Medicament container with multiple chambers

Abstract

Provided herein are medicament containers having multiple chambers and a hydrophobic porous filter in between. Also provided herein are methods of using a hydrophobic porous filter to separate different ingredients during storage and allow the mixing of different ingredients when needed. In some aspects, the medicament container is a dual chamber container.

Description

[0001] Attorney Docket No. 037370-1544187

[0002] MEDICAMENT CONTAINER WITH MULTIPLE CHAMBERS

[0003] This application claims the benefit of U.S. Provisional Application Serial No.

[0004] 63 / 789,515, filed April 16. 2025 titled “Medicament Container With Dual-Chamber and a Hydrophobic Porous Wall in Between,” the entire contents of which are hereby incorporated by reference.

[0005] TECHNICAL FIELD

[0006] According to certain aspects of this disclosure, a medicament container with multicomponent chambers includes a porous body located in an internal volume of the container. The porous body finds particular use in an adjustable activation force requirement to dispense single or multiple components. In specific examples, the shape of the porous body remains the same during fluid flow. The present disclosure generally is related to a multi-component medicament containers for administering two or more components, or for administering and flushing catheter and other vascular accessing devices, or for mixing and administering components.

[0007] BACKGROUND

[0008] Dual chamber medicament containers have become increasingly prevalent due to their ability to store and deliver two different medicaments or components separately until the moment of administration. This configuration is especially advantageous for formulations that are unstable or require mixing immediately prior to use, such as lyophilized drugs and diluents or certain biologic therapies. The frequency of use of dual chamber containers has grow n substantially, as they facilitate point-of-care preparation, reduce the risk of dosage errors, and support efficient workflow in busy healthcare settings. Additionally, such containers are often designed to maintain sterility of the chambers’ contents until the time of use, thereby minimizing the risk of contamination that can occur during manual mixing or transfer processes.

[0009] Dual chamber medicament containers are known in the art. Typically, the container housing of these containers are specifically designed and allow a separation wall to stop at a specific location, at that location the container having a liquid by-pass channel that allows a liquid to flow from one chamber to another chamber and mix the material in both chambers before injection to the targeted body. Production of conventional dual chamber medicamentcontainers requires elevated manufacturing time and cost due to the complexity of their design and the need for precise assembly and sterilization processes. Furthermore, conventional designs may be prone to operational errors or sterility breaches during mixing, and the necessity' for specially engineered housings further increases production costs and limits manufacturing flexibility'. Therefore, there is a need to simplify medicament containers having the ability to store and / or administer / mix two or more medicaments to patients in need thereof in clinical settings, while ensuring reliable sterilization, ease of use, and cost-effective manufacturing.

[0010] SUMMARY

[0011] Provided herein are multi-component containers. In a first example the multicomponent container includes: (a) a container body comprising an internal volume; (b) a porous barrier located in the internal volume; (c) a movable non-porous barrier located in the internal volume, the movable non-porous barrier movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contacts the porous barrier; (d) when the movable non-porous barrier is in the first position, the multi-component container comprising a first liquid component and a second component separated by the porous barrier, the first liquid component located between the movable non-porous barrier and the porous barrier; (e) when the movable non-porous barrier is in the first position, the porous barrier resists the first liquid component from flowing through a porous body of the porous barrier, wherein the porous body is hydrophobic and comprises at least one of a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media; (f) wherein, when the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous body of the porous barrier into contact with the second component. In some aspects, the porous body has a minimum water entry pressure that is greater than 1 psi. In further aspects, the porous body has a minimum water entry pressure that is greater than 5 psi. In some aspects, the porous body comprises at least one of a sintered porous plastic media or a sintered porous elastomeric media that has an average pore size less than 50 microns and an average porosity less than 60%. In some aspects, the porous body comprises a porous fiber media that has a density' in the range of 0.1 g / cm3to 5 g / cm3. In some aspects, the porous body is surrounded by a seal that seals against the container body in the internal volume. In some aspects, the first liquid component is a solvent, and the second component is a solute dissolvable in the solvent. In some aspects, the second component is a solid phasematerial suspend-able in the first liquid component. In some aspects, the second component is a second liquid component mixable with the first liquid component. In some aspects, the porous barrier is fixed in position in the container body. In some aspects, the porous barrier is movable in the container body. In further aspects, the container body comprises an outlet, and wherein movement of the non-porous barrier towards the outlet moves the porous barrier towards the outlet. In some aspects, the porous body further comprises a phase inversion porous membrane. In some aspects, the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier. In some aspects, the multicomponent container further comprises a third component. In further aspects, the third component may act as a flushing liquid prior to the administration of the second component and / or after the administration of the first liquid component.

[0012] Methods of using multi-component containers are also provided herein. In one example the method may include: (a) moving the non-porous barrier towards the porous barrier; (b) when moving the non-porous barrier towards the porous barrier causes the first liquid component to flow through the porous barrier into contact with the second component; (c) wherein when the non-porous barrier is at the first position and before moving the non-porous barrier towards the porous barrier, the porous barrier resists the first liquid component from flowing through the porous body of the porous barrier.

[0013] Further multi-component containers are provided herein. The multi-component containers may comprise: (a) a container body comprising an internal volume; (b) a porous barrier located in the internal volume; (c) a movable non-porous barrier located in the internal volume, the movable non-porous barrier movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contact the porous barrier; (d) when the movable non-porous barrier is in the first position, the multi-component container comprising a first liquid component and a second component separated by the porous barrier, the first liquid component located between the movable non-porous barrier and the porous barrier; (e) when the movable non-porous barrier is in the first position, the porous barrier resists the first liquid component from flowing through a porous body of the porous barrier, w herein the porous body is a porous membrane fixed on a support component; (I) wherein, when the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous bodyof the porous barrier into contact with the second component. In some aspects, the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier. In some aspects, the porous body is hydrophobic. In some aspects, the porous body comprises a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media. In some aspects, the multi-component container further comprises a third component. In further aspects, the third component acts as a flushing liquid prior to the administration of the second liquid component and / or after the administration of the first liquid component.

[0014] BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 shows schematically a conventional design of a dual chamber container which is disclosed in the U.S. Pat No. 11,439.755 B2.

[0016] Figure 2 shows schematically an additional type of conventional design of a dual chamber container according to U.S. Pat No. 10,940,037 B2.

[0017] Figure 3 is a cross-sectional view of a dual chamber medicament delivery' device with a porous wall dividing a first and second chamber in accordance with the present disclosure.

[0018] Figure 4 shows schematically a sintered porous plastic filter secured in a pipette tip of a medicament container in accordance with the present disclosure.

[0019] Figure 5A shows schematically an interior structure component in accordance with the present disclosure. Figure 5B is a cross-sectional view of an interior structure within an interior cavity of a medicament delivery device in accordance with the present disclosure.

[0020] Figure 5C is a cross-sectional view of an interior structure as described in FIG. 5A within an interior cavity' of a medicament delivery device in accordance with the present disclosure.

[0021] Figures 6A-C are illustrative, sequential steps, respectively showing a storage state (FIG. 6A), and dispensing of a first fluid in a first chamber, such as a drug, followed by dispensing a second fluid from a secondary chamber in accordance with the present disclosure.DETAILED DESCRIPTION

[0022] While various some aspects and aspects of the present disclosure are shown and described herein, such some aspects and aspects are provided by way of example only.

[0023] Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the some aspects described herein may be employed.

[0024] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in the application including, without limitation, patents, patent applications, articles, books, manuals, and treatises are hereby expressly incorporated by reference in their entirety for any purpose.

[0025] Introduction

[0026] Typical non-porous separation wall designs make the overall container complicated and increase the cost. Dual chamber designs with bypasses typically must be implemented in glass barrels and can require costly, and complicated, processes. The bypass cannot easily be molded as a plastic container since it is an undercut and may require secondary' steps, such as described in EP1972355A1 and DE102018108549B4.

[0027] The dual chamber designs provided herein can be implemented in glass, plastic, or other material containers. At least in some implementations, the designs provided herein do not require physical bypass creation within a container body. The examples of the inventive dual chamber designs with a porous separation wall provides an effective solution for multicomponent medicament containers.

[0028] A multi-component container

[0029] In an example a multi-component container includes a container body having an internal volume; a porous barrier located in the internal volume; and a movable non-porous barrier located in the internal volume. In some aspects, the movable non-porous barrier is movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contacts the porous barrier. In this example, when the movable non-porous barrier is in the first position, the multi-component container has a first liquid component and a second component separated by the porous barrier, the first liquid component located between the movable non-porous barrier and the porous barrier. In this example, when the movable non-porous barrier is in the first position, the porous barrierresists the first liquid component from flowing through a porous body of the porous barrier, wherein the porous body is hydrophobic and comprises at least one of a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media. In further aspects, when the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous body of the porous barrier into contact with the second component.

[0030] In some aspects, the porous separation wall may be formed of or contain any hydrophobic porous media. They include, but are not limited to, the following: Sintered porous plastic, sintered porous elastomeric media, or combinations thereof. Sintered porous plastic or sintered porous elastomeric media have self support properties and could be used alone as an insertion into the container. The sintered porous plastic or elastomeric media have an average porous size less than 50 microns, less than 40 microns, less than 30 microns, less than 20 microns or less than 10 microns. The sintered porous plastic or elastomeric media have an average porous volume less than 60 %, less than 50% less than 40% or less than 30%. The pore size and porous volume were measured by mercury intrusion method.

[0031] In some aspects, the porous body has a minimum water entry pressure that is greater than 1 psi, e.g., greater than 1.5 psi, greater than 2 psi, greater than 2.5 psi, greater than 3 psi, greater than 3.5 psi, greater than 4 psi, or greater than 4.5 psi. In further aspects, the porous body has a minimum water entry pressure that is greater than 5 psi, e.g., greater than 5.5 psi, greater than 6 psi, greater than 6.5 psi. greater than 7 psi, greater than 7.5 psi, greater than 8 psi, greater than 8.5 psi, greater than 9 psi, or greater than 9.5 psi. In some aspects, the porous body includes or is formed of at least one of a sintered porous plastic media or a sintered porous elastomeric media that has an average pore size less than 50 microns (e g., less than 40 microns, less than 30 microns, less than 20 microns, or less than 10 microns) and an average porosity less than 60% (e.g., less than 50%, less than 40%, less than 30%, less than 20%, or less than 10%). In some aspects, the porous body includes or is formed of a porous fiber media that has a density' in the range of 0.1 g / cm3to 5 g / cm3, e.g., from 0.2 g / cm3to 5 g / cm3, from 0.3 g / cm3to 5 g / cm3, from 0.4 g / cm3to 5 g / cm3, from 0.5 g / cm3to 5 g / cm3, from 1 g / cm3to 5 g / cm3, from 1.5 g / cm3to 5 g / cm3, from 2 g / cm3to 5 g / cm3, from 2.5 g / cm3to 5 g / cm3, from 3 g / cm3to 5 g / cm3, from 3.5 g / cm3to 5 g / cm3, from 4 g / cm3to 5 g / cm3, from 4.5 g / cm3to 5 g / cm3, from 0.1 g / cm3to 4.5 g / cm3, from 0.1 g / cm3to 4 g / cm3, from 0.1 g / cm3to 3.5 g / cm3, from 0.1 g / cm3to 3 g / cm3, from 0.1 g / cm3to 2.5 g / cm3, from 0.1 g / cm3to 2 g / cm3, from 0.1 g / cm3to 1.5 g / cm3. from 0.1 g / cm3to 1 g / cm3. or from 0.1 g / cm3to 0.5 g / cm3.Plastics suitable for use in sintered polymeric materials in at least some implementations may include polyolefins, polyamides, polyesters, rigid polyurethanes, polyacrylonitriles, polycarbonates, polyvinylchloride, polymethylmethacrylate, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfones, polystyrenes, polyether imides, polyetheretherketones, polysulfones, and combinations and copolymers thereof.

[0032] In some aspects, a polyolefin is polyethylene, polypropylene, and / or copolymers thereof. Polyethylene, in one aspect, is high density polyethylene (HDPE). High density polyethylene, as used herein, refers to polyethylene having a density ranging from about 0.92 g / cm3to about 0.97 g / cm3. In some aspects, high density polyethylene has a degree of cry stal I i ni (% from density) ranging from about 50 to about 90. In another aspect, polyethylene comprises ultrahigh molecular weight polyethylene (UHMWPE). Ultrahigh molecular weight polyethylene, as used herein, refers to polyethylene having a molecular weight greater than 1,000,000.

[0033] Elastomers suitable for use in sintered polymeric materials of the present invention, according to some aspects, comprise thermoplastic elastomers (TPE). Thermoplastic elastomers, in some aspects, comprise polyurethanes and thermoplastic polyurethanes (TPU). Thermoplastic polyurethanes, in some aspects, include multiblock copolymers comprising a polyurethane and a polyester or polyether.

[0034] In other aspects, elastomers suitable for use in sintered porous polymeric materials of the present disclosure comprise poly isobutylene, poly butenes, but l rubber, or combinations thereof. In another aspect, elastomers comprise copolymers of ethylene and other polymers such as polyethylene-propylene copolymer, referred to as EPM, ethylenebutene copolymer, polyethylene-octene copolymer, and polyehtylene-hexene copolymer. In a further aspect, elastomers comprise chlorinated polyethylene or chloro-sulfonated polyethylene.

[0035] In some aspects, elastomers suitable for use in sintered polymeric materials of the present invention comprise 1,3-dienes and derivatives thereof. 1,3-dienes include st rene-1,3-butadiene (SBR), styrene- 1,3-butadiene terpolymer with an unsaturated carboxylic acid (carboxylated SBR), acrylonitrile-l,3-butadiene (NBR or nitrile rubber), isobutyleneisoprene, cis-l,4-polyisoprene, 1,4-poly (1,3-butadiene), poly chloroprene, and block copolymers of isoprene or 1,3-butadiene with styrene such as styrene-ethylene-butadiene-styrene (SEBS). In other aspects, elastomers comprise polyalkene oxide polymers, acrylics, or polysiloxanes (silicones) or combinations thereof.In a further aspect, elastomers suitable for use in sintered polymeric materials of the present invention, in some aspects, comprise FORPRENE®, LAPRENE®, SKYPEL®, SKYTHANE®, SYNPRENE®, RIMFLEX®, Elexar, FLEXALLOY®, TEKRON®, DEXFLEX®, Typlax, Uceflex, ENGAGE®, HERCUPRENE®, Hi-fax, Novalene, Kraton, Muti-Flex, EVOPRENE®, HYTREL®, NORDEL®, VITON®, Vector, SILASTIC®, Santoprene, Elasmax, Affinity, ATTANE®. SARLINK®, etc.

[0036] Sintered porous media may include one or both plastic and elastomeric materials. Porous fiber media could be used as a porous separation wall in accordance with the present disclosure. In at least some implementations the fiber media may be a fiber plug manufactured by POREX corporation with bicomponent fibers. In one aspects, the fiber used to make a porous separation wall may be a bicomponent fiber. These bicomponent fibers include, but are not limited to, polyethylene / polypropylene (PE / PP),

[0037] polyethylene / poly ethylene terephthalate (PE / PET), polypropylene / poly ethylene terephthalate (PP / PET), poly ethylene terephthalate polypropylene / (PET / PP), co-polyethylene terephthalate / poly ethylene terephthalate (co-PET / PET). polyethylene terephthalate / Nylon (PET / Nylon), Nylon / polyethylene terephthalate (Nylon / PET), ethylene vinyl alcohol / poly ethylene terephthalate (EVOH / PET), Nylon / Nylon, EVOH / Nylon, and PET / polybutylenc terephthalate (PET / PBT). Bicomponent fibers may have different cross-sectional structures, such as core / sheath. side-by-side, tipped, islands in the sea, and segmented pie. The bicomponent fibers can also have different shapes, such as round, triloba!, and cross shaped structures. The fiber plug as a porous separation wall could have density may range from a value of about 0.2 g / cm3to about 0.7 g / cm3, from about 0.3 g / cm3to about 0.6 g / cm3.

[0038] In still other implementations a porous membrane could be used as a porous separation wall. When a membrane is used, the membrane in at least some implementations may need to be attached to a supporting component. The supporting component could be s polymer tube and membrane is welded to an end of polymeric tube. Polymeric tube provides the seal between the wall and container housing and membrane provide the communication channel between the dual chamber.

[0039] The membrane could be a polymeric membrane. Porous membranes include, but not be limited to, PVDF, Nylon, Polysulfone, poly ethersulfone (PES), or polyacrylonitrile membrane. In one aspect, the membrane can have an average pore size from 0.1 micron to 10 micron. In one aspect, a porous membrane is a phase-inversion porous membrane. In another aspect, polymeric membrane could be track etched membrane (TEM), such as track etchedmembraned manufactured by OXYPHEN. The TEM, include PET, polycarbonate or PEN based membrane.

[0040] In some aspects, the porous body is surrounded by a seal that seals against the container body in the internal volume. In some aspects, the first liquid component is a solvent, and the second component is a solute dissolvable in the solvent. In some aspects, the second component is a solid phase material suspend-able in the first liquid component. In some aspects, the second component is a second liquid component mixable with the first liquid component. In some aspects, the porous barrier is fixed in position in the container body.

[0041] In some aspects, the container body has an outlet, and movement of the non-porous barrier towards the outlet moves the porous barrier towards the outlet. In some aspects, the porous body further includes a phase inversion porous membrane. In some aspects, the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier. In some aspects, the multi-component container further comprises a second or third component. In some aspects, the second or third component acts as a flushing liquid prior to the administration of the first or second component and / or after the administration of the first liquid component.

[0042] Methods of Using

[0043] A method of using a multi-component container described herein is provided. In some aspects, the method comprises moving the non-porous barrier towards the porous barrier; wherein moving the non-porous barrier towards the porous barrier causes the first liquid component to flow through the porous barrier into contact with the second component; wherein when the non-porous barrier is at the first position and before moving the non-porous barrier toward the porous barrier, the porous barrier resists the first liquid component from flowing through the porous body of the porous barrier.

[0044] In some aspects, the multi-component container as described herein may be used in prefill syringes, as well as mechanical pen injectors. In implementations, in production, axial placement of the porous and non-porous barriers is done by automated assembly steps for mass production, which include mechanical stops as well as vacuum to remove air pockets. Insome aspects, the dual chamber with porous separation wall may be used on cartridges as well as prefilled syringes.

[0045] A multi-component container

[0046] A multi-component container with a container body forming an internal volume; a porous barrier located in the internal volume; and a movable non-porous barrier located in the internal volume is provided. In some aspects, the movable non-porous barrier movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contacts the porous barrier. In some aspects, the movable non-porous barrier is in the first position, the multi-component container contains a first liquid component and a second component separated by the porous barrier, and the first liquid component is located between the movable non-porous barrier and the porous barrier. In some aspects, the movable non-porous barrier is in the first position, the porous barrier resists the first liquid component from flowing through a porous body of the porous barrier, wherein the porous body is a porous membrane fixed on a support component. In some aspects, the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous body of the porous barrier into contact with the second component.

[0047] In some aspects, the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier. In some aspects, porous body is hydrophobic. In some aspects, the porous body comprises a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media. In some aspects, the multicomponent container further comprises a third component. In some aspects, the third component acts as a flushing liquid prior to the administration of the second component and / or after the administration of the first liquid component.

[0048] EXAMPLES FIG. 1 and FIG. 2 show conventional dual chamber containers as known in the prior art. FIG. 1 illustrates a conventional dual chamber container 100 with a septum-fluid seal 102 defining a distal end of a container housing. The interior of the container defines a first chamber 104 that holds an active ingredient and a second chamber 110 that holds a diluent.Each chamber 104, 106, is defined by a first rubber-stopper fluid seal 108 and / or a second rubber-stopper fluid seal 112. The second rubber-stopper fluid seal 112 defines a proximate end of the container housing. When a force is applied to the proximate end of the container housing, the first rubber-stopper fluid seal 108 and the second rubber-stopper fluid seal 112 move from a first position to a second position along a longitudinal axis of the conventional dual chamber container 100 towards the distal end of the container housing. At a certain point, the first rubber-stopper fluid seal 108 enters a bypass region of the second chamber 106 of the container housing. Once this position has been reached, the contents of the second chamber 110 interact and / or mix with the contents of the first chamber 104.

[0049] A problem with this conventional dual chamber container is that non-porous (e g., rubber) separation wall designs make the overall container complicated and increase the cost. Typical dual chamber designs with bypasses typically must be implemented in glass barrels. This process can be costly and complicated. The bypass cannot easily be molded as a plastic container since it is an undercut and may require secondary steps, such as described in EP1972355A1 and DE102018108549B4.

[0050] FIG. 2 shows an alternative type of conventional dual chamber container 200 with a septum-fluid seal 202 defining a distal end of a container housing 202 and a proximate end 204 opposite the distal end of the container housing. Within an interior of the container housing a first active substance and / or auxiliary agent 206 is disposed within a first chamber 214, in particular a lyophilized or pulverized active substance and / or auxiliary agent. A second chamber 21 houses a second active substance and / or auxiliary agent 212, in particular a liquid solvent. The first chamber 214 and the second chamber 216 are partitioned by elastomer plugs 210. When a force is applied to the proximate end of the container housing, the elastomer plugs 210 move from a first position to a second position. As the elastomer plugs 210 move toward the distal end of a container housing 202, the second active substance and / or auxiliary agent 212 enters a bypass region 208 of the container housing and assumes the volume of the first chamber 214. Thus, the first active substance and / or auxiliary agent 206 disposed within the first chamber 214 mixes with the second active substance and / or auxiliary agent 212. Such a conventional dual chamber container has the disadvantages as laid forth above in FIG. 1 and further in incorporation of a lyophilized or pulverized active substance and / or auxiliary agent. Especially in reconstitutions there is a problem that the diluent may not dissolve the solute completely. For example, the rate at which the contents of the second chamber 216 interact with the contents of the first chamber214 is not able to be controlled within a bypass chamber design. Table 1. Below further outlines the advantages of the present disclosure against conventional designs within the art.

[0051] Table 1.

[0052] Porous Multi-component Container Activation Force Over Ipsi and over 5psi

[0053] Activation Force Adjustment Adjustable

[0054] Break Loose Force Less than 5 lbs

[0055] Number of Break Loose Force 1 rubber stopper

[0056] Sensitivity to non-uniform lubrication low

[0057] Flow strength during flush low

[0058]

[0059] FIG. 3 is a perspective view of a medicament container 300, in this case a dual chamber carpule, in a longitudinal section. The medicament container 300 comprises a distal end 312 and a proximate end 314 of a container housing, which encloses an interior, substantially in the form of a cylinder. An end fluid seal 310 is arranged in the interior of the container housing such that the end fluid seal 310 is displaceable within the interior along a longitudinal axis. The interior of the container housing is divided herein into a first chamber 304 and a second chamber 308 by means of a porous wall 306.

[0060] In one aspect, the distal opening 312 is closed by a fluid seal 302 so that the first chamber 304 forms a closed space, which is delimited by the container housing, the porous wall 306 and the fluid seal 302. A first component is disposed within the first chamber 304. The first component may be an active ingredient and includes, but is not limited to, a liquid, a lyophilizate, a gas, or a pulverized substance. In one aspect the first chamber may be a flushing solution (e.g., saline or heparin). The second chamber 308 forms a closed space, which is delimited by the container housing, the porous wall 306 and the end fluid seal 310. A second component is disposed within the second chamber 308. The second component may be a diluent and includes, but is not limited to, a liquid, a gas. or other suitable diluents. In one aspect, the second chamber may be an active ingredient and includes, but is not limited to, a liquid, a lyophilizate, a gas, or a pulverized substance.

[0061] In an exemplary' aspect, the first chamber 304 comprises a solvent and an air bubble. The first chamber forms a closed space, which is delimited by the porous wall 306, the container housing and the fluid seal 302. After the fluid seal 302 has been opened, it is, bymeans of an application device, which is not shown here, possible to displace the end fluid seal 310 and. at the same time, the porous wall 306 in the direction of the fluid seal 302. In some aspects, the porous wall 306 is fixed in a position within the container housing. In further aspects, the porous wall 306 in a fixed position comprises a fixing structure though it may not be required in other aspects as described herein.

[0062] FIG. 4 provides an exemplary schematic illustration of which a porous wall, barrier, or other component could be secured in a container housing without a fixing structure. The container 400 includes a container housing 406, a proximal side 402, a distal side 404, and an interior structure 408. The interior structure may include, but is not limited to, a porous wall, barrier, or other component to be secured in a container housing 406 as provided herein. The interior structure 408 may be secured within a container housing 406 through contact with a tapered region. The proximal side 402 and distal side 404 of the container housing 406 provide an angle variation within the container housing 406 that provides a tapered structure to secure the interior structure 408. In one aspects, the interior structure 408 is a porous wall. In some aspects, a sintered porous polymeric media and porous fiber media could function as a pours separation wall alone, because the porous polymeric media and fiber media are self-supporting and could be inserted into the container without a support structure. In some aspects, the porous wall shape at one end will serve to orient the parts in a feeder bowl and also the tip geometry will minimize or eliminate dead volume at the container shoulder in case of expensive drugs. In one aspect, a tapered structure may include but is not limited to a sintered porous plastic filter secured in a pipette tip.

[0063] In some aspects, the porous wall is hydrophobic and is characterized by a minimal water entry pressure above 1 psi, above 2 psi, above 5 psi, or above 10 Psi. The minimal water entry pressure for the porous separation wall in a dual chamber container will prevent the liquid from accidentally moving the diluent from the back chamber into the front, active ingredient chamber prematurely. The activation force to push the liquid from the back chamber into the front chamber during reconstitution must be less than 5 lbs force. In pen injectors, the activation and injection force will be improved by the mechanical advantage of the pen injector. The dual chamber with porous separation wall may be used on cartridges as well as prefilled syringes.

[0064] To provide an improved fluid seal betw een the porous separation wall and the container housing, sintered porous polymeric media or fiber media are combined in some aspects with an air / fluid tight seal rubbery seal component. If needed, the addition of a compliant material by using the rubbery non-porous component provides a radial seal tosintered porous polymeric or porous fiber component before use. In some examples, a compliant material or gasket will be used around the porous plastic cylinder for more reliable fluid seal at the container wall.

[0065] In some implementations the addition of the porous sintered part may improve the lyophilization process used for the medicament. With earlier bypass designs, if the activation force to push sterile water through the bypass is high, the reconstituted drug can show foaming or bubbles filled with air pockets. This makes it hard to prime or remove air pockets from the drug container and the delivered dose to the patient may not be accurate. With porous plastic parts, water flow is done across porous part cylinder, diameter cross section and length, resulting in more resistance to water flow and slowing the water flow into drug chamber during reconstitution (drug mixing with diluent).

[0066] A further example aspect of an interior structure as described in FIG. 4 is provided in FIGS. 5A-C. FIG. 5A provides a schematic illustration of an exemplary interior structure. As described above, an interior structure may include, but is not limited to a porous wall, barrier, or other component to be secured in a container housing as provided herein. The shape of the interior structure may vary depending on the delimitation of the container housing. As shown, the interior structure may be shaped to reduce dead volume in the medicament container (which may be helpful, e.g., in the case of expensive drugs). FIG. 5B provides a perspective view of two duplicate interior structures within a container housing. In one aspect, the structure may include, but is not limited to, a rubber stopper. The rubber stopper may further provide a fluid and / or gas seal within the internal volume of the container housing by contacting, at least in part, the internal walls of the container housing. FIG. 5C provides a perspective view of two different interior structures within a container housing. In one aspect, the structure may include a variation of the structure provided in FIG. 5A and a rubber stopper.

[0067] FIGS. 6A-C depicts functional operation of the multi-component medicament container 600 as provided herein. FIG. 6A provides a perspective view of a multi-component medicament container 600 comprising: a main body which encloses an interior substantially in the form of a cylinder, a fluid seal 602 defining a distal side 612 and a proximal side 614 opposite the fluid seal 602. An end fluid seal 610 is arranged in the interior of the main body such that the end fluid seal 610 is displaceable in the interior along a longitudinal axis and separates a first, with respect to the end fluid seal 610, proximal region of the interior. The first region is divided herein into a first chamber 604 and a second chamber 608 by means of a porous wall 606.The first chamber 604 may include a disposed active ingredient. The active ingredient may include, but is not limited to, a solvent and an air bubble, or a lyophilizate element, which is essentially surrounded by air. The first chamber 604 forms a closed space, which is delimited by the porous wall 606, the container housing, and the first fluid seal 602. As described in FIG. 6B, after the fluid seal 602 has been opened, it is, by means of an application device, which is not shown here, possible to displace the end fluid seal 610, at the same time, the porous wall 606 in the direction of the first fluid seal 602. If the activation force requirements of the porous wall 606 are not met, the contents of the first chamber 604 are dispensed from the distal side 612 of the container and the contents of the second chamber 608 remain closed. The second chamber 608 may include a diluent. The diluent may include, but is not limited to. saline, heparin, or analogues thereof. The second chamber 608 forms a closed space, which is delaminated by the porous wall 606, the container housing, and the end fluid seal 610. Subsequent to the activation force requirements of the porous wall 606 being met and / or exceeded, this allows the contents of the second chamber 608 to be dispensed, as seen in FIG. 6C.

[0068] In an exemplary aspect, the multi-component medicament container 600 as described in FIG. 6A, the fluid seal 602 remains closed and, it is, by means of an application device, which is not shown, possible to displace the end fluid seal 610, in the direction of the first fluid seal 602. If the activation force requirements of the porous wall 606 are met and / or exceeded, the contents of the second chamber 608, (i.e.. the diluent) is transferred to the first chamber 604. This makes it possible to mix the contents of the two chambers 604, 608. If the end fluid seal 610 is displaced further in the direction of the fluid seal 602 by means of the application device, the mixed contents of the two chambers 604,608 is discharged from the interior via the distal fluid seal opening 612. In some aspects, due to lower breakout / sustaining force, during reconstitution as well as injection, between plastic porous and glass or plastic container, the mechanical or electromechanical push force will be lower during use

[0069] In an additional exemplary aspect, the multi-component medicament container 600 as generally described in FIG. 6A, may include a third chamber created within the second chamber 608 by the addition of a secondary porous wall. The third chamber forms a closed space, which is delaminated by a secondary7porous wall, the container housing, and an end fluid seal The third chamber may include a flushing solution (e.g., saline or heparin). The first and second porous wall may have different activation force requirements. Subsequent to the activation force requirements of the first and / or second porous wall being met and / orexceeded, this allows the contents of the third chamber to be dispensed, as described in previous exemplary aspects provided herein.

[0070] Although the disclosure herein provided a description with reference to aspects, it is to be understood that these aspects are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope thereof. Thus, it is intended that the present disclosure include modifications an variations that are within the scope of the appended claims and their equivalents. The appended claims are not limited to exemplary7aspect details of construction and the arrangement of component set forth in the description of illustrated in the drawings.

Claims

CLAIMS1. A multi-component container comprising:(a) a container body comprising an internal volume;(b) a porous barrier located in the internal volume;(c) a movable non-porous barrier located in the internal volume, the movable non-porous barrier movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contacts the porous barrier;(d) when the movable non-porous barrier is in the first position, the multicomponent container comprising a first liquid component and a second component separated by the porous barrier, the first liquid component located between the movable non-porous barrier and the porous barrier;(e) when the movable non-porous barrier is in the first position, the porous barrier resists the first liquid component from flowing through a porous body of the porous barrier, wherein the porous body is hydrophobic and comprises at least one of a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media;(f) wherein, when the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous body of the porous barrier into contact with the second component.

2. The multi-component container of claim 1 wherein the porous body has a minimum water entry pressure that is greater than 1 psi.

3. The multi-component container of claim 2 wherein the porous body has a minimum water entry pressure that is greater than 5 psi.

4. The multi-component container of claim 2 wherein the porous body comprises at least one of a sintered porous plastic media or a sintered porous elastomeric media that has an average pore size less than 50 microns and an average porosity’ less than 60%.

5. The multi-component container of claim 2 wherein the porous body comprises a porous fiber media that has a density in the range of 0.1 g / cm3to 5 g / cm3.

6. The multi-component container of claim 2 wherein the porous body is surrounded by a seal that seals against the container body in the internal volume.

7. The multi-component container of claim 1 wherein the first liquid component is a solvent, and the second component is a solute dissolvable in the solvent.

8. The multi-component container of claim 1 wherein the second component is a solid phase material suspend-able in the first liquid component.

9. The multi-component container of claim 1 wherein the second component is a second liquid component mixable with the first liquid component.

10. The multi-component container of claim 1 wherein the porous barrier is fixed in position in the container body.

11. The multi-component container of claim 1 wherein the porous barrier is movable in the container body.

12. The multi-component container of claim 11 wherein the container body comprises an outlet, and wherein movement of the non-porous barrier towards the outlet moves the porous barrier towards the outlet.

13. The multi-component container of claim 1 wherein the porous body further comprises a phase inversion porous membrane.

14. The multi-component container of claim 1, wherein the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier.

15. The multi-component container of claim 1, wherein the multi-component container further comprises a third component.

16. The multi-component container of claim 15, wherein the third component acts as a flushing liquid prior to the administration of the second component and / or after the administration of the first liquid component.

17. A method of using the container of claim 1, comprising:(a) moving the non-porous barrier towards the porous barrier;(b) wherein moving the non-porous barrier towards the porous barrier causes the first liquid component to flow through the porous barrier into contact with the second component;(c) wherein when the non-porous barrier is at the first position and before moving the non-porous barrier toward the porous barrier, the porous barrier resists the first liquid component from flowing through the porous body of the porous barrier.

18. A multi-component container comprising:(a) a container body comprising an internal volume;(b) a porous barrier located in the internal volume;(c) a movable non-porous barrier located in the internal volume, the movable non-porous barrier movable between a first position and a second position, wherein, when in the second position, the movable non-porous barrier directly contacts the porous barrier;(d) when the movable non-porous barrier is in the first position, the multicomponent container comprising a first liquid component and a second component separated by the porous barrier, the first liquid component located between the movable non-porous barrier and the porous barrier;(e) when the movable non-porous barrier is in the first position, the porous barrier resists the first liquid component from flowing through a porous body of the porous barrier, wherein the porous body is a porous membrane fixed on a support component;(f) wherein, when the movable non-porous barrier is moved to the second position, the porous barrier allows the first liquid component to flow through the porous body of the porous barrier into contact with the second component.

19. The multi-component container of claim 18, wherein the shape of the porous body remains the same when the movable non-porous barrier is in the first position and the porous barrier resists the first liquid component from flowing through the porous body and when the movable non-porous barrier is moved to the second position and the porous barrier allows the first liquid component to flow through the porous body of the porous barrier.

20. The multi-component container of claim 18, wherein the porous body is hydrophobic.

21. The multi-component container of claim 18, wherein the porous body comprises a sintered porous plastic media, a sintered porous elastomeric media, or a porous fiber media.

22. The multi-component container of claim 18, wherein the multicomponent container further comprises a third component.

23. The multi-component container of claim 22, wherein the third component acts as a flushing liquid prior to the administration of the second component and / or after the administration of the first liquid component.

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