 203 of Figure 10a. Figure 12 shows a receptacle 210 made as a laminated container, with an outer layer 211 and an inner layer 212 which, during use, delaminates from the outer layer. The complete doser 220 is formed by joining the outlet 213 of the receptacle 210 to the inlet 204 of the pump unit 202, in continuous communication with these. The dispenser that is described with reference to Figures 1 to 8 has a housing formed by two halves, and both are, at least, semi-rigid. However, an alternative possibility is that the main surface on which the button is provided is made of a semi-rigid material, but the opposite main surface is made of a flexible material, for example, a sheet of plastic material, whose peripheral edges can joining the edges of the semi-rigid material corresponding to the edges 3c in Figure 4. This joining could be done, for example, by means of welding (eg, ultrasonic or laser welding), by the use of an adhesive, or in any other suitable way. Provided that the sheet of flexible material is attached to the semi-rigid component so that the flexible material does not remain taut but has sufficient capacity to bend towards the semi-rigid component and thus reduce the volume between the sheet of flexible material and the semi-rigid component, it is it can dose the air inlet that is provided in the embodiment of Figures 1 to 8 by means of components 6 to 9 and thus improve the sterility of the device and also increase the possibility of avoiding the need to use a preservative in the liquid to be dosed . In this structure, the bridge should only be attached to the semi-rigid half of the housing. In addition, instead of forming a dip tube using part of the bridge (channel member 22) and the lower half of the housing, a conventional dip tube should be provided. In another alternative embodiment, the need for an air intake could be avoided by employing, for the dispenser housing, a structure of the so-called laminated structures. Containers are known, albeit for completely different purposes, in which the container body has an inner layer and an outer layer, and in which a portion of the inner layer delaminates from the outer layer under certain circumstances. By way of example, reference is made to EP-A-0550772 (Yoshino Kogyosho Co., Ltd) for a description that shows how to form a container in which delamination is caused by the pressure difference caused by the discharge of the product. content of the container by the action of a pump. By using a container in which only part of the inner layer is delaminated from the outer layer, portions of the inner surface where delamination does not occur are available as sites for mounting an actuator button and corresponding structure, or at least it has a similar function, to the bridge used in the embodiments of Figures 1 to 8. However, no air intake is needed, since when the delamination occurs, the volume of the receptacle containing the liquid to be dosed it can be reduced, simply, by itself.

Claims (21)

1. CLAIMS: 1 . A dispenser for a treatment composition of the respiratory tract; the dispenser comprises: a) a receptacle containing a fluid, which is a treatment composition for the respiratory tract; and b) a pump in continuous communication with the receptacle; the pump comprises a dose chamber and a pump actuator; and c) an outlet hole in continuous communication with the receptacle and the pump so that the drive of the pump can effect the supply of fluid from the dispenser through the outlet orifice, characterized in that the receptacle comprises a laminated container that is adapted for delaminate when the fluid is dosed from there.
2. 2. A liquid dispenser comprising: a) a suitable receptacle for containing the liquid; the receptacle comprises a laminated container comprising an outer layer comprising a rigid material and at least one other layer inside it, which can be de-laminated from the outer layer; and b) a pump in continuous communication with the receptacle and with an outlet hole; the pump comprises an upper pump half comprising a flexible actuator connected to the upper half of the pump and a lower pump half, characterized in that the action of pressing the flexible actuator is effective to dose a dose of fluid by means of the pump , and characterized in that each of the upper and lower halves of the pump are made with a unitary mold.
3. A dispenser for liquids comprising a) a pump body including two main separated surfaces having peripheral edges interconnected to define between them a substantially closed receptacle for containing a liquid to be dosed therefrom, and most of that body is practically rigid, b) a pumping chamber having an inlet valve communicating with the receptacle, and an outlet valve communicating with an outlet orifice; the chamber is operated by a pumping button provided along one of its main surfaces, characterized in that the pumping button defines a part of one of the main surfaces and functions as a wall of the pumping chamber, and the action of pressing the pumping button to its displaced position is adapted to make the liquid contained in the pumping chamber expelled by means of the outlet valve, and the return of the button to its first normal position causes the liquid to enter the chamber pumping by means of the inlet valve; characterized in that the dispenser further comprises an air inlet opening in continuous communication with the receptacle that allows ambient air to enter the receptacle during the return of the button to its first normal position and, after dosing the fluid, the opening for The air inlet is occluded by a cover that is permeable to gas to allow gas to flow into the receptacle, but impermeable to the liquid contained within the receptacle.
4. 4. A dispenser according to claim 3, further characterized in that the gas permeable cover is impermeable to microorganisms that could otherwise enter the receptacle.
5. 5. A dispenser for liquids comprising a) a body including two main spaced surfaces having peripheral edges interconnected to enclose a closed receptacle capable of containing a liquid to be dosed therebetween, and most of that body is practically rigid; b) a pump operated with a pumping button provided along one of the main surfaces, characterized in that the pumping button is formed as a part of one of the main surfaces; characterized in that the dispenser also comprises a dosing nozzle in continuous communication with the pump and comprising an outlet orifice for dosing the fluid; the nozzle is provided with an expulsion channel and with a closure member fixedly disposed in the expulsion channel upstream of the outlet orifice; the closure member comprises a fixed portion fixed with respect to the outlet orifice and an elastically deformable portion supporting a closure member which, when in its rest position, closes the outlet orifice and which, when the elastically deformable portion is deforms, opens the exit hole.
6. A dispenser according to claim 5, further characterized in that the pump comprises a pumping chamber having an inlet valve and which is actuated by the pumping button, which is provided along one of the main surfaces, characterized in that the pumping button is formed as a part of one of the main surfaces and serves as the wall of the pumping chamber, and the action of pressing the pumping button to its displaced position causes the liquid contained in the pumping chamber expelled, and the return of the button to its first normal position causes the liquid to enter the pumping chamber by means of the inlet valve; The dosing nozzle is in continuous communication with the pumping chamber.
7. A dispenser formed in accordance with any of the preceding claims, further comprising a cover that engages the dispenser body to cover and protect, from the external environment, at least the exit orifice; the cover comprises a closing element which, when the cover is adjusted in the closed position, engages with the outlet or the surface surrounding the outlet orifice to form a seal.
8. 8. A pump for dosing a fluid from a receptacle; the pump comprises a pump chamber comprising a lower plate, inlet and outlet ports, an actuator that forms at least part of at least one of the walls of the pump chamber, and a deformable resistance device within the pump chamber sandwiched between the lower plate and the actuator so that the deformable resistance device does not significantly interfere with the initial deformation of the actuator during actuation, but that resists the final deformation of the actuator; the deformation of the deformable resistance device will not occur until a threshold force is overcome, which will provide a response signal to the user in order to determine a complete actuation.
9. 9. A dispenser for liquids comprising a receptacle containing the liquid substance to be dosed and an outlet orifice; the receptacle includes at least one wall or portion of actuator wall that can be deformed by applying a pressing force to reduce the internal volume and thereby exert pressure on the liquid substance to supply it through the outlet orifice; at least one of the actuator walls has a predetermined threshold of resistance to deformation which must be overcome in order to deform it; characterized in that the predetermined threshold of resistance to deformation of the actuator wall is generated by the threshold resistance means located immediately below the wall or actuator wall portion; the threshold resistance means exerts practically no pressure on the fluid contained within the receptacle once the predetermined threshold of resistance to deformation has been overcome.
10. A dispenser according to any of the preceding claims, further characterized in that the outlet defines a fluid supply shaft, and further characterized in that the pump is operated with a force that is applied directly to the dispenser at an angle of at least 60 ° with respect to the fluid supply axis. eleven .
11. A dispenser for liquids comprising: a body comprising an upper half comprising a main surface and a lower half comprising a main surface; most of the body is practically rigid; the two main surfaces are opposite each other and have peripheral edges that are interconnected to define between them a substantially closed receptacle to contain therein a liquid to be dosed; the peripheral edges of the two halves comprise connection means to allow the hermetic sealing of the fluid of the two halves, characterized in that the peripheral edges of the two halves define an opening for the exit of the fluid when they are interconnected; and a bridge piece defining at least part of a fluid inlet channel and interposed between the upper and lower halves; the bridge piece further comprises a fluid outlet channel body emerging from the liquid dispenser by means of the fluid outlet opening defined by the upper and lower halves; the fluid outlet channel body comprises a sealing means that engages the edges of the fluid outlet opening to produce a fluid tight seal.
12. 12. A liquid dispenser comprising: a) a body comprising an upper half comprising a main surface and a lower half comprising a main surface; most of the body is practically rigid; the two main surfaces are opposite each other and have peripheral edges that are interconnected to define between them a substantially closed receptacle to contain therein a liquid to be dosed; the peripheral edges of the two halves comprise connection means to allow the hermetic sealing of the fluid of the two halves, characterized in that the peripheral edges of the two halves define an opening for the exit of the fluid when they are interconnected, characterized in that one of the halves it is formed with a material that is practically absorbing the laser radiation of a wavelength capable of welding the two halves together, and the other half is practically transmitting that radiation; and b) a bridge piece comprising a pump means and defining at least part of a fluid metering channel which is located between the upper and lower halves; The bridge piece further defines a fluid outlet channel body emerging from the liquid dispenser by means of the fluid outlet opening defined by the upper and lower halves.
13. A dispenser for liquids comprising: a) an upper doser half comprising a main surface; most of the upper half of the dispenser is practically rigid; the peripheral edges of the upper half extend in a generally perpendicular direction from the plane of the main surface; the upper half further comprises a pumping button formed as part of the main surface and serving as a wall of a pumping chamber; b) a bridge piece comprising a lower pump chamber plate; the lower plate of the pump chamber comprises an inlet port and an outlet port in continuous communication with the pump chamber, characterized in that the lower plate of the pump chamber is coupled with the pumping button of the upper half of the dispenser for making a seal so as to form a sealed pumping chamber; c) an input valve in continuous communication with the input port; d) an outlet valve in continuous communication with the outlet port; and e) a lower half of the dispenser comprising a flexible material attached to the peripheral perpendicular edges of the rigid upper half of the dispenser to produce a seal and define a flexible receptacle wall and so that the return of the pumping button after dosing makes that the liquid is brought to the pumping chamber by means of the inlet valve and the inlet port and generate a reduced pressure in the receptacle that causes the deformation of the flexible lower half of the doser to adapt to the reduced volume therein.
14. A dispenser according to any of claims 3, 4, 5, 6 and 13, further characterized in that the button is completely integral with the main surface of which it is part.
15. 15. A dispenser according to any of claims 3, 4, 5, 6 and 13, further characterized in that the button is partially integral with the main surface of which it is part.
16. 16. A dispenser according to any of claims 3, 4, 5, 6 and 13, further characterized in that the button is not an integral part of the main surface of which it is part.
17. 17. A liquid dispenser according to any of the preceding claims, further characterized in that the receptacle contains a liquid in the form of a medicament.
18. 18. A dispenser according to claim 17, further characterized in that the medicament is a composition for the treatment of the human respiratory tract.
19. 19. A dispenser according to claim 18, further characterized in that the composition is adapted for nasal treatment.
20. 20. A dispenser according to any of claims 17 to 19, further characterized in that the liquid is free of preservatives.
21. 21. A bridge piece for a modular design pump and pump; the bridge piece has a unitary structure and comprises: a) an inlet channel wall defining at least part of an inlet fluid channel; b) a lower surface of the pump chamber defining at least one wall of the pump chamber; c) an inlet port that communicates the inlet fluid channel with the pump chamber; d) an output port in continuous communication with the pump chamber; and e) a fluid outlet channel body in continuous communication with the outlet port; the fluid outlet channel body defines a fluid outlet channel therein.