JP2005002120A - ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形及びこれを含む医薬組成物 - Google Patents
ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形及びこれを含む医薬組成物 Download PDFInfo
- Publication number
- JP2005002120A JP2005002120A JP2004206157A JP2004206157A JP2005002120A JP 2005002120 A JP2005002120 A JP 2005002120A JP 2004206157 A JP2004206157 A JP 2004206157A JP 2004206157 A JP2004206157 A JP 2004206157A JP 2005002120 A JP2005002120 A JP 2005002120A
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- butylamine salt
- perindopril tert
- perindopril
- crystal form
- 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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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
- C07D209/04—Indoles; Hydrogenated indoles
- C07D209/30—Indoles; Hydrogenated indoles with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, directly attached to carbon atoms of the hetero ring
- C07D209/42—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Hospice & Palliative Care (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Vascular Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Indole Compounds (AREA)
Abstract
Description
−第1の実施態様に従って、クロロホルム中のペリンドプリルtert−ブチルアミン塩の溶液を加熱還流し、次いでその溶液を急速に0℃に冷却し、撹拌の後、得られる固体を濾過により回収すること、又は
−第2の実施態様に従って、酢酸エチル中のペリンドプリルtert−ブチルアミン塩の溶液を加熱還流し、その溶液を急速に0℃〜5℃に冷却し、こうして得られる固体を次いで濾過により回収する。固体をクロロホルムに懸濁し、懸濁液を周囲温度で5〜10日撹拌し、次いで固体を濾過により回収すること、
のいずれか
を特徴とする、製造方法に関する。
−ジーメンス(Siemens)D5005回折計、シンチレーション検出器、
−銅対陰極(λ=1.5405Å)、電圧40kV、強度40mA、
−マウンティングθ−θ、
−測定範囲:5°〜30°、
−各測定間の増分:0.02°、
−工程当たりの測定時間:2秒、
−可変スリット:v6、
−フィルターKβ(Ni)、
−内部標準なし、
−ジーメンススリットを用いるゼロ合わせ手順、
−EVAソフトウェア(バージョン5.0)を用いて処理される実験データ。
特許明細書EP 0,308,341に記載される方法によって得られたペリンドプリルtert−ブチルアミン塩100gを、クロロホルム500mlに溶解して還流加熱した。次に溶液を0℃に冷却し、その温度で一晩撹拌した。得られた固体を濾過により回収した。
ペリンドプリルtert−ブチルアミン塩のγ結晶形の粉末X線回折プロフィール(回折角)は、強度及び相対強度(最も強い線に対する百分率として表される)と一緒に下記の表に照合される有効な線によって与えられる。
特許明細書EP 0,308,341に記載される方法によって得られたペリンドプリルtert−ブチルアミン塩125gを、酢酸エチル1.5リットルに溶解して還流加熱した。次に溶液の温度を急速に0〜5℃にした。次いで得られた固体を濾過により回収し、次いでクロロホルム750gに懸濁した。懸濁液を周囲温度で5〜10日撹拌し、次いで固体を濾過により回収した。
それぞれ活性成分4mgを含む錠剤1000錠のための調剤処方:
実施例1の化合物 4g
ヒドロキシプロピルセルロース 2g
コムギデンプン 10g
乳糖 100g
ステアリン酸マグネシウム 3g
タルク 3g
Claims (6)
- 1つ以上の薬学的に許容しうる不活性な非毒性担体との組合せで、活性成分として、請求項1記載の化合物を含む医薬組成物。
- アンギオテンシンI変換酵素のインヒビターとして使用するための医薬の製造において使用するための、請求項2記載の医薬組成物。
- 心血管疾患の処置において使用するための医薬の製造において使用するための、請求項3記載の医薬組成物。
- 利尿薬をも含むことを特徴とする、請求項2〜4のいずれか1項記載の医薬組成物。
- 利尿薬が、インダパミドであることを特徴とする、請求項5記載の医薬組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0008791A FR2811318B1 (fr) | 2000-07-06 | 2000-07-06 | Nouvelle forme cristalline gamma du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
FR00/08791 | 2000-07-06 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001580868A Division JP3592296B2 (ja) | 2000-07-06 | 2001-07-06 | ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形、その製造方法及びこれを含む医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2005002120A true JP2005002120A (ja) | 2005-01-06 |
JP5016184B2 JP5016184B2 (ja) | 2012-09-05 |
Family
ID=8852170
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001580868A Expired - Fee Related JP3592296B2 (ja) | 2000-07-06 | 2001-07-06 | ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形、その製造方法及びこれを含む医薬組成物 |
JP2004206157A Expired - Fee Related JP5016184B2 (ja) | 2000-07-06 | 2004-07-13 | ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形及びこれを含む医薬組成物 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001580868A Expired - Fee Related JP3592296B2 (ja) | 2000-07-06 | 2001-07-06 | ペリンドプリルtert−ブチルアミン塩の新しいγ結晶形、その製造方法及びこれを含む医薬組成物 |
Country Status (36)
Country | Link |
---|---|
US (2) | US20030158121A1 (ja) |
EP (1) | EP1296948B1 (ja) |
JP (2) | JP3592296B2 (ja) |
KR (1) | KR100513572B1 (ja) |
CN (1) | CN1328258C (ja) |
AP (1) | AP1452A (ja) |
AR (1) | AR029570A1 (ja) |
AT (1) | ATE249435T1 (ja) |
AU (2) | AU2001276420B2 (ja) |
BG (1) | BG66239B1 (ja) |
BR (1) | BR0112211A (ja) |
CA (1) | CA2415447C (ja) |
CZ (1) | CZ302022B6 (ja) |
DE (1) | DE60100761T2 (ja) |
DK (1) | DK1296948T3 (ja) |
EA (1) | EA004275B1 (ja) |
EE (1) | EE05286B1 (ja) |
ES (1) | ES2206423T3 (ja) |
FR (1) | FR2811318B1 (ja) |
GE (1) | GEP20043362B (ja) |
HK (1) | HK1058199A1 (ja) |
HR (1) | HRP20030078B1 (ja) |
HU (1) | HU228115B1 (ja) |
ME (1) | ME01367B (ja) |
MX (1) | MXPA02012904A (ja) |
NO (1) | NO323445B1 (ja) |
NZ (1) | NZ523311A (ja) |
OA (1) | OA12306A (ja) |
PL (1) | PL348491A1 (ja) |
PT (1) | PT1296948E (ja) |
RS (1) | RS51621B (ja) |
SI (1) | SI1296948T1 (ja) |
SK (1) | SK287452B6 (ja) |
UA (1) | UA57187C2 (ja) |
WO (1) | WO2001083439A2 (ja) |
ZA (1) | ZA200300025B (ja) |
Families Citing this family (31)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2811319B1 (fr) * | 2000-07-06 | 2002-08-23 | Adir | Nouvelle forme cristalline beta du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
FR2811320B1 (fr) * | 2000-07-06 | 2002-08-23 | Adir | Nouvelle forme cristalline alpha du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
FR2834893B1 (fr) * | 2002-01-23 | 2004-02-27 | Servier Lab | Composition pharmaceutique orodispersible de perindopril |
GB2395195A (en) * | 2002-11-18 | 2004-05-19 | Cipla Ltd | Preparation of perindopril from carboxy-protected precursor, & perindopril monohydrates for use as angiotensin converting enzyme (ACE) inhibitors |
EA008603B1 (ru) * | 2003-06-24 | 2007-06-29 | Ле Лаборатуар Сервье | Новые кристаллические формы периндоприл эрбумина |
AU2003263584A1 (en) * | 2003-08-21 | 2005-03-10 | Hetero Drugs Limited | Process for pure perindopril tert-butylamine salt |
JP4677611B2 (ja) | 2003-10-21 | 2011-04-27 | レ ラボラトワール セルヴィエ | 結晶ペリンドプリルエルブミンの新規な調製方法 |
SI21704A (en) * | 2004-01-14 | 2005-08-31 | Lek Farmacevtska Druzba Dd | New crystal form of perindopril, procedure of its preparation, pharmaceutical preparations containing this form and their application in treatment of hypertensia |
SI21703A (en) | 2004-01-14 | 2005-08-31 | Lek Farmacevtska Druzba Dd | Inclusion complexes of perindopril, procedure of their preparation, pharmaceutical compositions containing these complexes and their application in treatment of hypertensia |
LT1729739T (lt) * | 2004-03-29 | 2016-11-10 | Les Laboratoires Servier | Kietos farmacinės kompozicijos gamybos būdas |
SI21800A (sl) | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
SI21881A (sl) | 2004-10-15 | 2006-04-30 | Diagen, Smartno Pri Ljubljani, D.O.O. | Nove kristalne oblike perindopril erbumin hidratov, postopek za njihovo pripravo in farmacevtske oblike, ki vsebujejo te spojine |
SG125976A1 (en) * | 2005-03-11 | 2006-10-30 | Servier Lab | New gama crystalline form of perindopril tert-butylamine salt, a process for its preparation and pharmaceutical compositions containing it |
SG125975A1 (en) * | 2005-03-11 | 2006-10-30 | Servier Lab | New alpha crystalline form of perindopril tert-butylamine salt, a process for its preparation and pharmaceutical compositions containing it |
JP2006290825A (ja) * | 2005-04-13 | 2006-10-26 | Shiono Chemical Co Ltd | アルファ型ペリンドプリルエルブミンの製造法 |
WO2007017894A2 (en) * | 2005-05-05 | 2007-02-15 | Arch Pharmalabs Limited | PREPARATION OF NOVEL CRYSTALLINE η(ETA) FORM OF PERINDOPRIL ERBUMINE |
WO2007020012A1 (en) * | 2005-08-12 | 2007-02-22 | Lek Pharmaceuticals D.D. | A process for the preparation of perindopril erbumine |
WO2007020009A1 (en) * | 2005-08-12 | 2007-02-22 | Sandoz Ag | New crystalline form of perindopril erbumine |
EP1815857A1 (en) | 2006-02-02 | 2007-08-08 | LEK Pharmaceuticals D.D. | A pharmaceutical composition comprising perindopril |
WO2007092758A2 (en) * | 2006-02-03 | 2007-08-16 | Dr. Reddy's Laboratories Ltd. | Crystalline forms of perindopril erbumine |
FR2897865B1 (fr) * | 2006-02-28 | 2008-04-18 | Servier Lab | Forme cristalline beta du sel d'arginine du perindopril, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
FR2897866B1 (fr) | 2006-02-28 | 2008-04-18 | Servier Lab | Forme cristalline alpha du sel d'arginine du perindopril, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
WO2008114270A1 (en) * | 2007-03-22 | 2008-09-25 | Aarti Healthcare Limited | Process for the preparation of perindopril erbumine salt and novel polymorph (s) thereof |
WO2008120241A2 (en) * | 2007-03-29 | 2008-10-09 | Ipca Laboratories Limited | Novel alcohol solvates of perindopril erbumine |
SI22543A (sl) | 2007-06-27 | 2008-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nove soli perindoprila |
EP2318365B1 (en) * | 2008-06-24 | 2015-08-12 | Mylan Laboratories Limited | Novel polymorphic forms of perindopril (l)-arginine and process for the preparation thereof |
KR200453510Y1 (ko) * | 2009-02-09 | 2011-05-11 | 윤유원 | 튀김유 정제기 |
KR101041878B1 (ko) * | 2009-03-26 | 2011-06-15 | 신준호 | 튀김장치용 찌꺼기 제거장치 |
SI23149A (sl) | 2009-09-21 | 2011-03-31 | Silverstone Pharma | Nove benzatinske soli ACE inhibitorjev, postopek za njihovo pripravo in njihova uporaba za zdravljenje kardiovaskularnih bolezni |
PT105315B (pt) | 2010-09-29 | 2013-01-16 | Inst Superior Tecnico | Uma nova forma cristalina hidratada de erbumina de perindopril, métodos para a sua preparação e sua utilização em preparações farmacêuticas |
EP3842035A1 (en) | 2019-12-23 | 2021-06-30 | KRKA, d.d., Novo mesto | Composition for the preparation of perindopril arginine granules, a method for their preparation and pharmaceutical composition comprising the granules |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH01110696A (ja) * | 1987-09-17 | 1989-04-27 | Adir | ペルインドプリルの工業的製造法 |
WO1999025374A1 (fr) * | 1997-11-19 | 1999-05-27 | Adir Et Compagnie | Combinaison d'un inhibiteur de l'enzyme de conversion de l'angiotensine et d'un diuretique pour le traitement des desordres microcirculatoires |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
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FR2503155A2 (fr) * | 1980-10-02 | 1982-10-08 | Science Union & Cie | Nouveaux imino diacides substitues, leurs procedes de preparation et leur emploi comme inhibiteur d'enzyme |
FR2620703B1 (fr) * | 1987-09-17 | 1991-10-04 | Adir | Procede de synthese industrielle de l'acide perhydroindole carboxylique - 2(2s, 3as, 7as). application a la synthese de carboxyalkyl dipeptides |
FR2811320B1 (fr) * | 2000-07-06 | 2002-08-23 | Adir | Nouvelle forme cristalline alpha du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
FR2811319B1 (fr) * | 2000-07-06 | 2002-08-23 | Adir | Nouvelle forme cristalline beta du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
-
2000
- 2000-07-06 FR FR0008791A patent/FR2811318B1/fr not_active Expired - Fee Related
-
2001
- 2001-06-07 UA UA2003021019A patent/UA57187C2/uk unknown
- 2001-07-05 HU HU0102814A patent/HU228115B1/hu not_active IP Right Cessation
- 2001-07-06 WO PCT/FR2001/002169 patent/WO2001083439A2/fr active IP Right Grant
- 2001-07-06 KR KR10-2003-7000117A patent/KR100513572B1/ko not_active IP Right Cessation
- 2001-07-06 ME MEP-2008-672A patent/ME01367B/me unknown
- 2001-07-06 NZ NZ523311A patent/NZ523311A/en not_active IP Right Cessation
- 2001-07-06 CN CNB018123538A patent/CN1328258C/zh not_active Expired - Fee Related
- 2001-07-06 PT PT01954060T patent/PT1296948E/pt unknown
- 2001-07-06 AU AU2001276420A patent/AU2001276420B2/en not_active Ceased
- 2001-07-06 SK SK150-2003A patent/SK287452B6/sk not_active IP Right Cessation
- 2001-07-06 OA OA1200200399A patent/OA12306A/en unknown
- 2001-07-06 BR BR0112211-8A patent/BR0112211A/pt not_active Application Discontinuation
- 2001-07-06 ES ES01954060T patent/ES2206423T3/es not_active Expired - Lifetime
- 2001-07-06 EA EA200300104A patent/EA004275B1/ru not_active IP Right Cessation
- 2001-07-06 GE GE5074A patent/GEP20043362B/en unknown
- 2001-07-06 AT AT01954060T patent/ATE249435T1/de active
- 2001-07-06 AU AU7642001A patent/AU7642001A/xx active Pending
- 2001-07-06 AR ARP010103224A patent/AR029570A1/es not_active Application Discontinuation
- 2001-07-06 CA CA002415447A patent/CA2415447C/fr not_active Expired - Fee Related
- 2001-07-06 EE EEP200300003A patent/EE05286B1/xx not_active IP Right Cessation
- 2001-07-06 US US10/312,903 patent/US20030158121A1/en not_active Abandoned
- 2001-07-06 EP EP01954060A patent/EP1296948B1/fr not_active Expired - Lifetime
- 2001-07-06 PL PL01348491A patent/PL348491A1/xx not_active Application Discontinuation
- 2001-07-06 DE DE60100761T patent/DE60100761T2/de not_active Expired - Lifetime
- 2001-07-06 RS YU100302A patent/RS51621B/sr unknown
- 2001-07-06 SI SI200130029T patent/SI1296948T1/xx unknown
- 2001-07-06 MX MXPA02012904A patent/MXPA02012904A/es active IP Right Grant
- 2001-07-06 JP JP2001580868A patent/JP3592296B2/ja not_active Expired - Fee Related
- 2001-07-06 DK DK01954060T patent/DK1296948T3/da active
- 2001-07-06 CZ CZ20030358A patent/CZ302022B6/cs not_active IP Right Cessation
- 2001-07-06 AP APAP/P/2002/002709A patent/AP1452A/en active
-
2003
- 2003-01-02 ZA ZA200300025A patent/ZA200300025B/en unknown
- 2003-01-06 NO NO20030051A patent/NO323445B1/no not_active IP Right Cessation
- 2003-02-05 BG BG107534A patent/BG66239B1/bg unknown
- 2003-02-06 HR HR20030078A patent/HRP20030078B1/xx not_active IP Right Cessation
-
2004
- 2004-02-12 HK HK04100948A patent/HK1058199A1/xx not_active IP Right Cessation
- 2004-03-29 US US10/811,727 patent/US20040248817A1/en not_active Abandoned
- 2004-07-13 JP JP2004206157A patent/JP5016184B2/ja not_active Expired - Fee Related
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH01110696A (ja) * | 1987-09-17 | 1989-04-27 | Adir | ペルインドプリルの工業的製造法 |
WO1999025374A1 (fr) * | 1997-11-19 | 1999-05-27 | Adir Et Compagnie | Combinaison d'un inhibiteur de l'enzyme de conversion de l'angiotensine et d'un diuretique pour le traitement des desordres microcirculatoires |
Also Published As
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