Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
  • B65D81/3261—Flexible containers having several compartments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2093—Containers having several compartments for products to be mixed
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
  • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
  • B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
  • B65B3/022—Making containers by moulding of a thermoplastic material
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
  • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
  • B65B31/024—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for wrappers or bags
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
  • B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
  • B65D1/04—Multi-cavity bottles
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
  • B65D35/22—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with two or more compartments
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
  • B65D81/3277—Ampoules
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
  • B65D81/3283—Cylindrical or polygonal containers, e.g. bottles, with two or more substantially axially offset, side-by-side compartments for simultaneous dispensing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2027—Separating means having frangible parts
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B2230/00—Aspects of the final package
  • B65B2230/02—Containers having separate compartments isolated from one another
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
  • B65B51/04—Applying separate sealing or securing members, e.g. clips
  • B65B51/046—Applying a closure element to the mouths of bags

Definitions

• the field of the invention is dispensing disposable liquid containers, particularly dual containers.
• BFS Blow-Fill-Seal
• FDA U.S. Food and Drug Administration
• blow-fill-seal (BFS) and form-fill-seal (FFS) Technology is to reduce contamination by forming the container (for example, by blowing into a mold), then filling and sealing the formed container within a closed sterile chamber. These operations are generally all performed within the same machine. This process greatly reduces the chance of
• this technology can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
• the mandrel is used to fill the container with the desired substance, generally a liquid or a flowing powder. After filling the mandrel is retracted and a secondary top mold applied to seal or form a sealing structure for the container. These steps take place inside of a sterile chamber, and produce a sterile product. The product is then discharged to a non-sterile area for labeling, packaging and distribution.
• Current processes are limited to generating a container that provides only a single product, or at best a series of containers that provide single products that are dispensed individually.
• a disposable container which allows us to dispense a unit dose of sterile liquid medications is particularly useful for persons who need to take medication on a daily basis, as there is no large volume stock of medication to become contaminated and the need for accurate measurement is reduced.
• the contents of such disposable containers may not require the addition of preservatives, which many people are sensitive to.
• United States Patent Application Publication No. 2007/0187429, to Fioretto (filed February 15, 2006) describes a dual container where one container is attached to one end of a second container, essentially connected back to back.
• the described containers are not sterile, and it is not clear that they can be manufactured using sterile filling conditions. It is not apparent that such these containers can safely contain a product that requires sterility.
• the inventive subject matter provides apparatus and methods for a multi dispensing, disposable and sterile container.
• the multi container has two or more physically separated reservoir, which can be connected by channels. For example, two liquids are stored in two separated reservoirs, one is an aqueous buffer with water-soluble compounds and the other is oil with oil-soluble compounds.
• the multi container can be held all reservoirs together on the top of each other along seal. As a result, a person can be easily consume multiple substances together at once by providing pressure on the top of reservoirs.
• the size of the aperture in one channel connected to a reservoir can be the same or greater than that in the other reservoir connected to the other reservoir.
• an aperture size can be adjusted to provide consistent flow rates between reservoirs that contain liquids having different viscosities or other rheological characteristics.
• liquid channels extended from reservoirs are completely separated.
• zigzag liquid channels are extended from reservoirs and merged together downstream of the zigzag channels, such that two liquids from two separated reservoirs are not mixed easily in the presence of zigzag channels.
• two liquids can be mixed together under sterile conditions by compression onto the reservoirs prior to consumption of substances.
• the channels extended from more than one reservoir can be merged together, such that at least two contents are mixed together prior to mixing one or more contents from other reservoirs.
• FIG. l is a cross sectional view of a dual reservoir container or dispenser of the inventive concept.
• FIG. 2 depicts a container or dispenser of the inventive concept having three reservoirs.
• FIG. 3 depicts container or dispenser of the inventive concept that incorporates a mixing feature.
• FIG. 4 depicts an alternative container or dispenser of the inventive concept that incorporates multiple mixing features.
• the inventive subject matter provides apparatus and methods for a multi sterile container which is capable of dispensing and being disposable.
• the multi container has two or more physically separated reservoirs, which join in common flow path to dispense to different fluid contents of the reservoirs simultaneously.
• Such a multi container can include one or more mixing regions along such a flow path and/or at a juncture of flow paths from individual reservoirs in order to enhance mixing.
• the diameter of a flow path and/or the size of an aperture in fluid communication with a reservoir can be dimensioned to control the rate of fluid flow along the flow path, for example to provide for proportionate mixing of the contents of one fluid reservoir with another upon dispensing.
• Multi containers of the inventive concept can be manufactured and filled using blow-fill-seal and/or form-fill-seal technologies to provide a single device presenting two or more different sterile contents.
• a device permits separate storage of stable (e.g. stable for at least 6 months or more at ambient temperature, stable for at least 6 months at 2° C to 8° C) precursors to an active formulation formed on mixing of the stable precursors, where the active formulation is itself unstable (e.g. degrades or otherwise becomes unusable within 6 months or less at ambient temperature, degrades or otherwise becomes unusable within 6 months or less at 2° C to 8° C).
• inventive subject matter provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
• the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term“about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some
• the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some
• embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
• FIG. 1 generally illustrates an example of one embodiment of the invention.
• Figure 1 shows a dual container 100 that includes a first and a second reservoir (110 and 120, respectively) separated by a sealing feature 130.
• the reservoirs can be essentially independent, but coupled to one another at one or more points (for example at one or both ends).
• First and second liquid channels (140 and 150, respectively) can be connected from these first and second reservoirs 110 and 120.
• such channels can be relatively short (e.g. essentially apertures); in other embodiments such channels can extend as lumens, channels, and/or passages from the reservoirs.
• liquids from the reservoirs 110, 120 exit the dispensing device via an exit aperture 160.
• an exit aperture 160 On dispensing, liquids from the reservoirs 110, 120 exit the dispensing device via an exit aperture 160.
• channels 140, 150 from the reservoirs 110,120 can merge into a common dispensing channel 155 positioned upstream from the exit aperture 160.
• Such an exit aperture 160 can be blocked or sealed by a sealing feature 180 that is removed (for example, by twisting, cutting, or tearing) immediately prior to use to open or expose the exit aperture 160.
• an end of either or both of the first 140 and second 150 liquid channels can be sealed, such that liquid in the first reservoir 110 is partially or completely separated from liquid in the second reservoir 120.
• the first and second reservoirs 110, 120 and/or associated channels can be coupled to a common backing or sheet 170, which can serve to protect and properly position the reservoirs for dispensing.
• the common backing or sheet 170 is limited to a portion (for example, a dispensing end) of the reservoirs 110, 120. In other embodiments a common backing or sheet 170 extends around all or a portion of lateral and/or terminal (i.e. non-dispensing) walls of the reservoirs 110, 120. In other embodiments the reservoirs 110, 120 are essentially independent with the exception of one or more attachment points (i.e. able to move independently except where coupled to one another). Although shown with two reservoirs, the Inventor contemplates that dispensers of the inventive concept can include 3, 4, or more reservoirs, each of which can include different contents.
• the exit aperture 160 can be blocked or sealed by a sealing device 180 or feature that is removed or disrupted prior to use.
• a sealing feature can be a simple heat seal imprint ted at or near the exit aperture 160.
• Such a heat seal can be continuous or discontinuous (e.g.‘stitched.).
• the sealing device can include a cap, tab, or similar device to facilitate removal.
• the dispensing device is configured such that in use a user holds both reservoirs on the top of each other with the sealing device at the bottom, such that to the user can easily remove the sealing device and dispense the two liquids together at once by manual compression of one or more reservoirs.
• the dispenser can include three or more reservoirs 210, 215, 220, at least two of which can include different flowable materials (e.g. powders, liquids, gels, foams, etc.).
• reservoirs 210, 215, 220 at least two of which can include different flowable materials (e.g. powders, liquids, gels, foams, etc.).
• channels in fluid communication with each of the reservoirs can merge together prior to or at the exit aperture.
• fluid channels from a subset (i.e. some but not all) of the reservoirs can be merged together prior to joining the contents of the remaining reservoirs, such that the contents of that subset of reservoirs are mixed together prior to mixing one or more contents from other reservoirs.
• a flow channel 245 from one reservoir 215 can join with a flow channel 250 from a second reservoir 220 to form a secondary channel 252 where the contents of these reservoirs are mixed before joining with a flow channel 240 from a third reservoir 210.
• the contents of all reservoirs are mixed in a common flow channel 255 on use of the device.
• contents of a reservoir containing an aqueous solution can be mixed with the contents of a reservoir containing a surfactant by merging of fluid channels connected to these reservoirs at a point upstream from the merging of a fluid channel in communication with a reservoir containing an oil or similar organic fluid.
• Such staged mixing of the contents of different reservoirs of a dispenser of the inventive concept can facilitate mixing of contents and/or the formation of emulsions or suspensions upon mixing.
• Such a“dual container” can be manufactured using blow-fill-seal technology.
• the reservoirs and channels can be molded and the sealing feature between the reservoirs readily deformed by manual pressure.
• Each reservoir can be completely or partially separated, such that each reservoir encloses a different composition and/or liquid. This arrangement advantageously permits individual optimization and stabilization of otherwise potentially incompatible liquid compositions.
• the composition of a flowable material in one reservoir can be different from that of a flowable material stored in a different reservoir of the same dispensing device.
• suitable flowable materials include liquids (e.g. solutions, suspensions, emulsions), powders, gels, foams, and non-Newtonian fluids that become flowable upon application of pressure.
• the contents of one reservoir can include an aqueous buffer and one or more water-soluble compounds where the contents of another reservoir of the same dispensing device can include an oil and one or more oil-soluble compounds.
• the contents of one reservoir can include a first water-soluble compound and an aqueous buffer having a pH optimized for storage of the water-soluble compound, and where the contents of a second reservoir include a different water-soluble compound and a different aqueous buffer having a different pH.
• the dispenser can include three or more reservoirs that are connected next, allowing a user to store three or more different types of liquids such as aqueous solution at pH 7, aqueous solution at pH 10 and oil solution and mix them upon use.
• the reservoirs can include a mixing feature to facilitate thorough and consistent mixing of the contents of reservoirs upon dispensing.
• flow channels 340, 350 in fluid communication with different reservoirs 310, 320 can join in a common mixing region or fixture 360 configured to facilitate mixing of the reservoir’s contents.
• a circular or spherical mixing feature can provide vortex flow that provides thorough and complete mixing prior to exiting through a common fluid channel 355 on use of the device.
• Such a common fluid channel 355 can terminate in a sealing feature 380 that is removed prior to dispensing.
• a dispenser of the inventive concept can include two or more mixing devices, some of which can be configured for mixing of reservoir contents and others for more vigorous agitation of the blended contents.
• FIG. 4 An example of such an embodiment is shown in FIG. 4.
• flow channels 440, 450 from different reservoirs 410, 420 join at a primary mixing feature 460, which can be configured to provide basic mixing of reservoir contents.
• primary mixing feature 460 can be configured as a sphere or with a circular cross section in order to facilitate vortex flow that provides thorough mixing.
• the mixed reservoir contents pass through one or more secondary mixing features 462, 464, 466 arranged along the common fluid channel 455 that provide additional mixing and/or agitation of the mixed reservoir contents.
• a common fluid channel 455 can terminate in a sealing feature 480 that is removed prior to dispensing
• Such secondary mixing features can have a configuration similar to that of the primary mixing feature, or can have a different
• Containers or dispenser of the inventive concept can be made of any suitable material, preferably a polymer that is suitable for blow-fill-seal manufacturing, is chemically resistant to the stored contents, and is pliable at the thicknesses used.
• Materials and wall thickness of a reservoir are preferably selected to be compressible or readily deformable by manual pressure applied by a person of average health.
• Suitable polymers include polyethylene, polypropylene, polyester, and/or silicone.
• the walls of the reservoirs can be of uniform thickness and relatively smooth, but pliable.
• the walls of a reservoir can be pleated or of an accordion-type, in order to apply greater pressure to reservoir contents and/or ensure more complete emptying of a reservoir that would be afforded by simple lateral compression.
• the reservoirs can be transparent or translucent.
• all or part of the dispenser or container can be opaque (for example, to permit storage of light-sensitive components). This can be achieved by incorporation of pigments into the polymer prior to molding or by post-molding treatment (for example painting or metallization).
• the material used for molding of a reservoir can be water resistant, have low oxygen permeability, and/or be opaque to at least one of visible and ultraviolet light.
• Reservoir walls can range in thickness from about 50 pm to about 3 mm, and are preferably about 1.5 mm or less.
• the contents of a reservoir can be any types of flowable material, such as an aqueous or organic liquid, a flowable powder, a gel, a cream, a foam, or a non-Newtonian fluid that becomes flowable upon application of pressure.
• Typical reservoir contents are formulated to produce products for medical use, including (but not limited to) pharmaceutical eye drops, oral liquid solutions, pharmaceutical creams, and adhesive materials (for example, epoxies for bone fixation, dental work, and/or wound closure) on-site at the time of use.
• pharmaceutical eye drops including (but not limited to) pharmaceutical eye drops, oral liquid solutions, pharmaceutical creams, and adhesive materials (for example, epoxies for bone fixation, dental work, and/or wound closure) on-site at the time of use.
• adhesive materials for example, epoxies for bone fixation, dental work, and/or wound closure
• an activator in a separate reservoir can be mixed with a precursor stored in the other reservoir and that requires activation. Activation then takes place on formation a mixture on dispensing, and the active mixture used immediately.
• the same strategy can be applied to a mixture, for example when a mixture is unstable over time.
• the container herein provides an immediate use of the mixture after mixing of at least two solutions.
• a scale mark or similar visible indicia of volume can be included on one or more reservoirs of the dispensing device. This permits a user to dispense a desired portion of a reservoir’s contents. Such an embodiment advantageously permits use of a container or dispenser to produce more than one dose.
• the sealing feature can be reusable, for example being threaded or dimensioned to provide a friction fit over or within a fluid channel exiting the dispenser.
• each individual reservoir can range from about 50 pL to about 5 mL, preferably from about 100 pL to about 2 mL. It should be appreciated that all of the contents of a reservoir may not be dispensed upon use, and the volumes of the reservoirs adjusted appropriately.
• the reservoirs in a dual reservoir container the reservoirs can be sized to dispense about half amount of a desired single dose volume produced when reservoir contents are mixed together. For example, if a final volume of about 0.4 mL is desired, each reservoir can be dimensioned to deliver about 200 pL of liquid.
• the stored liquids can exit their respective reservoirs via an aperture and/or channel associated with the reservoir.
• the shape of the aperture and/or channel can be preferably circular or elliptical.
• the diameter of such an aperture and/or channel connected to a first reservoir can be the same or greater than that in a different reservoir of the dispensing device and in fluid communication with the first reservoir.
• the length of a flow channel of a container or dispenser of the inventive concept can range from less than 2 mm to about 20 mm. In more preferred embodiments, the length can range from about 3 mm to about 10 mm.
• Apertures can range in size from about 100 pm to about 5 mm, and are preferably from about 200 pm to about 2 mm.
• the size of apertures associated with different reservoirs can be different and selected to provide a desired mixing ratio between reservoir contents upon dispensing. For example, smaller apertures can be provided for reservoirs having contents that are intended to be minority components of a composite composition.
• Another embodiment of the inventive concept is a method of treating a disease or condition by local application of a pharmaceutical mixture that is produced on-site at or immediately prior to application.
• the pharmaceutical mixture can have insufficient stability to permit formulation as a single, uniform formulation.
• a container or dispenser as described above is provided that includes the components of the pharmaceutical mixture in different reservoirs, where they can be stored under stabilizing conditions. Upon opening and dispensing of the contents of the dispenser or container the functional pharmaceutical mixture is generated for immediate application.
• a dispenser or container of the inventive concept can be used to generate an oil-in water emulsion that provides a non-water soluble pharmaceutical agent in a suspension of a physiologically compatible aqueous buffer.
• a dispenser or container of the inventive concept can be provided that generates a micellar suspension of a pharmaceutically active components in a physiologically compatible buffer (for example, by addition of and subsequent vigorous mixing with a suitable surfactant).
• one component of the pharmaceutical mixture can be provided as a stable but inactive precursor, which is activated by mixing with an activating compound stored in a different reservoir on dispensing.
• containers or dispensers of the inventive concept are formed using blow-fill-seal technology under sterile conditions.
• one or more parisons can be generated by the same or different mandrels, and placed in a mold assembly or portion thereof corresponding to a specific reservoir.
• a single parison is provided to mold assembly configured to generate two or more reservoirs upon further processing.
• two or more parisons are provided (for example, by independent mandrels) that each correspond to a reservoir upon further processing.
• Placement of the parison(s) within the mold assembly can leave one or more exposed neck(s) that provides access to the reservoir’s interior.
• each parison has a neck.
• a single neck can service two or more parisons. Inflation through the neck(s) form individual reservoirs within the mold assembly. These reservoirs can then be filled via their respective necks with their respective flowable contents, using the same mandrel or different mandrels. Mixing of contents between the reservoirs during or after filling can be prevented by sealing a common fluid flow channel (thereby preventing flow through reservoir-associated flow channels) and or/by surface tension across an aperture that leads to a reservoir-associated flow channel.
• a mold assembly utilized to form reservoirs can include components that provide for non-reservoir features, such as flow channels between the reservoirs, mixing chambers, and other features as detailed above.
• a secondary mold assembly can be applied (for example, at least in part to a protruding neck) to provide for non-reservoir features, such as flow channels between reservoirs, mixing chamber, sealing features, etc.
• molds or mold portions provide for contact points between the parisons that provide fixation of the reservoirs to each other in the final dispenser or container.
• containers and/or dispensers of the inventive concept can be subjected to post-molding and filling processes, such as painting, metallization, and labeling.
• containers and/or dispensers of the inventive concept can include machine- readable indicia (for example, a bar code, and RFID chip, etc.) that provides manufacturing information such as production facility, production date, expiration date, and individual product identification.

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• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Hematology (AREA)
• Ceramic Engineering (AREA)
• Chemical & Material Sciences (AREA)
• Dispersion Chemistry (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

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Publications (2)

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• 2018
  • 2018-02-20 WO PCT/US2018/018855 patent/WO2019164478A1/en unknown
  • 2018-02-20 EP EP18906979.2A patent/EP3755642A4/de not_active Withdrawn
  • 2018-02-20 AU AU2018410224A patent/AU2018410224A1/en not_active Abandoned

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