EP2394931A1 - Conteneur et fermeture pour produits stérilisés ou à faible teneur en bactéries sans conservateurs - Google Patents
Conteneur et fermeture pour produits stérilisés ou à faible teneur en bactéries sans conservateurs Download PDFInfo
- Publication number
- EP2394931A1 EP2394931A1 EP11169358A EP11169358A EP2394931A1 EP 2394931 A1 EP2394931 A1 EP 2394931A1 EP 11169358 A EP11169358 A EP 11169358A EP 11169358 A EP11169358 A EP 11169358A EP 2394931 A1 EP2394931 A1 EP 2394931A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- ions
- container according
- zeolite
- products
- 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.)
- Granted
Links
- 230000001580 bacterial effect Effects 0.000 title claims abstract description 20
- 239000003755 preservative agent Substances 0.000 title claims abstract description 17
- 230000000844 anti-bacterial effect Effects 0.000 claims abstract description 72
- 239000000203 mixture Substances 0.000 claims abstract description 57
- 238000009516 primary packaging Methods 0.000 claims abstract description 15
- 239000010457 zeolite Substances 0.000 claims description 34
- -1 gold ions Chemical class 0.000 claims description 24
- 229910052709 silver Inorganic materials 0.000 claims description 22
- 238000004806 packaging method and process Methods 0.000 claims description 21
- 229910021536 Zeolite Inorganic materials 0.000 claims description 20
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 claims description 20
- 229910021645 metal ion Inorganic materials 0.000 claims description 19
- 239000004332 silver Substances 0.000 claims description 19
- 239000012815 thermoplastic material Substances 0.000 claims description 19
- 239000011701 zinc Substances 0.000 claims description 16
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 claims description 13
- 150000002500 ions Chemical class 0.000 claims description 13
- 241000894006 Bacteria Species 0.000 claims description 10
- 229910000166 zirconium phosphate Inorganic materials 0.000 claims description 10
- LEHFSLREWWMLPU-UHFFFAOYSA-B zirconium(4+);tetraphosphate Chemical compound [Zr+4].[Zr+4].[Zr+4].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O LEHFSLREWWMLPU-UHFFFAOYSA-B 0.000 claims description 10
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 7
- 229910000323 aluminium silicate Inorganic materials 0.000 claims description 5
- 235000012211 aluminium silicate Nutrition 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 239000005995 Aluminium silicate Substances 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 4
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 239000000919 ceramic Substances 0.000 claims description 3
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 2
- JYIBXUUINYLWLR-UHFFFAOYSA-N aluminum;calcium;potassium;silicon;sodium;trihydrate Chemical compound O.O.O.[Na].[Al].[Si].[K].[Ca] JYIBXUUINYLWLR-UHFFFAOYSA-N 0.000 claims description 2
- 229910001603 clinoptilolite Inorganic materials 0.000 claims description 2
- 239000010949 copper Substances 0.000 claims description 2
- 229910052802 copper Inorganic materials 0.000 claims description 2
- 229910052675 erionite Inorganic materials 0.000 claims description 2
- 229910052737 gold Inorganic materials 0.000 claims description 2
- 239000010931 gold Substances 0.000 claims description 2
- 229910052680 mordenite Inorganic materials 0.000 claims description 2
- 239000004417 polycarbonate Substances 0.000 claims description 2
- 229920000515 polycarbonate Polymers 0.000 claims description 2
- 239000002952 polymeric resin Substances 0.000 claims description 2
- 239000004800 polyvinyl chloride Substances 0.000 claims description 2
- 229910052665 sodalite Inorganic materials 0.000 claims description 2
- 229920003002 synthetic resin Polymers 0.000 claims description 2
- 229920002725 thermoplastic elastomer Polymers 0.000 claims description 2
- PZZYQPZGQPZBDN-UHFFFAOYSA-N aluminium silicate Chemical compound O=[Al]O[Si](=O)O[Al]=O PZZYQPZGQPZBDN-UHFFFAOYSA-N 0.000 claims 2
- UNYSKUBLZGJSLV-UHFFFAOYSA-L calcium;1,3,5,2,4,6$l^{2}-trioxadisilaluminane 2,4-dioxide;dihydroxide;hexahydrate Chemical compound O.O.O.O.O.O.[OH-].[OH-].[Ca+2].O=[Si]1O[Al]O[Si](=O)O1.O=[Si]1O[Al]O[Si](=O)O1 UNYSKUBLZGJSLV-UHFFFAOYSA-L 0.000 claims 1
- 229910052676 chabazite Inorganic materials 0.000 claims 1
- 229920005992 thermoplastic resin Polymers 0.000 abstract description 21
- 244000005700 microbiome Species 0.000 abstract description 18
- 239000000047 product Substances 0.000 description 55
- 229920005989 resin Polymers 0.000 description 8
- 239000011347 resin Substances 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- 230000035755 proliferation Effects 0.000 description 7
- 241000228245 Aspergillus niger Species 0.000 description 6
- 241000222122 Candida albicans Species 0.000 description 5
- 239000008187 granular material Substances 0.000 description 5
- 229920003023 plastic Polymers 0.000 description 5
- 239000004033 plastic Substances 0.000 description 5
- 229910052725 zinc Inorganic materials 0.000 description 5
- 208000034809 Product contamination Diseases 0.000 description 4
- 230000000845 anti-microbial effect Effects 0.000 description 4
- 235000013305 food Nutrition 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 241000233866 Fungi Species 0.000 description 3
- 239000002537 cosmetic Substances 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000002054 inoculum Substances 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 229920013716 polyethylene resin Polymers 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 238000004321 preservation Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- VAZJLPXFVQHDFB-UHFFFAOYSA-N 1-(diaminomethylidene)-2-hexylguanidine Polymers CCCCCCN=C(N)N=C(N)N VAZJLPXFVQHDFB-UHFFFAOYSA-N 0.000 description 2
- 229920002413 Polyhexanide Polymers 0.000 description 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 2
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 2
- 241000191967 Staphylococcus aureus Species 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 description 2
- 238000007664 blowing Methods 0.000 description 2
- 229940095731 candida albicans Drugs 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 230000000378 dietary effect Effects 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 229940127557 pharmaceutical product Drugs 0.000 description 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 101800001776 Nuclear inclusion protein B Proteins 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 238000010420 art technique Methods 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- MTAZNLWOLGHBHU-UHFFFAOYSA-N butadiene-styrene rubber Chemical compound C=CC=C.C=CC1=CC=CC=C1 MTAZNLWOLGHBHU-UHFFFAOYSA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000011081 inoculation Methods 0.000 description 1
- 239000012263 liquid product Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 1
- 229960002216 methylparaben Drugs 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229910052755 nonmetal Inorganic materials 0.000 description 1
- 239000006072 paste Substances 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
- 229960004906 thiomersal Drugs 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
- 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
-
- 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
- B65D1/0207—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
Definitions
- the present invention relates to a container and a relative closing element for sterilised products or products with low bacterial load free of preservatives.
- the present invention relates to a container and relative closing element suitable for limiting and/or reducing the growth of bacteria within a sterile product and/or with low bacterial load free of preservatives, during usage.
- the present invention further relates to a primary packaging device for the above-mentioned products as well as to the use of the above-mentioned device for limiting and/or reducing the growth of bacteria within these products during usage.
- a primary packaging device for the above-mentioned products as well as to the use of the above-mentioned device for limiting and/or reducing the growth of bacteria within these products during usage.
- products that may be stored in the containers of the present invention are pharmaceutical products, medical devices, cosmetic products, dietetic and food products. Such products may be in form of liquid, gel, suspension, paste, powder or granules.
- microorganisms naturally present in large amounts and various species, may contaminate products packaged in sterile conditions or with low bacterial load (for example pharmaceutical products) once the container is opened by the consumer and they can multiply very quickly, especially if the environmental conditions are not such as to favour the growth and proliferation thereof.
- microorganisms for example, bacteria, fungi, yeasts, mildews, etc.
- bacteria for example, bacteria, fungi, yeasts, mildews, etc.
- the packaging of pharmaceutical, cosmetic, dietetic and food products should prevent the product contamination by the microorganisms present in the environment outside the container as much as possible once it has been opened for the first time, that is, after the user has used the first product dose and has closed the container back to store the remaining product thereof for the subsequent administrations.
- the reclosable containers suitable for containing products intended for being used in portions (doses) at subsequent times are called pluridose or multidose containers.
- the formulations of the products of the above-mentioned type in the prior art are generally admixed with preserving substances, suitable for limiting or preventing the microbial growth that may develop within the same products during the usage thereof.
- preserving substances suitable for limiting or preventing the microbial growth that may develop within the same products during the usage thereof.
- Preservatives suitable for such purpose are, for example, benzalkonium chloride, sodium thiomersal, clorexidin, methylparaben, ethylparaben, propylparaben, phenol, polyhexamethylenebiguanide (PHMB), N-hydroxymethylglicinate, chlorbutanol.
- the use of containers provided with filters, or other mechanical devices that prevent the passage of microorganisms has been proposed in the prior art.
- the filters or other mechanical devices present in the container allows the output to the outside of the product and at the same time they prevent the inlet of microorganisms within the container.
- the containers having closing elements of the type described in WO0026100 ensure higher hygienic conditions than those of the containers having conventional closing elements; however, they are only suitable for containing products that do not require sterility or particularly low bacterial load conditions (for example food liquids), as on the other hand are the conditions required for the pharmaceutical or cosmetic products.
- the Applicant does not know any container for sterile products or with a low bacterial load, made of a plastic material, capable of reducing and/or preventing the concurrent proliferation of bacteria and fungi, such as Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus niger according to the requirements set forth by the European Pharmacopoeia, by the United States Pharmacopoeia and by the Japanese Pharmacopoeia.
- the object of the present invention is to overcome the drawbacks highlighted by the prior art.
- the object of the present invention is a reclosable container for sterilised products or products with low bacterial load free of preservatives, suitable for limiting and/or reducing the growth of bacteria within said products, characterised in that the inner surface of said container that may come to contact with said product is made of a thermoplastic resin comprising an antibacterial composition.
- a further object of the present invention is also a closing element for containers associable to a container of the above type, characterised in that it is made from a thermoplastic resin comprising an antibacterial composition.
- a further object of the present invention is a primary packaging device for sterile products or with low bacterial load free of preservatives comprising said container and said closing element.
- a further object of the present invention is the use of said primary packaging device for packaging sterile products or with low bacterial load free of preservatives.
- the primary packaging device is a dispensing device of the multidose type comprising a container, which contains a sterile product and/or with low bacterial load free of preservatives, and the relative closing element.
- the device may be opened by the user for taking a dose of the contents and then closed back for storing the product until the next use.
- the device prevents the product contamination by external microorganisms both during the pick up of a dose and between one pick up and the next one.
- thermoplastic material wherein an antibacterial composition is dispersed for making a reclosable container and the relative closing element allows making a packaging device suitable for containing sterile products or with low bacterial load that are preserved over time and also during the different usage steps (administration) of the product, preventing the addition of preservatives of any kind to the formulation of the product to be preserved.
- the container is an enclosure wherein at least the inner surface is made of a material consisting of a thermoplastic resin comprising an antibacterial composition.
- a thermoplastic resin comprising an antibacterial composition.
- inner surface of the container it is meant the surface that may come to contact with the product during the product packaging steps and the subsequent use by the end user.
- the enclosure that makes up the container is made entirely of said thermoplastic resin comprising an antibacterial composition.
- thermoplastic material suitable for making the container of the present invention and the relative closing element is a thermoplastic material comprising, or consisting of, a polymeric resin for example selected from: polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinylchloride (PVC), polycarbonate (PC) and thermoplastic rubber (for example, poly-butadiene-styrene (PBS)).
- a polymeric resin for example selected from: polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinylchloride (PVC), polycarbonate (PC) and thermoplastic rubber (for example, poly-butadiene-styrene (PBS)).
- the antibacterial composition is a chemical composition capable of exerting a prevention action in the proliferation of microorganisms and/or of reduction of the number thereof where these are present.
- antibacterial action shall be indicated as "antibacterial action”.
- microorganisms refers to unicellular organisms classified as bacteria, fungi, yeasts, mildews and spores.
- the antibacterial composition present in the thermoplastic resin comprises metal ions with antibacterial action.
- the metal ions with antibacterial action are selected from the group consisting of silver, copper, zinc, gold and mixtures thereof.
- silver ions are used due to the higher antibacterial efficacy thereof. Even more preferably, mixtures of silver ions and zinc ions are used.
- Metal ions are supported on solid supports, such as ceramic structures based on zirconium phosphate and/or on supports of the aluminium silicate type (zeolites).
- solid supports such as ceramic structures based on zirconium phosphate and/or on supports of the aluminium silicate type (zeolites).
- aluminium silicates that may be used to this end are the following: zeolite A, zeolite X, zeolite Y, zeolite T, sodalite, mordenite, analcite, clinoptilolite, cabazite, erionite and mixtures thereof.
- zeolites A are used due to the higher ionic exchange capability thereof.
- zeolites A containing silver ions even more preferably those containing silver and zinc ions at the same time due to the antibacterial efficacy against a larger number of microorganisms.
- compositions containing metal ions supported on structures based on zirconium phosphate are described in US 5296238 .
- the ions with antibacterial action are deposited on said supports based on zirconium phosphate or of the aluminium silicate type through deposition and/or ionic exchange reactions according to the known prior art techniques.
- the content of metal ions with antibacterial action present in the zeolites is lower than the ionic exchange saturation capability of zeolites. Therefore, besides containing the metal ions having a specific antibacterial action, the zeolites used for the purposes of the present invention may also contain other ions (metal and non metal), such as for example alkaline metals, alkaline-earth metals, protons and ammonium ions.
- the total content of metal ions with antibacterial action in zeolite is generally variable within the range 2-25% by weight referred to the weight of the dried zeolite, preferably within the range 5-20% by weight.
- the drying temperature of zeolites may vary according to the thermal stability of the different zeolites and of the type of counter-ions present; in the case of zeolite A, the reference drying temperature is within the range 400-800°C.
- Zeolites containing metal ions are available on the market.
- these may be supported on the same support (zeolite or structure based on zirconium phosphate) or on different supports.
- thermoplastic material comprising the antibacterial compositions described above may be intensified by suitably selecting the metal ions and the relative support.
- thermoplastic resins wherein an antibacterial composition comprising silver ions and zinc ions has been dispersed.
- the weight ratio between silver ions and zinc ions (Ag/Zn) in the antibacterial composition varies within the range 0.04 ⁇ Ag/Zn ⁇ 20, preferably within the range 0.15 ⁇ Ag/Zn ⁇ 10, more preferably within the range 0.31 ⁇ Ag/Zn ⁇ 1.
- This combination of ions is preferably supported on zeolitic structures, in particular on zeolites of the type A.
- the antibacterial compositions comprising silver and zinc ions allow obtaining packaging that meets the antimicrobial efficacy requirements set forth by the European Pharmacopoeia, by the United States Pharmacopoeia and by the Japanese Pharmacopoeia.
- the antibacterial compositions comprising silver and zinc ions, preferably supported on zeolites A, are capable of ensuring an effective action in limiting the proliferation and reducing the number of microorganisms Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus niger.
- the antibacterial compositions may contain one or more zeolites and/or supports based on zirconium phosphate exchanged with metal ions having an antibacterial action.
- An antibacterial composition having a given concentration of one or more metal ions may be prepared by mixing different supports having different concentrations of the metal ions, up to obtaining the desired concentration of ions with antibacterial action in the composition.
- the antibacterial composition may be prepared by mixing the respective supports exchanged with the metal ions (for example one type of ion per each support) in solid form (granules or powders).
- antibacterial compositions described above may be incorporated in the thermoplastic resins using the techniques and the equipment known in the field of thermoplastic material processing.
- the containers and the relative closing elements may be obtained in various shapes and dimensions.
- the antibacterial composition is generally added to the thermoplastic material in such amount as to have an overall concentration of metal ions with antibacterial action variable within the range 0.01-10.0% by weight referred to the weight of the thermoplastic material that makes up the container (and the relative closing element), preferably within the range 0.01-7.0% by weight, even more preferably within the range 0.1-5.0% by weight.
- the antibacterial compositions may be dispersed as a solid (granular or powder) in the thermoplastic resin, also at the solid state (granules) by mechanical mixing.
- the mixture of thermoplastic granules and antibacterial composition is then transformed into the end product (container and/or closing element) with the usual techniques for processing thermoplastic materials.
- the antibacterial compositions may be combined to the thermoplastic resin during the melting operation.
- thermoplastic materials comprise drawing (extrusion), moulding, injection, injection-blowing, extrusion-blowing and Blow-Fill-Seal.
- thermoplastic resin containing the antibacterial composition may also be extruded in the shape of small "pellets” (granules), usable subsequently as starting material for producing the containers and the relative closing elements with above-mentioned the techniques.
- the mechanism at the basis of the antibacterial action in the containers object of the present invention is essentially related to the contact between the antibacterial composition present on the surface of the thermoplastic material the container and the product contained therein are made of.
- the antibacterial efficacy depends in particular on the extension of the container surface in contact with the product and on the duration of such contact.
- the containers and the relative closing elements are made of are generally sufficient for ensuring the desired antibacterial action for a period of time compatible with the product usage time, in some particular cases however, the antibacterial performances of the container may not be sufficient for the intended use. This may happen, for example, if the container has walls with reduced thickness and thus exhibits reduced amounts of ions of the antibacterial composition on the inner surface in contact with the product.
- thermoplastic material comprising the antibacterial composition making containers with a suitable shape, such as those exemplified in figures 1 and 2 .
- Figure 1 schematically shows a primary packaging device 1 suitable for containing ophthalmic liquids (for example a collyrium) comprising a container 2 and the relative closing element 3.
- Device 1 also comprises a dropper 4, fixed on the closing element 3.
- Elements 2-4 of device 1 are made of a thermoplastic resin comprising an antibacterial composition according to the present invention.
- a liquid product 5 is present inside container 1 whose aseptic features obtained with the product sterilisation upon the packaging thereof are to be preserved.
- a projection 6 (in the specific case having a tubular shape) associated to the closing element 3 is provided within the container.
- Projection 6 is also made of a thermoplastic resin comprising an antibacterial composition and therefore it also has an antibacterial action when its surface comes to contact with the product 5 contained in container 2.
- the presence of projection 6, in practice, increases the overall surface the product can come to contact with during its preservation period inside container 2 during the use of the contained product.
- Figure 2 shows a second embodiment of the technical solution exemplified in figure 1.
- Figure 2 shows a primary packaging device 21 comprising a container 22 and the relative closing element 23.
- Device 21 also comprises a dropper 24, fixed to the closing element 23.
- Elements 22, 23 and 24 are made of a thermoplastic resin comprising an antibacterial composition according to the present invention.
- a product 5 (for example an ophthalmic liquid), the low bacterial load features whereof are to be preserved, is present inside container 22.
- container 22 may comprise one or more moveable bodies 25 therein, having at least the outer surface made of a thermoplastic resin comprising an antibacterial composition according to the invention.
- the moveable bodies 25, in particular the outer surface containing the antibacterial composition are in contact with product 5.
- the moveable bodies have such dimensions as to not come out of the packaging through the dropper opening, which only allows the spilling of product 5 for the administration to the user.
- the container may also have projections 27, associated for example to the bottom wall of the container, which extend inwards of the container. Also in the case of the device shown in figure 2 , the presence of the moveable bodies 25 and optionally of projections 27 increases the overall surface the product may come in contact with, during the storage within container 2, thus intensifying the own antibacterial action of the inner surface of container 22.
- a first primary packaging device comprising a container and relative closing element (packaging A) was prepared using a polyethylene resin for both components (container and closing element).
- An antibacterial composition comprising silver and zinc ions supported on a zeolite A was dispersed in the resin.
- Zeolite A contained 5% by weight of silver ions, 12% by weight of zinc ions (percentages by weight referred to the weight of exchanged and dried zeolite) and optional residual ammonium or hydrogen ions (that is, the original synthesis counter-ions of zeolite).
- the antibacterial composition was mixed with the resin in amounts equal to 2% by weight referred to the overall weight of the thermoplastic resin.
- a second primary packaging device comprising a container and the relative closing element (packaging B) was prepared with the same methods described in Example 1, using a polyethylene resin admixed with the same antibacterial composition as in Example 1.
- the antibacterial composition was mixed with the resin in amounts equal to 5% by weight referred to the overall weight of the thermoplastic resin.
- a third primary packaging device comprising a container and the relative closing element (packaging C) was prepared with the same methods described in Example 1, but using a polyethylene resin admixed with an antibacterial composition consisting of silver ions dispersed on a ceramic structure based on zirconium phosphate.
- the concentration of Ag ions on the support was equal to 30% by weight referred to the overall weight of the exchanged and dried support.
- the antibacterial composition was mixed with the resin in amounts equal to 8% by weight referred to the overall weight of the thermoplastic resin.
- the efficacy was assessed in terms of logarithmic reduction of the number of vital microorganisms compared to the number of microorganisms introduced with the inoculum.
- the experimental data show that the antibacterial composition of packagings A and B, wherein silver and zinc ions are present at the same time, is capable of meeting the requirements of the European Pharmacopoeia of Table 1.
- the data further show that the efficacy of the compound increases as its concentration in the resin increases.
- containers made with the same thermoplastic resin as in example 1 but containing the antibacterial composition in amounts equal to 1% by weight referred to the overall weight of the thermoplastic resin show an antibacterial efficacy comparable to that of packaging A.
- packaging C wherein the antibacterial composition only contains silver ions supported on zirconium phosphate, it is only partly effective against the tested bacteria and mildews, not respecting the reduction values expected in the case of the Aspergillus niger.
- the examples shows the efficacy of the devices of the present invention in limiting and reducing the growth of microorganisms; in particular, the experimental results confirm that the container and the relative closing element of Examples 1 and 2 may be used as packaging for the primary packaging of sterile products or with a low bacterial load free from preservatives in compliance with the requirements set forth by the European Pharmacopoeia, by the United States Pharmacopoeia and by the Japanese Pharmacopoeia.
- the yield test was run on some samples of device A of Example 1 according to the guidelines of the European Pharmacopoeia for the primary packaging devices of plastic material for pharmaceutical use. The test showed an average yield value of 12 ppm, lower than the maximum value allowed of 50 ppm.
- each device was filled with 10 ml of distilled water and stored sealed at controlled temperature of 25°C or 40°C for 10 days.
- the concentration of Ag and Zn ions present in the water was measured at the end of the storage period using the methods for determining zinc and silver IRSA CNR 3320 and IRSA CNR 3070.
- the content of Ag ions in the distilled water was of 0.006 micrograms/device, in the samples stored at 25°C, and of 0.002 micrograms/device in the samples stored at 40°C.
- the content of Zn ions was of 0.069 micrograms/device (25°C) and 1.167 micrograms/device (40°C). Ag and Zn ions are released in the product in negligible amounts.
- aureus ATCC 6538 5.7x10 6 4.4x 10 6 1.7x 10 6 0.53 ⁇ 1.0x 10 2 >5.76 0 >6.76 - - 0 >6.76 0 >6.76 0 >6.76 P.aeruginosa ATCC 9027 4.5x10 6 2.7x 10 6 ⁇ 1.0x 10 2 >4.65 0 >6.65 - - - - 0 >6.65 0 >6.65 0 >6.65 C. albicans ATCC 10231 4.9x10 5 4.4x 10 5 - - 6. 0x 10 2 2.91 1.1x 10 4.65 0 >5.69 0 >5.69 0 >5.69 A.
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Ceramic Engineering (AREA)
- Food Science & Technology (AREA)
- Packages (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI2010A001048A IT1401452B1 (it) | 2010-06-10 | 2010-06-10 | Contenitore e relativa chiusura per prodotti sterili e/o a bassa carica batterica privi di conservanti |
Publications (3)
Publication Number | Publication Date |
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EP2394931A1 true EP2394931A1 (fr) | 2011-12-14 |
EP2394931B1 EP2394931B1 (fr) | 2014-08-13 |
EP2394931B9 EP2394931B9 (fr) | 2014-11-19 |
Family
ID=43032703
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP20110169358 Active EP2394931B9 (fr) | 2010-06-10 | 2011-06-09 | Conteneur et fermeture pour produits stérilisés ou à faible teneur en bactéries sans conservateurs |
Country Status (3)
Country | Link |
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EP (1) | EP2394931B9 (fr) |
ES (1) | ES2523379T3 (fr) |
IT (1) | IT1401452B1 (fr) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IT201700017297A1 (it) * | 2017-02-16 | 2018-08-16 | The Bright Company Srl | Borraccia multiuso per la purificazione dei liquidi |
IT201800021265A1 (it) | 2018-12-27 | 2020-06-27 | S M P S R L | Materiale composto, contenitore e prodotto sterili |
IT202100002579A1 (it) * | 2021-02-05 | 2022-08-05 | Alexandria S R L | Contenitore per liquidi |
Citations (8)
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JPH03150122A (ja) * | 1989-07-12 | 1991-06-26 | Kamaya Kagaku Kogyo Co Ltd | 抗菌容器およびその製造方法 |
JPH03289476A (ja) * | 1990-04-05 | 1991-12-19 | Takeuchi Press Ind Co Ltd | 抗菌性容器 |
US5296238A (en) | 1991-02-26 | 1994-03-22 | Toagosei Chemical Industry Co., Inc. | Microbicides |
US5518774A (en) * | 1995-06-26 | 1996-05-21 | Olin Corporation | In-can and dry coating antimicrobial |
JPH08151083A (ja) * | 1994-11-30 | 1996-06-11 | Kenji Nakamura | 防菌効果のある嵌合容器 |
WO2000026100A1 (fr) | 1998-10-29 | 2000-05-11 | Agion Technologies L.L.C. | Fermetures plastiques bactericides pour recipients a boissons |
US6179141B1 (en) * | 1996-08-06 | 2001-01-30 | Kenji Nakamura | Container assembly provided with anitbacterial agent against slow-leak bacteria |
EP2113466A1 (fr) * | 2008-04-29 | 2009-11-04 | Adim Scandolara SpA | Tube flexible fabriqué à base de matériel plastique antibactérien, particulièrement pour le conditionnement de produits cosmétiques, pharmaceutiques et alimentaires |
-
2010
- 2010-06-10 IT ITMI2010A001048A patent/IT1401452B1/it active
-
2011
- 2011-06-09 EP EP20110169358 patent/EP2394931B9/fr active Active
- 2011-06-09 ES ES11169358.6T patent/ES2523379T3/es active Active
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
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JPH03150122A (ja) * | 1989-07-12 | 1991-06-26 | Kamaya Kagaku Kogyo Co Ltd | 抗菌容器およびその製造方法 |
JPH03289476A (ja) * | 1990-04-05 | 1991-12-19 | Takeuchi Press Ind Co Ltd | 抗菌性容器 |
US5296238A (en) | 1991-02-26 | 1994-03-22 | Toagosei Chemical Industry Co., Inc. | Microbicides |
JPH08151083A (ja) * | 1994-11-30 | 1996-06-11 | Kenji Nakamura | 防菌効果のある嵌合容器 |
US5518774A (en) * | 1995-06-26 | 1996-05-21 | Olin Corporation | In-can and dry coating antimicrobial |
US6179141B1 (en) * | 1996-08-06 | 2001-01-30 | Kenji Nakamura | Container assembly provided with anitbacterial agent against slow-leak bacteria |
WO2000026100A1 (fr) | 1998-10-29 | 2000-05-11 | Agion Technologies L.L.C. | Fermetures plastiques bactericides pour recipients a boissons |
EP2113466A1 (fr) * | 2008-04-29 | 2009-11-04 | Adim Scandolara SpA | Tube flexible fabriqué à base de matériel plastique antibactérien, particulièrement pour le conditionnement de produits cosmétiques, pharmaceutiques et alimentaires |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IT201700017297A1 (it) * | 2017-02-16 | 2018-08-16 | The Bright Company Srl | Borraccia multiuso per la purificazione dei liquidi |
IT201800021265A1 (it) | 2018-12-27 | 2020-06-27 | S M P S R L | Materiale composto, contenitore e prodotto sterili |
WO2020136556A1 (fr) * | 2018-12-27 | 2020-07-02 | S.M.P. S.R.L. | Matériau composite, récipient et produit stérile |
US12098014B2 (en) | 2018-12-27 | 2024-09-24 | S.M.P. S.R.L. | Compound material, container and sterile product |
IT202100002579A1 (it) * | 2021-02-05 | 2022-08-05 | Alexandria S R L | Contenitore per liquidi |
Also Published As
Publication number | Publication date |
---|---|
EP2394931B1 (fr) | 2014-08-13 |
IT1401452B1 (it) | 2013-07-26 |
ITMI20101048A1 (it) | 2011-12-11 |
ES2523379T3 (es) | 2014-11-25 |
EP2394931B9 (fr) | 2014-11-19 |
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