JP2017515821A5 - - Google Patents
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- Publication number
- JP2017515821A5 JP2017515821A5 JP2016566935A JP2016566935A JP2017515821A5 JP 2017515821 A5 JP2017515821 A5 JP 2017515821A5 JP 2016566935 A JP2016566935 A JP 2016566935A JP 2016566935 A JP2016566935 A JP 2016566935A JP 2017515821 A5 JP2017515821 A5 JP 2017515821A5
- Authority
- JP
- Japan
- Prior art keywords
- rifaximin
- crystal form
- pharmaceutical composition
- composition according
- temperature
- 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
- NZCRJKRKKOLAOJ-XRCRFVBUSA-N rifaximin Chemical compound OC1=C(C(O)=C2C)C3=C4N=C5C=C(C)C=CN5C4=C1NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@H](C)[C@@H](OC)\C=C\O[C@@]1(C)OC2=C3C1=O NZCRJKRKKOLAOJ-XRCRFVBUSA-N 0.000 claims description 22
- 229960003040 rifaximin Drugs 0.000 claims description 21
- 239000013078 crystal Substances 0.000 claims 9
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- XXJWXESWEXIICW-UHFFFAOYSA-N diethylene glycol monoethyl ether Chemical compound CCOCCOCCO XXJWXESWEXIICW-UHFFFAOYSA-N 0.000 claims 3
- 229940075557 diethylene glycol monoethyl ether Drugs 0.000 claims 3
- 206010012735 Diarrhoea Diseases 0.000 claims 2
- 238000002441 X-ray diffraction Methods 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 208000002551 irritable bowel syndrome Diseases 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000002244 precipitate Substances 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- 239000012453 solvate Substances 0.000 claims 2
- 208000000668 Chronic Pancreatitis Diseases 0.000 claims 1
- 241000193163 Clostridioides difficile Species 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 206010012742 Diarrhoea infectious Diseases 0.000 claims 1
- 208000004232 Enteritis Diseases 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- 208000018522 Gastrointestinal disease Diseases 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- 206010022678 Intestinal infections Diseases 0.000 claims 1
- 208000012868 Overgrowth Diseases 0.000 claims 1
- 208000035467 Pancreatic insufficiency Diseases 0.000 claims 1
- 206010033645 Pancreatitis Diseases 0.000 claims 1
- 206010033649 Pancreatitis chronic Diseases 0.000 claims 1
- 206010071061 Small intestinal bacterial overgrowth Diseases 0.000 claims 1
- 206010046914 Vaginal infection Diseases 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 206010009887 colitis Diseases 0.000 claims 1
- 238000013270 controlled release Methods 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- RKTYLMNFRDHKIL-UHFFFAOYSA-N copper;5,10,15,20-tetraphenylporphyrin-22,24-diide Chemical compound [Cu+2].C1=CC(C(=C2C=CC([N-]2)=C(C=2C=CC=CC=2)C=2C=CC(N=2)=C(C=2C=CC=CC=2)C2=CC=C3[N-]2)C=2C=CC=CC=2)=NC1=C3C1=CC=CC=C1 RKTYLMNFRDHKIL-UHFFFAOYSA-N 0.000 claims 1
- 239000006071 cream Substances 0.000 claims 1
- 125000004122 cyclic group Chemical group 0.000 claims 1
- 208000007784 diverticulitis Diseases 0.000 claims 1
- 208000001848 dysentery Diseases 0.000 claims 1
- 201000006549 dyspepsia Diseases 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 208000007386 hepatic encephalopathy Diseases 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 208000028774 intestinal disease Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000012454 non-polar solvent Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 238000001556 precipitation Methods 0.000 claims 1
- 239000000047 product Substances 0.000 claims 1
- 230000007142 small intestinal bacterial overgrowth Effects 0.000 claims 1
- 210000000813 small intestine Anatomy 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000001228 spectrum Methods 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 description 2
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461992017P | 2014-05-12 | 2014-05-12 | |
| US61/992,017 | 2014-05-12 | ||
| PCT/IB2015/053342 WO2015173697A1 (en) | 2014-05-12 | 2015-05-07 | New solvated crystal form of rifaximin, production, compositions and uses thereof |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017515821A JP2017515821A (ja) | 2017-06-15 |
| JP2017515821A5 true JP2017515821A5 (enExample) | 2018-06-14 |
| JP6576953B2 JP6576953B2 (ja) | 2019-09-18 |
Family
ID=53276210
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016566935A Active JP6576953B2 (ja) | 2014-05-12 | 2015-05-07 | リファキシミンの新規溶媒和物結晶形、生成物、組成物及びそれらの使用 |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US9938298B2 (enExample) |
| EP (2) | EP3143027B1 (enExample) |
| JP (1) | JP6576953B2 (enExample) |
| KR (1) | KR102362719B1 (enExample) |
| AU (1) | AU2015260837B2 (enExample) |
| CA (1) | CA2940601C (enExample) |
| DK (2) | DK3546464T3 (enExample) |
| EA (1) | EA030457B1 (enExample) |
| ES (2) | ES2742106T3 (enExample) |
| HR (2) | HRP20191520T1 (enExample) |
| HU (2) | HUE050054T2 (enExample) |
| NZ (1) | NZ723571A (enExample) |
| PL (2) | PL3546464T3 (enExample) |
| PT (2) | PT3546464T (enExample) |
| RS (2) | RS60576B1 (enExample) |
| SI (2) | SI3546464T1 (enExample) |
| WO (1) | WO2015173697A1 (enExample) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI335218B (en) * | 2003-02-19 | 2011-01-01 | Panion & Bf Biotech Inc | Ferric organic compounds, uses thereof and methods of making same |
| PT1698630E (pt) | 2005-03-03 | 2014-09-15 | Alfa Wassermann Spa | Novas formas polimorfas de rifaximina, processos para a sua produção e a sua utilização nas preparações medicinais |
| EP2927235B1 (en) | 2014-03-31 | 2017-02-08 | Euticals S.P.A. | Polymorphic mixture of rifaximin and its use for the preparation of solid formulations |
| ES2742106T3 (es) | 2014-05-12 | 2020-02-13 | Alfasigma Spa | Nueva forma de cristal solvatado de rifaximina, producción, composiciones y usos de la misma |
| KR20210054521A (ko) | 2018-09-06 | 2021-05-13 | 파흐호흐슐레 노르트베스치바이츠 | 약물 방출 제어형 제형 |
| WO2020208140A1 (en) | 2019-04-12 | 2020-10-15 | Sandoz Ag | Rifaximin-containing granules |
| GR1010652B (el) * | 2023-04-20 | 2024-03-12 | Φαρματεν Α.Β.Ε.Ε., | Φαρμακευτικο σκευασμα που περιλαμβανει εναν αντιμικροβιακο παραγοντα και μεθοδος για την παρασκευη αυτου |
| WO2025170483A1 (ru) * | 2024-02-07 | 2025-08-14 | Общество с ограниченной ответственностью "БИННОФАРМ ГРУПП" | Фармацевтическая композиция, обладающая антибиотической активностью |
Family Cites Families (85)
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| IT1154655B (it) | 1980-05-22 | 1987-01-21 | Alfa Farmaceutici Spa | Derivati imidazo-rifamicinici metodi per la loro preparazione e loro uso come sostanza ad azione antibatterica |
| IT1199374B (it) | 1984-05-15 | 1988-12-30 | Alfa Farmaceutici Spa | Processo per la preparazione di pirido-imidazo-rifamicine |
| CA1215976A (en) | 1984-05-15 | 1986-12-30 | Vincenzo Cannata | New process for the synthesis of imidazo rifamycins |
| IT1199413B (it) | 1984-09-26 | 1988-12-30 | Alfa Farmaceutici Spa | Processo per la preparazione di pirido-imidazo-rifamicine |
| US5356625A (en) | 1986-08-28 | 1994-10-18 | Enzacor Properties Limited | Microgranular preparation useful in the delivery of biologically active materials to the intestinal regions of animals |
| US5443826A (en) | 1988-08-02 | 1995-08-22 | Borody; Thomas J. | Treatment of gastro-intestinal disorders with a fecal composition or a composition of bacteroides and E. Coli |
| IT1253711B (it) | 1991-12-17 | 1995-08-23 | Alfa Wassermann Spa | Formulazioni farmaceutiche vaginali contenenti rifaximin e loro uso nel trattamento delle infezioni vaginali |
| IT1264494B1 (it) | 1993-03-23 | 1996-09-24 | Alfa Wassermann Spa | Uso di rifaximin e di formulazioni che la contengono nel trattamento delle dispepsie gastriche originate da helicobacter |
| US6861053B1 (en) | 1999-08-11 | 2005-03-01 | Cedars-Sinai Medical Center | Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth |
| US5840332A (en) | 1996-01-18 | 1998-11-24 | Perio Products Ltd. | Gastrointestinal drug delivery system |
| DE69739394D1 (de) | 1996-10-16 | 2009-06-18 | Napo Pharmaceuticals Inc | Enteral-formulierungen von proanthocyanidzusammensetzungen gegen diarrhöe |
| IT1290679B1 (it) | 1997-02-14 | 1998-12-10 | Alfa Wassermann Spa | Uso della rifaximina e delle composizioni farmaceutiche che la contengono nel trattamento della diarrea da criptosporidiosi. |
| US6770623B1 (en) | 1997-12-09 | 2004-08-03 | Eli Lilly And Company | Stabilized teriparatide solutions |
| US20030059471A1 (en) | 1997-12-15 | 2003-03-27 | Compton Bruce Jon | Oral delivery formulation |
| US20030157174A1 (en) | 2000-03-23 | 2003-08-21 | Takayuki Tsukuda | Enteric granular preparations of hardly water soluble drugs characterized by containing water-repellent component |
| DE10045547A1 (de) | 2000-09-14 | 2002-04-04 | Infineon Technologies Ag | Verfahren zur systemunabhängigen digitalen Erzeugung von Mobilkommunikations-Sendesignalen verschiedener Mobilfunkstandards |
| US8101209B2 (en) | 2001-10-09 | 2012-01-24 | Flamel Technologies | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles |
| US20080262024A1 (en) | 2003-11-07 | 2008-10-23 | Giuseppe Claudio Viscomi | Rifaximin compositions and method of use |
| US7902206B2 (en) | 2003-11-07 | 2011-03-08 | Alfa Wassermann, S.P.A. | Polymorphic forms α, β and γ of rifaximin |
| US7906542B2 (en) | 2004-11-04 | 2011-03-15 | Alfa Wassermann, S.P.A. | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
| US7923553B2 (en) | 2003-11-07 | 2011-04-12 | Alfa Wassermann, S.P.A. | Processes for the production of polymorphic forms of rifaximin |
| ITMI20032144A1 (it) | 2003-11-07 | 2005-05-08 | Alfa Wassermann Spa | Forme polimorfe di rifaximina, processi per ottenerle e |
| US20050196418A1 (en) | 2004-03-04 | 2005-09-08 | Yu Ruey J. | Bioavailability and improved delivery of alkaline pharmaceutical drugs |
| SE528938C2 (sv) | 2005-02-08 | 2007-03-20 | Ortic Ab | Hydroformningsenhet |
| US20060210483A1 (en) | 2005-03-02 | 2006-09-21 | Kodsi Robert E | Non-systemic antibiotic formulations and related method of use and treatment of upper respiratory infections |
| US8003118B2 (en) | 2005-03-02 | 2011-08-23 | Kodsi Robert E | Use of rifaximin for the prevention of aspiration pneumonia and/or sepsis |
| US20060210492A1 (en) | 2005-03-02 | 2006-09-21 | Kodsi Robert E | Use of rifaximin for treatment and prevention of periodontal conditions |
| PT1698630E (pt) | 2005-03-03 | 2014-09-15 | Alfa Wassermann Spa | Novas formas polimorfas de rifaximina, processos para a sua produção e a sua utilização nas preparações medicinais |
| ITBO20050123A1 (it) | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
| ITMI20061692A1 (it) | 2006-09-05 | 2008-03-06 | Alfa Wassermann Spa | Uso di polioli per ottenere forme polimorfe stabili di rifaximina |
| AU2007298733B2 (en) | 2006-09-22 | 2012-11-08 | Cipla Limited | Rifaximin |
| ITMI20071241A1 (it) | 2007-06-20 | 2008-12-21 | Solmag S P A | Processo per la preparazione di rifaximina amorfa e rifaximina amorfa cosi' ottenuta |
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| ES2742106T3 (es) | 2014-05-12 | 2020-02-13 | Alfasigma Spa | Nueva forma de cristal solvatado de rifaximina, producción, composiciones y usos de la misma |
| WO2016063289A2 (en) | 2014-10-22 | 2016-04-28 | Strides Arcolab Limited | Pharmaceutical tablet compositions comprising rifaximin |
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| ES2738024T5 (es) | 2016-03-24 | 2022-10-24 | Sandoz Ag | Composición estable al almacenamiento que comprende rifaximina alfa |
| HUE056045T2 (hu) | 2016-03-24 | 2022-01-28 | Sandoz Ag | Rifaximin alfa és delta tartalmú gyógyászati készítmény |
| US9988398B2 (en) | 2016-06-07 | 2018-06-05 | Cadila Healthcare Limited | Crystalline form of rifaximin and process for its preparation |
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| WO2018178777A1 (en) | 2017-03-31 | 2018-10-04 | Granules India Limited | Process for the preparation of rifaximin crystalline form |
| US11052071B2 (en) | 2017-04-26 | 2021-07-06 | Sandoz Ag | Oral dosage form comprising rifaximin in form beta |
-
2015
- 2015-05-07 ES ES15726344T patent/ES2742106T3/es active Active
- 2015-05-07 DK DK19169546.9T patent/DK3546464T3/da active
- 2015-05-07 EP EP15726344.3A patent/EP3143027B1/en active Active
- 2015-05-07 EA EA201692110A patent/EA030457B1/ru unknown
- 2015-05-07 WO PCT/IB2015/053342 patent/WO2015173697A1/en not_active Ceased
- 2015-05-07 EP EP19169546.9A patent/EP3546464B1/en active Active
- 2015-05-07 HR HRP20191520 patent/HRP20191520T1/hr unknown
- 2015-05-07 HU HUE19169546A patent/HUE050054T2/hu unknown
- 2015-05-07 NZ NZ723571A patent/NZ723571A/en unknown
- 2015-05-07 PT PT191695469T patent/PT3546464T/pt unknown
- 2015-05-07 HU HUE15726344 patent/HUE044748T2/hu unknown
- 2015-05-07 PL PL19169546T patent/PL3546464T3/pl unknown
- 2015-05-07 DK DK15726344.3T patent/DK3143027T3/da active
- 2015-05-07 AU AU2015260837A patent/AU2015260837B2/en active Active
- 2015-05-07 US US15/310,436 patent/US9938298B2/en active Active
- 2015-05-07 SI SI201531304T patent/SI3546464T1/sl unknown
- 2015-05-07 PT PT15726344T patent/PT3143027T/pt unknown
- 2015-05-07 CA CA2940601A patent/CA2940601C/en active Active
- 2015-05-07 KR KR1020167031391A patent/KR102362719B1/ko active Active
- 2015-05-07 PL PL15726344T patent/PL3143027T3/pl unknown
- 2015-05-07 RS RS20200857A patent/RS60576B1/sr unknown
- 2015-05-07 RS RSP20191133 patent/RS59250B1/sr unknown
- 2015-05-07 SI SI201530871T patent/SI3143027T1/sl unknown
- 2015-05-07 JP JP2016566935A patent/JP6576953B2/ja active Active
- 2015-05-07 ES ES19169546T patent/ES2810010T3/es active Active
-
2018
- 2018-02-27 US US15/907,117 patent/US10428086B2/en active Active
-
2020
- 2020-07-13 HR HRP20201093TT patent/HRP20201093T1/hr unknown
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