Improvements related to container filling and closure

Abstract

The present invention provides improved or commercially acceptable alternative containers and methods for filling and sealing them. [Solution] A method for filling and sealing a container body, comprising the steps of i) providing a container body that is open at a first end and open at a second end; ii) inserting a first stopper into the container body through the first end as desired; iii) positioning the first stopper inside the container body by displacing the first stopper towards the second end as desired; iv) filling the container body with fluid through the first end; and v) sealing the first end of the container body with a second stopper so that the fluid is held in the container body between the first and second stoppers, wherein the second stopper includes a flange portion that engages with at least a portion of the rim of the first end of the container body when the first end of the container body is sealed, thereby preventing the second stopper from subsequently moving inside the container body toward the second end of the container body.

Description

Technical Field

[0001] The disclosure of the present invention relates to a method of filling and plugging a container body, a container for a fluid, and the use of such a container in a dispensing device. The container may be intended for use, for example, in a nasal dispensing device.

Background Art

[0002] It is known to provide for a metered dose of a drug in a sealed container, such as a vial, to be dispensed from a dispensing device. One example is described in EP0827782A2, in which a piercing element is provided on a piston that pierces a sealing member within the vial. The sealing member is then displaced into the vial and the drug is pushed out of the vial through the pierced opening in the sealing member. The drug then passes through a channel formed within the piston and is discharged from the dispenser. Another example is described in EP3820625A2, which according to its summary, a device for dispensing a fluid product comprises a body, a reservoir containing one or two doses of the fluid product, said reservoir including a plug for closing the reservoir in a sealed manner prior to operation, a dispensing head provided with a dispensing orifice, and dispensing means for dispensing at least a portion of the fluid product through the dispensing orifice during operation, the device including a needle, the tip of which is adapted to pierce the plug during operation, the reservoir being filled with the fluid product and being crimped under vacuum by the plug such that the residual air volume present in the reservoir between the fluid product and the plug is substantially zero.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

[0004] While sealed containers for fluids such as pharmaceuticals are available, there remains a need to provide improved or at least commercially acceptable alternative containers and methods for filling and sealing them. [Means for solving the problem]

[0005] A first aspect of the disclosure of the present invention is, i) A step of providing a container body that is open at a first end and open at a second end, ii) The step of optionally inserting the first stopper into the container body through the first end, iii) The step of positioning the first stopper inside the container body by arbitrarily displacing the first stopper toward the second end, iv) The step of filling the container body with fluid through the first end, and v) The step of sealing the first end of the container body with the second stopper so that fluid is retained in the container body between the first stopper and the second stopper, Includes, The second stopper includes a flange portion that engages with at least a portion of the rim of the first end of the container body when sealing the first end of the container body during use, thereby preventing the second stopper from subsequently moving within the container body toward the second end of the container body. The present invention provides a method for filling a container and sealing it.

[0006] For example, the second stopper may include a plug portion that protrudes into the first end of the container body and a flange portion that extends over at least a portion of the rim of the first end of the container body when the second stopper is in its sealed position. During use, the maximum radial spread of the flange portion is greater than the maximum radial spread of the plug portion.

[0007] Beneficially, the container configuration results in an arrangement that allows the first stopper to slide within the container body until it contacts the second stopper during dispensing. In this way, the volume reduction within the container body can be precisely controlled, as the end-stop point is determined by the contact between the two stoppers. This allows for better control of the amount of volume lost from the container, both in terms of the absolute volume of residual fluid and the consistency of each container. For example, the contact surfaces of the stoppers can have a partially or fully complementary shape to reduce the loss gap formed when the stoppers are in contact with each other. This, in turn, can increase the predictability of the volume of fluid being dispensed.

[0008] In addition, contact between the needle and the bottom of the container body (which can be made of glass) can be prevented because the second stopper can function as an elastic receptor for the end of the needle, thereby preventing collision of the needle with the container body. This can reduce startup noise and vibration, which can lead to a better user experience and increase user confidence in the device. This also reduces the risk of container body breakage due to contact with the needle, especially when a large operating force is required to dispense the medicine.

[0009] In addition, the plug-to-plug contact at the end of the delivery stroke can function to provide a damped, gentle stop, which can also contribute to further reducing startup noise and vibration.

[0010] In addition, the second stopper can be contacted or struck by the pusher component of the dispensing device when the dispensing device is started, at the time the dispensing force is first applied to the container during use. Beneficially, the pusher component can be struck or struck by the second stopper, which can be formed of a relatively soft elastic material. This can also contribute to further reducing startup noise and vibration.

[0011] Beneficially, this method avoids the need to apply a vacuum during fluid filling and / or sealing of the container body.

[0012] In the embodiment, the first stopper is configured to be perforated during subsequent dispensing of fluid from the container body. In the embodiment, the second stopper is configured to remain stationary axially with respect to the container body during subsequent dispensing of fluid from the container body.

[0013] The first stopper may be configured as a sliding stopper that can move axially along the length of the container body.

[0014] In some embodiments, prior to step v), the container body and the fluid within the container body may be subjected to at least partial vacuum to remove gas from the headspace of the container body located between the free surface of the fluid and the first end of the container body. In such embodiments, step v) can be carried out under at least partial vacuum.

[0015] In some other embodiments, filling and stomp may be carried out at atmospheric pressure. In such embodiments, the step of sealing the first end of the container body with the second stopper in step v) may also act to displace the fluid and the first stopper toward the second end. In embodiments, in step iv), the fluid is filled into the container body until the fluid fills the container body to the level of the first end or substantially fills it. In some examples, the fluid may be filled into the container body to a level that allows the first sealing rib of the second stopper to engage with the container body before the second stopper comes into contact with the fluid.

[0016] A second aspect of the disclosure of the present invention is, Before assembly, the container body has an opening at the first end and an opening at the second end, A first stopper positioned inside the container body, A second stopper located at the first end, Includes, The first stopper and the second stopper define a chamber for holding fluid between them. The second stopper includes a flange portion that engages with at least a part of the rim of the first end of the container body during use to prevent movement of the second stopper within the container body toward the second end of the container body. Provide a container for a fluid.

[0017] The second stopper can include a plug portion that protrudes into the first end of the container body and a flange portion that extends across at least a part of the rim of the first end of the container body. In use, the maximum radial spread of the flange portion is greater than the maximum radial spread of the plug portion.

[0018] In an embodiment, the first stopper is configured to be pierced during subsequent dispensing of fluid from the container body. In an embodiment, the second stopper is configured to remain axially stationary relative to the container body during subsequent dispensing of fluid from the container body.

[0019] The first stopper can be configured as a slidable stopper that can move axially along the length of the container body.

[0020] In an embodiment, the container body can be filled with fluid and stoppered using the method of the first aspect as described above.

[0021] A third aspect of the disclosure of the present invention provides for the use of a container of the second aspect in a dispensing device, optionally a nasal spray device.

[0022] In an embodiment, during operation of the dispensing device, the first stopper is pierced by a hollow needle to provide an outlet for the fluid, and the container body and the second stopper are moved as a unit relative to the first stopper to pressurize and dispense the fluid. For example, in an embodiment, the second stopper is configured to remain axially stationary relative to the container body during dispensing of fluid from the container body.

[0023] A fourth aspect of the disclosure of the present invention is a) providing a container according to the second aspect; b) The step of drilling a first plug to provide an outlet for the fluid, c) The step of moving the container body and the second stopper as a unit relative to the first stopper so as to pressurize the fluid inside the container body and thereby dispense the fluid from the outlet for the fluid, The present invention provides a method for dispensing a fluid containing [a specific fluid].

[0024] In this embodiment, the second stopper remains stationary axially with respect to the container body while the fluid is being dispensed from the container body.

[0025] A fifth aspect of the disclosure of the present invention provides a dispensing device including a container according to the second aspect.

[0026] In some cases, the dispensing device may be a nasal dispensing device. In some cases, the fluid in the dispensing device's container may consist of a single dose of nasal medication.

[0027] The container body of the above embodiment can be formed from a wide range of suitable materials, such as glass or plastic polymers, as will be recognized by those skilled in the art. Examples of suitable glasses include type 1 borosilicate "Fiolax Clear" and type 2. Examples of suitable polymers include polypropylene, polyethylene, polystyrene, cyclic olefin copolymers, such as Topas® COC, available from TOPAS Advanced Polymers GmbH, Frankfurt-Hoechst, Germany, and liquid crystal polymers, such as Zenite® LCP, available from DuPont, Wilmington, USA.

[0028] The container body may consist of an elongated tube that can be cylindrical. The container body may include outwardly rotated flanges at either or both of its first and second ends. Alternatively, either or both rims may simply consist of the end faces of a tubular element without outwardly rotated flanges.

[0029] The first and / or second stoppers of the above embodiments may be formed from a wide range of suitable materials that would be recognized by those skilled in the art, such as elastomers or thermoplastic elastomers, e.g., EPDM, polychloroprene, hydrogenated nitrile, butyl, halobutyl, chlorobutyl, bromobutyl, dynamically crosslinked EPDM / PP (Santoprene®), Mediprene®, styrene-based block copolymers, or formulations thereof. Other suitable materials include high-density polyethylene, low-density polyethylene, and liquid silicone rubber (LSR).

[0030] The outer surface of either or both of the stoppers may be provided with one or more sealing features, such as ribs or rings, to enhance the sealing function of the stopper.

[0031] The first plug may have an H-shaped configuration that increases the contact pressure by directing the fluid pressure toward the radial seal, thereby reducing dynamic leakage.

[0032] The fluid confined within the container of the above embodiment may consist of a single-dose fluid or may contain multiple doses of fluid. The fluid may contain a pharmaceutical. As used herein, the term pharmaceutical is intended to encompass any pharmaceutical, compound, composition, drug, agent, or product that can be delivered or administered to a human or animal, such as pharmaceuticals, drugs, biologics, and medical preparations. Examples include anti-allergic agents, analgesics, bronchodilators, antihistamines, therapeutic proteins and peptides, cough suppressants, prophylactic agents for angina, antibiotics, anti-inflammatory agents, hormones, or sulfonamides such as vasoconstrictive amines, enzymes, alkaloids, or steroids, or combinations of two or more of these. In particular, examples include isoproterenol [alpha-(isopropylaminomethyl)protocatecyl alcohol], phenylephrine, phenylpropanolamine, glucagon, adrenochrome, trypsin, epinephrine, ephedrine, narcotin, codeine, atropine, heparin, morphine, dihydromorphinone, ergotamine, scopolamine, metapyrylene, cyanocobalamin, terbutaline, limiterol, salbutamol, ipratropium bromide and salbutamol, flunisolide, This includes colchicine, pirbuterol, beclomethasone, orciprenaline, fentanyl, and diamorphine, streptomycin, penicillin, procainepenicillin, tetracycline, chlorotetracycline, and hydroxytetracycline, adrenocorticotropic hormone and adrenocortical hormones, such as cortisone, hydrocortisone, hydrocortisone acetate, and prednisolone, insulin, cromolyn sodium, and mometasone, or combinations of two or more of these.Pharmaceuticals include, for example, acetate, benzenesulfonate, benzoate, bicarbonate, vitatalate, bromide, calcium edetate, cansylate, carbonate, chloride, citrate, dihydrochloride, edetate, edisylate, estrate, esylate, fumarate, fluceptate, gluconate, glutamate, glycolyl arsanilate, hexyl resorcinate, hydrobromide, hydrochloride, hydroxynaphthate, iodide, isethionate, lactate, lactobionate, malatinate. These can be used as common free bases or salts of one or more of these in the art, such as methyl bromide, maleate, mandelate, mesylate, methyl bromide, methyl nitrate, methyl sulfate, mucate, napsilate, nitrate, pamoate (embonate), pantothenate, phosphate, diphosphate, polygalacturonate, salicylate, stealate, basic acetate, succinate, sulfate, tannate, tartarate, and triethiozides, or combinations of two or more of these. Cationic salts known in the art to be pharmaceutically acceptable, such as alkali metal salts like Na and K, ammonium salts, and amines, such as glycine, ethylenediamine, choline, diethanolamine, triethanolamine, octadecylamine, diethylamine, triethylamine, 1-amino-2-propanol-amino-2-(hydroxymethyl)propane-1,3-diol, and salts of 1-(3,4-dihydroxyphenyl)-2-isopropylaminoethanol, may also be used. The pharmaceutical is typically suitable for nasal inhalation and can be provided in any fluid form suitable for that purpose, for example, as a solvent or supported liquid, such as a solution or powder suspension in ethanol or isopropyl alcohol. Alternatively, the pharmaceutical may be suitable for sublingual or ocular administration. The pharmaceutical may be suitable, for example, for the treatment of asthma.Examples include salbutamol, beclomethasone, salmeterol, fluticasone, formoterol, terbutaline, sodium cromoglycate, budesonide and flunisolide, and physiologically acceptable salts (e.g., salbutamol sulfate, salmeterol xinafoate, fluticasone propionate, beclomethasone dipropionate and terbutaline sulfate), solvating compounds and esters, and combinations of two or more of these. Individual isomers, such as R-salbutamol, may also be used. A pharmaceutical product may be suitable, for example, for the treatment of migraines. One example is sumatriptan. As will be seen below, a pharmaceutical product may contain one or more active ingredients, such as flutiform. One or more surfactants may be included if desired.

[0033] With reference to the attached drawings, one or more embodiments of the disclosure of the present invention will be described below simply as examples. [Brief explanation of the drawing]

[0034] [Figure 1] This is a schematic diagram of a container for containing a fluid. [Figure 2] This is a schematic diagram showing the first step of filling the container body and sealing it. [Figure 3] This is a schematic diagram showing the second step of filling the container body and sealing it. [Figure 4] This is a cross-sectional view of a dispensing apparatus including a container filled using the method shown in Figure 2 or Figure 3. [Modes for carrying out the invention]

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in the field to which the claimed subject matter pertains. It should be understood that the above summary of the disclosure of the invention and the following examples are merely illustrative and descriptive and do not limit any of the claimed subject matter.

[0036] The following description relates to embodiments of the disclosure of the present invention. The description of embodiments does not mean that all possible embodiments of the disclosure of the present invention claimed in the appended claims are included. Many modifications, improvements, and equivalents not expressly listed in the following embodiments may fall under the appended claims. Features described as part of one embodiment can be combined with features of one or more other embodiments unless the other is clearly required in relation to the present.

[0037] Figure 1 shows a container 1 that confines the fluid 23. The container 1 includes a container body 10 that is open at a first end 11 and a second end 12 before assembly.

[0038] A first stopper 21 is positioned at or near the second end 12 of the container body 10. A second stopper 22 is positioned at or near the first end 11 of the container body 10. The first stopper 21 and the second stopper 22 define a chamber 24 between them. The fluid 23 is held in the chamber 24 between the first stopper 21 and the second stopper 22.

[0039] The container body 10 forms the container 1 in a sealed state using the first stopper 21 and the second stopper 22. In this embodiment, the container 1 consists of only three components: the container body 10, the first stopper 21, and the second stopper 22.

[0040] The second stopper 22 includes a restraining element that, when inserted into the first end 11, engages with at least a portion of the rim 13 of the first end 11 of the container body 10, thereby preventing subsequent axial movement of the second stopper 22 toward its second end 12 within the container body 10 when the fluid 23 is dispensed. As shown in the figure, the restraining element includes a flange portion 32 that can engage with at least a portion of the rim 13 of the first end 11 of the container body 10 when in use. In the illustrated example, the second stopper 22 includes a plug portion 31 that axially projects into the first end 11 of the container body 10, and a flange portion 32 that extends radially from the plug portion 31 over at least a portion of the rim 13 of the first end 11 of the container body 10. The flange portion 32 can be annular and configured to extend over the annular portion of the rim 13. The angular spread of the flange portion 32 can be continuous so as to cover substantially all of the angular spread of the rim 13 when in use. Alternatively, the angular spread of the flange portion 32 can be discontinuous. For example, the flange portion 32 may include one or more radial projections. If the flange portion 32 includes two or more radial projections, the angles between adjacent projections can be the same. For example, if the flange portion 32 includes three radial projections, the angle between each adjacent projection can be 120 degrees. One or more ribs 33 may be provided on the plug portion 31. In some cases, two ribs 33 may be provided. The ribs 33 may be annular. The ribs 33 may function to enhance the sealing function of the second plug 22.

[0041] The first stopper 21 can be configured as a sliding stopper that can move axially along the length of the container body 10. The first stopper 21 may include a plug form without a flange portion of the type provided on the second stopper 22. One or more ribs 34 may be provided on the first stopper 21. Three ribs 34 may be provided. The ribs 34 may be annular. The ribs 34 may function to enhance the sealing function of the first stopper 21 and / or allow the first stopper 21 to function as a sliding seal.

[0042] In this embodiment, the container body 10 is filled with fluid 23 and can be sealed with the first stopper 21 and the second stopper 22 using one of the following methods.

[0043] Figure 2 schematically illustrates the first method of filling and sealing the container body 10. Figure 3 schematically illustrates the second method of filling and sealing the container body 10. Both methods, in principle, include the following steps.

[0044] In step i), the container body 10 is provided to be open at a first end 11 and at a second end 12.

[0045] In step ii), the first stopper 21 is inserted into the container body 10 through the first end 11. In an alternative embodiment, the first stopper 21 can be inserted into the container body 10 through the second end 12.

[0046] In step iii), the first stopper 21 is optionally positioned within the container body 10 toward the second end 12. In some embodiments, the first stopper 21 is positioned within the container body 10 by being inserted through the first end 11 and then displaced within the container body 10 toward the second end 12. In some other embodiments, the first stopper 21 is inserted into the container body 10 through the second end 12 and optionally positioned within the container body 10 by some subsequent axial displacement within the container body 10.

[0047] In step iv), the fluid 23 is filled into the container body 10 through the first end 11.

[0048] In step v), the first end 11 of the container body 10 is sealed with the second stopper 22 so that the fluid 23 is held between the first stopper 21 and the second stopper 22 within the container body 10.

[0049] The second stopper 22 includes a flange portion 32 that, during step v), engages with at least a portion of the rim 13 of the first end 11 of the container body 10 during use to prevent further axial movement of the second stopper 22 within the container body 10 toward the second end 12 of the container body 10. The flange portion 32 extends over at least a portion of the rim 13 when the second stopper 22 is in the sealed position, as shown in Figure 2(v). The contact of the flange portion 32 with the rim 13 limits the extent to which the second stopper 22 can be axially inserted into the container body 10 and acts as a stop to prevent further axial movement of the second stopper 22 toward its second end 12 within the container body 10 during dispensing of the fluid 23 from the container 1.

[0050] In the embodiment of the first method shown in Figure 2, in step iii), the first stopper 21 is displaced within the container body 12 to a point close to or at the second end 12, as shown in Figure 2(iii). For example, the first stopper 21 can be positioned flush with the second end 12 or optionally within 2.0 mm, 1.0 mm, or 0.5 mm of the second end 12.

[0051] In the embodiment of the first method shown in Figure 2, in step iv), the volume of fluid 23 to be filled into the container body 10 is limited such that, after the fluid filling is complete, there is headspace 35 above the free surface of the fluid 23 as shown in Figure 2(iv). In some examples, the fluid 23 can be filled into the container body 10 to a level that allows at least the first rib 33 of the second stopper 22 to engage with the container body 10 before the second stopper 22 comes into contact with the fluid 23 in step v).

[0052] In the first method shown in Figure 2, prior to step v), the container body 10 and the fluid 23 inside the container body 10 are subjected to at least partial vacuum to remove gas from the headspace 35 of the container body 10 located between the free surface of the fluid 23 inside the container body 10 and the first end 11 of the container body 10, as shown in Figure 2(iv).

[0053] Furthermore, in the embodiment, step v) is carried out under at least partial vacuum. In this way, the sealed container 1 is achieved by inserting the second stopper 22 and sealing it under at least partial vacuum. The same vacuum or partial vacuum of step iv) can be maintained throughout step v), for example, when the fluid filling step iv) and the stoppering step v) are carried out at the same station or within a common vacuum housing.

[0054] Alternatively, the vacuum or partial vacuum in step iv) may be released between steps iv) and v) if, for example, it is necessary to move the fluid-filled container body 10 from the fluid-filling station to a stoppering and sealing station located at a different location or in a different housing, and a new vacuum or partial vacuum may be drawn before step v).

[0055] In the embodiment of the second method shown in Figure 3, filling and stomp are carried out at atmospheric pressure. In particular, the requirement of creating a vacuum or partial vacuum can be completely eliminated. For this purpose, in the embodiment, in step iii), the first stopper 21 is positioned midway within the container body 10 as shown in Figure 3(iii). The first stopper 21 can be positioned by being displaced from either the first end 11 or the second end 12, depending on which end of the first stopper 21 is inserted into the container body 10.

[0056] Furthermore, in the embodiment of the second method, in step iv), the volume of fluid 23 filled into the container body 10 is sufficient such that, after the body filling is complete, there is no headspace above the free surface of the fluid 23 or there is very limited headspace, as shown in Figure 3(iv). For example, the fluid 23 can be filled to within 2.0 mm, 1.0 mm, or 0.5 mm of the first end 11, or up to the edge of the first end 11.

[0057] In the embodiment of the second method, step v) sealing the first end 11 of the container body 10 with the second stopper 22 also acts to displace the fluid 23 and the first stopper 21 toward the second end 12.

[0058] Container 1 can be used in various dispensing devices. For example, container 1 can be used in a manually activated disposable device. Figure 4 shows an example of a dispensing device 100 that can be used to dispense fluid 23 from container 1. Dispensing device 100 is of the type fully described in WO2015 / 008048A1, the contents of which are thus entirely incorporated by reference.

[0059] The dispensing device 100 includes a housing 101 formed by an upper housing and a lower housing joined together to hold the container 1 between them. A sliding button 102 having a lower end that can be manually pressed with a finger or thumb is mounted in the lower housing. A slide 110 engages with the flange portion 32 of the second stopper 22. The slide 110 is biased upward by a spring 111, but is initially restrained by a trigger mechanism that prevents the slide 110 from moving upward until the sliding button 102 is pressed inward (as described in WO2015 / 008048A1).

[0060] The upper housing comprises, for example, a nozzle 103 which can be configured as a nose component. Within the nozzle 103 is an outlet orifice 105 which is in fluid communication with a hollow needle 104 extending inward within a fixed plunger 106 mounted in the upper housing. The hollow needle 104 protrudes from the lower end of the fixed plunger 106. The lower end of the fixed plunger 106 can engage with a first plug 21. Initially, a gap can be provided between the first plug 21 and the fixed plunger 106 so that the first plug 21 is not perforated by the hollow needle 104 at this point. In addition to or instead of this, the shape of the first plug 21 and the length of the hollow needle 104 can be configured so that the first plug 21 is not perforated when it first engages with the fixed plunger 106. For example, as shown in Figure 4, the first plug 21 may have an H-shaped configuration, and the end of the hollow needle 106 can first be received into the upper gap of the first plug 21 without perforating the intersecting parts of the first plug 21.

[0061] In other words, container 1 is positioned stationary between the fixed plunger 106 and the slide 110. When the sliding button 102 is pressed inward, the restraint on the slide 110 is removed, and the slide 110 moves upward, pressing the second stopper 22, the fluid 23, the first stopper 21, and the container body 10 of container 1 upward toward the nozzle 103. This upward movement first closes any initial gaps between the first stopper 21 and the fixed plunger 106, and then punctures the first stopper 21 with the hollow needle 104. The continued upward movement of the second stopper 22, the container body 10, and the fluid 23 pressurizes the fluid 23, as any further upward movement of the first stopper 21 is restrained by contact with the fixed plunger 106. As a result, the pressurized fluid 23 at this point is released along the hollow needle 104 and out of the outlet orifice 105. During dispensing, the container body 10 and the second stopper 22 move as a unit relative to the first stopper 21. For example, the second stopper 22 remains stationary axially with respect to the container body 10 during the dispensing of the fluid 23 and does not slide within the container body 10 itself.

[0062] The dispensing device 100 is provided merely as an example, and it will be understood that the container 1 can be used in conjunction with other devices configured to dispense the fluid 23.

[0063] It should be understood that, for clarity purposes, at least portions of the drawings and descriptions of the disclosure of the present invention have been simplified to focus on elements relevant to a clear understanding of the disclosure of the present invention, while other elements that may also exist but would be recognized by those skilled in the art have been omitted. Since such elements are well known to those skilled in the art and do not necessarily facilitate a better understanding of the disclosure of the present invention, no description of such elements is provided herein. [Explanation of Symbols]

[0064] 10 Container body 11 First end 12 Second end 21 First stopper 22 Second stopper 23 Fluid

Claims

1. A method of filling the container body and sealing it, i) A step of providing a container body that is open at a first end and open at a second end, ii) The step of inserting the first stopper into the container body through the first end as desired, iii) The step of positioning the first stopper inside the container body by arbitrarily displacing the first stopper toward the second end, iv) The step of filling the container body with fluid through the first end, and v) The step of sealing the first end of the container body with the second stopper so that the fluid is held in the container body between the first stopper and the second stopper, Includes, The second stopper includes a flange portion that engages with at least a portion of the rim of the first end of the container body when sealing the first end of the container body during use, thereby preventing the second stopper from subsequently moving within the container body toward the second end of the container body. method.

2. The method according to claim 1, wherein the first stopper is configured to be perforated during subsequent dispensing of the fluid from the container body, and / or the second stopper is configured to remain stationary axially with respect to the container body during subsequent dispensing of the fluid from the container body.

3. The method according to claim 1 or 2, wherein the second stopper includes a plug portion that protrudes into the first end of the container body and a flange portion that extends over at least a portion of the rim of the first end of the container body when the second stopper is in its sealed position.

4. The method according to any one of claims 1 to 3, wherein the first stopper is configured as a slidable stopper that can move axially along the length of the container body.

5. The method according to any one of claims 1 to 4, wherein, prior to step v), the container body and the fluid inside the container body are subjected to at least partial vacuum to remove gas from the headspace of the container body located between the free surface of the fluid and the first end of the container body.

6. The method according to claim 5, wherein step v) is carried out at least under the partial vacuum.

7. The method according to any one of claims 1 to 4, wherein the filling step and the plugging step are carried out at atmospheric pressure.

8. The method according to claim 7, wherein step v) sealing the first end of the container body with the second stopper also acts to displace the fluid and the first stopper toward the second end.

9. The method according to claim 7 or 8, wherein in step iv), the fluid is filled into the container body until the fluid fills the container body to the level of the first end or substantially fills it.

10. A container for fluids, A container body that has an opening at the first end and an opening at the second end before assembly, A first stopper positioned inside the container body, A second plug positioned at the first end, Includes, The first stopper and the second stopper define a chamber for holding fluid between them. The second stopper includes a flange portion that engages with at least a portion of the rim at the first end of the container body during use to prevent the second stopper from moving within the container body toward the second end of the container body. container.

11. The container according to claim 10, wherein the second stopper includes a plug portion that protrudes into the first end of the container body and a flange portion that extends over at least a portion of the rim of the first end of the container body.

12. The container according to claim 10 or 11, wherein the first stopper is configured as a slidable stopper that can move axially along the length of the container body.

13. A container according to any one of claims 10 to 12, which is filled with a fluid and sealed using the method described in any one of claims 1 to 9.

14. Use of the container according to any one of claims 10 to 13 in a dispensing device, or optionally in a nasal spray device.

15. The use according to claim 14, wherein, during operation of the dispensing device, the first stopper is perforated by a hollow needle to provide an outlet for the fluid, and the container body and the second stopper are moved as a unit relative to the first stopper to pressurize and dispense the fluid.

16. A method for dispensing fluid, a) The step of providing the container according to any one of claims 10 to 13, b) The step of perforating the first plug to provide an outlet for the fluid, c) A step of moving the container body and the second stopper as a unit relative to the first stopper so as to pressurize the fluid inside the container body and thereby dispense the fluid from the outlet for the fluid, A method that includes this.

17. The method according to claim 16, wherein the second stopper remains stationary in the axial direction relative to the container body while the fluid is being dispensed from the container body.

18. A container according to any one of claims 10 to 13, A dispensing device that includes a dispensing device.

19. The dispensing device is a nasal dispensing device. Optionally, the fluid consists of a single dose of a nasal drug. The dispensing apparatus according to claim 18.

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