JP2019526591A5 - - Google Patents
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- Publication number
- JP2019526591A5 JP2019526591A5 JP2019512660A JP2019512660A JP2019526591A5 JP 2019526591 A5 JP2019526591 A5 JP 2019526591A5 JP 2019512660 A JP2019512660 A JP 2019512660A JP 2019512660 A JP2019512660 A JP 2019512660A JP 2019526591 A5 JP2019526591 A5 JP 2019526591A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutically acceptable
- group
- ezetimibe
- cellulose
- excipient
- 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
- OLNTVTPDXPETLC-XPWALMASSA-N ezetimibe Chemical compound N1([C@@H]([C@H](C1=O)CC[C@H](O)C=1C=CC(F)=CC=1)C=1C=CC(O)=CC=1)C1=CC=C(F)C=C1 OLNTVTPDXPETLC-XPWALMASSA-N 0.000 claims 19
- 229960000815 ezetimibe Drugs 0.000 claims 19
- 239000000546 pharmaceutical excipient Substances 0.000 claims 18
- 150000003839 salts Chemical class 0.000 claims 15
- 235000002639 sodium chloride Nutrition 0.000 claims 15
- 235000010980 cellulose Nutrition 0.000 claims 11
- 229920002678 cellulose Polymers 0.000 claims 11
- 239000001913 cellulose Substances 0.000 claims 11
- 239000007935 oral tablet Substances 0.000 claims 11
- 229940096978 oral tablet Drugs 0.000 claims 11
- BPRHUIZQVSMCRT-VEUZHWNKSA-N rosuvastatin Chemical compound CC(C)C1=NC(N(C)S(C)(=O)=O)=NC(C=2C=CC(F)=CC=2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(O)=O BPRHUIZQVSMCRT-VEUZHWNKSA-N 0.000 claims 11
- 229960000672 rosuvastatin Drugs 0.000 claims 11
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 10
- 239000011230 binding agent Substances 0.000 claims 9
- 239000000945 filler Substances 0.000 claims 9
- 229920002472 Starch Polymers 0.000 claims 8
- 150000002148 esters Chemical class 0.000 claims 8
- 239000012453 solvate Substances 0.000 claims 8
- 235000019698 starch Nutrition 0.000 claims 8
- 239000008107 starch Substances 0.000 claims 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 7
- 229930195725 Mannitol Natural products 0.000 claims 7
- 239000000594 mannitol Substances 0.000 claims 7
- 235000010355 mannitol Nutrition 0.000 claims 7
- 159000000000 sodium salts Chemical class 0.000 claims 7
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 6
- 239000007884 disintegrant Substances 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 6
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 5
- 235000021355 Stearic acid Nutrition 0.000 claims 5
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical compound [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 claims 5
- 229940063655 aluminum stearate Drugs 0.000 claims 5
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 5
- 235000013539 calcium stearate Nutrition 0.000 claims 5
- 239000008116 calcium stearate Substances 0.000 claims 5
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims 5
- 239000008187 granular material Substances 0.000 claims 5
- 229960001375 lactose Drugs 0.000 claims 5
- 239000008101 lactose Substances 0.000 claims 5
- 239000000314 lubricant Substances 0.000 claims 5
- 235000019359 magnesium stearate Nutrition 0.000 claims 5
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 5
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 5
- 239000008117 stearic acid Substances 0.000 claims 5
- 150000005846 sugar alcohols Chemical class 0.000 claims 5
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical class [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 4
- 229960001021 lactose monohydrate Drugs 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 3
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 3
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 3
- 239000004141 Sodium laurylsulphate Substances 0.000 claims 3
- 229940072056 alginate Drugs 0.000 claims 3
- 235000010443 alginic acid Nutrition 0.000 claims 3
- 229920000615 alginic acid Polymers 0.000 claims 3
- -1 alkyl sulphate Chemical compound 0.000 claims 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 3
- 229960000913 crospovidone Drugs 0.000 claims 3
- 239000008103 glucose Substances 0.000 claims 3
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 3
- 229920000609 methyl cellulose Polymers 0.000 claims 3
- 239000001923 methylcellulose Substances 0.000 claims 3
- 235000010981 methylcellulose Nutrition 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 3
- 239000003826 tablet Substances 0.000 claims 3
- 239000000454 talc Substances 0.000 claims 3
- 235000012222 talc Nutrition 0.000 claims 3
- 229910052623 talc Inorganic materials 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- 229920002261 Corn starch Polymers 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 2
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims 2
- 239000008120 corn starch Substances 0.000 claims 2
- 229960005168 croscarmellose Drugs 0.000 claims 2
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 2
- 150000004682 monohydrates Chemical class 0.000 claims 2
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 2
- NWZBFJYXRGSRGD-UHFFFAOYSA-M sodium;octadecyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCCCOS([O-])(=O)=O NWZBFJYXRGSRGD-UHFFFAOYSA-M 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims 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 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 229920001400 block copolymer Polymers 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 235000019329 dioctyl sodium sulphosuccinate Nutrition 0.000 claims 1
- YHAIUSTWZPMYGG-UHFFFAOYSA-L disodium;2,2-dioctyl-3-sulfobutanedioate Chemical compound [Na+].[Na+].CCCCCCCCC(C([O-])=O)(C(C([O-])=O)S(O)(=O)=O)CCCCCCCC YHAIUSTWZPMYGG-UHFFFAOYSA-L 0.000 claims 1
- 229940029140 ezetimibe 10 mg Drugs 0.000 claims 1
- 235000001727 glucose Nutrition 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 229910021653 sulphate ion Inorganic materials 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- 229920003169 water-soluble polymer Polymers 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CZPV2016-539 | 2016-09-05 | ||
| CZ2016-539A CZ2016539A3 (cs) | 2016-09-05 | 2016-09-05 | Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy |
| PCT/CZ2017/050037 WO2018041282A1 (en) | 2016-09-05 | 2017-08-31 | A pharmaceutical composition comprising rosuvastatin and ezetimibe and a preparation method thereof |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019526591A JP2019526591A (ja) | 2019-09-19 |
| JP2019526591A5 true JP2019526591A5 (enExample) | 2020-08-20 |
| JP7094944B2 JP7094944B2 (ja) | 2022-07-04 |
Family
ID=59955311
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019512660A Active JP7094944B2 (ja) | 2016-09-05 | 2017-08-31 | ロスバスタチン及びエゼチミブを含む医薬組成物並びにその調製方法 |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US11786526B2 (enExample) |
| EP (1) | EP3506888A1 (enExample) |
| JP (1) | JP7094944B2 (enExample) |
| KR (1) | KR102517765B1 (enExample) |
| CN (1) | CN110418637A (enExample) |
| CZ (1) | CZ2016539A3 (enExample) |
| EA (1) | EA201990652A1 (enExample) |
| IL (1) | IL265172B (enExample) |
| MA (1) | MA46100A (enExample) |
| MX (1) | MX389761B (enExample) |
| TW (1) | TWI811195B (enExample) |
| WO (1) | WO2018041282A1 (enExample) |
| ZA (1) | ZA201901342B (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7115825B2 (ja) * | 2017-06-28 | 2022-08-09 | 日医工株式会社 | エゼチミブ含有経口製剤及びその製造方法 |
| JP2019014700A (ja) * | 2017-07-11 | 2019-01-31 | 大原薬品工業株式会社 | エゼチミブ含有口腔内崩壊錠及びその製造方法 |
| WO2021019499A1 (en) | 2019-07-31 | 2021-02-04 | TECNIMEDE - Sociedade Técnico-medicinal, SA | Solid oral multiple-unit immediate release compositions, methods and uses thereof |
| WO2022023206A1 (en) * | 2020-07-27 | 2022-02-03 | Krka, D.D., Novo Mesto | Bilayer tablet comprising ezetimibe and atorvastatin |
| CN120000605A (zh) * | 2025-04-21 | 2025-05-16 | 山东齐都药业有限公司 | 瑞舒伐他汀依折麦布制剂及其制备方法 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE60319983T2 (de) * | 2003-09-01 | 2009-07-23 | Jpm - The Jordanian Pharmaceutical Manufacturing Co. Ltd. | Universelle Zusammensetzung zur kontrollierten Wirkstoffabgabe enthaltend Chitosan |
| WO2009024889A2 (en) | 2007-08-21 | 2009-02-26 | Ranbaxy Laboratories Limited | Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe |
| EP2168573A1 (en) | 2008-09-30 | 2010-03-31 | LEK Pharmaceuticals D.D. | Formulations comprising ezetimibe |
| EP2448919A2 (en) | 2009-07-02 | 2012-05-09 | Mahmut Bilgic | Solubility and stability enchancing pharmaceutical formulation |
| HUE038048T2 (hu) * | 2009-07-28 | 2018-09-28 | Egyt Gyogyszervegyeszeti Gyar | Új granulálási eljárás és ezzel elõállított granulátum |
| TR201009397A2 (tr) * | 2010-11-11 | 2012-05-21 | Bi̇lgi̇ç Mahmut | Rosuvastatin içeren farmasötik bileşimler. |
| WO2013066279A1 (en) | 2011-10-13 | 2013-05-10 | Mahmut Bilgic | Solid dosage forms comprising ezetimibe |
| US9763885B2 (en) * | 2012-05-01 | 2017-09-19 | Althera Laboratories Ltd. | Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases |
| MX2012014970A (es) * | 2012-12-18 | 2013-08-27 | Hetlabs Mexico S A De C V | Composiciones farmaceuticas que comprenden ezetimiba y rosuvastatina de calcio amorfo novedoso. |
| HU231036B1 (hu) * | 2013-09-30 | 2019-12-30 | Egis Gyógyszergyár Nyilvánosan Működő Részvénytársaság | Koleszterin bioszintézis gátló hatóanyagot és koleszterin abszorpciót gátló hatóanyagot tartalmazó kombinációs gyógyszerkészítmény |
| CN103585157B (zh) * | 2013-11-13 | 2016-02-03 | 武汉武药科技有限公司 | 一种含依折麦布和瑞舒伐他汀的双层片及其制备方法 |
| KR20150079373A (ko) * | 2013-12-30 | 2015-07-08 | 한미약품 주식회사 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 |
| KR101977785B1 (ko) * | 2014-06-25 | 2019-05-14 | 한미약품 주식회사 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법 |
| FR3030251B1 (fr) * | 2014-12-22 | 2018-11-02 | L'oreal | Composition comprenant un compose 4-(heterocycloalkyl)-benzene-1,3-diol et un solvant particulier |
| CN105310993A (zh) | 2015-11-17 | 2016-02-10 | 深圳信立泰药业股份有限公司 | 一种含有依折麦布的药物组合物及其制备方法 |
-
2016
- 2016-09-05 CZ CZ2016-539A patent/CZ2016539A3/cs unknown
-
2017
- 2017-08-31 CN CN201780067887.8A patent/CN110418637A/zh active Pending
- 2017-08-31 TW TW106129702A patent/TWI811195B/zh active
- 2017-08-31 IL IL265172A patent/IL265172B/en unknown
- 2017-08-31 US US16/330,268 patent/US11786526B2/en active Active
- 2017-08-31 EA EA201990652A patent/EA201990652A1/ru unknown
- 2017-08-31 EP EP17771980.4A patent/EP3506888A1/en active Pending
- 2017-08-31 JP JP2019512660A patent/JP7094944B2/ja active Active
- 2017-08-31 MX MX2019002516A patent/MX389761B/es unknown
- 2017-08-31 MA MA046100A patent/MA46100A/fr unknown
- 2017-08-31 KR KR1020197009428A patent/KR102517765B1/ko active Active
- 2017-08-31 WO PCT/CZ2017/050037 patent/WO2018041282A1/en not_active Ceased
-
2019
- 2019-03-04 ZA ZA2019/01342A patent/ZA201901342B/en unknown
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