HRP20220856T1 - Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe - Google Patents
Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe Download PDFInfo
- Publication number
- HRP20220856T1 HRP20220856T1 HRP20220856TT HRP20220856T HRP20220856T1 HR P20220856 T1 HRP20220856 T1 HR P20220856T1 HR P20220856T T HRP20220856T T HR P20220856TT HR P20220856 T HRP20220856 T HR P20220856T HR P20220856 T1 HRP20220856 T1 HR P20220856T1
- Authority
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- Croatia
- Prior art keywords
- pharmaceutical preparation
- preparation according
- total weight
- taste
- plasticizer
- Prior art date
Links
- 229960002232 sodium phenylbutyrate Drugs 0.000 title claims 4
- VPZRWNZGLKXFOE-UHFFFAOYSA-M sodium phenylbutyrate Chemical compound [Na+].[O-]C(=O)CCCC1=CC=CC=C1 VPZRWNZGLKXFOE-UHFFFAOYSA-M 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 14
- 239000011248 coating agent Substances 0.000 claims 5
- 238000000576 coating method Methods 0.000 claims 5
- 239000002202 Polyethylene glycol Substances 0.000 claims 4
- 230000000873 masking effect Effects 0.000 claims 4
- 239000004014 plasticizer Substances 0.000 claims 4
- 229920001223 polyethylene glycol Polymers 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 3
- 229940079593 drug Drugs 0.000 claims 3
- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 claims 2
- 206010010356 Congenital anomaly Diseases 0.000 claims 2
- 229920003119 EUDRAGIT E PO Polymers 0.000 claims 2
- 229920000881 Modified starch Polymers 0.000 claims 2
- 239000008118 PEG 6000 Substances 0.000 claims 2
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- NEDGUIRITORSKL-UHFFFAOYSA-N butyl 2-methylprop-2-enoate;2-(dimethylamino)ethyl 2-methylprop-2-enoate;methyl 2-methylprop-2-enoate Chemical group COC(=O)C(C)=C.CCCCOC(=O)C(C)=C.CN(C)CCOC(=O)C(C)=C NEDGUIRITORSKL-UHFFFAOYSA-N 0.000 claims 2
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 claims 2
- 239000000391 magnesium silicate Substances 0.000 claims 2
- 229910052919 magnesium silicate Inorganic materials 0.000 claims 2
- 235000019792 magnesium silicate Nutrition 0.000 claims 2
- 210000001161 mammalian embryo Anatomy 0.000 claims 2
- 230000004060 metabolic process Effects 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 208000015122 neurodegenerative disease Diseases 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- JKNCOURZONDCGV-UHFFFAOYSA-N 2-(dimethylamino)ethyl 2-methylprop-2-enoate Chemical compound CN(C)CCOC(=O)C(C)=C JKNCOURZONDCGV-UHFFFAOYSA-N 0.000 claims 1
- 241000208140 Acer Species 0.000 claims 1
- 208000014094 Dystonic disease Diseases 0.000 claims 1
- 208000001019 Inborn Errors Metabolism Diseases 0.000 claims 1
- 229920002774 Maltodextrin Polymers 0.000 claims 1
- 239000005913 Maltodextrin Substances 0.000 claims 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 208000018737 Parkinson disease Diseases 0.000 claims 1
- 239000011324 bead Substances 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 208000010118 dystonia Diseases 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 208000016245 inborn errors of metabolism Diseases 0.000 claims 1
- 201000008319 inclusion body myositis Diseases 0.000 claims 1
- 208000015978 inherited metabolic disease Diseases 0.000 claims 1
- 229940035034 maltodextrin Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 208000002320 spinal muscular atrophy Diseases 0.000 claims 1
- 239000006188 syrup Substances 0.000 claims 1
- 235000020357 syrup Nutrition 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 230000004143 urea cycle Effects 0.000 claims 1
- 210000002700 urine Anatomy 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
Claims (14)
1. Farmaceutski pripravak za oralnu primjenu natrijevog fenilbutirata, naznačen time, da sadrži:
50-65% spomenutog natrijevog fenilbutirata, prema ukupnoj masi; i
5-30% obloge za maskiranje okusa, koja sadrži polimer formiran od dimetilaminoetil metakrilata, butil metakrilata, i metil metakrilata, prema ukupnoj masi;
pri čemu polimer jest Eudragit E PO;
dok navedeni Eudragit E PO sadrži 50-75% po masi obloge za maskiranje okusa;
gdje se farmaceutski pripravak formulira kao mnoštvo sprejom nanesenih kuglica, koje sadrže jezgru zametka, sloj lijeka koji sadrži navedeni natrijev fenilbutirat, i navedenu oblogu za maskiranje okusa.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da spomenuti sloj lijeka nadalje sadrži vezivno sredstvo od 3-10% prema ukupnoj masi, dok poželjno pritom vezivno sredstvo jest HPMC E 5.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da spomenuti sloj lijeka nadalje sadrži plastifikator od 0,1-1% prema ukupnoj masi, dok poželjno pritom navedeni plastifikator jest polietilen glikol, još poželjnije navedeni polietilen glikol jest PEG6000.
4. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da spomenuta obloga za maskiranje okusa nadalje sadrži plastifikator od 1-9% prema ukupnoj masi, dok poželjno pritom navedeni plastifikator jest polietilen glikol, još poželjnije navedeni polietilen glikol jest PEG6000.
5. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da spomenuta obloga za maskiranje okusa nadalje sadrži hidrirani magnezijev silikat od 4-15% prema ukupnoj masi, dok poželjno pritom spomenuti hidrirani magnezijev silikat jest talk.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da spomenuti pripravak sadrži 1-35% prema ukupnoj masi, navedene jezgre zametka, dok poželjno pritom spomenuta jezgra zametka sadrži mikrokristalnu celulozu.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja:
prirođene pogreške u metabolizmu;
prirođene pogreške u metabolizmu koja je bolest urina mirisa javorovog sirupa; ili
prirođene pogreške u metabolizmu koja je poremećaj ciklusa uree.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja:
neurodegenerativnog poremećaja; ili
neurodegenerativnog poremećaja koji je Parkinsonova bolest.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja spinalne muskularne atrofije.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja inkluzijskog miozitisa tijela.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja distonije.
12. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 7 do 11, naznačen time, da se navedeni pripravak primjenjuje u kombinaciji s nosačem za doziranje i s tekućinom, tako da konačni viskozitet bude u rasponu od otprilike 50-1750 mPa.s (cP).
13. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da navedena tekućina je voda.
14. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12 ili 13, naznačen time, da nosač za doziranje je modificirani kukuruzni škrob ili kombinacija modificiranog kukuruznog škroba i maltodekstrina.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662308614P | 2016-03-15 | 2016-03-15 | |
PCT/US2016/057415 WO2017160345A1 (en) | 2016-03-15 | 2016-10-17 | Palatable compositions including sodium phenylbutyrate and uses thereof |
EP16894786.9A EP3429559B1 (en) | 2016-03-15 | 2016-10-17 | Palatable compositions including sodium phenylbutyrate and uses thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20220856T1 true HRP20220856T1 (hr) | 2022-10-14 |
Family
ID=59847918
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220856TT HRP20220856T1 (hr) | 2016-03-15 | 2016-10-17 | Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe |
Country Status (21)
Country | Link |
---|---|
US (5) | US20170266115A1 (hr) |
EP (2) | EP3429559B1 (hr) |
JP (2) | JP7136763B2 (hr) |
KR (1) | KR20190008840A (hr) |
AU (1) | AU2016398029B2 (hr) |
BR (1) | BR112018068665B1 (hr) |
CA (1) | CA3017573A1 (hr) |
DK (1) | DK3429559T3 (hr) |
ES (1) | ES2922749T3 (hr) |
HR (1) | HRP20220856T1 (hr) |
HU (1) | HUE059630T2 (hr) |
IL (2) | IL296490A (hr) |
LT (1) | LT3429559T (hr) |
MX (2) | MX2018011229A (hr) |
PL (1) | PL3429559T3 (hr) |
PT (1) | PT3429559T (hr) |
RS (1) | RS63383B1 (hr) |
SA (1) | SA518400020B1 (hr) |
SG (1) | SG11201807979SA (hr) |
SI (1) | SI3429559T1 (hr) |
WO (1) | WO2017160345A1 (hr) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20190008840A (ko) | 2016-03-15 | 2019-01-25 | 에이서 테라퓨틱스 인크. | 소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도 |
EP4178562A1 (en) * | 2020-07-07 | 2023-05-17 | Acer Therapeutics Inc. | Methods of administering taste masked phenylbutyrate and compositions therefor |
CN113332267A (zh) * | 2021-03-31 | 2021-09-03 | 中山大学孙逸仙纪念医院 | 苯丁酸钠在制备预防或治疗帕金森病的药物中的应用 |
IT202100019613A1 (it) | 2021-07-23 | 2023-01-23 | Kolfarma S R L | Formulazione farmaceutica o di integratore alimentare contenente alfa-lattoalbumina e acido butirrico o un suo sale |
CN216570857U (zh) * | 2021-08-11 | 2022-05-24 | Acer治疗公司 | 改善药物物质适口性的剂型和多个剂型 |
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EP2599477A1 (en) * | 2011-11-30 | 2013-06-05 | Lunamed AG | 4-Phenylbutyric acid sustained release formulation |
US8993041B2 (en) | 2012-10-15 | 2015-03-31 | New Jersey Institute Of Technology | Taste masked active pharmaceutical powder compositions and processes for making them |
CN105560203A (zh) | 2013-01-28 | 2016-05-11 | 万平 | 定位速释生物粘附剂及其制备方法和应用 |
JP6147711B2 (ja) | 2014-05-26 | 2017-06-14 | 富士フイルム株式会社 | 医薬用組成物及びその製造方法、並びに口腔内崩壊錠及びその製造方法 |
KR20190008840A (ko) | 2016-03-15 | 2019-01-25 | 에이서 테라퓨틱스 인크. | 소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도 |
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2016
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- 2016-10-17 RS RS20220651A patent/RS63383B1/sr unknown
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- 2016-10-17 HU HUE16894786A patent/HUE059630T2/hu unknown
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- 2016-10-17 AU AU2016398029A patent/AU2016398029B2/en active Active
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- 2016-10-17 DK DK16894786.9T patent/DK3429559T3/da active
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2018
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2020
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