JP2009510068A5 - - Google Patents
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- JP2009510068A5 JP2009510068A5 JP2008533471A JP2008533471A JP2009510068A5 JP 2009510068 A5 JP2009510068 A5 JP 2009510068A5 JP 2008533471 A JP2008533471 A JP 2008533471A JP 2008533471 A JP2008533471 A JP 2008533471A JP 2009510068 A5 JP2009510068 A5 JP 2009510068A5
- Authority
- JP
- Japan
- Prior art keywords
- direct compression
- tablet
- active ingredient
- granulation
- melt
- 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
- 238000007907 direct compression Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- XEKOWRVHYACXOJ-UHFFFAOYSA-N acetic acid ethyl ester Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drugs Drugs 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000007909 melt granulation Methods 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- CTPDSKVQLSDPLC-UHFFFAOYSA-N 2-(oxolan-2-ylmethoxy)ethanol Chemical compound OCCOCC1CCCO1 CTPDSKVQLSDPLC-UHFFFAOYSA-N 0.000 description 1
- 229960003105 Metformin Drugs 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000007891 compressed tablet Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000009474 hot melt extrusion Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- KFZMGEQAYNKOFK-UHFFFAOYSA-N iso-propanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 1
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Description
製薬業者は迅速な加工時間および経費の利点のために、湿式または乾式造粒法よりも直接圧縮技術の使用を好む。しかしながら通常直接圧縮は、薬物または活性成分が薬学的に許容される錠剤を形成するために要求される物理的特性を有するこれらの状況に限定される。しかしながら直接圧縮法を使用できる前に、多くの成分が必要な特性を有していないので、しばしば一つまたはそれより多い賦形剤を活性成分と組み合わせなければならない。製剤に添加される各賦形剤は最終製品の錠剤の大きさを増すので、製造者は、直接圧縮法の使用をしばしば圧縮錠剤あたり低用量の活性成分を含有する製剤に限定される。
メトホルミン顆粒が湿式造粒により水またはエタノール、イソプロパノール、酢酸エチル、グリコフロール、プロピレングリコールのような有機溶媒から選択される溶媒を用いて生成される本明細書で記載されるような錠剤または医薬組成物。
メトホルミン顆粒が溶融造粒により生成される本明細書で記載されるような錠剤または医薬組成物。溶融造粒過程は「Hot-melt extrusion Technique」: A Review;Iranian Journal of Pharmaceutical Research 3:3-16(2004);Rina Chokshi et al. または総説Joerg Breitenbach 「Melt extrusion: from process to drug delivery technology」: European Journal of Pharmaceutics and Biopharmaceutics 54:107-117(2002)(双方を出典明示により本明細書の一部とする)のような多くの出版物に記載されている。
メトホルミン顆粒が溶融造粒により生成される本明細書で記載されるような錠剤または医薬組成物。溶融造粒過程は「Hot-melt extrusion Technique」: A Review;Iranian Journal of Pharmaceutical Research 3:3-16(2004);Rina Chokshi et al. または総説Joerg Breitenbach 「Melt extrusion: from process to drug delivery technology」: European Journal of Pharmaceutics and Biopharmaceutics 54:107-117(2002)(双方を出典明示により本明細書の一部とする)のような多くの出版物に記載されている。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US72262405P | 2005-09-29 | 2005-09-29 | |
| US60/722,624 | 2005-09-29 | ||
| PCT/US2006/037198 WO2007041053A2 (en) | 2005-09-29 | 2006-09-25 | Formulation comprising metformin and vildagli ptin |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013146163A Division JP2013241429A (ja) | 2005-09-29 | 2013-07-12 | 新規製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009510068A JP2009510068A (ja) | 2009-03-12 |
| JP2009510068A5 true JP2009510068A5 (ja) | 2009-11-05 |
| JP5415762B2 JP5415762B2 (ja) | 2014-02-12 |
Family
ID=37876819
Family Applications (8)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008533471A Active JP5415762B2 (ja) | 2005-09-29 | 2006-09-25 | 新規製剤 |
| JP2013146163A Withdrawn JP2013241429A (ja) | 2005-09-29 | 2013-07-12 | 新規製剤 |
| JP2015201008A Active JP6270793B2 (ja) | 2005-09-29 | 2015-10-09 | 新規製剤 |
| JP2017202104A Withdrawn JP2018052945A (ja) | 2005-09-29 | 2017-10-18 | 新規製剤 |
| JP2019042906A Withdrawn JP2019131567A (ja) | 2005-09-29 | 2019-03-08 | 新規製剤 |
| JP2020151616A Active JP7194153B2 (ja) | 2005-09-29 | 2020-09-09 | 新規製剤 |
| JP2022065829A Pending JP2022106763A (ja) | 2005-09-29 | 2022-04-12 | 新規製剤 |
| JP2023193231A Pending JP2024028702A (ja) | 2005-09-29 | 2023-11-13 | 新規製剤 |
Family Applications After (7)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013146163A Withdrawn JP2013241429A (ja) | 2005-09-29 | 2013-07-12 | 新規製剤 |
| JP2015201008A Active JP6270793B2 (ja) | 2005-09-29 | 2015-10-09 | 新規製剤 |
| JP2017202104A Withdrawn JP2018052945A (ja) | 2005-09-29 | 2017-10-18 | 新規製剤 |
| JP2019042906A Withdrawn JP2019131567A (ja) | 2005-09-29 | 2019-03-08 | 新規製剤 |
| JP2020151616A Active JP7194153B2 (ja) | 2005-09-29 | 2020-09-09 | 新規製剤 |
| JP2022065829A Pending JP2022106763A (ja) | 2005-09-29 | 2022-04-12 | 新規製剤 |
| JP2023193231A Pending JP2024028702A (ja) | 2005-09-29 | 2023-11-13 | 新規製剤 |
Country Status (33)
| Country | Link |
|---|---|
| US (4) | US20080227825A1 (ja) |
| EP (1) | EP1948149B2 (ja) |
| JP (8) | JP5415762B2 (ja) |
| KR (2) | KR101595169B1 (ja) |
| CN (1) | CN101277688B (ja) |
| AR (1) | AR055441A1 (ja) |
| AT (1) | ATE533481T1 (ja) |
| AU (1) | AU2006297444B2 (ja) |
| BR (1) | BRPI0616694B8 (ja) |
| CA (1) | CA2623011C (ja) |
| CY (1) | CY1112305T1 (ja) |
| DK (1) | DK1948149T4 (ja) |
| EC (1) | ECSP088318A (ja) |
| ES (1) | ES2377572T5 (ja) |
| GT (1) | GT200600426A (ja) |
| HK (1) | HK1121372A1 (ja) |
| IL (1) | IL189856A (ja) |
| JO (2) | JOP20180109A1 (ja) |
| MA (1) | MA29854B1 (ja) |
| MY (1) | MY144975A (ja) |
| NO (2) | NO346101B1 (ja) |
| NZ (1) | NZ566430A (ja) |
| PE (1) | PE20070583A1 (ja) |
| PH (1) | PH12014500051B1 (ja) |
| PL (1) | PL1948149T5 (ja) |
| PT (1) | PT1948149E (ja) |
| RU (1) | RU2483716C9 (ja) |
| SG (4) | SG10201809313WA (ja) |
| SI (1) | SI1948149T2 (ja) |
| TN (1) | TNSN08146A1 (ja) |
| TW (1) | TWI389685B (ja) |
| WO (1) | WO2007041053A2 (ja) |
| ZA (1) | ZA200801773B (ja) |
Families Citing this family (80)
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| US7501426B2 (en) | 2004-02-18 | 2009-03-10 | Boehringer Ingelheim International Gmbh | 8-[3-amino-piperidin-1-yl]-xanthines, their preparation and their use as pharmaceutical compositions |
| DE102004054054A1 (de) | 2004-11-05 | 2006-05-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine |
| KR20080007357A (ko) * | 2005-05-10 | 2008-01-18 | 노파르티스 아게 | 압축성이 열등한 치료학적 화합물을 갖는 조성물을제조하는 압출방법 |
| US7772191B2 (en) | 2005-05-10 | 2010-08-10 | Boehringer Ingelheim International Gmbh | Processes for preparing of glucopyranosyl-substituted benzyl-benzene derivatives and intermediates therein |
| DE102005035891A1 (de) | 2005-07-30 | 2007-02-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | 8-(3-Amino-piperidin-1-yl)-xanthine, deren Herstellung und deren Verwendung als Arzneimittel |
| JOP20180109A1 (ar) * | 2005-09-29 | 2019-01-30 | Novartis Ag | تركيبة جديدة |
| CA2633167A1 (en) | 2005-12-16 | 2007-07-12 | Merck & Co., Inc. | Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin |
| EP1852108A1 (en) | 2006-05-04 | 2007-11-07 | Boehringer Ingelheim Pharma GmbH & Co.KG | DPP IV inhibitor formulations |
| CN109503584A (zh) | 2006-05-04 | 2019-03-22 | 勃林格殷格翰国际有限公司 | 多晶型 |
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| FR2928836B1 (fr) * | 2008-03-21 | 2011-08-26 | Servier Lab | Forme galenique secable permettant une liberation modifiee du principe actif |
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| AU2014262269B2 (en) * | 2008-04-03 | 2017-02-02 | Boehringer Ingelheim International Gmbh | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
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| BRPI0916997A2 (pt) | 2008-08-06 | 2020-12-15 | Boehringer Ingelheim International Gmbh | Inibidor de dpp-4 e seu uso |
| MX2011002558A (es) | 2008-09-10 | 2011-04-26 | Boehringer Ingelheim Int | Terapia de combinacion para el tratamiento de diabetes y estados relacionados. |
| US20200155558A1 (en) | 2018-11-20 | 2020-05-21 | Boehringer Ingelheim International Gmbh | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug |
| KR101054911B1 (ko) | 2008-10-17 | 2011-08-05 | 동아제약주식회사 | 디펩티딜펩티다아제-ⅳ의 활성을 저해하는 화합물 및 다른 항당뇨 또는 항비만 약물을 유효성분으로 함유하는 당뇨 또는 비만의 예방 및 치료용 약학적 조성물 |
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| PL2395983T3 (pl) | 2009-02-13 | 2020-09-07 | Boehringer Ingelheim International Gmbh | Kompozycja farmaceutyczna zawierająca inhibitor sglt2, inhibitor dpp-iv i ewentualnie dalszy środek przeciwcukrzycowy oraz jej zastosowania |
| EP2459531B1 (en) * | 2009-07-31 | 2019-09-11 | KRKA, D.D., Novo Mesto | Granulate comprising vildagliptin and process for its preparation |
| EP2295083A1 (de) | 2009-09-15 | 2011-03-16 | Ratiopharm GmbH | Pharmazeutische Zusammensetzung mit den Wirkstoffen Metformin und Sitagliptin oder Vildagliptin |
| SI2486029T1 (sl) | 2009-09-30 | 2015-10-30 | Boehringer Ingelheim International Gmbh | Postopki za pripravo z glukopiranozilom substituiranih benzil-benzenskih derivatov |
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| KR102647472B1 (ko) * | 2018-07-31 | 2024-03-14 | 한미약품 주식회사 | 디펩티딜 펩티다아제-4 억제제 및 메트포르민을 포함하는 경구용 고형 복합제제 및 이의 제조방법 |
| GR1009644B (el) * | 2018-09-25 | 2019-11-12 | Φαρματεν Α.Β.Ε.Ε. | Φαρμακευτικο σκευασμα που περιλαμβανει βιλνταγλιπτινη και μετφορμινη και μεθοδος για την παρασκευη αυτου |
| RU2712097C1 (ru) * | 2018-09-28 | 2020-01-24 | Общество с ограниченной ответственностью "Необиотек" | Ингибитор дипептидилпептидазы-4 для лечения сахарного диабета 2-го типа, соединения (варианты) |
| WO2020098904A1 (en) | 2018-11-12 | 2020-05-22 | Pharmaceutical Oriented Services Ltd | Dosage form containing metformin and a dipeptidyl peptidase iv inhibitor |
| KR102362342B1 (ko) * | 2020-01-31 | 2022-02-14 | 주식회사 경보제약 | 빌다글립틴 및 메트포민 포함하는 복합 정제 |
| RU2727898C1 (ru) * | 2020-02-25 | 2020-07-24 | Общество с ограниченной ответственностью «Необиотек» | Фармацевтическая композиция на основе действующего вещества, ингибитора дипептидилпептидазы-4, для предупреждения развития и лечения сахарного диабета 2 типа |
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| WO2022070209A1 (en) * | 2020-09-29 | 2022-04-07 | Dr. Reddy's Laboratories Limited | Biphasic release fixed dose combination formulations |
| CN114306267A (zh) * | 2020-09-30 | 2022-04-12 | 深圳翰宇药业股份有限公司 | 一种西格列汀二甲双胍片制剂及其制备方法 |
| GB2599950A (en) * | 2020-10-16 | 2022-04-20 | Zentiva Ks | Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same |
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| US3174901A (en) * | 1963-01-31 | 1965-03-23 | Jan Marcel Didier Aron Samuel | Process for the oral treatment of diabetes |
| US3621097A (en) * | 1970-03-30 | 1971-11-16 | Jan Marcel Didier Aron Samuel | Method and compositions for treatment of mental illness |
| DE3720757A1 (de) * | 1987-06-24 | 1989-01-05 | Bayer Ag | Dhp-manteltablette |
| IT1276130B1 (it) * | 1995-11-14 | 1997-10-27 | Gentili Ist Spa | Associazione glibenclamide-metformina, composizioni farmaceutiche che la contengono e loro uso nel trattamento del diabete mellito di tipo |
| DE19823831A1 (de) * | 1998-05-28 | 1999-12-02 | Probiodrug Ges Fuer Arzneim | Neue pharmazeutische Verwendung von Isoleucyl Thiazolidid und seinen Salzen |
| CO5150173A1 (es) * | 1998-12-10 | 2002-04-29 | Novartis Ag | Compuestos n-(glicilo sustituido)-2-cianopirrolidinas inhibidores de peptidasa de dipeptidilo-iv (dpp-iv) los cuales son efectivos en el tratamiento de condiciones mediadas por la inhibicion de dpp-iv |
| PT1248604E (pt) * | 2000-01-21 | 2007-01-31 | Novartis Ag | Associações compreendendo inibidor de dipeptidilpeptidase-iv |
| US7510728B2 (en) * | 2000-10-06 | 2009-03-31 | Takeda Pharmaceutical Company Limited | Solid preparations |
| JP4848558B2 (ja) * | 2001-05-08 | 2011-12-28 | トーアエイヨー株式会社 | 塩酸メトホルミン含有速放性錠剤 |
| FR2824825B1 (fr) * | 2001-05-15 | 2005-05-06 | Servier Lab | Nouveaux derives d'alpha-amino-acides, leur procede de preparation et les compositions pharmaceutiques qui les contiennent |
| WO2004110422A1 (en) * | 2003-06-16 | 2004-12-23 | Ranbaxy Laboratories Limited | Extended-release tablets of metformin |
| DK3023095T3 (en) * | 2004-01-20 | 2018-08-20 | Novartis Ag | Directly pressed wording and approach |
| AU2005299808B2 (en) * | 2004-10-25 | 2009-08-20 | Novartis Ag | Combination of DPP-IV inhibitor, PPAR antidiabetic and metformin |
| GT200600008A (es) * | 2005-01-18 | 2006-08-09 | Formulacion de compresion directa y proceso | |
| GT200600218A (es) * | 2005-06-10 | 2007-03-28 | Formulación y proceso de compresión directa | |
| JOP20180109A1 (ar) * | 2005-09-29 | 2019-01-30 | Novartis Ag | تركيبة جديدة |
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