JP2015536995A5 - - Google Patents
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- Publication number
- JP2015536995A5 JP2015536995A5 JP2015541981A JP2015541981A JP2015536995A5 JP 2015536995 A5 JP2015536995 A5 JP 2015536995A5 JP 2015541981 A JP2015541981 A JP 2015541981A JP 2015541981 A JP2015541981 A JP 2015541981A JP 2015536995 A5 JP2015536995 A5 JP 2015536995A5
- Authority
- JP
- Japan
- Prior art keywords
- container
- long
- budesonide
- term stable
- acid
- 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
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims description 59
- 229960004436 budesonide Drugs 0.000 claims description 59
- 230000007774 longterm Effects 0.000 claims description 46
- 239000007788 liquid Substances 0.000 claims description 40
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 39
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- 150000003839 salts Chemical class 0.000 claims description 20
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 18
- 239000000203 mixture Substances 0.000 claims description 18
- RWPGFSMJFRPDDP-UHFFFAOYSA-L potassium metabisulfite Chemical compound [K+].[K+].[O-]S(=O)S([O-])(=O)=O RWPGFSMJFRPDDP-UHFFFAOYSA-L 0.000 claims description 18
- 229940043349 potassium metabisulfite Drugs 0.000 claims description 18
- 235000010263 potassium metabisulphite Nutrition 0.000 claims description 18
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical compound NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 claims description 16
- 229960004963 mesalazine Drugs 0.000 claims description 16
- 206010009900 Colitis ulcerative Diseases 0.000 claims description 15
- 201000006704 Ulcerative Colitis Diseases 0.000 claims description 15
- MFBOGIVSZKQAPD-UHFFFAOYSA-M sodium butyrate Chemical compound [Na+].CCCC([O-])=O MFBOGIVSZKQAPD-UHFFFAOYSA-M 0.000 claims description 15
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical group OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 14
- AGBQKNBQESQNJD-UHFFFAOYSA-N lipoic acid Chemical compound OC(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-N 0.000 claims description 14
- 235000019136 lipoic acid Nutrition 0.000 claims description 14
- 229960002663 thioctic acid Drugs 0.000 claims description 14
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 12
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 12
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 12
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 12
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 12
- 235000010234 sodium benzoate Nutrition 0.000 claims description 12
- 239000004299 sodium benzoate Substances 0.000 claims description 12
- 239000003963 antioxidant agent Substances 0.000 claims description 11
- 230000003078 antioxidant effect Effects 0.000 claims description 11
- 235000006708 antioxidants Nutrition 0.000 claims description 11
- 229960000265 cromoglicic acid Drugs 0.000 claims description 11
- VLARUOGDXDTHEH-UHFFFAOYSA-L disodium cromoglycate Chemical compound [Na+].[Na+].O1C(C([O-])=O)=CC(=O)C2=C1C=CC=C2OCC(O)COC1=CC=CC2=C1C(=O)C=C(C([O-])=O)O2 VLARUOGDXDTHEH-UHFFFAOYSA-L 0.000 claims description 11
- 239000005711 Benzoic acid Substances 0.000 claims description 9
- 235000010233 benzoic acid Nutrition 0.000 claims description 9
- 239000012530 fluid Substances 0.000 claims description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 6
- 239000002516 radical scavenger Substances 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 229910052751 metal Inorganic materials 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- IZFHEQBZOYJLPK-SSDOTTSWSA-N (R)-dihydrolipoic acid Chemical compound OC(=O)CCCC[C@@H](S)CCS IZFHEQBZOYJLPK-SSDOTTSWSA-N 0.000 claims description 2
- AGBQKNBQESQNJD-SSDOTTSWSA-N (R)-lipoic acid Chemical compound OC(=O)CCCC[C@@H]1CCSS1 AGBQKNBQESQNJD-SSDOTTSWSA-N 0.000 claims description 2
- UOQHWNPVNXSDDO-UHFFFAOYSA-N 3-bromoimidazo[1,2-a]pyridine-6-carbonitrile Chemical compound C1=CC(C#N)=CN2C(Br)=CN=C21 UOQHWNPVNXSDDO-UHFFFAOYSA-N 0.000 claims description 2
- CIWBSHSKHKDKBQ-DUZGATOHSA-N D-isoascorbic acid Chemical compound OC[C@@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-DUZGATOHSA-N 0.000 claims description 2
- 229940123457 Free radical scavenger Drugs 0.000 claims description 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical compound OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 claims description 2
- 235000010323 ascorbic acid Nutrition 0.000 claims description 2
- 229960005070 ascorbic acid Drugs 0.000 claims description 2
- 239000011668 ascorbic acid Substances 0.000 claims description 2
- 238000000354 decomposition reaction Methods 0.000 claims description 2
- 235000010350 erythorbic acid Nutrition 0.000 claims description 2
- 229940026239 isoascorbic acid Drugs 0.000 claims description 2
- 229940099563 lactobionic acid Drugs 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 229940001584 sodium metabisulfite Drugs 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- 239000012453 solvate Substances 0.000 claims description 2
- 150000003573 thiols Chemical class 0.000 claims description 2
- 150000007524 organic acids Chemical class 0.000 claims 3
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- 235000015165 citric acid Nutrition 0.000 claims 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 235000010199 sorbic acid Nutrition 0.000 claims 1
- 239000004334 sorbic acid Substances 0.000 claims 1
- 229940075582 sorbic acid Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 description 8
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261724678P | 2012-11-09 | 2012-11-09 | |
| US61/724,678 | 2012-11-09 | ||
| PCT/US2013/069449 WO2014074995A1 (en) | 2012-11-09 | 2013-11-11 | Enema composition for treatment of ulcerative colitis having long term stability |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015536995A JP2015536995A (ja) | 2015-12-24 |
| JP2015536995A5 true JP2015536995A5 (cg-RX-API-DMAC7.html) | 2016-12-22 |
| JP6423353B2 JP6423353B2 (ja) | 2018-11-14 |
Family
ID=50682294
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015541981A Expired - Fee Related JP6423353B2 (ja) | 2012-11-09 | 2013-11-11 | 潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US8809308B2 (cg-RX-API-DMAC7.html) |
| EP (2) | EP2916818B1 (cg-RX-API-DMAC7.html) |
| JP (1) | JP6423353B2 (cg-RX-API-DMAC7.html) |
| AU (1) | AU2013342069B2 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2891090A1 (cg-RX-API-DMAC7.html) |
| ES (1) | ES2622372T3 (cg-RX-API-DMAC7.html) |
| MX (1) | MX2015005837A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2014074995A1 (cg-RX-API-DMAC7.html) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8916546B2 (en) | 2003-08-29 | 2014-12-23 | Therapeutic Research Llc | Materials and methods for treatment and diagnosis of disorders associated with oxidative stress |
| AU2013342069B2 (en) * | 2012-11-09 | 2018-05-31 | Haz Two, Llc | Enema composition for treatment of ulcerative colitis having long term stability |
| EA201791686A8 (ru) | 2015-01-26 | 2018-10-31 | Др. Фальк Фарма Гмбх | Клизма для ректального введения |
| WO2018122086A1 (en) * | 2016-12-28 | 2018-07-05 | Dr. Falk Pharma Gmbh | Enema for rectal application |
| DK3870226T3 (da) * | 2018-10-24 | 2023-09-18 | Ferring Bv | Mukoadhæsive farmaceutiske sammensætninger af kortikosteroider |
Family Cites Families (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4211777A (en) | 1977-11-25 | 1980-07-08 | Fisons Limited | Compositions comprising a compound having sodium cromoglycate activity and aminosalicylic acid |
| WO1981002671A1 (en) | 1980-03-20 | 1981-10-01 | Ferring Farma Lab | Pharmaceutical composition and method for the treatment of colitis ulcerosa and crohn's disease by oral administration |
| US4657900A (en) | 1983-09-27 | 1987-04-14 | Rowell Laboratories | Pharmaceutical article of manufacture comprising a bisulfite stabilized aqueous solution of 5-aminosalicylic acid and method |
| EP0382066A3 (de) | 1989-02-09 | 1992-01-08 | ASTA Medica Aktiengesellschaft | Verwendung von Dihydroliponsäure als Analgetikum, Antiphlogistikum und/oder Zytoprotektivum |
| GB8909559D0 (en) | 1989-04-26 | 1989-06-14 | Smith Kline French Lab | Pharmaceutical compositions |
| US5378470A (en) | 1989-07-25 | 1995-01-03 | Henning Berlin Gmbh | Rectally administered pharmaceutical preparation |
| PT95826B (pt) | 1989-11-09 | 1997-11-28 | Asta Medica Ag | Processo para a preparacao de composicoes farmaceuticas contendo como ingrediente activo acido r-alfa-liponico ou acido s-alfa-liponico |
| US5569670A (en) | 1992-06-05 | 1996-10-29 | Asta Medica Aktiengesellschaft | Combination medications containing alpha-lipoic acid and related |
| DE4218572A1 (de) | 1992-06-05 | 1993-12-09 | Asta Medica Ag | Synergistische Kombination von Arzneimitteln enthaltend als Wirkstoff alpha-Liponsäure, Dihydroliponsäure, deren Metaboliten sowie die oxidierten und reduzierten Enantiomere der alpha-Liponsäure wie die R-alpha-Liponsäure oder S-alpha-Liponsäure sowie Metaboliten der alpha-Liponsäure mit den Vitaminen A, B1-6, B12, C und E |
| US20050090553A1 (en) | 1992-06-30 | 2005-04-28 | Shapiro Howard K. | Compositions and method for treatment of chronic inflammatory diseases |
| US8178516B2 (en) | 1992-06-30 | 2012-05-15 | Sylvan Labs, LLC | Compositions and method for treatment of chronic inflammatory diseases |
| US6444221B1 (en) | 1992-06-30 | 2002-09-03 | Howard K. Shapiro | Methods of treating chronic inflammatory diseases using carbonyl trapping agents |
| US5563131A (en) | 1994-08-04 | 1996-10-08 | Pherin Corporation | Pregnane steroids as neurochemical initiators of change in human hypothalamic function and related pharmaceutical compositions and methods |
| DE4446891A1 (de) * | 1994-12-27 | 1996-07-04 | Falk Pharma Gmbh | Stabile wäßrige Budesonid-Lösung |
| DE19509806A1 (de) | 1995-03-21 | 1996-09-26 | Basf Ag | Lagerstabile Arzneiformen |
| US5817630A (en) | 1997-03-18 | 1998-10-06 | Austin Nutriceutical Corporation | Glutathione antioxidant eye drops |
| US6197749B1 (en) | 1997-10-29 | 2001-03-06 | Ajinomoto Co., Inc. | Method of suppressing immune responses by reducing intracellular content of glutathione in macrophages and monocytes |
| US6262019B1 (en) | 1998-04-30 | 2001-07-17 | Vit-Immune, L. C. | Method of treatment of glutathione deficient mammals |
| AR042572A1 (es) | 1999-04-02 | 2005-06-29 | Sod Conseils Rech Applic | Derivados de acido lipoico, procedimiento para su preparacion, medicamentos y composiciones farmaceuticas que los contienen y utilizacion de dichos derivados para la preparacion de los referidos medicamentos |
| US6664287B2 (en) | 2000-03-15 | 2003-12-16 | Bethesda Pharmaceuticals, Inc. | Antioxidants |
| EP1172110A3 (de) | 2000-07-07 | 2003-09-17 | Basf Aktiengesellschaft | Verwendung von Liponsäure zur Verbesserung der Bioverfügbarkeit von Mineralsalzen |
| CN1543345A (zh) | 2001-05-09 | 2004-11-03 | 诺瓦提斯公司 | 使用匹美莫司进行选择性免疫调节的方法 |
| US20030235571A1 (en) | 2002-06-19 | 2003-12-25 | Gabriel Gojon-Romanillos | Systemic treatment of pathological conditions resulting from oxidative stress and/or redox imbalance |
| JP2006513147A (ja) | 2002-09-10 | 2006-04-20 | ナショナル ジューイッシュ メディカル アンド リサーチ センター | 粘液または痰の液化のための生成物および処理 |
| US7157444B2 (en) | 2002-12-21 | 2007-01-02 | Deanna Jean Nelson | Aminosalicylate derivatives for treatment of inflammatory bowel disease |
| WO2004071488A1 (en) | 2003-02-04 | 2004-08-26 | Chrysalis Technologies Incorporated | Perfluorocarbon and hydrofluorocarbon formulations and methods of making and using same |
| SE0300480D0 (sv) * | 2003-02-21 | 2003-02-21 | Astrazeneca Ab | Novel compounds |
| US20060264408A1 (en) | 2003-03-06 | 2006-11-23 | Haj-Yehia Abdullah I | Sod minic multifunctional compounds for treating inflammatory bowel disease |
| WO2005009510A2 (en) | 2003-07-23 | 2005-02-03 | The Regents Of The University Of California | Penetration enhancer combinations for transdermal delivery |
| US7312243B1 (en) | 2003-08-29 | 2007-12-25 | Jay Pravda | Materials and methods for treatment of gastrointestinal disorders |
| WO2008156671A2 (en) | 2007-06-13 | 2008-12-24 | Jay Pravda | Materials and methods for treatment and diagnosis of disorders associated with oxidative stress |
| US20100112088A1 (en) | 2003-08-29 | 2010-05-06 | Jay Pravda | Materials and methods for treatment of disorders associated with oxidative stress |
| US8916546B2 (en) * | 2003-08-29 | 2014-12-23 | Therapeutic Research Llc | Materials and methods for treatment and diagnosis of disorders associated with oxidative stress |
| US8318210B2 (en) | 2005-02-28 | 2012-11-27 | Neos Therapeutics, Lp | Compositions and methods of making sustained release liquid formulations |
| CA2608631C (en) * | 2005-06-09 | 2014-07-29 | Biolipox Ab | Method and composition for treating inflammatory disorders |
| RU2008122978A (ru) * | 2005-11-09 | 2009-12-20 | Комбинаторкс, Инкорпорейтед (Us) | Способы, композиции и наборы для лечения медицинских состояний |
| US7842709B2 (en) | 2006-09-08 | 2010-11-30 | Ore Pharmaceuticals Inc. | Method for treating inflammatory diseases of the digestive tract |
| US20080066739A1 (en) | 2006-09-20 | 2008-03-20 | Lemahieu Edward | Methods and systems of delivering medication via inhalation |
| AU2008321396A1 (en) * | 2007-11-13 | 2009-05-22 | Meritage Pharma, Inc. | Compositions for the treatment of inflammation of the gastrointestinal tract |
| US7750027B2 (en) | 2008-01-18 | 2010-07-06 | Oxagen Limited | Compounds having CRTH2 antagonist activity |
| EP2416650B1 (en) * | 2009-04-10 | 2020-02-26 | Abraxis BioScience, LLC | Nanoparticle formulations and uses therof |
| AU2013342069B2 (en) * | 2012-11-09 | 2018-05-31 | Haz Two, Llc | Enema composition for treatment of ulcerative colitis having long term stability |
-
2013
- 2013-11-11 AU AU2013342069A patent/AU2013342069B2/en not_active Ceased
- 2013-11-11 US US14/076,560 patent/US8809308B2/en not_active Expired - Fee Related
- 2013-11-11 JP JP2015541981A patent/JP6423353B2/ja not_active Expired - Fee Related
- 2013-11-11 WO PCT/US2013/069449 patent/WO2014074995A1/en not_active Ceased
- 2013-11-11 EP EP13852751.0A patent/EP2916818B1/en not_active Not-in-force
- 2013-11-11 MX MX2015005837A patent/MX2015005837A/es unknown
- 2013-11-11 ES ES13852751.0T patent/ES2622372T3/es active Active
- 2013-11-11 CA CA2891090A patent/CA2891090A1/en not_active Abandoned
- 2013-11-11 EP EP17153669.1A patent/EP3181120A1/en not_active Withdrawn
-
2014
- 2014-07-08 US US14/326,096 patent/US9238037B2/en not_active Expired - Fee Related
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