JP2004533999A5 - - Google Patents
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- Publication number
- JP2004533999A5 JP2004533999A5 JP2002571032A JP2002571032A JP2004533999A5 JP 2004533999 A5 JP2004533999 A5 JP 2004533999A5 JP 2002571032 A JP2002571032 A JP 2002571032A JP 2002571032 A JP2002571032 A JP 2002571032A JP 2004533999 A5 JP2004533999 A5 JP 2004533999A5
- Authority
- JP
- Japan
- Prior art keywords
- atorvastatin calcium
- mixture
- active ingredient
- adjusting substance
- pharmaceutical preparation
- 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
- 229960001770 Atorvastatin calcium Drugs 0.000 claims 6
- FQCKMBLVYCEXJB-MNSAWQCASA-L atorvastatin calcium Chemical compound [Ca+2].C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC([O-])=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1.C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC([O-])=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 FQCKMBLVYCEXJB-MNSAWQCASA-L 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 4
- 239000004480 active ingredient Substances 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N HCl Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 229910000041 hydrogen chloride Inorganic materials 0.000 claims 2
- 210000004051 Gastric Juice Anatomy 0.000 claims 1
- 230000003113 alkalizing Effects 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- -1 excipients Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
Claims (3)
- アトルバスタチンカルシウムが、微紛したアモルファス形アトルバスタチンカルシウムを含んでなり、
医薬製剤が、ｐＨ３の９００ｍｌの０．００１Ｍ ＨＣｌ溶液である仮想胃液中に溶解される場合に、アトルバスタチンカルシウムのｐＫａ＋１と同じまたはそれ以上のｐＨに上記溶液の上記ｐＨを上げる特性をもつことを特徴とする、活性成分に上記アトルバスタチンカルシウムを含む医薬製剤、及びｐＨ調整物質。 - 上記ｐＨ調整物質が、単独投与によって上記ＨＣｌ溶液のｐＨ値を、ｐＫａ＋１と同じまたはそれ以上に高くするために、該ｐＨ調整物質の量が製剤において調整されることを特徴とする請求項１から３のいずれかに記載の医薬製剤。
- （ａ）微紛したアモルファス形アトルバスタチンカルシウムの形である上記活性成分を、アルカリ化及び／または緩衝剤、賦形剤、結合剤、崩壊剤及び界面活性剤からなる群の少なくとも１つの構成と混合するステップ；
（ｂ）上記混合体を均質化するステップ；
（ｃ）上記混合体への追加成分の添加ステップ；
（ｄ）混合体を再度均一化するステップ；及び
（ｅ）再度均一化された混合体を投与可能な形に最終処理するステップ
からなる、活性成分にアトルバスタチンカルシウムを含む医薬製剤の調製のためのプロセス。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200100069A SI20848A (sl) | 2001-03-14 | 2001-03-14 | Farmacevtska formulacija, ki vsebuje atorvastatin kalcij |
| PCT/IB2002/000736 WO2002072073A2 (en) | 2001-03-14 | 2002-03-13 | Pharmaceutical formulation comprising atorvastatin calcium |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2004533999A JP2004533999A (ja) | 2004-11-11 |
| JP2004533999A5 true JP2004533999A5 (ja) | 2005-06-02 |
| JP4295988B2 JP4295988B2 (ja) | 2009-07-15 |
Family
ID=20432850
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2002571032A Expired - Lifetime JP4295988B2 (ja) | 2001-03-14 | 2002-03-13 | 医薬形態のアトルバスタチンカルシウム、その構成物、及びアトルバスタチンカルシウムを含む医薬製剤 |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US7030151B2 (ja) |
| EP (2) | EP1499297B1 (ja) |
| JP (1) | JP4295988B2 (ja) |
| KR (1) | KR100905730B1 (ja) |
| CN (1) | CN1630510B (ja) |
| AT (1) | ATE500818T1 (ja) |
| BG (1) | BG66339B1 (ja) |
| BR (1) | BR0207880A (ja) |
| CA (1) | CA2440331C (ja) |
| CZ (1) | CZ306128B6 (ja) |
| DE (1) | DE60239425D1 (ja) |
| ES (2) | ES2361609T3 (ja) |
| HR (1) | HRP20030726B1 (ja) |
| HU (1) | HU230213B1 (ja) |
| IL (2) | IL157534A0 (ja) |
| ME (1) | ME00517B (ja) |
| MX (1) | MXPA03008340A (ja) |
| PL (2) | PL211803B1 (ja) |
| RS (2) | RS51746B (ja) |
| RU (1) | RU2293555C2 (ja) |
| SI (2) | SI20848A (ja) |
| SK (1) | SK287925B6 (ja) |
| UA (1) | UA78201C2 (ja) |
| WO (1) | WO2002072073A2 (ja) |
| ZA (1) | ZA200306575B (ja) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USRE44578E1 (en) | 2000-04-10 | 2013-11-05 | Teva Pharmaceutical Industries, Ltd. | Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids |
| CA2406574C (en) | 2000-04-10 | 2006-12-05 | Teva Pharmaceutical Industries, Ltd. | Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids |
| IL156055A0 (en) * | 2000-11-30 | 2003-12-23 | Teva Pharma | Novel crystal forms of atorvastatin hemi calcium and processes for their preparation as well as novel processes for preparing other forms |
| CA2626317A1 (en) | 2000-12-27 | 2002-07-04 | Teva Pharmaceutical Industries Ltd. | Crystalline forms of atorvastatin |
| PL367943A1 (en) | 2001-06-29 | 2005-03-07 | Warner-Lambert Company Llc | Crystalline forms of 'r-(r*,r*)!-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-'phenylamino)carbonyl!-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin) |
| MXPA04007905A (es) * | 2002-02-14 | 2004-11-26 | Ranbaxy Lab Ltd | Formulaciones de atorvastatin estabilizadas con adiciones de metal alcali. |
| US20070053976A1 (en) * | 2002-05-17 | 2007-03-08 | Eisai R & D Management Co., Ltd. | Novel combination of drugs as antidepressant |
| AU2003298514A1 (en) * | 2002-05-17 | 2004-05-04 | Eisai Co., Ltd. | Methods and compositions using cholinesterase inhibitors |
| CA2385529A1 (en) * | 2002-05-21 | 2003-11-21 | Bernard Charles Sherman | Stable dosage forms comprising atorvastatin calcium |
| SI21302A (sl) * | 2002-10-11 | 2004-04-30 | LEK farmacevtska dru�ba d.d. | Stabiliziran farmacevtski izdelek z amorfno aktivno učinkovino |
| SI21402A (sl) | 2003-02-12 | 2004-08-31 | LEK farmacevtska dru�ba d.d. | Obloženi delci in farmacevtske oblike |
| US7790197B2 (en) | 2003-06-09 | 2010-09-07 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
| US20050271717A1 (en) * | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of atorvastatin |
| CA2465693A1 (en) | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
| CA2465565A1 (en) * | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
| TR200301614A2 (tr) * | 2003-09-26 | 2005-10-21 | Bi̇ofarma İlaç Sanayi̇ Ve Ti̇caret A.Ş. | Atorvastatin kalsiyum tablet formülasyonunun hazırlanması için yeni yöntem |
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| CA2672554C (en) | 2004-07-20 | 2012-01-03 | Warner-Lambert Company Llc | Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl).beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1) |
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| US20090208539A1 (en) | 2004-11-22 | 2009-08-20 | Adel Penhasi | Stable atorvastatin formulations |
| US20090088465A1 (en) * | 2004-12-02 | 2009-04-02 | Stephen Craig Dyar | Pharmaceutical Compositions of Amorphous Atorvastatin and Process for Preparing Same |
| ES2263370B1 (es) * | 2005-02-16 | 2007-12-01 | Ercros Industrial, S.A. | Atorvastatina calcica amorfa estabilizada y procedimiento para su obtencion. |
| US20080182887A1 (en) * | 2005-02-22 | 2008-07-31 | Sun Pharmaceutical Industries Limited | Stable Oral Pharmaceutical Composition |
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| CA2547216A1 (en) * | 2005-09-21 | 2007-03-21 | Renuka D. Reddy | Process for annealing amorphous atorvastatin |
| BRPI0520669A2 (pt) * | 2005-11-21 | 2009-06-02 | Teva Pharma | dosagem farmacêutica que reduz o efeito do alimento encontrado para administração de atorvastatina |
| EP1923057A1 (en) * | 2005-11-21 | 2008-05-21 | Teva Pharmaceutical Industries Ltd | Atorvastatin pharmaceutical formulation |
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| EP1810667A1 (en) * | 2006-01-20 | 2007-07-25 | KRKA, tovarna zdravil, d.d., Novo mesto | Pharmaceutical composition comprising amorphous atorvastatin |
| EP1818049A3 (en) * | 2006-02-10 | 2008-11-19 | LifeCycle Pharma A/S | Stabilized Atorvastatin |
| US20080038332A1 (en) * | 2006-08-10 | 2008-02-14 | Cai Gu Huang | Stable pharmaceutical formulation comprising atorvastatin calcium |
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| MY159533A (en) * | 2009-01-02 | 2017-01-13 | Univ Putra Malaysia | Porous bioceramic composition for bone repair |
| JO3635B1 (ar) | 2009-05-18 | 2020-08-27 | Millennium Pharm Inc | مركبات صيدلانية صلبة وطرق لانتاجها |
| KR101248804B1 (ko) * | 2010-05-14 | 2013-03-29 | 한미사이언스 주식회사 | ＨＭＧ-ＣｏＡ 환원효소 억제제 및 이베살탄을 포함하는 이층정 약제학적 복합제제 |
| KR20120011249A (ko) | 2010-07-28 | 2012-02-07 | 주식회사 경보제약 | 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법 |
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| CN102755322B (zh) * | 2012-07-24 | 2013-12-11 | 兆科药业（广州）有限公司 | 一种乐卡地平和阿托伐他汀复方制剂 |
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| CN104013617A (zh) * | 2014-05-13 | 2014-09-03 | 万特制药(海南)有限公司 | 一种含有依折麦布和阿托伐他汀钙的组合物及其制备方法 |
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| CN110339365A (zh) * | 2018-04-02 | 2019-10-18 | 强生化学制药厂股份有限公司 | 一种可提高口服他汀类药物生体可用率的医药组合物及其用途 |
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| KR20210098059A (ko) | 2020-01-31 | 2021-08-10 | 주식회사 일원바이오 | 양춘사 추출물을 유효성분으로 함유하는 고지혈증 또는 동맥경화의 예방, 개선 또는 치료용 조성물 |
| KR102643099B1 (ko) | 2020-01-31 | 2024-03-05 | 주식회사 일원바이오 | 양춘사 및 백출 복합 추출물을 유효성분으로 함유하는 고지혈증 또는 동맥경화의 예방, 개선 또는 치료용 조성물 |
| CA3195103A1 (en) * | 2020-05-22 | 2021-11-25 | Durect Corporation | Treatment of non-alcoholic steatohepatitis (nash) |
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-
2001
- 2001-03-14 SI SI200100069A patent/SI20848A/sl not_active IP Right Cessation
-
2002
- 2002-02-13 IL IL15753402A patent/IL157534A0/xx unknown
- 2002-03-13 EP EP02702654A patent/EP1499297B1/en not_active Expired - Lifetime
- 2002-03-13 KR KR1020037011535A patent/KR100905730B1/ko active IP Right Grant
- 2002-03-13 AT AT02702654T patent/ATE500818T1/de not_active IP Right Cessation
- 2002-03-13 WO PCT/IB2002/000736 patent/WO2002072073A2/en active IP Right Grant
- 2002-03-13 UA UA2003098317A patent/UA78201C2/xx unknown
- 2002-03-13 SI SI200230945T patent/SI1499297T1/sl unknown
- 2002-03-13 RU RU2003130378/15A patent/RU2293555C2/ru active
- 2002-03-13 CZ CZ2003-2469A patent/CZ306128B6/cs not_active IP Right Cessation
- 2002-03-13 PL PL371919A patent/PL211803B1/pl unknown
- 2002-03-13 BR BR0207880-5A patent/BR0207880A/pt not_active Application Discontinuation
- 2002-03-13 ES ES02702654T patent/ES2361609T3/es not_active Expired - Lifetime
- 2002-03-13 RS YU69603A patent/RS51746B/sr unknown
- 2002-03-13 RS RS20110313A patent/RS55021B1/sr unknown
- 2002-03-13 HU HU0303434A patent/HU230213B1/hu unknown
- 2002-03-13 EP EP10183122.0A patent/EP2263655B1/en not_active Expired - Lifetime
- 2002-03-13 US US10/471,906 patent/US7030151B2/en not_active Expired - Lifetime
- 2002-03-13 DE DE60239425T patent/DE60239425D1/de not_active Expired - Lifetime
- 2002-03-13 CA CA002440331A patent/CA2440331C/en not_active Expired - Lifetime
- 2002-03-13 SK SK1136-2003A patent/SK287925B6/sk unknown
- 2002-03-13 JP JP2002571032A patent/JP4295988B2/ja not_active Expired - Lifetime
- 2002-03-13 CN CN028064739A patent/CN1630510B/zh not_active Expired - Lifetime
- 2002-03-13 MX MXPA03008340A patent/MXPA03008340A/es active IP Right Grant
- 2002-03-13 ME MEP-2008-845A patent/ME00517B/me unknown
- 2002-03-13 PL PL396343A patent/PL217835B1/pl unknown
- 2002-03-13 ES ES10183122T patent/ES2417881T3/es not_active Expired - Lifetime
-
2003
- 2003-08-21 IL IL157534A patent/IL157534A/en active IP Right Grant
- 2003-08-22 ZA ZA200306575A patent/ZA200306575B/en unknown
- 2003-09-11 HR HRP20030726AA patent/HRP20030726B1/hr not_active IP Right Cessation
- 2003-09-12 BG BG108175A patent/BG66339B1/bg unknown
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