EP3339206A1 - Tamper-evident single-use container for holding unitary doses and a system of a tamper-evident single-use container and a closure - Google Patents
Tamper-evident single-use container for holding unitary doses and a system of a tamper-evident single-use container and a closure Download PDFInfo
- Publication number
- EP3339206A1 EP3339206A1 EP16306737.4A EP16306737A EP3339206A1 EP 3339206 A1 EP3339206 A1 EP 3339206A1 EP 16306737 A EP16306737 A EP 16306737A EP 3339206 A1 EP3339206 A1 EP 3339206A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- tamper
- container body
- head section
- evident
- 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.)
- Pending
Links
- 239000000463 material Substances 0.000 claims abstract description 28
- 229920003023 plastic Polymers 0.000 claims abstract description 22
- 239000004033 plastic Substances 0.000 claims abstract description 22
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 6
- 229940127557 pharmaceutical product Drugs 0.000 claims abstract description 6
- 239000007787 solid Substances 0.000 claims abstract description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 32
- 239000007789 gas Substances 0.000 claims description 24
- -1 globules Substances 0.000 claims description 10
- 238000003466 welding Methods 0.000 claims description 10
- 239000000126 substance Substances 0.000 claims description 9
- 239000002274 desiccant Substances 0.000 claims description 8
- 239000013543 active substance Substances 0.000 claims description 7
- 229920000642 polymer Polymers 0.000 claims description 7
- 238000002788 crimping Methods 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 4
- 229940123973 Oxygen scavenger Drugs 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000008187 granular material Substances 0.000 claims description 3
- 239000006187 pill Substances 0.000 claims description 3
- 239000008188 pellet Substances 0.000 claims description 2
- 239000002417 nutraceutical Substances 0.000 claims 1
- 235000021436 nutraceutical agent Nutrition 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 description 7
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 6
- 239000001301 oxygen Substances 0.000 description 6
- 229920001577 copolymer Polymers 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 3
- 238000005452 bending Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 239000005977 Ethylene Substances 0.000 description 2
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 2
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- 239000006096 absorbing agent Substances 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 2
- VSCWAEJMTAWNJL-UHFFFAOYSA-K aluminium trichloride Chemical compound Cl[Al](Cl)Cl VSCWAEJMTAWNJL-UHFFFAOYSA-K 0.000 description 2
- QVQLCTNNEUAWMS-UHFFFAOYSA-N barium oxide Chemical compound [Ba]=O QVQLCTNNEUAWMS-UHFFFAOYSA-N 0.000 description 2
- 239000002585 base Substances 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000003344 environmental pollutant Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 150000004679 hydroxides Chemical class 0.000 description 2
- 229910052742 iron Inorganic materials 0.000 description 2
- KWGKDLIKAYFUFQ-UHFFFAOYSA-M lithium chloride Chemical compound [Li+].[Cl-] KWGKDLIKAYFUFQ-UHFFFAOYSA-M 0.000 description 2
- 229920001684 low density polyethylene Polymers 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 231100000719 pollutant Toxicity 0.000 description 2
- 229920000747 poly(lactic acid) Polymers 0.000 description 2
- 229920013730 reactive polymer Polymers 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 230000000284 resting effect Effects 0.000 description 2
- 229920001169 thermoplastic Polymers 0.000 description 2
- 239000012815 thermoplastic material Substances 0.000 description 2
- 229960005486 vaccine Drugs 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical class [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 229920001634 Copolyester Polymers 0.000 description 1
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 description 1
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical class O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 1
- 229920000877 Melamine resin Polymers 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004642 Polyimide Substances 0.000 description 1
- 229920002367 Polyisobutene Polymers 0.000 description 1
- 229920000265 Polyparaphenylene Polymers 0.000 description 1
- 239000004721 Polyphenylene oxide Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- 229920001807 Urea-formaldehyde Polymers 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 150000001299 aldehydes Chemical class 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- QYMGIIIPAFAFRX-UHFFFAOYSA-N butyl prop-2-enoate;ethene Chemical class C=C.CCCCOC(=O)C=C QYMGIIIPAFAFRX-UHFFFAOYSA-N 0.000 description 1
- 229910001622 calcium bromide Inorganic materials 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- WGEFECGEFUFIQW-UHFFFAOYSA-L calcium dibromide Chemical compound [Ca+2].[Br-].[Br-] WGEFECGEFUFIQW-UHFFFAOYSA-L 0.000 description 1
- BRPQOXSCLDDYGP-UHFFFAOYSA-N calcium oxide Chemical compound [O-2].[Ca+2] BRPQOXSCLDDYGP-UHFFFAOYSA-N 0.000 description 1
- 239000000292 calcium oxide Substances 0.000 description 1
- ODINCKMPIJJUCX-UHFFFAOYSA-N calcium oxide Inorganic materials [Ca]=O ODINCKMPIJJUCX-UHFFFAOYSA-N 0.000 description 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 description 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 239000012024 dehydrating agents Substances 0.000 description 1
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical class O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
- 239000003822 epoxy resin Substances 0.000 description 1
- HDERJYVLTPVNRI-UHFFFAOYSA-N ethene;ethenyl acetate Chemical class C=C.CC(=O)OC=C HDERJYVLTPVNRI-UHFFFAOYSA-N 0.000 description 1
- CGPRUXZTHGTMKW-UHFFFAOYSA-N ethene;ethyl prop-2-enoate Chemical class C=C.CCOC(=O)C=C CGPRUXZTHGTMKW-UHFFFAOYSA-N 0.000 description 1
- YYXLGGIKSIZHSF-UHFFFAOYSA-N ethene;furan-2,5-dione Chemical class C=C.O=C1OC(=O)C=C1 YYXLGGIKSIZHSF-UHFFFAOYSA-N 0.000 description 1
- 229920006245 ethylene-butyl acrylate Polymers 0.000 description 1
- 229920006244 ethylene-ethyl acrylate Polymers 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 235000019256 formaldehyde Nutrition 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- LNEPOXFFQSENCJ-UHFFFAOYSA-N haloperidol Chemical compound C1CC(O)(C=2C=CC(Cl)=CC=2)CCN1CCCC(=O)C1=CC=C(F)C=C1 LNEPOXFFQSENCJ-UHFFFAOYSA-N 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 230000001632 homeopathic effect Effects 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 229920004889 linear high-density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- QENHCSSJTJWZAL-UHFFFAOYSA-N magnesium sulfide Chemical compound [Mg+2].[S-2] QENHCSSJTJWZAL-UHFFFAOYSA-N 0.000 description 1
- 150000001247 metal acetylides Chemical class 0.000 description 1
- 229910044991 metal oxide Inorganic materials 0.000 description 1
- 150000004706 metal oxides Chemical class 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000002808 molecular sieve Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000005011 phenolic resin Substances 0.000 description 1
- 235000021317 phosphate Nutrition 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920006260 polyaryletherketone Polymers 0.000 description 1
- 229920001748 polybutylene Polymers 0.000 description 1
- 229920001707 polybutylene terephthalate Polymers 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920000647 polyepoxide Polymers 0.000 description 1
- 229920001601 polyetherimide Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920006324 polyoxymethylene Polymers 0.000 description 1
- 229920006380 polyphenylene oxide Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920005629 polypropylene homopolymer Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- URGAHOPLAPQHLN-UHFFFAOYSA-N sodium aluminosilicate Chemical group [Na+].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O URGAHOPLAPQHLN-UHFFFAOYSA-N 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 150000004763 sulfides Chemical class 0.000 description 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-L sulfite Chemical class [O-]S([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-L 0.000 description 1
- 150000004764 thiosulfuric acid derivatives Chemical class 0.000 description 1
- 229910052718 tin Inorganic materials 0.000 description 1
- 239000011135 tin Substances 0.000 description 1
- 229920006337 unsaturated polyester resin Polymers 0.000 description 1
- 239000012855 volatile organic compound Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 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
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
- B65D1/023—Neck construction
- B65D1/0238—Integral frangible closures
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
- B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
- B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
- B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
- B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
- B65D81/268—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants the absorber being enclosed in a small pack, e.g. bag, included in the package
-
- 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
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/04—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
Definitions
- the invention relates to a tamper-evident single-use container for holding unitary dose products and a system of a tamper-evident single-use container and a closure.
- Single-use containers for pharmaceutical products are especially known from single-dose containers for holding a vaccine.
- Vaccine or other types of serum are often stored in single-use containers made of glass which are provided with a breakable head.
- Such containers are not useful for holding unitary dose products like loose pills or capsules, lozenges or granules.
- unitary dose products are usually packaged in tubular containers which are closed with a conventional openable cover.
- prior art containers are not tamper-evident because the cover can be repeatedly opened and closed.
- An inventive tamper-evident single-use container for holding unitary dose products, especially solid pharmaceutical products comprises a container body made of plastic material with a bottom end and a tubular top end and a head section closing the top end, wherein the head section is integrally connected to the container body at a connecting region.
- the thickness of the plastic material at the connecting region is reduced by at least 50% as compared to the wall thickness of the container body.
- Such container made of plastic material is advantageous over single-use containers made of glass in that, when removing the head section from the container body and the material of the connecting region is broken, no sharp-edged chips will be generated. Further, the inventive container is handled in a straightforward way in that it is the perceived top end of the container which is removed. The container is inviolable apart from the connecting region integrally connecting the head section to the container body. Once the head section has been removed, the container can no longer be closed again so that any tampering with the container will immediately become evident.
- the body of the container can be of any shape including a cylindrical shape with a round, oval or polygonal base. However, apart from cylindrical shapes, the container body can be of any geometry including irregular shapes.
- the head section is provided with protrusions and/or depressions which promote a firm grip. This feature helps the user to apply the required force to break the container.
- the protrusions and/or depressions can be molded as a part of the head section or can be provided using a further separate part which can be manufactured by bi-injection molding, overmolding or which can be molded in a separate manufacturing step before it is mounted to the container.
- the container and its head section are molded using a sliding splitmould in order to demould the container.
- the separate part can be customized depending on the user or the specific product intended to be contained. To this end, the separate part can be individualized as regards the shape, color, material or texture just to mention some examples.
- the plastic material according to the invention is preferably made of a suitable plastic material which is preferably selected from the group comprising radical or linear high and low density polyethylenes, copolymers of ethylene such as for example ethylene vinyl acetates, ethylene ethyl acrylates, ethylene butyl acrylates, ethylene maleic anhydrides, ethylene alpha olefines, regard-less of the methods of polymerisation or modification by grafting, homo polypropylene and copolymers, polybutene-1, polyisobutylene.
- Polyolefines are preferably selected to make the single-use container for cost reasons and because they are easy to use.
- polymer materials can be considered however such as polyvinyl chloride, copolymers of vinyl chloride, polyvinylidene chlorides, polystyrenes, copolymers of styrene, derivatives of cellulose, polyamides, polycarbonates, polyoxymethylenes, polyethylene terephthalates, polybutylene terephthalates, copolyesters, polyphenylene oxides, polymethyl methacrylates, copolymers of acrylate, fluoride polymers, polyphenylene sulphides, polyarylsulphones, polyaryletherketones, polyetherimides, polyimides, polyurethanes, phenol resins, melamine resins, urea resins, epoxy resins and unsaturated polyester resins.
- polyvinyl chloride copolymers of vinyl chloride, polyvinylidene chlorides, polystyrenes, copolymers of styrene, derivatives of cellulose, polyamides, polycarbonates, poly
- Biodegradable polymer materials with for example a starch base, are also possible such as polylactic acids (PLA).
- PLA polylactic acids
- the polymer used to produce the single-use container can also contain one or more additives such as fibers, expanding agents, additives such as stabilizers and colorants, sliding agents, demolding agents, adhesion agents or reinforced catching agents and/or any others according to the requirements of usage.
- additives such as fibers, expanding agents, additives such as stabilizers and colorants, sliding agents, demolding agents, adhesion agents or reinforced catching agents and/or any others according to the requirements of usage.
- the single-use container can also be made from injectable materials made in such a way that they are capable of absorbing various different pollutants such as humidity, oxygen, odour and other possible pollutants.
- the thermoplastic materials are thus themselves formulated with active agents belonging to a group of humidity absorbers, oxygen scavengers, odour absorbers and/or emitters of humidity or volatile olfactory organic compounds.
- Suitable dehydrating agents are selected from a group comprising silica gels, dehydrating clays, activated alumina, calcium oxide, barium oxide, natural or synthetic zeolites, molecular or similar sieves, or deliquescent salts such as magnesium sulfide, calcium chloride, aluminum chloride, lithium chloride, calcium bromide, zink chloride or the like.
- the dehydrating agent is a molecular sieve and/or a silica gel.
- a suitable oxygen collecting agent is selected from a group comprising metal powders having a reducing capacity, in particular iron, zinc, tin powders, metal oxides still having the ability to oxidize, in particular ferrous oxide, as well as compounds of iron such as carbides, carbonyls, hydroxides, used alone or in the presence of an activator such as hydroxides, carbonates, sulfites, thiosulfates, phosphates, organic acid salts, or hydrogen salts of alkaline metals or alkaline earth metals, activated carbon, activated alumina or activated clays.
- metal powders having a reducing capacity in particular iron, zinc, tin powders, metal oxides still having the ability to oxidize, in particular ferrous oxide, as well as compounds of iron such as carbides, carbonyls, hydroxides, used alone or in the presence of an activator such as hydroxides, carbonates, sulfites, thiosulfates, phosphates, organic acid salts, or
- agents for collecting oxygen can also be chosen from specific reactive polymers such as those described for example in the patents US 5,736,616 , WO 99/48963 and WO 98/051758 . These specific reactive polymers can be mixed with a thermoplastic polymer used to produce the single-use container according to the present invention.
- the amount of treatment agent introduced into the thermoplastic polymer to produce the single-use container according to the present invention expressed in percentage by weight can advantageously vary from 5% to 70%, preferably from 5% to 55% of the thermoplastic material used to produce the single-use container.
- the container By reducing the thickness of the plastic material at the connecting region by at least 50% as compared to the wall thickness of the container body, the container will be opened at a well-defined position.
- the plastic material of the container comprises a plastic polymer composition including an active substance, the active substance preferably being a desiccant.
- an active substance preferably being a desiccant.
- a single-use container only will have to maintain a certain inner atmosphere up to its single use. Since a plastic container always shows a residual amount of permeation based on its material properties (transmission rate), undesired gases might penetrate the walls of the container, such substances can already become trapped before reaching the inside of the container. In such a way, the unitary dose products packaged inside the single-use container can be best protected against an undesired contact with harmful substances, like water vapor or oxygen.
- the active substance can be a desiccant or can be different from a desiccant. It can be any substance or mixture of substances which trap and/or release certain compounds. It is possible, just to give some examples, to hold the unitary dose products inside the container free of oxygen or free of volatile organic compounds such as for example formaldehydes or other aldehydes.
- the head section has a round outer shape, preferably generally spherical outer shape. This makes the head section easy to grip by a user when a certain force will have to be applied in order to break the frangible connecting region between the head section and the container body.
- the tamper-evident single-use container further comprises a gorge on the head section.
- a gorge provides some protection of the thin-walled connecting region against an inadvertent mechanical impact.
- a gorge has the advantage that the circumferential length of the connecting region is reduced.
- the overall area of the connecting region i.e. the product of the wall thickness and the length of the connecting region, is decisive.
- a gorge reduces the circumferential length of the connecting region and facilitates the breaking of the connecting region or, when this is not required, makes it possible to increase the wall thickness as compared to a container without a gorge on the head section in the region between the container body and the head section.
- the angle A between the wall section of the container body and the wall section of the head section at the connecting region is at least 10°.
- the angle A corresponds to the maximum possible tilting of the head section around an axis perpendicular to the longitudinal axis of the container relative to the container body before the head section contacts the container body and prevents a further relative tilting motion of the head section.
- Such minimum angle of at least 10° is sufficient to tilt the head section to a sufficient degree so that the container will break at the connecting region.
- the connecting region bridges a distance between the container body and the head section, the length 1 of the connecting region in the direction of the distance being defined by 0 ⁇ 1 ⁇ 1mm, more preferably 0 ⁇ 1 ⁇ 0,5mm.
- the connecting region is preferably arranged and dimensioned such that the connecting region can be broken by tilting the head section relative to the container body around an axis which is perpendicular to the longitudinal axis of the container. Examples in the prior art in which the connecting region can be broken by a relative rotation around the longitudinal axis of the tubular container body between the head section and the tubular container body requires a high force so that the wall thickness of the connecting region has to be made very small. This, however, makes the connecting region vulnerable against any inadvertent impacts.
- the maximum outer dimensions of the head section are such that the head section does not protrude beyond the outer extension of the tubular container body.
- the maximum outer dimensions of the head section is preferably smaller than the outer diameter of the tubular container body.
- the maximum outer dimensions of the head section are preferably larger than the inner diameter of the tubular container body. In this manner, the head section, once it has been broken, cannot be used to reclose the container body.
- the head section is shaped so that the head section, once removed from the container body, cannot be turned upside down and used to reclose the container body.
- This can be achieved e.g. by providing the upper part of the head section which is aligned with the fictitious extension of the inner wall surface of the cylindrical container body with a shape which cannot be inserted into the container body and become engaged therein.
- the tangent to that upper part of the head section which is aligned with the fictitious extension of the inner wall surface of the cylindrical container body should form an angle B to the longitudinal axis of the container body which exceeds 30°, preferably 45°.
- the cylindrical container body has an inner diameter d in and an outer diameter d out , and wherein a maximum outer outer diameter d head of the head section is selected to satisfy the equation d in ⁇ d head ⁇ d out .
- the wall thickness of the container body at the tubular top end thereof is at least 0.5mm, more preferred 0,8mm. This makes the plastic material of the container body sufficiently rigid in the region of the tubular top end such that the head can be easily broken while the container body maintains its basic shape without deforming or bending during breakage.
- the thickness of the plastic material at the connecting region is less than 0.5mm, preferably between 0.1mm and 0.5mm and more preferably between 0.1mm and 0.3mm. As outlined above, it is not the thickness alone of the plastic material of the connecting region, but also the length of the connecting region which determines the resistance of the single-use container against breaking at the contact region.
- single-use containers are usually of relatively small dimensions especially when storing pharmaceutical products. Therefore, on the basis of common sizes for such single-use containers for pharmaceutical substances, the above-mentioned range of the thickness of the plastic material was found to provide a sufficient stability to the container and, at the same time, to make it possible for an average adult to open the container by breaking the connecting region.
- the length of the connecting region is less than 0.3mm.
- the container body is provided with an interior annular shoulder close to its bottom end.
- an annular shoulder close to the bottom end provides a stop for receiving and positioning a cover for closing the container at its bottom end, especially if the cover is integrated in the container body without protruding beyond the bottom end.
- the bottom end of the container is closed by (heat) welding together the lower end of the container body.
- This is an easy-to-perform process step for closing the container once the unitary dose products to be stored inside the container have been inserted into the container. Further, no extra part for closing the container is required.
- the wall thickness at the open end of the container body shall not exceed preferably 0,5mm, most preferably 0,3mm.
- the thickness of the container wall is not constant: the open end of the container wall has preferably a wall thickness of 0,5mm or less to allow for the welding operation, whereas the top end of the container has a wall thickness of 0,5mm or more to be sufficiently rigid to allow for breaking the connecting region.
- the tamper-evident single-use container comprises a cover closing the bottom end of the container body.
- the provision of a cover is the easiest option for closing the single-use container after the product to be stored therein has been inserted.
- the cover is received in the bottom end of the container body such that it does not protrude beyond the bottom end in a longitudinal direction of the container body. In this manner, the cover cannot be easily removed and the container cannot be openend unless the user breaks the connecting region to the head section.
- the container can be filled by placing it on a conveying surface, upside down. After filling, a cover is assembled by e.g. placing the cover above the container opening and pressing the cover onto the container body.
- the cover is provided with a recess which, in the assembled state, faces toward the outside of the container.
- This recess is used to grip the cover in the process of placing the cover above the container opening and pushing the cover when closing the container.
- the cover has a flat surface facing, in the assembled state, the outside of the container.
- the assembly of such cover can use a vacuum holder.
- the container and the cover can be provided with interlocking form-fit elements like a circumferential groove on the container body and a corresponding shaped and arranged circumferential rib on the cover.
- the form-fit connection of the rib and the groove additionally provides a sealing contact between the container body and the cover.
- the position of the rib and the groove can be exchanged.
- a further advantage of the form-fit connection is the high resistance of the cover against being removed again from the container body. This increases the safety that the container cannot be opened and tampered with by unauthorized persons.
- the cover can be provided with a flexible skirt or a deformable lip around its circumference which further improves the sealing relationship between the cover and the container body because the skirt compensates because of its flexibility manufacturing tolerances as well as unevenness of either the cover or the container body.
- the cover is attached to the container body by welding, crimping or a force fit, more preferably by welding or crimping.
- the invention also relates to a system of a tamper-evident single-use container and a cover which is adapted to close the bottom end of the container.
- the production and the delivery of the basic structure of the container and the provision and delivery of the cover can be carried out separately because the cover will only be attached to the bottom end of the container once the unitary dose product will have been introduced into the interior of the container.
- the cover comprises gas treating agent.
- the cover comprises a chamber filled with a gas treating agent or holds a tablet, a canister, a packet filled with a gas treating agent, preferably a gas releasing agent or gas adsorbing agent.
- the gas treating agent is entrained within the resin forming the cover.
- the gas treating agent is an oxygen scavenger so that, once the single-use container has been closed by means of the cover, the inner atmosphere of the container can be brought to and maintained at a reduced oxygen level.
- the gas treating agent is a desiccant so that, once the single-use container has been closed by means of the cover, the inner atmosphere of the container can be brought to and maintained at a controlled humidity level.
- the gas treating agent can be any substance or mixture of substances which trap and/or release component from/into the container headspace.
- the tamper-evident feature and the possibility to tailor the inner atmosphere of the container has a specific use for storing a pharmaceutical solid substance, preferably loose pills, pellets, globules, granules, powder or capsules.
- Fig. 1 shows a single-use container 10 in a three dimensional view.
- Fig. 2 is the corresponding cross-sectional view.
- the container 10 consists of a tubular container body 12 with a bottom end or open end 14 and a top end 16.
- a head section 18 is integrally formed with the container body 12 at the top end 16 of the container body.
- the thickness d 2 of the material at the connecting region is between 0.1mm and 0.5mm and preferably between 0.1mm and 0.25mm.
- the connecting region 20, which is the frangible region of the inventive container is on the inner side of the wall of the container. In other words, it starts from the inner side 28 of the wall forming the container body 12 which faces the interior 30 of the container. This serves the purpose that, when the connecting region is broken, the broken section faces towards the inside of the container so that a user grasping the opened container does not contact possible sharp edges of the broken connecting region. Further, such broken container is suitable for direct oral supply of the medication contained therein.
- the container body is provided close to its bottom end 14 with a shoulder 26 which, as can be seen in Figs. 3 and 4 , serves to receive a cover 24 in order to close the container after the unitary dose product or products to be filled into the container have been introduced into the interior 30 of the container.
- the cover 24 is fixed to the container body 12 by means of a press fit. As can be seen from Figs. 3 and 4 , the cover 24 does not protrude beyond the bottom end 14 of the container body.
- the head section 18 of the container has a spherical shape forming an annular protrusion 38 to promote a firm grip of the head section 18 by a user.
- an angle A is formed between the wall sections of the container body and the head section adjacent to the connecting region 20. This angle is at least 10°.
- the container body 12, the head section 18 as well as the connecting region 20 are made of plastic material, here in a single piece. The same preferably applies to the cover 24.
- the cover 24 can hold a gas treating agent.
- the gas treating agent could be embedded into the composition of the cover and/or container body 12. Further, the gas treating agent could be provided by means of a canister or by means of an active tablet which can for example be made of compressed desiccant or desiccant entrained polymer.
- Such canister 32 is schematically shown in Fig. 5 .
- the cover 24 is provided with a ring-shaped holding structure 34 which, when the cover 24 is press fit in the container body 12, firmly holds the canister 32.
- the cover comprises a gas treating agent.
- the cover comprises a chamber filled with a gas treating agent or holding a tablet, a canister, a packet filled with a gas treating agent, preferably a gas releasing agent or gas adsorbing agent.
- the gas treating agent is entrained within the resin forming the cover.
- the container 10 as shown in Fig. 5 differs from that as shown in Fig. 4 by the additional provision of a head section 18 which has a further part 36 that can be bi-injected, overmolded or simply attached onto the head section 18 in order to provide another part of a different color or a different material.
- Different colors can e.g. be used to distinguish different products contained in the container, like different homeopathic products or different medication dosing or strength.
- a further advantage is that a container with a simple shape can be used before it is later on customized by the further part 36. Such a simple shape of the container can be naturally demoulded.
- the container as shown in Fig. 6 has a head section 18 with a different shape. Unlike the head section as shown in the embodiments of Figs. 1 to 5 , the head section according to Fig. 6 does not have a spherical shape. It is provided with protrusions 38 which enable a user to firmly grip the head section of the container before breaking the connecting region 20 in the process of opening the container.
- the bottom end 14 of the container body 12 is provided with a shoulder 26.
- the container body 12 can also have the same thickness over its interior length without forming a shoulder close to the bottom end 14.
- Figs. 7 to 10 corresponds to that as shown and explained above with reference to Figs. 1 to 4 .
- the cover 24 is secured to the bottom end 14 of the container body by "crimping".
- the term "crimping" is supposed to describe that the cover 24 is inserted into the lower part of the container body and resting against the shoulder 26. After this, it is secured to the container body 12 by applying heat and pressure on the bottom end 14 of the container body 12 so that the bottom end 14 is bent towards the interior of the container body 12 and generates a form fit which prevents the remove of the cover 24 from the container 10.
- the section 40 of the container body close to its bottom end 14 it is preferably made longer in the longitudinal direction of the container as compared to the corresponding lower part 40 as shown e.g. in Fig. 2 such that it can be conveniently bent over a sufficient distance so as to firmly hold the cover 24 resting against the shoulder 26 of the container body.
- the container body once it has been filled with the unitary dose product or products, is closed using a cover 24.
- the cover is either press fit into the container body or affixed to the container body by crimping, it could also be fixed to the container body by welding or glueing.
- the embodiment as shown in Figs. 11 to 13 differs from that according to the preceding embodiments in that the container is not closed by means of a cover but by welding the lower end of the container body. Further, the head section 18 has additional depressions 48 to promote a firm grip of the head section by a user. As can be seen in Figs. 11 to 13 , a section 42 starting from the bottom end 14 of the container is welded onto itself in order to close the container. In such a way, no additional cover is necessary. For sealing the bottom section 42, the container body should have a certain flexibility. In order to achieve this, the wall thickness d1 of the container body at its bottom end can be made smaller than the wall thickness at the tubular top end of the container.
- the container body at the tubular top end can be made with a material that is different from the remaining part of the tubular container body, the last being made of a more flexible material.
- a container can be molded in one single shot or in two shots depending on the overall size of the container.
- the tubular part of the container body can be made by extrusion (for example in LDPE with a constant wall thickness d1a) and then be provided by overmolding with an integrally molded top end and head section (for example in another material such as polypropylene or HDPE and with a wall thickness at the top end d1b which is larger than d1a). It is also possible to manufacture the top end and head section, and to combine it with the extruded tubular part of the container body by welding and especially heat fusing or ultrasonic welding.
- the connecting region 20 has a distinct length 1 which is at most 0.3 mm and can be oriented in a longitudinal direction parallel to the rotational axis O or in a radial direction.
- the embodiment according to Fig. 14 is advantageous over that according to Fig. 15 in that a broken connecting region which might have sharp edges seems to be not problematic as long as the connecting region extends towards the interior of the container body. In such a case, the opened container can be brought to the mouth of the user for direct oral supply of medication or single dose product.
- the connecting region 20 is in a radial direction and bridges a distance between the lower end of the head section 18 and the upper end of the tubular container body 12.
- the maximum diameter of the head section d head is smaller than the outer diameter d out of the container body 12 but smaller than the inner diameter d in of the container body 12. Once broken, the head section cannot be used to reclose the container body.
- the force F applied by the user will act at the apex position of the head section with the greatest diameter of the head section d head , which forms the protrusion 38 or in the embodiment according to Fig. 15 , will act in the middle of the longitudinal extension of the protrusion 38, i.e. the region with the greatest diameter of the head section.
- the tamper-evident single-use container according to the invention cannot be closed in a way such that a user will immediately recognize if the container has been tampered with.
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Abstract
Description
- The invention relates to a tamper-evident single-use container for holding unitary dose products and a system of a tamper-evident single-use container and a closure.
- Single-use containers for pharmaceutical products are especially known from single-dose containers for holding a vaccine. Vaccine or other types of serum are often stored in single-use containers made of glass which are provided with a breakable head.
- Such containers are not useful for holding unitary dose products like loose pills or capsules, lozenges or granules. Such unitary dose products are usually packaged in tubular containers which are closed with a conventional openable cover. However, such prior art containers are not tamper-evident because the cover can be repeatedly opened and closed.
- Accordingly, there is a need for a single-use container which is specifically adapted for holding unitary dose products, especially solid pharmaceutical products and which is tamper-evident.
- This object is solved by a tamper-evident single-use container for holding unitary dose products with the features of claim 1, a system of such a tamper-evident single-use container and a cover therefore with the features of
claim 16, and the use of such a container according toclaim 18. Preferred embodiments follow from the other claims. - An inventive tamper-evident single-use container for holding unitary dose products, especially solid pharmaceutical products, comprises a container body made of plastic material with a bottom end and a tubular top end and a head section closing the top end, wherein the head section is integrally connected to the container body at a connecting region. The thickness of the plastic material at the connecting region is reduced by at least 50% as compared to the wall thickness of the container body.
- Such container made of plastic material is advantageous over single-use containers made of glass in that, when removing the head section from the container body and the material of the connecting region is broken, no sharp-edged chips will be generated. Further, the inventive container is handled in a straightforward way in that it is the perceived top end of the container which is removed. The container is inviolable apart from the connecting region integrally connecting the head section to the container body. Once the head section has been removed, the container can no longer be closed again so that any tampering with the container will immediately become evident.
- The body of the container can be of any shape including a cylindrical shape with a round, oval or polygonal base. However, apart from cylindrical shapes, the container body can be of any geometry including irregular shapes.
- The head section is provided with protrusions and/or depressions which promote a firm grip. This feature helps the user to apply the required force to break the container.
- The protrusions and/or depressions can be molded as a part of the head section or can be provided using a further separate part which can be manufactured by bi-injection molding, overmolding or which can be molded in a separate manufacturing step before it is mounted to the container.
- In case that the protrusions and/or depressions are integrally molded as a part of the head section, the container and its head section are molded using a sliding splitmould in order to demould the container.
- In case of the provision of a separate part with the protrusions and/or depressions, this simplifies the moulding of the container and increases the production rate. Further, the separate part can be customized depending on the user or the specific product intended to be contained. To this end, the separate part can be individualized as regards the shape, color, material or texture just to mention some examples.
- The plastic material according to the invention is preferably made of a suitable plastic material which is preferably selected from the group comprising radical or linear high and low density polyethylenes, copolymers of ethylene such as for example ethylene vinyl acetates, ethylene ethyl acrylates, ethylene butyl acrylates, ethylene maleic anhydrides, ethylene alpha olefines, regard-less of the methods of polymerisation or modification by grafting, homo polypropylene and copolymers, polybutene-1, polyisobutylene. Polyolefines are preferably selected to make the single-use container for cost reasons and because they are easy to use.
- Other polymer materials can be considered however such as polyvinyl chloride, copolymers of vinyl chloride, polyvinylidene chlorides, polystyrenes, copolymers of styrene, derivatives of cellulose, polyamides, polycarbonates, polyoxymethylenes, polyethylene terephthalates, polybutylene terephthalates, copolyesters, polyphenylene oxides, polymethyl methacrylates, copolymers of acrylate, fluoride polymers, polyphenylene sulphides, polyarylsulphones, polyaryletherketones, polyetherimides, polyimides, polyurethanes, phenol resins, melamine resins, urea resins, epoxy resins and unsaturated polyester resins.
- Biodegradable polymer materials, with for example a starch base, are also possible such as polylactic acids (PLA).
- Combinations of these polymers can be used, if desired. The polymer used to produce the single-use container can also contain one or more additives such as fibers, expanding agents, additives such as stabilizers and colorants, sliding agents, demolding agents, adhesion agents or reinforced catching agents and/or any others according to the requirements of usage.
- The single-use container can also be made from injectable materials made in such a way that they are capable of absorbing various different pollutants such as humidity, oxygen, odour and other possible pollutants. The thermoplastic materials are thus themselves formulated with active agents belonging to a group of humidity absorbers, oxygen scavengers, odour absorbers and/or emitters of humidity or volatile olfactory organic compounds.
- Suitable dehydrating agents are selected from a group comprising silica gels, dehydrating clays, activated alumina, calcium oxide, barium oxide, natural or synthetic zeolites, molecular or similar sieves, or deliquescent salts such as magnesium sulfide, calcium chloride, aluminum chloride, lithium chloride, calcium bromide, zink chloride or the like. Preferably the dehydrating agent is a molecular sieve and/or a silica gel.
- A suitable oxygen collecting agent is selected from a group comprising metal powders having a reducing capacity, in particular iron, zinc, tin powders, metal oxides still having the ability to oxidize, in particular ferrous oxide, as well as compounds of iron such as carbides, carbonyls, hydroxides, used alone or in the presence of an activator such as hydroxides, carbonates, sulfites, thiosulfates, phosphates, organic acid salts, or hydrogen salts of alkaline metals or alkaline earth metals, activated carbon, activated alumina or activated clays.
- Other agents for collecting oxygen can also be chosen from specific reactive polymers such as those described for example in the patents
US 5,736,616 ,WO 99/48963 WO 98/051758 - The amount of treatment agent introduced into the thermoplastic polymer to produce the single-use container according to the present invention expressed in percentage by weight can advantageously vary from 5% to 70%, preferably from 5% to 55% of the thermoplastic material used to produce the single-use container.
- By reducing the thickness of the plastic material at the connecting region by at least 50% as compared to the wall thickness of the container body, the container will be opened at a well-defined position.
- Preferably, the plastic material of the container comprises a plastic polymer composition including an active substance, the active substance preferably being a desiccant. This is an especially advantageous embodiment because unlike multi-use containers which are opened and closed several times with an accompanying at least partial change of the inner atmosphere of the container, a single-use container only will have to maintain a certain inner atmosphere up to its single use. Since a plastic container always shows a residual amount of permeation based on its material properties (transmission rate), undesired gases might penetrate the walls of the container, such substances can already become trapped before reaching the inside of the container. In such a way, the unitary dose products packaged inside the single-use container can be best protected against an undesired contact with harmful substances, like water vapor or oxygen. The active substance, however, can be a desiccant or can be different from a desiccant. It can be any substance or mixture of substances which trap and/or release certain compounds. It is possible, just to give some examples, to hold the unitary dose products inside the container free of oxygen or free of volatile organic compounds such as for example formaldehydes or other aldehydes.
- Preferably, the head section has a round outer shape, preferably generally spherical outer shape. This makes the head section easy to grip by a user when a certain force will have to be applied in order to break the frangible connecting region between the head section and the container body.
- Preferably, the tamper-evident single-use container further comprises a gorge on the head section. Such design has various advantages. Firstly, a gorge provides some protection of the thin-walled connecting region against an inadvertent mechanical impact. Further, a gorge has the advantage that the circumferential length of the connecting region is reduced. For breaking the single-use container along the connecting region, the overall area of the connecting region, i.e. the product of the wall thickness and the length of the connecting region, is decisive. The provision of a gorge reduces the circumferential length of the connecting region and facilitates the breaking of the connecting region or, when this is not required, makes it possible to increase the wall thickness as compared to a container without a gorge on the head section in the region between the container body and the head section.
- Preferably, the angle A between the wall section of the container body and the wall section of the head section at the connecting region is at least 10°. The angle A corresponds to the maximum possible tilting of the head section around an axis perpendicular to the longitudinal axis of the container relative to the container body before the head section contacts the container body and prevents a further relative tilting motion of the head section. Such minimum angle of at least 10° is sufficient to tilt the head section to a sufficient degree so that the container will break at the connecting region.
- According to a preferred embodiment, the connecting region bridges a distance between the container body and the head section, the length 1 of the connecting region in the direction of the distance being defined by 0 ≤ 1 ≤ 1mm, more preferably 0 ≤ 1 ≤ 0,5mm. The connecting region is preferably arranged and dimensioned such that the connecting region can be broken by tilting the head section relative to the container body around an axis which is perpendicular to the longitudinal axis of the container. Examples in the prior art in which the connecting region can be broken by a relative rotation around the longitudinal axis of the tubular container body between the head section and the tubular container body requires a high force so that the wall thickness of the connecting region has to be made very small. This, however, makes the connecting region vulnerable against any inadvertent impacts.
- According to a preferred embodiment, the maximum outer dimensions of the head section are such that the head section does not protrude beyond the outer extension of the tubular container body. In other words, the maximum outer dimensions of the head section is preferably smaller than the outer diameter of the tubular container body. This characteristic feature helps to maintain the integrity of the container because any force acting on a container lying on its side will not generate a force which could break the container. This is especially the case when a high number of containers are stored in a way such that many containers are lying on their side and being stacked in multiple rows in top of each other.
- Furthermore, according to a preferred embodiment, the maximum outer dimensions of the head section are preferably larger than the inner diameter of the tubular container body. In this manner, the head section, once it has been broken, cannot be used to reclose the container body.
- Preferably, the head section is shaped so that the head section, once removed from the container body, cannot be turned upside down and used to reclose the container body. This can be achieved e.g. by providing the upper part of the head section which is aligned with the fictitious extension of the inner wall surface of the cylindrical container body with a shape which cannot be inserted into the container body and become engaged therein. Specifically, the tangent to that upper part of the head section which is aligned with the fictitious extension of the inner wall surface of the cylindrical container body should form an angle B to the longitudinal axis of the container body which exceeds 30°, preferably 45°.
- According to a most preferred embodiment, the cylindrical container body has an inner diameter din and an outer diameter dout, and wherein a maximum outer outer diameter dhead of the head section is selected to satisfy the equation din < dhead < dout.
- Preferably, the wall thickness of the container body at the tubular top end thereof is at least 0.5mm, more preferred 0,8mm. This makes the plastic material of the container body sufficiently rigid in the region of the tubular top end such that the head can be easily broken while the container body maintains its basic shape without deforming or bending during breakage.
- According to a preferred embodiment, the thickness of the plastic material at the connecting region is less than 0.5mm, preferably between 0.1mm and 0.5mm and more preferably between 0.1mm and 0.3mm. As outlined above, it is not the thickness alone of the plastic material of the connecting region, but also the length of the connecting region which determines the resistance of the single-use container against breaking at the contact region. However, single-use containers are usually of relatively small dimensions especially when storing pharmaceutical products. Therefore, on the basis of common sizes for such single-use containers for pharmaceutical substances, the above-mentioned range of the thickness of the plastic material was found to provide a sufficient stability to the container and, at the same time, to make it possible for an average adult to open the container by breaking the connecting region.
- Furthermore, according to a preferred embodiment, the length of the connecting region is less than 0.3mm.
- Preferably, the container body is provided with an interior annular shoulder close to its bottom end. The provision of an annular shoulder close to the bottom end provides a stop for receiving and positioning a cover for closing the container at its bottom end, especially if the cover is integrated in the container body without protruding beyond the bottom end.
- According to an alternative preferred embodiment of the invention, the bottom end of the container is closed by (heat) welding together the lower end of the container body. This is an easy-to-perform process step for closing the container once the unitary dose products to be stored inside the container have been inserted into the container. Further, no extra part for closing the container is required.
- In such an embodiment, the wall thickness at the open end of the container body shall not exceed preferably 0,5mm, most preferably 0,3mm. In such an embodiment, the thickness of the container wall is not constant: the open end of the container wall has preferably a wall thickness of 0,5mm or less to allow for the welding operation, whereas the top end of the container has a wall thickness of 0,5mm or more to be sufficiently rigid to allow for breaking the connecting region.
- Preferably, the tamper-evident single-use container comprises a cover closing the bottom end of the container body. The provision of a cover is the easiest option for closing the single-use container after the product to be stored therein has been inserted. Once the single-use container has been closed by means of a cover, it must no longer be possible to reopen the container by removing the cover again. Therefore, according a preferred embodiment of the invention, the cover is received in the bottom end of the container body such that it does not protrude beyond the bottom end in a longitudinal direction of the container body. In this manner, the cover cannot be easily removed and the container cannot be openend unless the user breaks the connecting region to the head section. The container can be filled by placing it on a conveying surface, upside down. After filling, a cover is assembled by e.g. placing the cover above the container opening and pressing the cover onto the container body.
- Preferably, the cover is provided with a recess which, in the assembled state, faces toward the outside of the container. This recess is used to grip the cover in the process of placing the cover above the container opening and pushing the cover when closing the container.
- As an alternative, the cover has a flat surface facing, in the assembled state, the outside of the container. The assembly of such cover can use a vacuum holder.
- The container and the cover can be provided with interlocking form-fit elements like a circumferential groove on the container body and a corresponding shaped and arranged circumferential rib on the cover. The form-fit connection of the rib and the groove additionally provides a sealing contact between the container body and the cover. The position of the rib and the groove can be exchanged. A further advantage of the form-fit connection is the high resistance of the cover against being removed again from the container body. This increases the safety that the container cannot be opened and tampered with by unauthorized persons.
- According to another preferred embodiment, the cover can be provided with a flexible skirt or a deformable lip around its circumference which further improves the sealing relationship between the cover and the container body because the skirt compensates because of its flexibility manufacturing tolerances as well as unevenness of either the cover or the container body.
- Preferably, the cover is attached to the container body by welding, crimping or a force fit, more preferably by welding or crimping.
- The invention also relates to a system of a tamper-evident single-use container and a cover which is adapted to close the bottom end of the container. The production and the delivery of the basic structure of the container and the provision and delivery of the cover can be carried out separately because the cover will only be attached to the bottom end of the container once the unitary dose product will have been introduced into the interior of the container.
- According to a preferred embodiment of the invention, the cover comprises gas treating agent. In an embodiment the cover comprises a chamber filled with a gas treating agent or holds a tablet, a canister, a packet filled with a gas treating agent, preferably a gas releasing agent or gas adsorbing agent. In another embodiment, the gas treating agent is entrained within the resin forming the cover. Thus, after the unitary dose product has been inserted into the container, the container will be closed by means of the cover. After this, the closed inner atmosphere of the container will be appropriately treated and maintained by means of the gas treating agent filled into the canister or chamber. in one embodiment, the gas treating agent is an oxygen scavenger so that, once the single-use container has been closed by means of the cover, the inner atmosphere of the container can be brought to and maintained at a reduced oxygen level. In another embodiment, the gas treating agent is a desiccant so that, once the single-use container has been closed by means of the cover, the inner atmosphere of the container can be brought to and maintained at a controlled humidity level. The gas treating agent can be any substance or mixture of substances which trap and/or release component from/into the container headspace.
- Because of its convenient use, the tamper-evident feature and the possibility to tailor the inner atmosphere of the container, it has a specific use for storing a pharmaceutical solid substance, preferably loose pills, pellets, globules, granules, powder or capsules.
- In the following, some preferred embodiments of the invention will be described with reference to the accompanying drawings, in which
- Figs. 1 and 2
- show a three dimensional view and a cross-sectional view of a first embodiment of the inventive container without a cover;
- Figs. 3 and 4
- show a three dimensional view and a cross-sectional view of the container according to
Figs. 1 and 2 but with acover 24; - Fig. 5
- shows a cross-sectional view of an alternative container similar to that according to
Fig. 4 but with a co-moulded head section; - Fig. 6
- shows a cross-sectional view of a further embodiment of the inventive container with a different shape of the head section;
- Figs. 7 and 8
- show a three dimensional view and a cross-sectional view of a further embodiment of the inventive container without a cover;
- Figs. 9 and 10
- show a three dimensional view and a cross-sectional view of the container according to
Figs. 7 and 8 but with acover 24 heat crimped after filling of the unitary dose product (not shown) - Fig. 11
- shows a side view of a further embodiment of an inventive container;
- Fig. 12
- shows another side view of the container according to
Fig. 11 ; - Fig. 13
- shows a three dimensional view of the container as shown in
Figs. 11 and 12 ; and - Figs. 14 and 15
- show schematic half-cuts of the upper part of the single-use container with different orientations of the connecting region.
- Throughout the description the same or similar elements will be denoted by the same reference numerals.
-
Fig. 1 shows a single-use container 10 in a three dimensional view.Fig. 2 is the corresponding cross-sectional view. Thecontainer 10 consists of atubular container body 12 with a bottom end oropen end 14 and atop end 16. Ahead section 18 is integrally formed with thecontainer body 12 at thetop end 16 of the container body. Between thetop end 16 of the container body and thehead section 18, there is a connectingregion 20 having a wall thickness d2 which is less than 50% of the thickness d1 of the tubular container body. Specifically, the thickness d2 of the material at the connecting region is between 0.1mm and 0.5mm and preferably between 0.1mm and 0.25mm. - Throughout the embodiments, the connecting
region 20, which is the frangible region of the inventive container, is on the inner side of the wall of the container. In other words, it starts from theinner side 28 of the wall forming thecontainer body 12 which faces the interior 30 of the container. This serves the purpose that, when the connecting region is broken, the broken section faces towards the inside of the container so that a user grasping the opened container does not contact possible sharp edges of the broken connecting region. Further, such broken container is suitable for direct oral supply of the medication contained therein. - The container body is provided close to its
bottom end 14 with ashoulder 26 which, as can be seen inFigs. 3 and 4 , serves to receive acover 24 in order to close the container after the unitary dose product or products to be filled into the container have been introduced into the interior 30 of the container. In the specific embodiment as shown inFigs. 3 and 4 , thecover 24 is fixed to thecontainer body 12 by means of a press fit. As can be seen fromFigs. 3 and 4 , thecover 24 does not protrude beyond thebottom end 14 of the container body. - The
head section 18 of the container has a spherical shape forming anannular protrusion 38 to promote a firm grip of thehead section 18 by a user. At the lower part of thehead section 18, there is a gorge orperipheral depression 22. Further, an angle A is formed between the wall sections of the container body and the head section adjacent to the connectingregion 20. This angle is at least 10°. - According to the invention, the
container body 12, thehead section 18 as well as the connectingregion 20 are made of plastic material, here in a single piece. The same preferably applies to thecover 24. - As an alternative or in addition to the provision of a plastic polymer composition including an active substance, the
cover 24 can hold a gas treating agent. The gas treating agent could be embedded into the composition of the cover and/orcontainer body 12. Further, the gas treating agent could be provided by means of a canister or by means of an active tablet which can for example be made of compressed desiccant or desiccant entrained polymer.Such canister 32 is schematically shown inFig. 5 . Thecover 24 is provided with a ring-shapedholding structure 34 which, when thecover 24 is press fit in thecontainer body 12, firmly holds thecanister 32. - In alternative embodiments, the cover comprises a gas treating agent. In an embodiment the cover comprises a chamber filled with a gas treating agent or holding a tablet, a canister, a packet filled with a gas treating agent, preferably a gas releasing agent or gas adsorbing agent. In another embodiment, the gas treating agent is entrained within the resin forming the cover.
- The
container 10 as shown inFig. 5 differs from that as shown inFig. 4 by the additional provision of ahead section 18 which has afurther part 36 that can be bi-injected, overmolded or simply attached onto thehead section 18 in order to provide another part of a different color or a different material. Different colors can e.g. be used to distinguish different products contained in the container, like different homeopathic products or different medication dosing or strength. A further advantage is that a container with a simple shape can be used before it is later on customized by thefurther part 36. Such a simple shape of the container can be naturally demoulded. - The container as shown in
Fig. 6 has ahead section 18 with a different shape. Unlike the head section as shown in the embodiments ofFigs. 1 to 5 , the head section according toFig. 6 does not have a spherical shape. It is provided withprotrusions 38 which enable a user to firmly grip the head section of the container before breaking the connectingregion 20 in the process of opening the container. - Throughout the embodiments as shown in
Figs. 1 to 6 , thebottom end 14 of thecontainer body 12 is provided with ashoulder 26. However, this is not necessarily the case. Thecontainer body 12 can also have the same thickness over its interior length without forming a shoulder close to thebottom end 14. - The embodiment of
Figs. 7 to 10 corresponds to that as shown and explained above with reference toFigs. 1 to 4 . The only difference, however, is the way in which thecover 24 is fixed to thecontainer body 12. In the embodiment as shown inFigs. 7 to 10 , thecover 24 is secured to thebottom end 14 of the container body by "crimping". The term "crimping" is supposed to describe that thecover 24 is inserted into the lower part of the container body and resting against theshoulder 26. After this, it is secured to thecontainer body 12 by applying heat and pressure on thebottom end 14 of thecontainer body 12 so that thebottom end 14 is bent towards the interior of thecontainer body 12 and generates a form fit which prevents the remove of thecover 24 from thecontainer 10. In order to enable the bending of thesection 40 of the container body close to itsbottom end 14, it is preferably made longer in the longitudinal direction of the container as compared to the correspondinglower part 40 as shown e.g. inFig. 2 such that it can be conveniently bent over a sufficient distance so as to firmly hold thecover 24 resting against theshoulder 26 of the container body. - Throughout the embodiments as shown in
Figs. 1 to 10 , the container body, once it has been filled with the unitary dose product or products, is closed using acover 24. Besides the specific embodiments as shown, in which the cover is either press fit into the container body or affixed to the container body by crimping, it could also be fixed to the container body by welding or glueing. - The embodiment as shown in
Figs. 11 to 13 differs from that according to the preceding embodiments in that the container is not closed by means of a cover but by welding the lower end of the container body. Further, thehead section 18 hasadditional depressions 48 to promote a firm grip of the head section by a user. As can be seen inFigs. 11 to 13 , asection 42 starting from thebottom end 14 of the container is welded onto itself in order to close the container. In such a way, no additional cover is necessary. For sealing thebottom section 42, the container body should have a certain flexibility. In order to achieve this, the wall thickness d1 of the container body at its bottom end can be made smaller than the wall thickness at the tubular top end of the container. Furthermore, or alternatively, the container body at the tubular top end can be made with a material that is different from the remaining part of the tubular container body, the last being made of a more flexible material. Such a container can be molded in one single shot or in two shots depending on the overall size of the container. For example, the tubular part of the container body can be made by extrusion (for example in LDPE with a constant wall thickness d1a) and then be provided by overmolding with an integrally molded top end and head section (for example in another material such as polypropylene or HDPE and with a wall thickness at the top end d1b which is larger than d1a). It is also possible to manufacture the top end and head section, and to combine it with the extruded tubular part of the container body by welding and especially heat fusing or ultrasonic welding. - The embodiments according to
Figs. 14 and 15 serve to illustrate general principles of the invention and are not limited to any geometries shown in addition to those as described below. As can be seen fromFigs. 14 and 15 , the connectingregion 20 has a distinct length 1 which is at most 0.3 mm and can be oriented in a longitudinal direction parallel to the rotational axis O or in a radial direction. The embodiment according toFig. 14 is advantageous over that according toFig. 15 in that a broken connecting region which might have sharp edges seems to be not problematic as long as the connecting region extends towards the interior of the container body. In such a case, the opened container can be brought to the mouth of the user for direct oral supply of medication or single dose product. - In the embodiment according to
Fig. 14 , the connectingregion 20 is in a radial direction and bridges a distance between the lower end of thehead section 18 and the upper end of thetubular container body 12. The maximum diameter of the head section dhead is smaller than the outer diameter dout of thecontainer body 12 but smaller than the inner diameter din of thecontainer body 12. Once broken, the head section cannot be used to reclose the container body. - When tilting the
head section 18 relative to thecontainer body 12, the force F applied by the user will act at the apex position of the head section with the greatest diameter of the head section dhead, which forms theprotrusion 38 or in the embodiment according toFig. 15 , will act in the middle of the longitudinal extension of theprotrusion 38, i.e. the region with the greatest diameter of the head section. In both cases, there is a considerable longitudinal distance between force F, which is the center of the force applied, and the connectingregion 20 which generates a sufficient bending moment on the frangible connecting region. This momentum reduces the effort to open the single-use container. - The tamper-evident single-use container according to the invention cannot be closed in a way such that a user will immediately recognize if the container has been tampered with.
Claims (18)
- Tamper-evident single-use container for holding unitary dose products, especially solid pharmaceutical products, comprising:- a container body (12) made of a plastic material with a bottom end (14) and a tubular top end (16); and- a head section (18) closing the top end (16); wherein the head section (18) is integrally connected to the container body (12) at a connecting region (20); wherein- the thickness of the plastic material at the connecting region (20) is reduced by at least 50% as compared to the wall thickness of the container body (12); and wherein- the head section (18) is provided with protrusions (38) and/or depressions (48).
- Tamper-evident single-use container according to claim 1, characterized in that the plastic material of the container (10) comprises a plastic polymer composition including an active substance, the active substance preferably being a desiccant.
- Tamper-evident single-use container according to claim 1 or 2, characterized in that the head section (18) has a round outer shape, preferably a generally spherical outer shape.
- Tamper-evident single-use container according to any of the preceding claims, further comprising a gorge (22) on the head section (18).
- Tamper-evident single-use container according to claim 4, wherein the angle (A) between the wall section of the container body (12) and the wall section of the head section (18) at the connecting region is at least 10°.
- Tamper-evident single-use container according to any of the preceding claims, characterized in that the maximum outer dimensions of the head section (18) are such that the head section (18) does not protrude beyond the outer extension of the tubular container body (12).
- Tamper-evident single-use container according to any of the preceding claims, characterized in that the thickness of the plastic material at the connecting region (20) is less than 0.5mm. Preferably is between 0.1 mm and 0.5 mm and more preferably between 0.1 mm and 0.3 mm.
- Tamper-evident single-use container according to any of the preceding claims, characterized in that the container body (12) is provided with an interior annular shoulder (26) close to the bottom end (14).
- Tamper-evident single-use container according to any of claims 1 to 8, characterized in that the bottom end (14) of the container (10) is closed by welding.
- Tamper-evident single-use container according to any of the claims 1 to 9, further comprising a cover (24) closing the bottom end (14) of the container body (12).
- Tamper-evident single-use container according to claim 11, characterized in that the cover (24) does not protrude beyond the bottom end (14) in a longitudinal direction of the container body (12).
- Tamper-evident single-use container according to claim 11 or 12, wherein the cover (24) is attached to the container body (12) by welding, crimping or a force fit.
- System of a tamper-evident single-use container (10) according to any of the claims 1 to 10 and a cover (24) which is adapted to close the bottom end (14) of the container (10).
- System of a tamper-evident single-use container and a cover according to claim 14, wherein the cover (24) holds a canister or an active tablet (22) comprising a gas treating agent, preferably a gas releasing agent or gas adsorbing agent.
- System of a tamper-evident single-use container and a cover according to claim 16, the gas treating agent being an oxygen scavenger or a desiccant.
- Use of the tamper-evident single-use container according to any of the claims 1 to 14, for storing a pharmaceutical or nutraceutical substance, preferably loose pills, pellets, globules, granules, powder or capsules.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16306737.4A EP3339206A1 (en) | 2016-12-20 | 2016-12-20 | Tamper-evident single-use container for holding unitary doses and a system of a tamper-evident single-use container and a closure |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16306737.4A EP3339206A1 (en) | 2016-12-20 | 2016-12-20 | Tamper-evident single-use container for holding unitary doses and a system of a tamper-evident single-use container and a closure |
Publications (1)
Publication Number | Publication Date |
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EP3339206A1 true EP3339206A1 (en) | 2018-06-27 |
Family
ID=57794094
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP16306737.4A Pending EP3339206A1 (en) | 2016-12-20 | 2016-12-20 | Tamper-evident single-use container for holding unitary doses and a system of a tamper-evident single-use container and a closure |
Country Status (1)
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EP (1) | EP3339206A1 (en) |
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FR2639026A1 (en) * | 1988-11-15 | 1990-05-18 | Air Sec Sa | Tube for once-only use |
EP0456532A1 (en) * | 1990-05-10 | 1991-11-13 | L'oreal | Bale-type device for applying a liquid or pasty product and process for manufacturing said device |
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WO1998051758A1 (en) | 1997-05-16 | 1998-11-19 | Chevron Chemical Company Llc | Photoinitiators and oxygen scavenging compositions |
WO1999048963A2 (en) | 1998-03-25 | 1999-09-30 | Chevron Phillips Chemical Company Lp | Oxygen scavengers with reduced oxidation products for use in plastic films and beverage and food containers |
DE102011115525A1 (en) * | 2011-10-11 | 2013-04-11 | Boehringer Ingelheim International Gmbh | Two-part bottle packaging device for containing pharmaceutical tablets or capsules, has bottle body and bottle base, where bottle is closed with pressure lock or with pressure lock injected at bottle body or with separate rotary lock |
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2016
- 2016-12-20 EP EP16306737.4A patent/EP3339206A1/en active Pending
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FR1181592A (en) * | 1958-07-21 | 1959-06-17 | Tuboplast France | Container with built-in stopper |
EP0076418A2 (en) * | 1981-10-02 | 1983-04-13 | Ermenegildo Montalbetti | Method for manufacturing sealed plastics containers, in particular flacons, vials, and/or the like, and containers obtained thereby |
US4703610A (en) * | 1986-07-21 | 1987-11-03 | Morris Bach | Unitary tamper proof container |
FR2639026A1 (en) * | 1988-11-15 | 1990-05-18 | Air Sec Sa | Tube for once-only use |
EP0456532A1 (en) * | 1990-05-10 | 1991-11-13 | L'oreal | Bale-type device for applying a liquid or pasty product and process for manufacturing said device |
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