JP2010522244A5 - - Google Patents
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- JP2010522244A5 JP2010522244A5 JP2010501128A JP2010501128A JP2010522244A5 JP 2010522244 A5 JP2010522244 A5 JP 2010522244A5 JP 2010501128 A JP2010501128 A JP 2010501128A JP 2010501128 A JP2010501128 A JP 2010501128A JP 2010522244 A5 JP2010522244 A5 JP 2010522244A5
- Authority
- JP
- Japan
- Prior art keywords
- present
- amount
- weight
- tablet
- propylene glycol
- 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.)
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 36
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 34
- 239000002775 capsule Substances 0.000 claims 32
- GOADIQFWSVMMRJ-UPGAGZFNSA-N dapagliflozin propanediol monohydrate Chemical compound O.C[C@H](O)CO.C1=CC(OCC)=CC=C1CC1=CC([C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)=CC=C1Cl GOADIQFWSVMMRJ-UPGAGZFNSA-N 0.000 claims 21
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 18
- 235000019359 magnesium stearate Nutrition 0.000 claims 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 18
- 239000000377 silicon dioxide Substances 0.000 claims 17
- 235000012239 silicon dioxide Nutrition 0.000 claims 17
- 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 16
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 16
- 229960000913 crospovidone Drugs 0.000 claims 16
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 16
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 16
- 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 12
- 238000009472 formulation Methods 0.000 claims 12
- 229960001375 lactose Drugs 0.000 claims 12
- 239000008101 lactose Substances 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 12
- 239000003963 antioxidant agent Substances 0.000 claims 8
- 230000003078 antioxidant effect Effects 0.000 claims 8
- 239000002738 chelating agent Substances 0.000 claims 7
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 6
- 229960001681 croscarmellose sodium Drugs 0.000 claims 6
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 6
- 230000000181 anti-adherent effect Effects 0.000 claims 5
- 239000000454 talc Substances 0.000 claims 5
- 229910052623 talc Inorganic materials 0.000 claims 5
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 5
- 229920000881 Modified starch Polymers 0.000 claims 4
- 229960004977 anhydrous lactose Drugs 0.000 claims 4
- 239000007884 disintegrant Substances 0.000 claims 4
- 239000000945 filler Substances 0.000 claims 4
- 229920003109 sodium starch glycolate Polymers 0.000 claims 4
- 229940079832 sodium starch glycolate Drugs 0.000 claims 4
- 239000008109 sodium starch glycolate Substances 0.000 claims 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 239000000853 adhesive Substances 0.000 claims 2
- 230000003111 delayed effect Effects 0.000 claims 2
- 239000010410 layer Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000011253 protective coating Substances 0.000 claims 2
- 230000001225 therapeutic effect Effects 0.000 claims 2
- 201000001320 Atherosclerosis Diseases 0.000 claims 1
- 208000002177 Cataract Diseases 0.000 claims 1
- 208000002705 Glucose Intolerance Diseases 0.000 claims 1
- 208000035150 Hypercholesterolemia Diseases 0.000 claims 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 claims 1
- 208000031226 Hyperlipidaemia Diseases 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- 206010022489 Insulin Resistance Diseases 0.000 claims 1
- 208000017170 Lipid metabolism disease Diseases 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- 208000017442 Retinal disease Diseases 0.000 claims 1
- 206010038923 Retinopathy Diseases 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 229920001688 coating polymer Polymers 0.000 claims 1
- 239000003086 colorant Substances 0.000 claims 1
- 235000021588 free fatty acids Nutrition 0.000 claims 1
- 201000001421 hyperglycemia Diseases 0.000 claims 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 claims 1
- 201000008980 hyperinsulinism Diseases 0.000 claims 1
- 208000006575 hypertriglyceridemia Diseases 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 208000028867 ischemia Diseases 0.000 claims 1
- 210000003734 kidney Anatomy 0.000 claims 1
- 201000001119 neuropathy Diseases 0.000 claims 1
- 230000007823 neuropathy Effects 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 208000033808 peripheral neuropathy Diseases 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 201000009104 prediabetes syndrome Diseases 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 230000029663 wound healing Effects 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US89628607P | 2007-03-22 | 2007-03-22 | |
| US60/896,286 | 2007-03-22 | ||
| PCT/US2008/057888 WO2008116179A1 (en) | 2007-03-22 | 2008-03-21 | Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014021320A Division JP5813147B2 (ja) | 2007-03-22 | 2014-02-06 | ダパグリフロジンプロピレングリコール水和物を含む医薬製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2010522244A JP2010522244A (ja) | 2010-07-01 |
| JP2010522244A5 true JP2010522244A5 (enExample) | 2011-04-21 |
| JP5475636B2 JP5475636B2 (ja) | 2014-04-16 |
Family
ID=39671801
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010501128A Active JP5475636B2 (ja) | 2007-03-22 | 2008-03-21 | ダパグリフロジンプロピレングリコール水和物を含む医薬製剤 |
| JP2014021320A Active JP5813147B2 (ja) | 2007-03-22 | 2014-02-06 | ダパグリフロジンプロピレングリコール水和物を含む医薬製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014021320A Active JP5813147B2 (ja) | 2007-03-22 | 2014-02-06 | ダパグリフロジンプロピレングリコール水和物を含む医薬製剤 |
Country Status (28)
| Country | Link |
|---|---|
| US (5) | US7851502B2 (enExample) |
| EP (3) | EP4245299A3 (enExample) |
| JP (2) | JP5475636B2 (enExample) |
| KR (5) | KR101502292B1 (enExample) |
| CN (2) | CN102743340B (enExample) |
| AR (1) | AR065809A1 (enExample) |
| AU (1) | AU2008228714B2 (enExample) |
| BR (2) | BR122017015098B8 (enExample) |
| CA (2) | CA2929811C (enExample) |
| CL (1) | CL2008000823A1 (enExample) |
| CY (3) | CY1123143T1 (enExample) |
| DK (2) | DK2139494T3 (enExample) |
| EA (2) | EA020288B1 (enExample) |
| ES (2) | ES2950089T3 (enExample) |
| FI (1) | FI2508188T3 (enExample) |
| FR (1) | FR20C1042I1 (enExample) |
| HR (2) | HRP20230691T1 (enExample) |
| HU (3) | HUE062284T2 (enExample) |
| LT (3) | LT2139494T (enExample) |
| MX (4) | MX391854B (enExample) |
| NO (1) | NO2020028I1 (enExample) |
| PE (1) | PE20090185A1 (enExample) |
| PL (2) | PL2508188T3 (enExample) |
| PT (2) | PT2139494T (enExample) |
| RS (1) | RS60258B1 (enExample) |
| SI (2) | SI2139494T1 (enExample) |
| TW (1) | TW200904405A (enExample) |
| WO (1) | WO2008116179A1 (enExample) |
Families Citing this family (122)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA91546C2 (uk) * | 2005-05-03 | 2010-08-10 | Бьорінгер Інгельхайм Інтернаціональ Гмбх | КРИСТАЛІЧНА ФОРМА 1-ХЛОР-4-(β-D-ГЛЮКОПІРАНОЗ-1-ИЛ)-2-[4-((S)-ТЕТРАГІДРОФУРАН-3-ІЛОКСИ)-БЕНЗИЛ]-БЕНЗОЛУ, СПОСІБ ЇЇ ОДЕРЖАННЯ ТА ЇЇ ЗАСТОСУВАННЯ ПРИ ПРИГОТУВАННІ ЛІКАРСЬКИХ ЗАСОБІВ |
| US7772191B2 (en) | 2005-05-10 | 2010-08-10 | Boehringer Ingelheim International Gmbh | Processes for preparing of glucopyranosyl-substituted benzyl-benzene derivatives and intermediates therein |
| TW200726755A (en) * | 2005-07-07 | 2007-07-16 | Astellas Pharma Inc | A crystalline choline salt of an azulene derivative |
| PE20080697A1 (es) * | 2006-05-03 | 2008-08-05 | Boehringer Ingelheim Int | Derivados de benzonitrilo sustituidos con glucopiranosilo, composiciones farmaceuticas que contienen compuestos de este tipo, su uso y procedimiento para su fabricacion |
| WO2008075736A1 (ja) * | 2006-12-21 | 2008-06-26 | Astellas Pharma Inc. | Ｃ－グリコシド誘導体の製造方法及びその合成中間体 |
| TW200904454A (en) | 2007-03-22 | 2009-02-01 | Bristol Myers Squibb Co | Methods for treating obesity employing an SGLT2 inhibitor and compositions thereof |
| TW200904405A (en) | 2007-03-22 | 2009-02-01 | Bristol Myers Squibb Co | Pharmaceutical formulations containing an SGLT2 inhibitor |
| CL2008002427A1 (es) * | 2007-08-16 | 2009-09-11 | Boehringer Ingelheim Int | Composicion farmaceutica que comprende 1-cloro-4-(b-d-glucopiranos-1-il)-2-[4-((s)-tetrahidrofurano-3-iloxi)bencil]-benceno combinado con 1-[(4-metilquinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(r)-aminopiperidin-1-il)xantina; y su uso para tratar diabetes mellitus tipo 2. |
| NZ600110A (en) * | 2007-09-10 | 2013-03-28 | Janssen Pharmaceutica Nv | Process for the preparation of compounds useful as inhibitors of sglt |
| EP2236137B1 (en) * | 2008-01-31 | 2015-06-24 | Astellas Pharma Inc. | Pharmaceutical composition for treatment of fatty liver diseases |
| JP5820269B2 (ja) * | 2008-05-22 | 2015-11-24 | アストラゼネカ・アクチエボラーグＡｓｔｒａｚｅｎｅｃａ Ａｋｔｉｅｂｏｌａｇ | Ｓｇｌｔ２阻害剤を使用する高尿酸血症の治療方法およびｓｇｌｔ２阻害剤を含有する組成物 |
| CN102149280B (zh) | 2008-07-15 | 2017-05-24 | 泰拉科斯有限公司 | 氘化苄基苯衍生物及其使用方法 |
| US9056850B2 (en) * | 2008-10-17 | 2015-06-16 | Janssen Pharmaceutica N.V. | Process for the preparation of compounds useful as inhibitors of SGLT |
| WO2010045656A2 (en) * | 2008-10-17 | 2010-04-22 | Nectid, Inc. | Novel sglt2 inhibitor dosage forms |
| CN102387783A (zh) * | 2009-02-13 | 2012-03-21 | 贝林格尔.英格海姆国际有限公司 | 包含吡喃葡萄糖基二苯基甲烷衍生物的药物组合物、其药物剂型、其制备方法及其在患者中改善血糖控制的用途 |
| EP4684831A3 (en) | 2009-02-13 | 2026-03-11 | Boehringer Ingelheim International GmbH | Sglt2 inhibitor for improving glycemic control |
| HUE050287T2 (hu) | 2009-02-13 | 2020-11-30 | Boehringer Ingelheim Int | SGLT2-inhibitort, DPP-IV-inhibitort és adott esetben egy további antidiabetikus hatóanyagot tartalmazó gyógyászati készítmény és alkalmazásai |
| CN102639125A (zh) * | 2009-05-27 | 2012-08-15 | 百时美施贵宝公司 | 使用sglt2抑制剂及其组合物在对先前用其它抗糖尿病药进行的治疗具有耐受的患者中治疗ii型糖尿病的方法 |
| US20110009347A1 (en) | 2009-07-08 | 2011-01-13 | Yin Liang | Combination therapy for the treatment of diabetes |
| US8772512B2 (en) | 2009-07-10 | 2014-07-08 | Janssen Pharmaceutica Nv | Crystallisation process for 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl] benzene |
| BR112012007085B8 (pt) * | 2009-09-30 | 2021-05-25 | Boehringer Ingelheim Int | processos para a preparação de derivados de benzil-benzeno substituídos com glicopiranosila |
| NZ598318A (en) | 2009-09-30 | 2014-02-28 | Boehringer Ingelheim Int | Method for the preparation of a crystalline form of 1-chloro-4- (beta-d-glucopyranos-1-yl)-2-(4-((s)-tetrahydrofuran-3-yloxy)benzyl)benzene |
| UY32919A (es) * | 2009-10-02 | 2011-04-29 | Boehringer Ingelheim Int | Composición farmacéutica, forma de dosificación farmacéutica, procedimiento para su preparación, mé todos para su tratamiento y sus usos |
| PH12012500698A1 (en) * | 2009-10-14 | 2016-05-27 | Janssen Pharmaceutica Nv | Process for the preparation of compounds useful as inhibitors of sglt2 |
| CN102740839B (zh) | 2009-11-13 | 2015-05-06 | 阿斯利康(瑞典)有限公司 | 立即释放片剂 |
| AU2014218385B2 (en) * | 2009-11-13 | 2016-02-25 | Astrazeneca Ab | Bilayer tablet formulations |
| CN105193761B (zh) * | 2009-11-13 | 2019-12-06 | 阿斯利康(瑞典)有限公司 | 双层片剂 |
| WO2011107494A1 (de) | 2010-03-03 | 2011-09-09 | Sanofi | Neue aromatische glykosidderivate, diese verbindungen enthaltende arzneimittel und deren verwendung |
| EP2368552A1 (en) * | 2010-03-25 | 2011-09-28 | Boehringer Ingelheim Vetmedica GmbH | 1-[(3-cyano-pyridin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-[3-(r)-amino-piperidin-1-yl]-xanthine for the treatment of a metabolic disorder of a predominantly carnivorous non-human animal |
| US20140088027A1 (en) | 2010-03-30 | 2014-03-27 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition comprising an sglt2 inhibitor and a ppar- gamma agonist and uses thereof |
| ES2596291T3 (es) | 2010-05-11 | 2017-01-05 | Janssen Pharmaceutica, N.V. | Formulaciones farmacéuticas que comprenden derivados de 1-(beta-d-glucopiranosil)-2-tienilmetilbenceno como inhibidores de sglt |
| CN106890147A (zh) * | 2010-05-11 | 2017-06-27 | 田边三菱制药株式会社 | 含1‑(β‑D‑吡喃葡糖基)‑3‑(苯基噻吩基甲基)苯化合物的片剂 |
| EP2582709B1 (de) | 2010-06-18 | 2018-01-24 | Sanofi | Azolopyridin-3-on-derivate als inhibitoren von lipasen und phospholipasen |
| US8530413B2 (en) | 2010-06-21 | 2013-09-10 | Sanofi | Heterocyclically substituted methoxyphenyl derivatives with an oxo group, processes for preparation thereof and use thereof as medicaments |
| TW201215387A (en) | 2010-07-05 | 2012-04-16 | Sanofi Aventis | Spirocyclically substituted 1,3-propane dioxide derivatives, processes for preparation thereof and use thereof as a medicament |
| TW201221505A (en) | 2010-07-05 | 2012-06-01 | Sanofi Sa | Aryloxyalkylene-substituted hydroxyphenylhexynoic acids, process for preparation thereof and use thereof as a medicament |
| TW201215388A (en) | 2010-07-05 | 2012-04-16 | Sanofi Sa | (2-aryloxyacetylamino)phenylpropionic acid derivatives, processes for preparation thereof and use thereof as medicaments |
| US20120009259A1 (en) * | 2010-07-06 | 2012-01-12 | Urbain Alfons Clementina Delaet | Formulation for co-therapy treatment of diabetes |
| JP5167389B2 (ja) * | 2010-07-07 | 2013-03-21 | 日本たばこ産業株式会社 | クエン酸第二鉄を含む錠剤 |
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| WO2013045413A1 (en) | 2011-09-27 | 2013-04-04 | Sanofi | 6-(4-hydroxy-phenyl)-3-alkyl-1h-pyrazolo[3,4-b]pyridine-4-carboxylic acid amide derivatives as kinase inhibitors |
| EP3763374A1 (en) * | 2011-10-17 | 2021-01-13 | Lexicon Pharmaceuticals, Inc. | Solid dosage forms of (s)-ethyl 2-amino-3-(4-(2-amino-6-((r)-1-(4-chloro-2-(3-methyl-1h-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate |
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| US9145434B2 (en) | 2012-07-26 | 2015-09-29 | Boehringer Ingelheim International Gmbh | Crystalline complex of 1-cyano-2-(4-cyclopropyl-benzyl)-4-(ss-d-glucopyranos-1-yl)-benzene, methods for its preparation and the use thereof for preparing medicaments |
| HK1208621A1 (en) * | 2012-08-30 | 2016-03-11 | 大正制药株式会社 | Combination of sglt2 inhibitor and anti-hypertension drug |
| HUE051406T2 (hu) | 2012-11-14 | 2021-03-01 | Grace W R & Co | Biológiailag aktív anyagot és rendezetlen szervetlen oxidot tartalmazó kompozíciók |
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| PT2981269T (pt) | 2013-04-04 | 2023-10-10 | Boehringer Ingelheim Vetmedica Gmbh | Tratamento de distúrbios metabólicos em animais equinos |
| US20140303097A1 (en) | 2013-04-05 | 2014-10-09 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| US11813275B2 (en) | 2013-04-05 | 2023-11-14 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| CA2812519A1 (en) | 2013-04-05 | 2014-10-05 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| TR201901110T4 (tr) | 2013-04-05 | 2019-02-21 | Boehringer Ingelheim Int | Empagliflozinin terapötik kullanımları. |
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| CN105828815B (zh) * | 2013-12-17 | 2020-03-27 | 勃林格殷格翰动物保健有限公司 | 猫科动物中代谢紊乱的治疗 |
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| KR101483259B1 (ko) | 2012-08-28 | 2015-01-14 | 주식회사 아모센스 | 무수축 바리스타 기판 및 그 제조 방법 |
| WO2014178040A1 (en) | 2013-04-29 | 2014-11-06 | Mapi Pharma Ltd. | Co-crystals of dapagliflozin |
| CN104829572B (zh) | 2014-02-10 | 2019-01-04 | 江苏豪森药业集团有限公司 | 达格列净新晶型及其制备方法 |
| JP6575470B2 (ja) | 2016-09-07 | 2019-09-18 | トヨタ自動車株式会社 | 走行装置 |
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