EP3073981B1 - Beverage cartridge containing pharmaceutical actives - Google Patents

Beverage cartridge containing pharmaceutical actives Download PDF

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Publication number
EP3073981B1
EP3073981B1 EP14809262.0A EP14809262A EP3073981B1 EP 3073981 B1 EP3073981 B1 EP 3073981B1 EP 14809262 A EP14809262 A EP 14809262A EP 3073981 B1 EP3073981 B1 EP 3073981B1
Authority
EP
European Patent Office
Prior art keywords
cartridge
child
resistant
layer
lidding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP14809262.0A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3073981A1 (en
Inventor
Kurt Franklin Trombley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Procter and Gamble Co
Original Assignee
Procter and Gamble Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Procter and Gamble Co filed Critical Procter and Gamble Co
Publication of EP3073981A1 publication Critical patent/EP3073981A1/en
Application granted granted Critical
Publication of EP3073981B1 publication Critical patent/EP3073981B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/70—Containers, packaging elements or packages, specially adapted for particular articles or materials for materials not otherwise provided for
    • B65D85/804—Disposable containers or packages with contents which are mixed, infused or dissolved in situ, i.e. without having been previously removed from the package
    • B65D85/8043—Packages adapted to allow liquid to pass through the contents
    • 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
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • 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

Definitions

  • the present invention is related to a beverage cartridge and more particularly, a cartridge that is adapted to make beverages containing pharmaceutical actives.
  • a child-resistant cartridge according to claim 1 is provided.
  • the current cartridges are not adapted to be used with pharmaceutical actives for two reasons.
  • the current cartridge does not provide a sufficient barrier to environmental conditions to prevent degradation.
  • the current cartridges are not child-resistant. It has been observed that children are able to open the current cartridges with their teeth and then using their fingers to peel off the lidding to access the contents or by applying pressure to the lidding with their thumb to puncture the lidding. Furthermore, once a child figured out how to open one cartridge, he was able to quickly open additional cartridges.
  • the cartridges of the present invention can provide a sufficient barrier from environmental conditions including humidity and gases, including oxygen, and can be child-resistant.
  • the structure and/or material(s) of the base and/or the lidding can provide long term stability for the pharmaceutical actives and/or child-resistance.
  • the cartridge has a base and a lidding structure.
  • the base can be a multi-layer laminate, which can include polychlorotrifluoroethylene (PCTFE), an adhesive, and polyethylene terephthalate with a glycol modifier (PETG).
  • the lidding is a multi-layer laminate structure that can comprise aluminum foil, adhesive, and a plastic.
  • the base and/or the lidding can be tear resistant.
  • the bottom of the base and/or the lidding can still be penetrable by a needle or penetrator of the automatic brewing machine.
  • the cartridge is adapted for use in an automatic machine such as a single serving automatic brewing machine.
  • Some of these machines can have a penetrator or needle that can penetrate the lidding and then provide a flow of water, frequently hot water, through the hole in the lidding, while a second penetrator or needle pushes through the bottom of the base to receive the outflow of the beverage and dispense it into a cup or container.
  • the base and the lidding layer are child resistant, in some examples, they can be penetrated by a penetrator or needle of a brewing machine.
  • the child-resistant and/or barrier features do not interfere with normal operation of the automatic brewing machine.
  • active or “pharmaceutical active” includes all compounds and compositions that can be used to treat and/or prevent illness and/or provide overall health and wellness benefits in mammals, particularly humans.
  • particularly useful actives include over-the-counter (OTC) actives, behind the counter actives, and prescription actives, vitamins, minerals, plant-derived materials, energy boosting materials, probiotics, fiber, prebiotics, and combinations thereof.
  • OTC over-the-counter
  • child-resistant means a cartridge or other packaging that is designed or constructed to be significantly difficult for young children to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.
  • solvent refers to passing into solution.
  • disintegrate refers to breaking up into small parts.
  • primary packaging refers a packaging component that is or may be in direct contact with the dosage form.
  • releasably joined refers to configurations in which a first element is secured to a second element, such that the first element and the second element can be separated with no or minimal damage to the first and second elements.
  • tear resistant means capable of experiencing a reasonable level of stress and/or deformation without experiencing a significant loss of integrity. Stress and/or deformation can be applied by a number of movements including, but not limited to, biting, pulling, pealing, poking, pushing and/or jabbing at the cartridge. In one example, any of these movements can be performed by a child, and tear resistant refers to a material that is capable of experiencing a reasonable level of stress and/or deformation without experiencing a significant loss of integrity when undergoing forces that can be applied by a child. In one example, the child is six years or younger, in another example five years or younger, in another example four years or younger, in another example three or younger, in another example two or younger, and in another example 18 months or younger. In one example, even though the cartridge is tear resistant, it can still be punctured with the needle or penetrator of an automatic brewing machine.
  • the term “treat” or “treating” includes preventing, alleviating, ameliorating, inhibiting, or mitigating one or more health conditions in a mammal, in particular a human and in one example an adult human.
  • health conditions can include respiratory conditions.
  • FIG. 1 shows an exploded view of cartridge 1 and FIG. 2 shows a side sectional view of cartridge 1.
  • Cartridge 1 includes base 10 and lidding 20.
  • Base 10 includes opening 11 and outwardly facing rim 13.
  • Base 10 can have the shape of a cup, cylinder, bowl, or an inverted truncated cone.
  • Base 10 can include component 12, which can include an active and/or an excipient. In one example, the component can be a powder.
  • Bottom 15 of base 10 can be penetrable by a penetrator or needle during use.
  • inner surface 26 of lidding 20 can be permanently joined to rim 13 of base 10 at seal 25.
  • the lidding can be joined to the base by any suitable method.
  • the lidding has a coating that is heat activated, causing it to attach to the rim of the base when exposed to heat.
  • the lidding can be attached using ultrasonic frequency and in another example the lidding can be attached using induction heating.
  • the lidding can be attached with a contact adhesive.
  • Lidding 20 can be a child-resistant laminate with outer layer 21 and inner layer 22.
  • Outer layer 21 can provide the child-resistance and can be tear resistant while still be penetrable by a needle or other penetrator of an automatic brewing machine.
  • outer layer 21 can contain reinforced strands 24, which can provide additional child resistance. Reinforced strands 24 can form a mesh across lidding 20 and in one example, the mesh can be open at the location where the lidding is intended to be punctured by a needle or penetrator.
  • the reinforced strands can be embedded in the child-resistant laminate.
  • the reinforced strands are underneath the outer layer.
  • the reinforced strands can be underneath the inner layer.
  • the reinforced strands can be between the outer layer and the inner layer. In another example, the reinforced strands can be embedded in the outer layer and/or the inner layer.
  • the reinforced strands can be made of any suitable material including nylon, polypropylene, fiberglass, and combinations thereof.
  • Inner layer 22 can reduce the amount of gasses, including oxygen, from entering cartridge 1.
  • Inner layer 22 can be made out of any suitable material and in one example, inner layer 22 can be made out of aluminum foil. Inner layer 22 can be opaque which can provide additional child-resistance. In another example, inner layer 22 can also include ink. In one example, outer layer 21 and inner layer 22 are permanently joined by an adhesive.
  • the lidding can be both child-resistant and provide an adequate barrier from gasses and humidity, while still being penetrable by a needle or other penetrator of an automatic brewing machine.
  • the lidding is a laminate.
  • the laminate has at least three layers, in another example at least four layers, and in another example at least five layers.
  • one or more layers of the lidding can be opaque and in another example one or more layers of the lidding can be transparent.
  • FIG. 3 is an example of a side sectional view of lidding 30 for a beverage cartridge.
  • Lidding 30 can comprise outer layer 32, second layer 33, third layer 34, and inner layer 35.
  • Outer layer 32 comprises polyethylene terephthalate (PET)
  • second layer 33 can comprise orientated polyamide (OPA)
  • third layer 34 can comprise aluminum
  • inner layer 35 comprises linear low-density polyethylene (LLDPE).
  • PET polyethylene terephthalate
  • OPA orientated polyamide
  • LLDPE linear low-density polyethylene
  • ink is between the outer layer and the second layer.
  • ink is printed on the outer layer.
  • a heat seal coating partially or entirely covers the inner layer.
  • FIGS. 4A and 4B are examples of liddings with weakened areas.
  • the weakened area can be in the region that is intended to be punctured by a needle or other penetrator of an automatic brewing machine. This weakened area can allow the lidding to be child resistant while still allowing the lid to be penetrated by a needle or penetrator.
  • the weakened area can extend partially or completely through one or more layers of the laminate lidding. In one example, the weakened area is on the outer layer of the lidding. In another example, the weakened area is not on the outer layer of the lidding because a child could see the weakened area and gain access or pick and peel at an edge of the weakened area. In one example, the weakened area does not penetrate the inner layer.
  • the weakened area only penetrates or partially penetrates the outer layer.
  • the weakened can be small enough so it is difficult for a child to use it to access the cartridge contents.
  • the weakened area is from about 1 mm to about 12 mm at its widest point, in another example from about 2 mm to about 10 mm, and in another example from about 3 mm to about 8 mm.
  • FIG. 4A is an example of lidding 40 with a weakened area, hole 42.
  • the hole can be any suitable shape. Non-limiting examples of shapes can include a circle, square, diamond, rectangle, triangle, star, cross, oval, and combinations thereof.
  • FIG. 4B is an example of lidding 45 with a weakened area, scored portion 47.
  • Scored portion 47 can be in any of the shapes listed above, as well as an "x”, cross-hatching, multiple dots, and combinations thereof.
  • FIG. 5 is an example of a side sectional view of beverage cartridge 5 with more than one compartment.
  • the actives and/or excipients are incompatible and separating them prolongs the stability of the components.
  • the components are in different states, for example one component is a solid and the other is a liquid.
  • one compartment contains a component with an active and another compartment contains a component with a flavor, which could allow for more robust flavor delivery, particularly if the flavor was a liquid.
  • beverage cartridge 5 has first compartment 51 containing first component 53 and second compartment 52 containing second component 54. First compartment 51 and second compartment 52 are separated by divider 55.
  • the divider can be any suitable material.
  • the divider partially or completely dissolves or partially or completely disintegrates, when exposed to hot or cold water.
  • the divider can be a mesh or woven material that separates the components when they are solid but when the components dissolve in water, the solution can travel through the mesh or woven material.
  • the divider can be punctured with the needle or penetrator from the automatic brewing machine. When the divider is punctured, water and the second component can flow from the second compartment to the first compartment.
  • the beverage cartridge can have multiple compartments.
  • the beverage cartridge can have at least two compartments, in another example at least three compartments, and in another example at least four compartments.
  • the compartments can extend in any direction including horizontally across the cartridge, vertically from the bottom of the base to the lidding, diagonally, or combinations thereof.
  • FIG. 6 is an example of side sectional view of beverage cartridge 6 with multiple chambers.
  • Cartridge 6 has first chamber 61 containing first component 63 and second chamber 62 containing second component 64.
  • the chambers not only can keep the components separate until just before use but they can also allow the user to select which actives she wants in her beverage.
  • the automatic brewing machine can have an upper needle 66, which punctures lidding 65, approximately in the center, and does not puncture first chamber 61 or second chamber 62. Simultaneously, lower needle 67 punctures the bottom 68 of base 69 and chamber 63. Lower needle 67 does not puncture the middle of base 67, instead it punctures off center.
  • the chambers can be made of a frangible material and/or can be pre-scored so when the lower needle punctures the chamber it cracks or breaks completely in two or more parts.
  • Non-limiting examples of frangible materials can include starch based films, water soluble modified cellulose films such as hydroxyethyl cellylose, ethyl vinyl acetate films, and combinations thereof.
  • water soluble modified cellulose films such as hydroxyethyl cellylose, ethyl vinyl acetate films, and combinations thereof.
  • the first chamber may contain an active to treat aches and pains, such as acetaminophen or ibuprofen
  • the second chamber may contain an active to treat cough, such as dextromethorphan. If the consumer does not have a cough she can position the cartridge in the automatic beverage brewer such that only the chamber that has the actives for aches and pains is penetrated by the bottom needle. However, if the consumer wants both actives she can brew twice, puncturing both chambers.
  • the chamber can contain different flavors allowing the user to select a flavor of her beverage.
  • the upper needle can puncture both chambers.
  • the lower needle punctures only one chamber and liquid from the upper needle can flow into both chambers but the beverage will only be able to flow out of the chamber punctured by lower needle.
  • the consumer can make a beverage with the desired components.
  • the cartridge can have any suitable number of chambers.
  • the cartridge can have at least two chambers, in another example at least three chambers, and in another example at least four chambers.
  • the cartridge could have a single chamber that could allow the consumer to make a beverage with just the component outside the chamber or with both components.
  • the chambers can be used to separate incompatible components.
  • FIG. 7 is an example of a cartridge 7 with a base 70, lidding 71, and a filter 72.
  • Filter 72 contains component 73.
  • the filter can be used when brewing a drink, such as coffee or tea. The water will seep through the filter and extract the essence of the components and the solid particles will be retained in the filter.
  • the actives and/or other excipients can dissolve into the water as it passes through the filter.
  • the cartridge with a filter can be used to brew coffee or tea containing actives.
  • the cartridge does not contain a filter.
  • the ingredients are packaged in a separate container and added by the consumer, or person preparing the beverage for the consumer, before or after their beverage is brewed by the automatic brewing machine.
  • the ingredient can be a flavor and in another example the ingredient can contain one or more actives.
  • the separate container can be a sachet.
  • the separate container can contain a liquid.
  • the separate container can contain a solid, where the solid can be a powder, nonpareils, capsule, tablet, or combinations thereof.
  • the consumer uses the automatic brewing system to puncture the top of the cartridge but before brewing the beverage the consumer reopens the machine and adds the separately packaged ingredient to the cartridge through the hole made by the automatic brewing machine and then recloses the machine and brews their beverage.
  • the base can be made of any suitable material(s) that provide the desired barrier properties and child-resistance and can still be penetrated by the needle or penetrator of the automatic brewing machine.
  • suitable material(s) that can be incorporated into the laminate material of the base can include high-density polyethylene (HDPE), cyclic olefin copolymers (COC), biaxally orientated polyamide (OPA), polypropylene (PP), polyester (PET), amorphous polyethylene terephthalate (APET), polyvinyl chloride (PVC), polyethylene (PE), aluminum foil, and combinations thereof.
  • the laminate can include a polyvinylidene chloride coating and in another example the laminate can include ethylvinyl alcohol (EVOH).
  • the base can be transparent and in another example the base can be opaque.
  • the base can be a laminate made from polychlorotrifluoroethene (PCTFE), an optional adhesive, and polyethylene terepthalate glycol (PETG).
  • PETG can be from about 25 ⁇ m to about 1.5 mm thick, in another example from about 50 ⁇ m to about 1 mm, in another example from about 100 ⁇ m to about 500 ⁇ m, and in another example from about 200 ⁇ m to about 300 ⁇ m.
  • the PCTFE can be from about 10 ⁇ m to about 250 ⁇ m, in another example from about 25 ⁇ m to about 150 ⁇ m, in another example from about 30 ⁇ m to about 100 ⁇ m, and in another example from about 40 ⁇ m to about 75 ⁇ m.
  • the base can be a laminate with an inner layer and an outer layer.
  • the inner layer can be EVOH, or another material that is difficult for a child to puncture or tear.
  • the inner layer and the outer layer of the base can be releasably joined.
  • the inner layer can separate from the outer layer. This separation can slow the child down, which can give a parent or caregiver more time to intervene and prevent the child from accessing cartridges. This separation may also make the child feel like they are making progress getting the package open, when in reality delaminating these two layers is not contributing to gaining access to the component, since the child cannot break through the inner and/or outer layer.
  • the maximum thickness of the base material can be greater than the maximum thickness of current pharmaceutical product barrier materials, such as cavities on a blister card, because the cartridge has dimensions larger than a typical pharmaceutical product enclosure.
  • base material with a greater starting thickness provides for sufficient thickness when the base of the cartridge is formed because the material is stretched by a greater degree towards the bottom of the cartridge base.
  • the lidding can be tear resistant.
  • the lidding is a multi-layer laminate.
  • Non-limiting examples of materials that can be incorporated into the laminate material of the lidding can include aluminum foil, PCTFE, EVOH, HDPE, OPA, COC, PP, PET, APET, PVC, PE, and combinations thereof.
  • the layers of the laminate can be affixed by an adhesive layer, which can comprise a polyolefin material like low density polyethylene (LDPE).
  • an adhesive layer which can comprise a polyolefin material like low density polyethylene (LDPE).
  • the laminate has an outer layer, a second layer, and an inner layer.
  • the outer layer is PET
  • the second layer is foil
  • the inner layer is LLDPE.
  • the outer layer or PET layer is 23 ⁇ m thick.
  • the second layer or foil layer is 18 ⁇ m thick.
  • the inner layer or LLDPE layer is25 ⁇ m thick.
  • the base, lidding, and/or cartridge can provide an effective barrier.
  • the base, lidding, and/or cartridge can have a final moisture vapor transmission rate of about 2 x 10 -5 to about 2 x 10 -3 g/cartridge/day, in another example from about 1 x 10 -4 to about 6 x 10 -4 g/cartridge/day, and in another example from about 2 x 10 -4 to about 3 x 10 -4 g/cartridge/day, as determined by the United States Pharmacopeial (USP) ⁇ 671> (August 1, 2013).
  • USP United States Pharmacopeial
  • the cartridge can provide long term stability to the pharmaceutical actives.
  • the pharmaceutical active in the cartridge have a shelf life of at least about 1 year, in another example at least about 18 months, in another example at least about 2 years, and in another example at least about 2.5 years.
  • shelf life refers to the time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
  • shelf life testing The conditions under which shelf life testing is conducted, the specific measurements and the minimum requirements for usable, fit for consumption or saleable can be set by governmental or regulatory bodies and can be published in guidance documents such as the United States Pharmacopeial (USP) or ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2), Step 4, of the version published February 6 th , 2003.
  • USP United States Pharmacopeial
  • ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2), Step 4 of the version published February 6 th , 2003.
  • the pharmaceutical active is at least about 90% of label for at least 1 year, in another example for at least about 1.5 years, in another example for at least about 2 years, and in another example for at least about 3 years. In another example the pharmaceutical active is at least about 95% of label for at least 1 year, alternatively at least about 1.5 years, alternatively at least about 2 years.
  • the cartridge may provide long term stability by maintaining the pharmaceutical active above about 80% or label for at least about 1 year, alternatively at least about 1.5 years, alternatively at least 2 years.
  • the cartridges can be in secondary packaging.
  • the secondary package can be a standard paperboard box that contains from about 1 to about 12 cartridges, and in another example from about 3 to about 6 cartridges.
  • the secondary package can be child-resistant.
  • the secondary package can contribute to the overall child-resistance of the cartridge.
  • each cartridge is individually packaged in a secondary package.
  • the secondary packaging can provide additional barrier properties to help prolong stability of the components.
  • the cartridge can be used with an automatic brewing machine and can be adapted to fit in an automatic brewing machine.
  • the cartridges are disposable which means that the cartridge can be disposed of or discarded after a limited number of uses.
  • the cartridge can be used five or fewer times, in another example three or fewer times, in another example two or fewer times, and in another example the cartridge is used only one time.
  • the cartridge can be reused and can be refilled with a component containing an active and/or an excipient.
  • the component can include both one or more actives and/or one or more excipients.
  • the component can be in any suitable form including, but not limited to, a powder, a liquid, a gel, or a tablet.
  • excipients can include flavors, sweeteners, disintegrants, fillers, colors, lubricants, glidants, sorbents, preservatives, sensates, and combinations thereof.
  • the component is a powder that dissolves as the water passes through the cartridge.
  • the component is a concentrated liquid that can be diluted when the water passes through the cartridge.
  • the component is only partially dissolved or extracted to make the beverage.
  • the cartridge can contain one or more actives.
  • the beverage containing actives can be consumed by adults and children 12 years and over.
  • the beverage containing actives can be intended to be consumed by children, often under the supervision of an adult.
  • the actives can treat a variety of symptoms including, but not limited to, symptoms from cold, flu, or allergies.
  • Non-limiting examples of actives can include decongestants, expectorants, antihistamines, antitussives, pain relievers, and combinations thereof.
  • the cartridge can provide multi-symptom relief of cold and/or flu symptoms and can be intended for use at night.
  • the cartridge can deliver about 650 mg acetaminophen, about 30 mg dextromethorphan HBr, about 10 mg of phenylephrine, about 30 to about 60 mg of pseudoephedrine, and/or about 12.5 mg doxylamine succinate during a single brew cycle.
  • how much active is delivered does not necessarily mean that the cartridge contains this amount of active.
  • the cartridge will likely contain more active than what is delivered to the user since in some examples, not all of the active will be transferred from the cartridge to the beverage.
  • the delivered amount of active can be within 10% of the monographed amount.
  • the cartridge can help relieve occasional sleeplessness and/or can help reduce the time to fall asleep if you have difficulty falling asleep.
  • the cartridge can provide about 50 mg diphenhydramine HCl or about 25 mg of doxylamine succinate.
  • the cartridge can help the user treat allergy symptoms.
  • the cartridge can deliver about 25 mg to about 50 mg diphenhydramine HCl, about 10mg loratadine, about 650 mg to about 1000 mg acetaminophen, about 7.5 mg to about 12.5 mg doxylamine, and/or about 10 mg phenylephrine.
  • the cartridges can be sold in combination with other products, in particular products containing over-the-counter actives or vitamins and/or minerals.
  • the cartridge can contain actives intended for nighttime relief of cold and/or flu symptoms and the cartridge can be packaged or otherwise sold in combination with actives intended for daytime relief of cold and/or flu symptoms such as acetaminophen, dextromethorphan, and phenylephrine.
  • the cartridge can contain vitamins, for instance a tea containing vitamins, and it can be packaged or otherwise sold in combination with over-the-counter actives, for instance actives containing daytime and/or nighttime relief of cold and/or flu symptoms.
  • the over-the-counter actives can be any dosage form including, but not limited to, a liquid, solid dosage forms such as liquicaps or tablets, or a cartridge.
  • the automatic brewing machine can dispense an entire dose of active as determined by the monograph.
  • the active can quickly dissolve or can be extracted into water as it is being brewed.
  • the cartridge can contain more than the monographed dosage of the active in order to ensure that the correct dosage is in the consumer's cup.
  • the beverage can be any volume.
  • the beverage is from about 100 mL to about 500 mL, in another example from about 125 mL to about 250 mL, in another example from about 130 mL to about 250 mL, and in another example about 150 mL to about 200 mL.
  • the beverage is about 6 fluid ounces (177.41 mL) and in another example the beverage is about 8 fluid ounces (236.59 mL).
  • the automatic brewing machine can be rinsed with water or otherwise cleaned to remove residual actives and/or excipients.
  • a brewing cycle can be conducted by the consumer without a cartridge in the machine.
  • the automatic brewing machine can be cleaned with water.
  • the automatic brewing machine can be cleaned with a cleaning agent, for instance a cleaning agent comprising vinegar.
  • the cartridge is child-resistant and can be given a rating that is referred to as the F value.
  • the F Value refers to the number of unit doses to which access is considered a test failure.
  • the number following the "F” refers to the number of unit doses that may produce serious personal injury or serious illness based on a 25-pound (11.4 kg) child.
  • the Child-Resistant Test is a standardized test and can be found in 16 C.F.R. ⁇ 1700 Poison Prevention Packaging.
  • about 80% or more of the children in the child resistance test cannot access the contents of 5 cartridges or fewer. In another example about 80% or more of the children in the child resistance test cannot access the contents of 4 cartridges or fewer. In another example, about 80% or more of the children in the child resistance test cannot access the contents of 3 cartridges or fewer. In another example, about 80% or more of the children in the child resistance test cannot access the contents of 2 cartridges or fewer.
  • the child-resistant testing can be conducted according to the Code of Federal Regulations Title 16: Part 1700.
  • the Child-Resistant Screening Test can be conducted as follows: For the Child-Resistant Screening Test the children are between 42-51 months of age. Both boys and girls are selected in approximately even numbers.
  • test failure is defined as any child who gains access to the cartridge contents.
  • the test was a failure if any child accessed the contents of three or more cartridges during the full 10 minutes of testing.
  • gained access to means that the actives have been removed or can be removed in whole or in part.
  • the active can be removed if any amount of active can spill out of the cartridge if it is inverted. If a cartridge or package is breached and the contents are not removed but could be removed, this is still considered access.
  • the children are tested two at a time.
  • the two children are escorted to the test area and are seated so there is no physical barrier between the children and the tester.
  • the tester will talk to the children to make them at ease.
  • the children are not given the impression that they are in a race or a contest, they are not offered a reward, and they are not told that the test is a game or that it is fun.
  • To begin the test the tester shall hand the children identical cartridges and say "Please try and open this for me.” If the child refuses to participate after the test has started, the tester shall reassure the child and gently encourage the child to try. If the child continues to refuse, the tester shall ask the child to hold the cartridge in his/her lap until the other child is finished. This pair of children shall not be eliminated from the results unless the refusing child disrupts the participation of the other child.
  • the tester shall minimize conversations with the children as long as they continue to attempt to open their packages.
  • the tester shall not discourage the children verbally or with facial expressions. If a child gets frustrated or bored and stops trying to open his/her cartridge, the tester shall reassure the child and gently encourage the child to keep trying.
  • the children should be allowed freedom of movement to work on their cartridges as long as the tester can watch both children (e.g. they can stand up, get down on the floor, or bang or pry the package).
  • the children shall be allowed to talk to each other about opening the cartridges and shall be allowed to watch each other try to open packages. If the child opens his/her cartridge, the tester shall say, "Thank you,” and take the opened cartridge from the child and give the child another unopened cartridge.
  • the tester shall ask the children to put their cartridges down and then shall demonstrate how to open the cartridge. This demonstration is done by performing a demonstration of how to use the cartridge in the machine, a Keurig® K75 Platinum Edition brewer. The children shall not be allowed to continue to try to open their cartridges during the demonstration period. The tester shall say, "watch me use this package.” Once the tester gets the children's full attention, the tester shall hold the demo package approximately two feet from the children and open the package at a normal speed as if the tester were going to use the contents. There shall be no exaggerated opening movements. The tester shall not discuss or describe how to open the package. After opening the package, the tester shall show the children the package.
  • the children are given a second five-minute period to try and open their cartridges.
  • the tester begins the five minute period by saying, "now you try to open your packages.” If both children have not used their teeth to try to open their packages during the first 5 minutes, the tester shall say immediately before or soon after beginning the second 5-minute period, "You can use your teeth if you want to.” This is the only statement that the tester shall make about using teeth. The test shall continue for another five minutes or until both children have opened their packages, whichever comes first.
  • Example 1 shows the results from the Child-Resistant Screening Test.
  • the procedures for the Child-Resistant Screening Test were followed as described above.
  • the trial used Swiss Miss K-Cups® (purchased at Keurig.com, on October 25 th , 2013, lot number 6696 PL120, expiration date January 17, 2015).
  • Table 1 shows how many cartridges were opened and how long it took to open each one.
  • Table 2 describes how each of the cartridges that were opened was accessed.
  • the top was reinforced with packing tape that was reinforced with fiber.
  • the tape was adhered over the lidding of the Swiss Miss K-Cup® and a hotplate was used to further bond the tape to the lidding.
  • Table 2 Gender Age (mo) Description of how cartridges were opened during the first 5 min test period Description of how cartridges were opened during the second 5 min test period 7*
  • Female 45 Child used teeth Child was given a cartridge with reinforced tape for the second five minutes. Child peeled re-enforced tape and then used teeth.
  • Male 51 n/a Child punctured with finger to open the first cartridge and then used his teeth to open the five others.
  • the Child-Resistance Screening Test with the Swiss Miss K-Cups® had a 65% pass rate.
  • the container passed if the child opened two or fewer cartridges. This is not an acceptable level of child-resistance for beverage products that contain pharmaceutical products, especially products containing acetaminophen or diphenhydramine. Almost all of the children who accessed the contents, used their teeth to puncture the lidding. Thus, in order to make a child resistant cartridge it can be important to have a lidding that cannot be punctured or torn by biting.
  • One child opened the package by applying steady pressure with his thumb to puncture the foil lidding. Thus, the lidding can also be made child resistant if it is not susceptible to being opened by pressing.
  • Example 2 shows the results from the second Child-Resistant Screening Test utilizing laminate lidding structure believed to be superior to those tested in Example 1.
  • the procedures for the Child-Resistant Screening Test were followed as described above.
  • This example used the same base as Example 1; however the lidding had a different laminate structure.
  • the laminate had an outer layer, a second layer, and an inner layer.
  • the outer layer was 12 ⁇ m PET, the second layer was 9 ⁇ m foil, and the inner layer was 25 ⁇ m LLDPE.
  • the outer layer was connected to the second layer with adhesive and the second layer was connected to the inner layer with adhesive.
  • the cartridges were filled with Ovaltine® (batch number #401158801G). Table 3, below, shows how many cartridges were opened and how long it took to open each one.
  • Table 4 describes the method used for each child who opened three or more cartridges during the Child-Resistant Screening Test.
  • Table 3 Gender Age (group) First 5 min test period Second 5 min test period Time to open cartridge (min) Time to open cartridge (min) 1 2 3 4 5 6 1 2 3 4 5 6 1 Female A 2 Male B 3 Male A 4 Male B 4:40 5 Female B 6 Female B 7 Female C 6:00 8:02 8 Male C 9 Female B 6:01 7:12 7:16 10 Female C 7:16 7:45 8:22 11 Male C 1:40 1:54 2:31 12** Male C 7:34 8:01 9:05 13 Female C 14 Male C 15 Female C 16 Female C 17 Female B 18 Female A 19 Male A 20 Female A 7:20 8:43 9:21 **Child found a way to access the product using an artifact of the method used to make the prototype samples for testing.
  • This Child-Resistance Screening Test with the laminate lidding of Example 2 had a 75% pass rate counting child #12 and a 80% pass rate if he was excluded.
  • the container passed if the child opened three or fewer cartridges. 75% is not an acceptable level of child-resistance (80% is the minimum level of acceptance) for beverage products that contain pharmaceutical products, especially products containing acetaminophen or diphenhydramine. Almost all of the children who accessed the contents, used their teeth or fingers to puncture the lidding. Thus, in order to make a child resistant cartridge it can be important to have a lidding that cannot be punctured or torn by biting.
  • Example 3 shows the results from the third Child-Resistant Screening Test utilizing new packaging component materials believed to be superior to those tested in Example 1 and Example 2.
  • the procedures for the Child-Resistant Screening Test were followed as described above.
  • the trial used the same base as Example 1; however the lidding had a different laminate structure.
  • the laminate had an outer layer, a second layer, and an inner layer.
  • the outer layer was 23 ⁇ m PET, the second layer was 18 ⁇ m foil, and the inner layer was 25 ⁇ m LLDPE.
  • the outer layer was connected to the second layer with adhesive and the second layer was connected to the inner layer with adhesive.
  • the cartridges were filled with Ovaltine® (batch number #401158801G).
  • Table 5 shows how many cartridges were opened and how long it took to open each one.
  • This Child-Resistance Screening Test with the laminate lidding of Example 3 had a 90% pass rate.
  • the container passed if the child opened three or fewer cartridges. 90% is an acceptable level of child-resistance (80% is the minimum level of acceptance) for beverage products which contain pharmaceutical products, especially products containing acetaminophen or diphenhydramine.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nutrition Science (AREA)
  • Packages (AREA)
  • Apparatus For Making Beverages (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Laminated Bodies (AREA)
EP14809262.0A 2013-11-27 2014-11-26 Beverage cartridge containing pharmaceutical actives Not-in-force EP3073981B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361909556P 2013-11-27 2013-11-27
PCT/US2014/067518 WO2015081145A1 (en) 2013-11-27 2014-11-26 Beverage cartridge containing pharmaceutical actives

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EP3073981A1 EP3073981A1 (en) 2016-10-05
EP3073981B1 true EP3073981B1 (en) 2019-07-24

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EP (1) EP3073981B1 (ru)
CN (1) CN105848625B (ru)
AU (2) AU2014354787B2 (ru)
CA (1) CA2929863A1 (ru)
MX (1) MX2016006449A (ru)
RU (1) RU2669392C1 (ru)
WO (1) WO2015081145A1 (ru)

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US20170280929A1 (en) 2016-03-30 2017-10-05 Eco 2, Llc Descaling device for a beverage machine and method of descaling a beverage machine
IT201600111266A1 (it) * 2016-11-04 2018-05-04 Safta Spa Capsula, metodo di fabbricazione, film multistrato
US10881582B2 (en) * 2018-06-11 2021-01-05 Glaxosmithkline Consumer Healthcare Holdings (Us) Llc Individual dose pack
WO2020039411A2 (en) * 2019-09-28 2020-02-27 Famatek Gmbh Capsule comprising a main and a supplemental precursor ingredient, method for production of said capsule and method for preparing a beverage

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US9936834B2 (en) * 2010-02-01 2018-04-10 Bedford Systems Llc Method and apparatus for cartridge-based carbonation of beverages
DK2921087T3 (en) * 2010-02-01 2017-01-30 Keurig Green Mountain Inc PROCEDURE AND APPARATUS FOR PATTERN-BASED CARBONIZATION OF BEVERAGES
DE102011052149A1 (de) * 2011-07-26 2013-01-31 Cavonic GmbH Verpackungsbehälter, Herstellungsverfahren sowie Herstellungsvorrichtung
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WO2014127467A1 (en) * 2013-02-25 2014-08-28 2266170 Ontario Inc. Single serve capsule for improved extraction efficiency and flavor retention

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GR1010650B (el) * 2023-01-17 2024-03-12 Ιουλια Κλεωνος Τσετη Φαρμακευτικη συνθεση παρακεταμολης υπο υδατοδιαλυτη μορφη εντος ερμητικα κλειστου δοχειου για παρασκευη ζεστου ροφηματος
WO2024153959A1 (en) * 2023-01-17 2024-07-25 Ioulia Tseti Pharmaceutical composotion of paracetamol in a water-soluble form in a hermetically sealed container for preparing a hot beverage

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AU2017245390B2 (en) 2019-03-07
RU2016118811A (ru) 2017-12-28
AU2017245390A1 (en) 2017-11-02
RU2669392C1 (ru) 2018-10-11
MX2016006449A (es) 2016-07-19
AU2014354787B2 (en) 2017-08-10
AU2014354787A1 (en) 2016-05-19
CA2929863A1 (en) 2015-06-04
WO2015081145A1 (en) 2015-06-04
CN105848625B (zh) 2019-07-09
CN105848625A (zh) 2016-08-10
EP3073981A1 (en) 2016-10-05

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