SK11632003A3 - Stabilný farmaceutický prípravok obsahujúci modifikáciu II torsemidu - Google Patents
Stabilný farmaceutický prípravok obsahujúci modifikáciu II torsemidu Download PDFInfo
- Publication number
- SK11632003A3 SK11632003A3 SK1163-2003A SK11632003A SK11632003A3 SK 11632003 A3 SK11632003 A3 SK 11632003A3 SK 11632003 A SK11632003 A SK 11632003A SK 11632003 A3 SK11632003 A3 SK 11632003A3
- Authority
- SK
- Slovakia
- Prior art keywords
- torsemide
- modification
- torsemide modification
- pharmaceutical formulation
- stable pharmaceutical
- Prior art date
Links
- NGBFQHCMQULJNZ-UHFFFAOYSA-N Torsemide Chemical compound CC(C)NC(=O)NS(=O)(=O)C1=CN=CC=C1NC1=CC=CC(C)=C1 NGBFQHCMQULJNZ-UHFFFAOYSA-N 0.000 title claims abstract description 264
- 229960005461 torasemide Drugs 0.000 title claims abstract description 183
- 238000012986 modification Methods 0.000 title claims abstract description 163
- 230000004048 modification Effects 0.000 title claims abstract description 163
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 claims abstract description 32
- 239000000203 mixture Substances 0.000 claims abstract description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 9
- 238000009472 formulation Methods 0.000 claims abstract description 5
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 24
- 238000004090 dissolution Methods 0.000 claims description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 17
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 15
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 15
- 239000002245 particle Substances 0.000 claims description 12
- 230000008859 change Effects 0.000 claims description 10
- 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 description 9
- 229960000913 crospovidone Drugs 0.000 claims description 9
- 238000009826 distribution Methods 0.000 claims description 9
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 9
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 9
- 229940069328 povidone Drugs 0.000 claims description 9
- 229960004977 anhydrous lactose Drugs 0.000 claims description 8
- 238000000338 in vitro Methods 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 206010030113 Oedema Diseases 0.000 claims description 5
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 abstract description 11
- 238000000634 powder X-ray diffraction Methods 0.000 description 26
- 238000003860 storage Methods 0.000 description 23
- 239000004480 active ingredient Substances 0.000 description 12
- 239000000546 pharmaceutical excipient Substances 0.000 description 9
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 8
- 239000008108 microcrystalline cellulose Substances 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- 230000002411 adverse Effects 0.000 description 6
- 239000013078 crystal Substances 0.000 description 6
- 239000008187 granular material Substances 0.000 description 6
- 238000005259 measurement Methods 0.000 description 5
- 239000000843 powder Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- OCKGFTQIICXDQW-ZEQRLZLVSA-N 5-[(1r)-1-hydroxy-2-[4-[(2r)-2-hydroxy-2-(4-methyl-1-oxo-3h-2-benzofuran-5-yl)ethyl]piperazin-1-yl]ethyl]-4-methyl-3h-2-benzofuran-1-one Chemical compound C1=C2C(=O)OCC2=C(C)C([C@@H](O)CN2CCN(CC2)C[C@H](O)C2=CC=C3C(=O)OCC3=C2C)=C1 OCKGFTQIICXDQW-ZEQRLZLVSA-N 0.000 description 2
- 206010007559 Cardiac failure congestive Diseases 0.000 description 2
- 206010019280 Heart failures Diseases 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000007922 dissolution test Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 208000017169 kidney disease Diseases 0.000 description 2
- 208000019423 liver disease Diseases 0.000 description 2
- 239000000902 placebo Substances 0.000 description 2
- 229940068196 placebo Drugs 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000007790 solid phase Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 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 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 208000020832 chronic kidney disease Diseases 0.000 description 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 229940066468 demadex Drugs 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000004519 grease Substances 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002171 loop diuretic Substances 0.000 description 1
- 229940057948 magnesium stearate Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000008057 potassium phosphate buffer Substances 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 238000007634 remodeling Methods 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
Classifications
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/10—Antioedematous agents; Diuretics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18328800P | 2000-02-17 | 2000-02-17 | |
| US09/789,424 US6482417B2 (en) | 2000-02-17 | 2001-02-21 | Stable pharmaceutical formulation comprising torsemide modification II |
| PCT/US2001/005577 WO2002067935A1 (en) | 2000-02-17 | 2001-02-21 | A stable pharmaceutical formulation comprising torsemide modification ii |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SK11632003A3 true SK11632003A3 (sk) | 2004-04-06 |
Family
ID=27359046
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK1163-2003A SK11632003A3 (sk) | 2000-02-17 | 2001-02-21 | Stabilný farmaceutický prípravok obsahujúci modifikáciu II torsemidu |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US6482417B2 (sl) |
| EP (1) | EP1292303B1 (sl) |
| JP (1) | JP2004522780A (sl) |
| CN (1) | CN1505512A (sl) |
| AT (1) | ATE266404T1 (sl) |
| CA (1) | CA2410802A1 (sl) |
| DE (2) | DE1292303T1 (sl) |
| DK (1) | DK1292303T3 (sl) |
| ES (1) | ES2193007T3 (sl) |
| HR (1) | HRP20030762A2 (sl) |
| HU (1) | HUP0600143A2 (sl) |
| IL (1) | IL157539A0 (sl) |
| IS (1) | IS6919A (sl) |
| MX (1) | MXPA03007908A (sl) |
| NO (1) | NO20033699L (sl) |
| PT (1) | PT1292303E (sl) |
| SI (1) | SI1292303T1 (sl) |
| SK (1) | SK11632003A3 (sl) |
| TR (1) | TR200401462T4 (sl) |
| WO (1) | WO2002067935A1 (sl) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10013289A1 (de) * | 2000-03-17 | 2001-09-20 | Knoll Ag | Torasemid enthaltende pharmazeutische Zubereitungen |
| US20030022921A1 (en) * | 2001-02-21 | 2003-01-30 | Minutza Leibovici | Stable pharmaceutical formulation comprising torsemide modification II |
| ITMI20020639A1 (it) * | 2002-03-27 | 2003-09-29 | Cosma S P A | Composizioni farmaceutiche comprendenti come principio attivo 1-isopropil-3°(4-m-toluidino-3-pridil)sulfonil!-urea |
| JP2007509941A (ja) * | 2003-10-28 | 2007-04-19 | グラクソ グループ リミテッド | ラクトース無水物を用いる吸入医薬製剤およびその投与方法 |
| ES2244324B1 (es) * | 2004-03-25 | 2006-11-16 | Ferrer Internacional, S.A. | Composiciones diureticas de liberacion prolongada. |
| CN100421662C (zh) * | 2005-11-08 | 2008-10-01 | 周卓和 | 托拉塞米分散片及其制备方法和应用 |
| CN100372534C (zh) * | 2006-04-20 | 2008-03-05 | 南京海辰药业有限公司 | 托拉塞米冻干制剂及制备方法 |
| US20080213362A1 (en) * | 2007-02-02 | 2008-09-04 | Lawrence Solomon | Compositions and methods using torsemide |
| CN106038500A (zh) * | 2016-05-26 | 2016-10-26 | 南京正科医药股份有限公司 | 一种托拉塞米片 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1477664A (en) | 1974-04-17 | 1977-06-22 | Christiaens Sa A | Pyridine derivatives |
| DE3529529A1 (de) | 1985-08-17 | 1987-02-19 | Boehringer Mannheim Gmbh | Verfahren zur herstellung einer stabilen modifikation von torasemid |
| EP0812195B1 (en) * | 1995-02-28 | 2002-10-30 | Aventis Pharmaceuticals Inc. | Pharmaceutical composition for piperidinoalkanol compounds |
| US5914336A (en) * | 1998-06-02 | 1999-06-22 | Boehringer Mannheim Gmbh | Method of controlling the serum solubility of orally administered torasemide and composition relating thereto |
| CA2379322A1 (en) * | 1999-08-11 | 2001-02-15 | Teva Pharmaceutical Industries Ltd. | Torsemide polymorphs |
-
2001
- 2001-02-21 SK SK1163-2003A patent/SK11632003A3/sk not_active Application Discontinuation
- 2001-02-21 CN CNA018231683A patent/CN1505512A/zh active Pending
- 2001-02-21 DK DK01911078T patent/DK1292303T3/da active
- 2001-02-21 DE DE1292303T patent/DE1292303T1/de active Pending
- 2001-02-21 US US09/789,424 patent/US6482417B2/en not_active Expired - Fee Related
- 2001-02-21 SI SI200130132T patent/SI1292303T1/sl unknown
- 2001-02-21 JP JP2002567302A patent/JP2004522780A/ja not_active Withdrawn
- 2001-02-21 AT AT01911078T patent/ATE266404T1/de not_active IP Right Cessation
- 2001-02-21 HU HU0600143A patent/HUP0600143A2/hu unknown
- 2001-02-21 MX MXPA03007908A patent/MXPA03007908A/es not_active Application Discontinuation
- 2001-02-21 DE DE60103276T patent/DE60103276T2/de not_active Expired - Fee Related
- 2001-02-21 WO PCT/US2001/005577 patent/WO2002067935A1/en active IP Right Grant
- 2001-02-21 TR TR2004/01462T patent/TR200401462T4/xx unknown
- 2001-02-21 ES ES01911078T patent/ES2193007T3/es not_active Expired - Lifetime
- 2001-02-21 CA CA002410802A patent/CA2410802A1/en not_active Abandoned
- 2001-02-21 PT PT01911078T patent/PT1292303E/pt unknown
- 2001-02-21 EP EP01911078A patent/EP1292303B1/en not_active Revoked
- 2001-02-21 IL IL15753901A patent/IL157539A0/xx unknown
-
2003
- 2003-08-20 NO NO20033699A patent/NO20033699L/no not_active Application Discontinuation
- 2003-08-20 IS IS6919A patent/IS6919A/is unknown
- 2003-09-19 HR HR20030762A patent/HRP20030762A2/xx not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CN1505512A (zh) | 2004-06-16 |
| DE60103276D1 (de) | 2004-06-17 |
| IS6919A (is) | 2003-08-20 |
| CA2410802A1 (en) | 2002-09-06 |
| EP1292303A4 (en) | 2003-07-09 |
| WO2002067935A1 (en) | 2002-09-06 |
| IL157539A0 (en) | 2004-03-28 |
| DK1292303T3 (da) | 2004-09-06 |
| TR200401462T4 (tr) | 2004-08-23 |
| ES2193007T3 (es) | 2004-11-01 |
| DE1292303T1 (de) | 2003-09-18 |
| HUP0600143A2 (en) | 2006-10-28 |
| US6482417B2 (en) | 2002-11-19 |
| NO20033699L (no) | 2003-10-10 |
| MXPA03007908A (es) | 2004-12-06 |
| EP1292303A1 (en) | 2003-03-19 |
| PT1292303E (pt) | 2004-09-30 |
| HRP20030762A2 (en) | 2005-08-31 |
| DE60103276T2 (de) | 2005-06-23 |
| EP1292303B1 (en) | 2004-05-12 |
| SI1292303T1 (sl) | 2004-10-31 |
| JP2004522780A (ja) | 2004-07-29 |
| NO20033699D0 (no) | 2003-08-20 |
| ATE266404T1 (de) | 2004-05-15 |
| ES2193007T1 (es) | 2003-11-01 |
| US20020035135A1 (en) | 2002-03-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20200375968A1 (en) | Apixaban formulations | |
| JP2003508386A (ja) | 溶解性および経口吸収性を改善したベンズアミド誘導体含有製剤 | |
| EP2331074A1 (en) | Granulates, process for preparing them and pharmaceutical products containing them | |
| JP2010534211A (ja) | ジヒドロピリジンカルシウムチャンネルアンタゴニストを含む薬学的組成物とその調製方法 | |
| AU2022202500B2 (en) | Elagolix formulation | |
| MX2009002336A (es) | Composiciones de imatinib. | |
| JP3518601B2 (ja) | エバスタイムまたはその類似体に基づく医薬組成物 | |
| SK11632003A3 (sk) | Stabilný farmaceutický prípravok obsahujúci modifikáciu II torsemidu | |
| JP7428356B2 (ja) | 高いバイオアベイラビリティを有するソラフェニブの医薬組成物、ソラフェニブ経口固形製剤、及びその使用 | |
| US20210401748A1 (en) | Powder for oral suspension containing lamotrigine | |
| EA036288B1 (ru) | Фармацевтические лекарственные формы | |
| CZ20032513A3 (cs) | Stabilní farmaceutický přípravek obsahující modifikaci II torsemidu | |
| AU2017228681B2 (en) | Apixaban formulations | |
| US20030022921A1 (en) | Stable pharmaceutical formulation comprising torsemide modification II | |
| AU2001238617A1 (en) | A stable pharmaceutical formulation comprising torsemide modification II | |
| ZA200306679B (en) | A stable pharmaceutical formulation comprising torsemide modification II. | |
| KR20030077638A (ko) | 토르세마이드 변형체 ⅱ를 포함하는 안정한 약학 제제 | |
| DE20122564U1 (de) | Eine stabile pharmazeutische Formulierung die Torsemid Modifikation II enthält | |
| SK285964B6 (sk) | Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC9A | Refused patent application |