EP3073981B1 - Beverage cartridge containing pharmaceutical actives - Google Patents
Beverage cartridge containing pharmaceutical actives Download PDFInfo
- 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
Links
- 235000013361 beverage Nutrition 0.000 title description 42
- 238000012360 testing method Methods 0.000 claims description 45
- 239000000463 material Substances 0.000 claims description 24
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 20
- 239000011888 foil Substances 0.000 claims description 20
- 238000012216 screening Methods 0.000 claims description 15
- 239000000853 adhesive Substances 0.000 claims description 11
- 230000001070 adhesive effect Effects 0.000 claims description 11
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 11
- 229960005489 paracetamol Drugs 0.000 claims description 10
- 229960000520 diphenhydramine Drugs 0.000 claims description 8
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 8
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 6
- 229910052782 aluminium Inorganic materials 0.000 claims description 6
- 229920000092 linear low density polyethylene Polymers 0.000 claims description 5
- 239000004707 linear low-density polyethylene Substances 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 208000024891 symptom Diseases 0.000 claims description 5
- 230000005540 biological transmission Effects 0.000 claims description 2
- 239000010410 layer Substances 0.000 description 88
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- 230000004888 barrier function Effects 0.000 description 10
- 238000000034 method Methods 0.000 description 10
- -1 polychlorotrifluoroethylene Polymers 0.000 description 9
- 210000003811 finger Anatomy 0.000 description 8
- 239000000796 flavoring agent Substances 0.000 description 7
- 235000019634 flavors Nutrition 0.000 description 7
- 229920000728 polyester Polymers 0.000 description 7
- 238000004806 packaging method and process Methods 0.000 description 6
- 239000000825 pharmaceutical preparation Substances 0.000 description 6
- 206010022000 influenza Diseases 0.000 description 5
- 239000004615 ingredient Substances 0.000 description 5
- 229940127557 pharmaceutical product Drugs 0.000 description 5
- 229920002493 poly(chlorotrifluoroethylene) Polymers 0.000 description 5
- 239000005023 polychlorotrifluoroethylene (PCTFE) polymer Substances 0.000 description 5
- 239000007787 solid Substances 0.000 description 5
- 210000003813 thumb Anatomy 0.000 description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 4
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- 241001122767 Theaceae Species 0.000 description 4
- IKZZIQXKLWDPCD-UHFFFAOYSA-N but-1-en-2-ol Chemical compound CCC(O)=C IKZZIQXKLWDPCD-UHFFFAOYSA-N 0.000 description 4
- 230000007613 environmental effect Effects 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 201000009240 nasopharyngitis Diseases 0.000 description 4
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- 239000011782 vitamin Substances 0.000 description 4
- 229940088594 vitamin Drugs 0.000 description 4
- 229930003231 vitamin Natural products 0.000 description 4
- 235000013343 vitamin Nutrition 0.000 description 4
- 229920000089 Cyclic olefin copolymer Polymers 0.000 description 3
- 239000004713 Cyclic olefin copolymer Substances 0.000 description 3
- MKXZASYAUGDDCJ-SZMVWBNQSA-N LSM-2525 Chemical compound C1CCC[C@H]2[C@@]3([H])N(C)CC[C@]21C1=CC(OC)=CC=C1C3 MKXZASYAUGDDCJ-SZMVWBNQSA-N 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 229960001985 dextromethorphan Drugs 0.000 description 3
- 229920001903 high density polyethylene Polymers 0.000 description 3
- 239000004700 high-density polyethylene Substances 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- 229960001802 phenylephrine Drugs 0.000 description 3
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 229920000573 polyethylene Polymers 0.000 description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 238000009517 secondary packaging Methods 0.000 description 3
- 229920008790 Amorphous Polyethylene terephthalate Polymers 0.000 description 2
- 206010011224 Cough Diseases 0.000 description 2
- KBAUFVUYFNWQFM-UHFFFAOYSA-N Doxylamine succinate Chemical compound OC(=O)CCC(O)=O.C=1C=CC=NC=1C(C)(OCCN(C)C)C1=CC=CC=C1 KBAUFVUYFNWQFM-UHFFFAOYSA-N 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 241000124008 Mammalia Species 0.000 description 2
- 239000004952 Polyamide Substances 0.000 description 2
- 230000007815 allergy Effects 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000012459 cleaning agent Substances 0.000 description 2
- 235000020965 cold beverage Nutrition 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 229960005008 doxylamine succinate Drugs 0.000 description 2
- 229940126534 drug product Drugs 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 235000012171 hot beverage Nutrition 0.000 description 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 239000002648 laminated material Substances 0.000 description 2
- 229920001684 low density polyethylene Polymers 0.000 description 2
- 239000004702 low-density polyethylene Substances 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920002647 polyamide Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 239000004800 polyvinyl chloride Substances 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- GAWIXWVDTYZWAW-UHFFFAOYSA-N C[CH]O Chemical group C[CH]O GAWIXWVDTYZWAW-UHFFFAOYSA-N 0.000 description 1
- 239000004821 Contact adhesive Substances 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 1
- 229920010126 Linear Low Density Polyethylene (LLDPE) Polymers 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920006687 PET, APET Polymers 0.000 description 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000000954 anitussive effect Effects 0.000 description 1
- 229940125715 antihistaminic agent Drugs 0.000 description 1
- 239000000739 antihistaminic agent Substances 0.000 description 1
- 239000003434 antitussive agent Substances 0.000 description 1
- 229940124584 antitussives Drugs 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 1
- 239000000850 decongestant Substances 0.000 description 1
- 229940124581 decongestants Drugs 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 229960005178 doxylamine Drugs 0.000 description 1
- HCFDWZZGGLSKEP-UHFFFAOYSA-N doxylamine Chemical compound C=1C=CC=NC=1C(C)(OCCN(C)C)C1=CC=CC=C1 HCFDWZZGGLSKEP-UHFFFAOYSA-N 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- BFMKFCLXZSUVPI-UHFFFAOYSA-N ethyl but-3-enoate Chemical compound CCOC(=O)CC=C BFMKFCLXZSUVPI-UHFFFAOYSA-N 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 230000003419 expectorant effect Effects 0.000 description 1
- 229940066493 expectorants Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000008921 facial expression Effects 0.000 description 1
- 239000011152 fibreglass Substances 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 229960001680 ibuprofen Drugs 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 229960003088 loratadine Drugs 0.000 description 1
- JCCNYMKQOSZNPW-UHFFFAOYSA-N loratadine Chemical compound C1CN(C(=O)OCC)CCC1=C1C2=NC=CC=C2CCC2=CC(Cl)=CC=C21 JCCNYMKQOSZNPW-UHFFFAOYSA-N 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000000116 mitigating effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000003607 modifier Substances 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229940124641 pain reliever Drugs 0.000 description 1
- 239000011087 paperboard Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 239000002574 poison Substances 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000005033 polyvinylidene chloride Substances 0.000 description 1
- 235000013406 prebiotics Nutrition 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000009516 primary packaging Methods 0.000 description 1
- 239000006041 probiotic Substances 0.000 description 1
- 235000018291 probiotics Nutrition 0.000 description 1
- 229960003908 pseudoephedrine Drugs 0.000 description 1
- KWGRBVOPPLSCSI-WCBMZHEXSA-N pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
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- 238000006748 scratching Methods 0.000 description 1
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- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 239000000052 vinegar Substances 0.000 description 1
Images
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.
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Description
- The present invention is related to a beverage cartridge and more particularly, a cartridge that is adapted to make beverages containing pharmaceutical actives.
- Currently, there are a number of cartridges for use in automatic brewing machines that make a single serving of a beverage product, such as coffee or tea. However, current cartridges are not suitable for use with pharmaceutical actives because the actives are sensitive to environmental conditions, such as humidity and oxygen, and the actives can degrade in current cartridges. Furthermore, the Consumer Product Safety Commission (CPSC) requires the primary package is child-resistant if the cartridge contains certain active ingredients, such as acetaminophen and diphenhydramine.
WO 2013144838 discloses a cartridge including the technical features of the preamble ofclaim 1. - As such, there remains a need for a cartridge which is adapted for use in an automatic brewing machine that is both child-resistant and provides a barrier from environmental conditions to provide long term stability for pharmaceutical actives.
- A child-resistant cartridge according to
claim 1 is provided. -
-
FIG. 1 is a three-dimensional exploded view of a beverage cartridge; -
FIG. 2 is a side sectional view of a beverage cartridge ofFIG. 1 ; -
FIG. 3 is a side sectional view of a lidding for a beverage cartridge; -
FIG. 4A is a lidding for a beverage cartridge; -
FIG. 4B is a lidding for a beverage cartridge; -
FIG. 5 is a side sectional view of a beverage cartridge with two compartments; -
FIG. 6 is an example of a side sectional view of a beverage cartridge with two chambers; and -
FIG. 7 is an example three-dimensional exploded view of a beverage cartridge with a filter. - Many consumers enjoy drinking hot or cold beverages with pharmaceutical actives. A convenient and easy way to make a single serving of a hot or cold beverage is to use an automatic brewing machine with a cartridge. However, the current cartridges are not adapted to be used with pharmaceutical actives for two reasons. First, the current cartridge does not provide a sufficient barrier to environmental conditions to prevent degradation. Second, 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. In one example, 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. Furthermore, while being child-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 can meet the definition of child-resistant under the U.S. Poison Prevention Packaging Act of 1970 (16 C.F.R. §1700.14). Specifically, the cartridges can meet the definition of F=3 according to the Child-Resistant Testing as described herein. In another example, the cartridge can meet the definition of F=1 according to the Child-Resistant Testing, in another example F=2, in another example F=4, in another example F=5, and in another example F=6. In one example, the cartridge alone meets the definition of child-resistant without the secondary packaging.
- 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. Even though 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. In another example, the child-resistant and/or barrier features do not interfere with normal operation of the automatic brewing machine.
- As used herein, "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. Non-limiting examples of 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.
- As used herein, "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.
- As used herein, "dissolve" refers to passing into solution.
- As used herein, "disintegrate" refers to breaking up into small parts.
- As used herein, "permanently joined" refers to configurations in which a first element is secured to a second element such that the elements generally cannot be separated from one another without at least partially destroying one or both of the elements.
- As used herein, "primary packaging" refers a packaging component that is or may be in direct contact with the dosage form.
- As used herein, "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.
- As used herein, "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.
- As used herein, 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. Non-limiting examples of health conditions can include respiratory conditions.
- As used herein, the articles "a" and "an" are understood to mean one or more of the material that is claimed or described, for example, "an active" or "a compartment".
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FIG. 1 shows an exploded view ofcartridge 1 andFIG. 2 shows a side sectional view ofcartridge 1.Cartridge 1 includesbase 10 andlidding 20.Base 10 includesopening 11 and outwardly facingrim 13.Base 10 can have the shape of a cup, cylinder, bowl, or an inverted truncated cone.Base 10 can includecomponent 12, which can include an active and/or an excipient. In one example, the component can be a powder.Bottom 15 ofbase 10 can be penetrable by a penetrator or needle during use. - With reference to
FIG. 2 ,inner surface 26 oflidding 20 can be permanently joined torim 13 ofbase 10 atseal 25. The lidding can be joined to the base by any suitable method. In one example, the lidding has a coating that is heat activated, causing it to attach to the rim of the base when exposed to heat. In another example, the lidding can be attached using ultrasonic frequency and in another example the lidding can be attached using induction heating. Alternatively, the lidding can be attached with a contact adhesive. -
Lidding 20 can be a child-resistant laminate withouter layer 21 andinner 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. In one example,outer layer 21 can contain reinforcedstrands 24, which can provide additional child resistance. Reinforcedstrands 24 can form a mesh acrosslidding 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. In one example, the reinforced strands can be embedded in the child-resistant laminate. In another example, the reinforced strands are underneath the outer layer. In another example, the reinforced strands can be underneath the inner layer. In another example, 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 enteringcartridge 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 andinner 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. In one example, one or more layers of the lidding can be opaque and in another example one or more layers of the lidding can be transparent.
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FIG. 3 is an example of a side sectional view oflidding 30 for a beverage cartridge.Lidding 30 can compriseouter layer 32,second layer 33,third layer 34, andinner layer 35.Outer layer 32 comprises polyethylene terephthalate (PET),second layer 33 can comprise orientated polyamide (OPA),third layer 34 can comprise aluminum, andinner layer 35 comprises linear low-density polyethylene (LLDPE). Each layer is attached to an adjacent layer with an adhesive. In another example, ink is between the outer layer and the second layer. In another example, ink is printed on the outer layer. In another example, 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. In another example, the weakened area only penetrates or partially penetrates the outer layer. In one example, the weakened can be small enough so it is difficult for a child to use it to access the cartridge contents. In one example, 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 oflidding 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 oflidding 45 with a weakened area, scoredportion 47. Scoredportion 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 ofbeverage cartridge 5 with more than one compartment. For some components it could be advantageous to separate some of the ingredients until immediately before they are consumed. In one example, the actives and/or excipients are incompatible and separating them prolongs the stability of the components. In another example, the components are in different states, for example one component is a solid and the other is a liquid. In another example, 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. - In
FIG. 5 ,beverage cartridge 5 hasfirst compartment 51 containingfirst component 53 andsecond compartment 52 containingsecond component 54.First compartment 51 andsecond compartment 52 are separated bydivider 55. - The divider can be any suitable material. In one example the divider partially or completely dissolves or partially or completely disintegrates, when exposed to hot or cold water. In another example, 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. In another example, 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. In one example, 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.
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FIG. 6 is an example of side sectional view ofbeverage cartridge 6 with multiple chambers.Cartridge 6 hasfirst chamber 61 containingfirst component 63 andsecond chamber 62 containingsecond 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. - In one example, the automatic brewing machine can have an
upper needle 66, which punctures lidding 65, approximately in the center, and does not puncturefirst chamber 61 orsecond chamber 62. Simultaneously,lower needle 67 punctures the bottom 68 ofbase 69 andchamber 63.Lower needle 67 does not puncture the middle ofbase 67, instead it punctures off center. Thus by arrangingcartridge 6 with a particular orientation in the brewing machine, one chamber could be broken, while the other chamber remains intact. In one example, 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. When the brewing begins, water will flow out the upper needle and flow around the intact chamber, while combining with the components of the broken chamber and making a beverage with the desired components. - For instance, the first chamber may contain an active to treat aches and pains, such as acetaminophen or ibuprofen, and 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.
- In another example, the chamber can contain different flavors allowing the user to select a flavor of her beverage.
- In another example, 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. Thus, the consumer can make a beverage with the desired components.
- The cartridge can have any suitable number of chambers. In one example, the cartridge can have at least two chambers, in another example at least three chambers, and in another example at least four chambers. In one example, 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.
- In another example, the chambers can be used to separate incompatible components.
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FIG. 7 is an example of acartridge 7 with abase 70,lidding 71, and afilter 72.Filter 72 containscomponent 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. In one example, the actives and/or other excipients can dissolve into the water as it passes through the filter. In one example, the cartridge with a filter can be used to brew coffee or tea containing actives. - In one example, the cartridge does not contain a filter.
- In another example, at least one of 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. In one example the ingredient can be a flavor and in another example the ingredient can contain one or more actives. In one example, the separate container can be a sachet. In one example, the separate container can contain a liquid. In another example the separate container can contain a solid, where the solid can be a powder, nonpareils, capsule, tablet, or combinations thereof. In another example, 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. Non-limiting examples of materials 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. In another example the laminate can include a polyvinylidene chloride coating and in another example the laminate can include ethylvinyl alcohol (EVOH). In one example, the base can be transparent and in another example the base can be opaque.
- In one example, the base can be a laminate made from polychlorotrifluoroethene (PCTFE), an optional adhesive, and polyethylene terepthalate glycol (PETG). In one example, the PETG can be from about 25 µm to about 1.5 mm thick, in another example from about 50 µm to about 1 mm, in another example from about 100 µm to about 500 µm, and in another example from about 200 µm to about 300 µm. In another example, the PCTFE can be from about 10 µm to about 250 µm, in another example from about 25 µm to about 150 µm, in another example from about 30 µm to about 100 µm, and in another example from about 40 µm to about 75 µm.
- In one example, the base can be a laminate with an inner layer and an outer layer. In one example, 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. When the child tries to open the container, for instance by puncturing, tearing, or biting, 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.
- In one example, 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. Using 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.
- Current lidding can be removed by children with a combination of biting and scratching. Thus, 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.
- For both the laminate in the lidding layer and the base, the layers of the laminate can be affixed by 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, and the inner layer is LLDPE.
- The outer layer or PET layer is 23 µm thick.
- The second layer or foil layer is 18 µm thick.
- The inner layer or LLDPE layer is25 µm thick.
- The base, lidding, and/or cartridge can provide an effective barrier. In one example, 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).
Follow Method 1 of the procedure for Single-Unit Containers and Unit-Dose Containers for Capsules and Tablets. - The cartridge can provide long term stability to the pharmaceutical actives. In one example, 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. As used herein, "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. 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 6th, 2003.
- In one example, 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. In one example, 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. In another example, the secondary package can be child-resistant. In one example, the secondary package can contribute to the overall child-resistance of the cartridge. In another example the secondary package can be an F=1 child-resistant package, in another example an F=2 child-resistant package, and in another example an F=3 child-resistant package. In another example, each cartridge is individually packaged in a secondary package. In another example, the secondary packaging can provide additional barrier properties to help prolong stability of the components.
- In one example, the cartridge can be used with an automatic brewing machine and can be adapted to fit in an automatic brewing machine.
- In one example, the cartridges are disposable which means that the cartridge can be disposed of or discarded after a limited number of uses. In one example, 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. In another example, 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. Non-limiting example of excipients can include flavors, sweeteners, disintegrants, fillers, colors, lubricants, glidants, sorbents, preservatives, sensates, and combinations thereof. In one example, the component is a powder that dissolves as the water passes through the cartridge. In another example, the component is a concentrated liquid that can be diluted when the water passes through the cartridge. In yet another example, the component is only partially dissolved or extracted to make the beverage.
- The cartridge can contain one or more actives. In one example, the beverage containing actives can be consumed by adults and
children 12 years and over. In another example, 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.
- In one example, 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.
- In some examples, 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. Furthermore, according to government regulations, such as the USP, the delivered amount of active can be within 10% of the monographed amount.
- In another example, 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.
- In another example, 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.
- In another example, the cartridges can be sold in combination with other products, in particular products containing over-the-counter actives or vitamins and/or minerals. In one example, 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. In another example, 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. Thus, the active can quickly dissolve or can be extracted into water as it is being brewed. In one example, 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. In one example 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. In one example, the beverage is about 6 fluid ounces (177.41 mL) and in another example the beverage is about 8 fluid ounces (236.59 mL).
- In one example, following each use the automatic brewing machine can be rinsed with water or otherwise cleaned to remove residual actives and/or excipients. For example, a brewing cycle can be conducted by the consumer without a cartridge in the machine. In one example, the automatic brewing machine can be cleaned with water. In another example, the automatic brewing machine can be cleaned with a cleaning agent, for instance a cleaning agent comprising vinegar. Some consumers may also want to clean the brewing machine before brewing the beverage.
- 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. In one example, the child-resistant package is an F=1 package, in another example an F=2 package, in yet another example an F=3 package, in another example an F=4 package, and in yet another example an F=5 package.
- In one example 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. - A test failure is defined as any child who gains access to the cartridge contents. For the following experiment, the test was a failure if any child accessed the contents of three or more cartridges during the full 10 minutes of testing. As used herein, "gained access to" means that the actives have been removed or can be removed in whole or in part. In the case of a cartridge, 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.
- Each child will be given 5 minutes to open his/her cartridge. 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.
- At the end of the 5-minute period, 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.
- Then, 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 25th, 2013, lot number 6696 PL120, expiration date January 17, 2015). Table 1, below, 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.
Table 1 Gender Age (mo) 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 Male 42 2 Female 43 3 Female 43 4 Male 45 5 Female 45 6 Male 46 7* Female 45 1:42 2:54 3:22 3:42 4:20 4:31 6:10 8 Female 49 4:30 6:29 6:43 7:04 7:14 7:24 9 Male 51 6:00 6:25 6:31 6:50 6:58 7:05 10 Female 49 11 Male 51 12* Male 50 5:58 6:57 7:38 9:12 13 Male 46 14 Female 42 15 Female 43 16 Female 43 17 Male 48 5:32 6:01 6:31 6:39 6:59 7:21 18 Male 50 5:21 5:46 6:01 6:13 6:32 7:16 19 Female 48 7:49 8:06 8:32 8:57 9:59 10:12 20 Male 43 7:00 7:36 8:07 8:32 9:19 10:00 21 Male 50 *Child was given a cartridge that had a reinforced top for second five minute test period. 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. 8 Female 49 Child used teeth. Child used teeth to puncture foil top and then used fingers to tear the foil. 9 Male 51 n/a Child punctured with finger to open the first cartridge and then used his teeth to open the five others. 12* Male 50 n/a Child was given a cartridge with reinforced tape for the second five minutes. Child peeled the the reinforced tape and then used teeth. 17 Male 48 n/a Child used teeth to puncture foil top and then used fingers to tear the foil. 18 Male 50 n/a Child used teeth to puncture foil top and then used fingers to tear the foil. 19 Female 48 n/a Child punctured foil top with thumb. 20 Male 43 n/a Child used teeth to puncture foil top and then used fingers to tear the foil. - 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.
- It is also interesting to note that after the children saw the demonstration and were told they could use their teeth, many more children gained access to the contents of the cartridge. Also, if a child was able to open one cartridge, he or she was generally able to open the remaining cartridges very quickly. Therefore, in order to make the cartridge child-resistant, it may be necessary to make the cartridge tear resistant.
- Although the cartridges which were reinforced with packing tape were not child resistant, it did take the children longer to access the contents of these cartridges. Thus, if the heat seal was stronger, the child-resistant properties of the package may be improved.
- Although the two children who received cartridges with reinforced tops were able to access the contents, they were not able to access the contents by biting or otherwise puncturing the reinforced tape. Instead, they were able to separate the reinforced tape from the K-Cup® lidding by pealing. Therefore, if the packing tape was more securely adhered to the lidding, for instance in a laminate structure, a sufficient level of child-resistance could be achieved.
- 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 µm PET, the second layer was 9 µm foil, and the inner layer was 25 µm 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. Age groups are as follows: A=42-44 months, B=45-48 months, and C=49-51 months old.
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. It is believed, that normal manufacturing would not allow this access method to be as successful. Table 4 Gender Age (group) Description of how cartridges were opened 9 Female B Peeled lid, poked with thumbs/finger, struck against floor 10 Female C Peeled lid, struck against floor 11 Male C Poked hard with thumb/ knuckle 12** Male C Peeled lid, crushed until plastic formed small hole, banged on package, poking at thin spot in plastic (artifact of prototyping) 20 Female A Peeled lid, used teeth after demo - 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 µm PET, the second layer was 18 µm foil, and the inner layer was 25 µm 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, below, shows how many cartridges were opened and how long it took to open each one. Table 6, describes the method used for each child who opened three or more cartridges during the Child-Resistant Screening Test. Age groups are as follows: A=42-44 months, B=45-48 months, and C=49-51 months old.
Table 5 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 Male B 2 Male B 3 Female A 4 Male A 5 Male B 6 Female A 7 Female B 8 Male B 9 Male B 6:27 6:53 7:02 10 Female B 9:58 11 Female C 12 Male B 13 Male C 14 Female C 7:58 15 Male C 16 Female C 2:17 2:40 3:09 17 Female C 18 Male A 19 Male B 20 Female B Table 6 Gender Age (mo) Description of how cartridges were opened 9 Male B Peeled lid, used teeth after demo to access all three containers 16 Female C No detail given except required very little effort - 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.
Claims (14)
- A child-resistant cartridge (5, 6, 7) adapted to be used with an automatic brewing machine comprising:a. a base (10, 69, 70) wherein the base (10, 69, 70) contains a pharmaceutical active; andb. a lidding (20, 40, 45, 65, 71) wherein the lidding (20, 40, 45, 65, 71) comprises a multilayer laminate comprising an outer layer (21, 32) and an inner layer (22, 35);
characterized in that
the laminate further comprises a second layer (33), the outer layer being a 23 µm PET layer, the second layer being a 18 µm foil and the inner layer being a 25 µm LLDPE layer, and the outer layer is connected to the second layer with adhesive and the second layer is connected to the inner layer with adhesive, so that the cartridge (5, 6, 7) is made of tear resistant materials sufficient to prevent 80% of children from accessing the contents of three or more cartridges during a Child-Resistant Screening Test. - The child-resistant cartridge of claim 1 wherein the cartridge comprises a final moisture vapor transmission rate of about 2 x 10-5 to about 2 x 10-3 g/cartridge/day.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims further comprising an excipient and wherein the excipient and the pharmaceutical active are a powder.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims further comprising an excipient and wherein the excipient and the pharmaceutical active are a concentrated liquid.
- The child-resistant cartridge of anyone of the preceding claims wherein the base further comprises a first compartment (51, 61) containing the pharmaceutical active (53, 63) and a second compartment (52, 62) containing a second pharmaceutical active (54, 64) wherein the first compartment and the second compartment are separated by a divider (55).
- The child-resistant cartridge of claim 6 wherein the divider (55) is a mesh.
- The child-resistant cartridge (5, 6, 7) of claim 5 wherein the pharmaceutical active and the second pharmaceutical active are incompatible.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the base (10, 69, 70) further comprises a first chamber (51, 61) containing the pharmaceutical active (53, 63) and a second chamber (52, 62) containing a second pharmaceutical active (54, 64) wherein the pharmaceutical active and the second pharmaceutical active are adapted to treat different symptoms wherein the cartridge (5, 6, 7) is adapted so only the first chamber (51, 61) or the second chamber (52, 62) is penetrated by a lower needle (67) of an automatic brewing machine during one brewing cycle.
- The child-resistant cartridge (5, 6, 7) of claim 8 wherein the first chamber (51, 61) and the second chamber (52, 62) are made from a frangible material.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the lidding (20, 40, 45, 65, 71) further comprises reinforced strands (24).
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the second layer (33) comprises aluminum foil.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the lidding (20, 40, 45, 65, 71) further comprises a weakened area.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the cartridge (5, 6, 7) contains a pharmaceutical active comprising diphenhydramine and wherein the cartridge (5, 6, 7) can deliver about 50 mg of diphenhydramine during a brew cycle.
- The child-resistant cartridge (5, 6, 7) of anyone of the preceding claims wherein the pharmaceutical actives comprise acetaminophen and wherein the cartridge (5, 6, 7) can deliver about 650 mg of acetaminophen during a brew cycle.
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 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3073981A1 EP3073981A1 (en) | 2016-10-05 |
EP3073981B1 true EP3073981B1 (en) | 2019-07-24 |
Family
ID=52014447
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14809262.0A Not-in-force EP3073981B1 (en) | 2013-11-27 | 2014-11-26 | Beverage cartridge containing pharmaceutical actives |
Country Status (7)
Country | Link |
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EP (1) | EP3073981B1 (en) |
CN (1) | CN105848625B (en) |
AU (2) | AU2014354787B2 (en) |
CA (1) | CA2929863A1 (en) |
MX (1) | MX2016006449A (en) |
RU (1) | RU2669392C1 (en) |
WO (1) | WO2015081145A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GR1010650B (en) * | 2023-01-17 | 2024-03-12 | Ιουλια Κλεωνος Τσετη | Pharmaceutical water-soluble paraketamol composition contained in a hermetically closed container for the preparation of beverages |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
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DE202015008067U1 (en) * | 2015-09-01 | 2016-12-02 | LigaLife GmbH & Co. KG | Capsule for a production of a liquid food |
DE102015115250A1 (en) * | 2015-09-10 | 2017-03-16 | Pester Pac Automation Gmbh | Use of a packaging |
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 (en) * | 2016-11-04 | 2018-05-04 | Safta Spa | CAPSULE, MANUFACTURING METHOD, MULTILAYER FILM |
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 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1586534A1 (en) * | 2004-02-18 | 2005-10-19 | MDS Global Holding Ltd. | Dispensing of a substance |
JP2013514831A (en) * | 2009-12-18 | 2013-05-02 | グリーン マウンテン コーヒー ロースターズ,インク. | Beverage forming apparatus and method using sonic energy |
ES2563195T3 (en) * | 2010-02-01 | 2016-03-11 | Keurig Green Mountain, Inc. | Method and apparatus for carbonation based on beverage cartridge |
US9936834B2 (en) * | 2010-02-01 | 2018-04-10 | Bedford Systems Llc | Method and apparatus for cartridge-based carbonation of beverages |
DE102011052149A1 (en) * | 2011-07-26 | 2013-01-31 | Cavonic GmbH | Packaging container, manufacturing method and manufacturing device |
CN104321265B (en) * | 2012-03-26 | 2018-07-03 | 萨龙股份公司 | For the method for the capsule and the manufacture capsule of beverage |
CA2902231C (en) * | 2013-02-25 | 2016-02-09 | 2266170 Ontario Inc. | Single serve capsule for improved extraction efficiency and flavor retention |
-
2014
- 2014-11-26 WO PCT/US2014/067518 patent/WO2015081145A1/en active Application Filing
- 2014-11-26 EP EP14809262.0A patent/EP3073981B1/en not_active Not-in-force
- 2014-11-26 MX MX2016006449A patent/MX2016006449A/en active IP Right Grant
- 2014-11-26 CA CA2929863A patent/CA2929863A1/en not_active Abandoned
- 2014-11-26 CN CN201480064906.8A patent/CN105848625B/en not_active Expired - Fee Related
- 2014-11-26 RU RU2016118811A patent/RU2669392C1/en not_active IP Right Cessation
- 2014-11-26 AU AU2014354787A patent/AU2014354787B2/en not_active Ceased
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2017
- 2017-10-12 AU AU2017245390A patent/AU2017245390B2/en not_active Ceased
Non-Patent Citations (1)
Title |
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None * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GR1010650B (en) * | 2023-01-17 | 2024-03-12 | Ιουλια Κλεωνος Τσετη | Pharmaceutical water-soluble paraketamol composition contained in a hermetically closed container for the preparation of beverages |
Also Published As
Publication number | Publication date |
---|---|
CN105848625A (en) | 2016-08-10 |
RU2669392C1 (en) | 2018-10-11 |
WO2015081145A1 (en) | 2015-06-04 |
EP3073981A1 (en) | 2016-10-05 |
AU2014354787A1 (en) | 2016-05-19 |
CA2929863A1 (en) | 2015-06-04 |
AU2014354787B2 (en) | 2017-08-10 |
AU2017245390A1 (en) | 2017-11-02 |
MX2016006449A (en) | 2016-07-19 |
AU2017245390B2 (en) | 2019-03-07 |
CN105848625B (en) | 2019-07-09 |
RU2016118811A (en) | 2017-12-28 |
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