RU2016138577A - Жидкая фармцевтическая композиция - Google Patents
Жидкая фармцевтическая композиция Download PDFInfo
- Publication number
- RU2016138577A RU2016138577A RU2016138577A RU2016138577A RU2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A
- Authority
- RU
- Russia
- Prior art keywords
- pharmaceutical composition
- liquid pharmaceutical
- composition according
- sodium
- magnesium oxide
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title claims 13
- 239000008194 pharmaceutical composition Substances 0.000 title claims 13
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 9
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 230000003113 alkalizing effect Effects 0.000 claims 3
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000000395 magnesium oxide Substances 0.000 claims 3
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims 3
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims 3
- 239000001630 malic acid Substances 0.000 claims 3
- 235000011090 malic acid Nutrition 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- GOZDTZWAMGHLDY-UHFFFAOYSA-L sodium picosulfate Chemical compound [Na+].[Na+].C1=CC(OS(=O)(=O)[O-])=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OS([O-])(=O)=O)C=C1 GOZDTZWAMGHLDY-UHFFFAOYSA-L 0.000 claims 3
- 229960005077 sodium picosulfate Drugs 0.000 claims 3
- 239000003002 pH adjusting agent Substances 0.000 claims 2
- 239000002244 precipitate Substances 0.000 claims 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonium chloride Substances [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims 1
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims 1
- 235000011114 ammonium hydroxide Nutrition 0.000 claims 1
- 210000001072 colon Anatomy 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000001508 potassium citrate Substances 0.000 claims 1
- 229960002635 potassium citrate Drugs 0.000 claims 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims 1
- 235000011082 potassium citrates Nutrition 0.000 claims 1
- 235000011118 potassium hydroxide Nutrition 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000008213 purified water Substances 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 235000011121 sodium hydroxide Nutrition 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4425—Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- 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
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
-
- 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
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (10)
1. Жидкая фармацевтическая композиция, которая является физически и химически стабильной, содержащая пикосульфат натрия, оксид магния, лимонную кислоту и яблочную кислоту.
2. Жидкая фармацевтическая композиция по п. 1, которую используют для очищения толстого кишечника.
3. Жидкая фармацевтическая композиция по п. 1, где однократная доза жидкой фармацевтической композиции находится в диапазоне от 50 мл до 500 мл.
4. Жидкая фармацевтическая композиция по п. 1, где рН жидкой фармацевтической композиции находится в диапазоне от 4,1 до 5,4.
5. Жидкая фармацевтическая композиция по п. 1, содержащая эксципиент и очищенную воду.
6. Жидкая фармацевтическая композиция по п. 5, где эксципиент представляет собой по меньшей мере один эксципиент, выбранный из группы, состоящей из регулирующего рН агента, стабилизатора, консерванта, подсластителя и ароматизирующего ингредиента.
7. Жидкая фармацевтическая композиция по п. 6, где регулирующий рН агент представляет собой подщелачивающий агент.
8. Жидкая фармацевтическая композиция по п. 7, где подщелачивающий агент представляет собой по меньшей мере один подщелачивающий агент, выбранный из группы, состоящей из гидроксида натрия, гидроксида калия, бикарбоната натрия, раствора аммиака, цитрата калия, триэтаноламина и цитрата натрия.
9. Жидкая фармацевтическая композиция по п. 1, где пикосульфат натрия, оксид магния, лимонная кислота и яблочная кислота имеют массовое соотношение 0,003~0,009:1~3:3,5~10,5:0,01~13 (пикосульфат натрия : оксид магния : лимонная кислота : яблочная кислота).
10. Жидкая фармацевтическая композиция по п. 1, где физическая и химическая стабильность означает, что в течение 24 месяцев образуются примеси в количестве 2,0 мас.%, или меньше, и не происходит образования осадка, или образуется осадок в количестве 5,0 об.% или меньше.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2014-0032242 | 2014-03-19 | ||
| KR1020140032242A KR101420315B1 (ko) | 2014-03-19 | 2014-03-19 | 약학적 액제 조성물 |
| PCT/KR2014/005512 WO2015141897A1 (ko) | 2014-03-19 | 2014-06-23 | 약학적 액제 조성물 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2016138577A true RU2016138577A (ru) | 2018-04-20 |
| RU2668882C2 RU2668882C2 (ru) | 2018-10-04 |
Family
ID=51742358
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2016138577A RU2668882C2 (ru) | 2014-03-19 | 2014-06-23 | Жидкая фармацевтическая композиция |
Country Status (11)
| Country | Link |
|---|---|
| US (4) | US9827231B2 (ru) |
| EP (1) | EP3120835B1 (ru) |
| JP (1) | JP6347891B2 (ru) |
| KR (1) | KR101420315B1 (ru) |
| CN (1) | CN106456534B (ru) |
| AU (1) | AU2014386903B2 (ru) |
| CA (1) | CA2942878C (ru) |
| ES (1) | ES2907324T3 (ru) |
| MX (1) | MX366499B (ru) |
| RU (1) | RU2668882C2 (ru) |
| WO (1) | WO2015141897A1 (ru) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101420315B1 (ko) | 2014-03-19 | 2014-07-17 | 남봉길 | 약학적 액제 조성물 |
| JP2018523694A (ja) * | 2015-08-17 | 2018-08-23 | フェリング ベスローテン フェンノートシャップ | ピコスルファートおよびクエン酸マグネシウムを含む液体製剤 |
| CN108601842A (zh) * | 2016-01-28 | 2018-09-28 | 西梯茜生命工学股份有限公司 | 泻药组合物 |
| TW201804996A (zh) * | 2016-07-08 | 2018-02-16 | 輝凌責任有限公司 | 含有匹可硫酸鹽(picosulfate)之安定液體調配物 |
| KR101839773B1 (ko) | 2016-12-07 | 2018-03-19 | (주)대명산업 | 해초제거제 |
| KR101960268B1 (ko) * | 2017-01-04 | 2019-03-21 | 어업회사법인 블루오션(주) | 녹조류 제거제 |
| US11471447B2 (en) | 2019-06-20 | 2022-10-18 | Hetero Labs Limited | Stable pharmaceutical product and vessel comprising sodium picosulfate, magnesium oxide and citric acid |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JPS5697248A (en) | 1979-12-28 | 1981-08-05 | Tanaka Shiro | Conjugated compound of calcium citrate and calcium malate and its preparation |
| US5010069A (en) | 1989-05-15 | 1991-04-23 | Marion Laboratories, Inc. | Stable liquid form of 5-aminosalicylic acid |
| FR2647347A1 (fr) | 1989-05-24 | 1990-11-30 | Lucien Laboratoires | Agents et complexes de l'ion mg2+ facilitant l'absorption du magnesium dans un organisme humain ou animal, et compositions pharmaceutiques ou dietetiques utilisables pour l'administration de magnesium dans un organisme humain ou animal |
| JP2557111B2 (ja) | 1989-11-27 | 1996-11-27 | フジックス 株式会社 | 高濃度のマグネシウム溶液の製造方法及びそれによって得られたマグネシウム溶液並びにその用途 |
| ATE121719T1 (de) | 1990-06-14 | 1995-05-15 | Procter & Gamble | Calciumcitrat/malat-gemisch. |
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| ES2659716T3 (es) | 2007-10-12 | 2018-03-19 | Ferring International Center S.A. | Proceso para la fabricación de un producto farmacéutico que comprende ácido cítrico, óxido de magnesio, bicarbonato potásico y picosulfato sódico, composición farmacéutica que comprende gránulos obtenidos por tal proceso y productos intermedios de la misma |
| WO2011078828A1 (en) * | 2009-12-25 | 2011-06-30 | Mahmut Bilgic | Pharmaceutical composition with high purity |
| EP2568959A2 (en) * | 2010-05-14 | 2013-03-20 | Mahmut Bilgic | Formulations comprising a third generation cephalosporin and clavulanic acid |
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| EP2787982B1 (en) * | 2011-12-07 | 2023-03-08 | MSM Innovations, Inc. | Composition for bowel preparation |
| KR101155099B1 (ko) | 2012-03-29 | 2012-06-11 | 남봉길 | 장 세척용 조성물의 제조 방법 및 이에 의해 제조된 장 세척용 조성물 |
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| KR20150046310A (ko) * | 2012-08-29 | 2015-04-29 | 샐릭스 파마슈티컬스 인코포레이티드 | 완화제 조성물 및 변비 및 관련 위장관 질병 및 증상 치료를 위한 방법 |
| KR101517520B1 (ko) * | 2013-08-05 | 2015-05-04 | 이희엽 | 피코황산나트륨 함유 장 세척용 조성물의 제조방법 |
| IN2013MU02911A (ru) | 2013-09-10 | 2015-07-03 | Cadila Healthcare Ltd | |
| KR101420315B1 (ko) | 2014-03-19 | 2014-07-17 | 남봉길 | 약학적 액제 조성물 |
| JP2018523694A (ja) | 2015-08-17 | 2018-08-23 | フェリング ベスローテン フェンノートシャップ | ピコスルファートおよびクエン酸マグネシウムを含む液体製剤 |
| TW201804996A (zh) | 2016-07-08 | 2018-02-16 | 輝凌責任有限公司 | 含有匹可硫酸鹽(picosulfate)之安定液體調配物 |
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2014
- 2014-03-19 KR KR1020140032242A patent/KR101420315B1/ko active IP Right Grant
- 2014-06-23 CN CN201480078319.4A patent/CN106456534B/zh active Active
- 2014-06-23 RU RU2016138577A patent/RU2668882C2/ru active
- 2014-06-23 MX MX2016011938A patent/MX366499B/es active IP Right Grant
- 2014-06-23 WO PCT/KR2014/005512 patent/WO2015141897A1/ko active Application Filing
- 2014-06-23 AU AU2014386903A patent/AU2014386903B2/en active Active
- 2014-06-23 ES ES14886464T patent/ES2907324T3/es active Active
- 2014-06-23 EP EP14886464.8A patent/EP3120835B1/en active Active
- 2014-06-23 CA CA2942878A patent/CA2942878C/en active Active
- 2014-06-23 JP JP2017500775A patent/JP6347891B2/ja active Active
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2016
- 2016-07-20 US US15/214,768 patent/US9827231B2/en active Active
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2017
- 2017-11-27 US US15/822,298 patent/US10624879B2/en active Active
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2020
- 2020-04-13 US US16/847,608 patent/US11191753B2/en active Active
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2021
- 2021-12-03 US US17/542,052 patent/US20220193052A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| AU2014386903B2 (en) | 2020-01-30 |
| EP3120835A1 (en) | 2017-01-25 |
| US20200345708A1 (en) | 2020-11-05 |
| US20180235947A1 (en) | 2018-08-23 |
| US20220193052A1 (en) | 2022-06-23 |
| AU2014386903A1 (en) | 2016-11-03 |
| JP6347891B2 (ja) | 2018-06-27 |
| WO2015141897A1 (ko) | 2015-09-24 |
| RU2668882C2 (ru) | 2018-10-04 |
| KR101420315B1 (ko) | 2014-07-17 |
| CA2942878A1 (en) | 2015-09-24 |
| MX2016011938A (es) | 2017-05-30 |
| US11191753B2 (en) | 2021-12-07 |
| JP2017508815A (ja) | 2017-03-30 |
| CA2942878C (en) | 2021-08-24 |
| US20160324837A1 (en) | 2016-11-10 |
| CN106456534B (zh) | 2019-05-14 |
| EP3120835B1 (en) | 2021-12-08 |
| US9827231B2 (en) | 2017-11-28 |
| US10624879B2 (en) | 2020-04-21 |
| ES2907324T3 (es) | 2022-04-22 |
| EP3120835A4 (en) | 2017-10-18 |
| MX366499B (es) | 2019-07-11 |
| CN106456534A (zh) | 2017-02-22 |
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