JP2007530623A - 固形薬学的組成物を調製するためのプロセス - Google Patents
固形薬学的組成物を調製するためのプロセス Download PDFInfo
- Publication number
- JP2007530623A JP2007530623A JP2007505484A JP2007505484A JP2007530623A JP 2007530623 A JP2007530623 A JP 2007530623A JP 2007505484 A JP2007505484 A JP 2007505484A JP 2007505484 A JP2007505484 A JP 2007505484A JP 2007530623 A JP2007530623 A JP 2007530623A
- Authority
- JP
- Japan
- Prior art keywords
- perindopril
- salt
- carbonate
- composition
- indapamide
- 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
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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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Indole Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
(i)ペリンドプリルまたはその塩を、少なくとも1種の無機炭酸塩、少なくとも1種のキャリア、および必要に応じて他の成分と乾燥混合(dry mix)する工程、ならびに
(ii)工程(i)において得られた混合物を、所望の固形形態に乾燥加工(dry process)する工程。
(a)ペリンドプリルもしくはその塩、
(b)0.3重量%〜5.0重量%の含水量を有する少なくとも1種の微結晶性セルロースおよび無水ラクトース、
(c)必要に応じて、少なくとも1種の無機炭酸塩、ならびに
(d)必要に応じて、他の成分。
実施例2〜4(本発明)について、ペリンドプリルエルブミン、ならびにキャリアとして使用した物質、ならびに、他の成分を篩にかけた。実施例5〜7において、ペリンドプリルエルブミンとインダパミドとの好ましい組み合わせを用いた。滑沢剤であるステアリン酸マグネシウムを除いて、篩にかけた物質を、乾燥状態でブレンドした。その後、ステアリン酸マグネシウムをこの得られた混合物に添加し、そして、この混合物を、ホモジェナイズした。ホモジェナイズされた混合物を、次いで、穿孔打錠機(Wilhelm Fette製のExacta X)を用いて圧縮して、錠剤を得た。比較例として、実施例1についての以下の表に示された組成を有する、ペリンドプリルエルブミンを含有する市販の錠剤を用いた。
A:1000mlのメスフラスコに、0.92gのヘプタスルホン酸ナトリウムおよび1mlのトリエチルアミン(TEA)を加えて、水を容量まで充填し、そして、過塩素酸を用いて、溶液のpH値を2.0に調節することによって調製した、pH2.0の緩衝溶液
B:アセトニトリル。
Claims (17)
- ペリンドプリルまたはその塩の固形薬学的組成物を調製するためのプロセスであって、該プロセスは、以下:
(i)ペリンドプリルまたはその塩を、少なくとも1種の無機炭酸塩、少なくとも1種のキャリア、および必要に応じて他の成分と乾燥混合する工程、ならびに
(ii)工程(i)において得られた混合物を、所望の固形形態に乾燥加工する工程
を包含する、プロセス。 - 前記組成物が、ペリンドプリルの第三級ブチルアミン塩を含有する、請求項1に記載のプロセス。
- 前記無機炭酸塩が、炭酸ナトリウム、炭酸水素ナトリウム、炭酸マグネシウム、炭酸カルシウムまたは炭酸水素カルシウムである、請求項1または2に記載のプロセス。
- 前記ペリンドプリルまたはその塩の、無機炭酸塩に対するモル比が、1:0.1〜0.9、好ましくは、1:0.50〜0.83である、請求項1〜3のいずれか1項に記載のプロセス。
- 前記キャリアが、微結晶性セルロース、ラクトースまたはこれらの混合物である、請求項1〜4のいずれか1項に記載のプロセス。
- 前記微結晶性セルロースが、0.3重量%〜5.0重量%、好ましくは、0.3重量%〜1.5重量%の含水量を有する、請求項5に記載のプロセス。
- 前記ラクトースが、無水ラクトースである、請求項5または6に記載のプロセス。
- 前記工程(ii)が、前記混合物を直接圧縮することによって達成される、請求項1〜7のいずれか1項に記載のプロセス。
- 前記組成物がまた、インダパミドまたはその水和物を含有する、請求項1〜8のいずれか1項に記載のプロセス。
- 前記水和物が、インダパミド半水和物である、請求項9に記載のプロセス。
- 前記インダパミドまたはその水和物の粒子の90%が、80μm未満のサイズを有する、請求項9または10に記載のプロセス。
- 前記インダパミドまたはその水和物の粒子の90%が、70μm未満のサイズを有する、請求項11に記載のプロセス。
- ペリンドプリルまたはその塩の固形薬学的組成物であって、以下:
(a)ペリンドプリルまたはその塩、
(b)0.3重量%〜5.0重量%の含水量を有する、少なくとも1種の微結晶性セルロース、および、無水ラクトース、
(c)必要に応じて、少なくとも1種の無機炭酸塩、ならびに
(d)必要に応じて、他の成分
を含有する、組成物。 - 前記ペリンドプリルまたはその塩の、無機炭酸塩に対するモル比が、1:0.1〜0.9、好ましくは、1:0.50〜0.83である、請求項13に記載の組成物。
- 前記微結晶性セルロースが、0.3重量%〜1.5重量%の含水量を有する、請求項13または14に記載の組成物。
- さらに、インダパミドまたはその水和物を含有する、請求項15に記載の組成物。
- 前記インダパミドまたはその水和物の粒子の90容積%が、80μm未満のサイズを有する、請求項16に記載の組成物。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200410019845 DE102004019845A1 (de) | 2004-03-29 | 2004-03-29 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
DE102004019845.4 | 2004-03-29 | ||
DE102004059521A DE102004059521A1 (de) | 2004-12-09 | 2004-12-09 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
DE102004059521.6 | 2004-12-09 | ||
PCT/EP2005/003277 WO2005094793A1 (en) | 2004-03-29 | 2005-03-29 | Process for preparing a solid pharmaceutical composition |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2007530623A true JP2007530623A (ja) | 2007-11-01 |
JP4948392B2 JP4948392B2 (ja) | 2012-06-06 |
Family
ID=34963866
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007505484A Expired - Fee Related JP4948392B2 (ja) | 2004-03-29 | 2005-03-29 | 固形薬学的組成物を調製するためのプロセス |
Country Status (14)
Country | Link |
---|---|
US (2) | US20070172524A1 (ja) |
EP (1) | EP1729739B1 (ja) |
JP (1) | JP4948392B2 (ja) |
CY (1) | CY1118180T1 (ja) |
DK (1) | DK1729739T3 (ja) |
EA (1) | EA011712B1 (ja) |
ES (1) | ES2603856T3 (ja) |
HR (1) | HRP20161602T1 (ja) |
HU (1) | HUE031058T2 (ja) |
LT (1) | LT1729739T (ja) |
NO (1) | NO20064934L (ja) |
PL (1) | PL1729739T3 (ja) |
PT (1) | PT1729739T (ja) |
WO (1) | WO2005094793A1 (ja) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005094793A1 (en) | 2004-03-29 | 2005-10-13 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Process for preparing a solid pharmaceutical composition |
SI21800A (sl) * | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
BRPI0615607A2 (pt) * | 2005-08-30 | 2011-05-24 | Lek Pharmaceuticals | composição farmacêutica compreendendo perindopril ou seus sais |
RS53324B (en) | 2005-11-17 | 2014-10-31 | Silverstone Pharma Est. | STABLE FORMULATION OF AMORPHIC SALES OF PERINDOPRIL, PROCEDURE FOR THEIR PREPARATION, IN PARTICULAR INDUSTRIAL PREPARATION, AND THEIR USE IN HYPERTENSION THERAPY |
EP1815857A1 (en) | 2006-02-02 | 2007-08-08 | LEK Pharmaceuticals D.D. | A pharmaceutical composition comprising perindopril |
WO2007120930A2 (en) * | 2006-04-19 | 2007-10-25 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical compositions of 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivatives |
JP2009537538A (ja) * | 2006-05-15 | 2009-10-29 | アカドイア プハルマセウチカルス インコーポレーテッド | ピマバンセリン医薬製剤 |
WO2008068577A2 (en) * | 2006-12-01 | 2008-06-12 | Glenmark Pharmaceuticals Limited | Pharmaceutical compositions |
TWI435917B (zh) | 2006-12-27 | 2014-05-01 | Fujifilm Corp | 顏料分散組成物、硬化性組成物、彩色濾光片及其製造方法 |
SI22543A (sl) | 2007-06-27 | 2008-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nove soli perindoprila |
US20120142766A1 (en) * | 2007-11-21 | 2012-06-07 | Evolva Sa | Substituted 1,3-dioxanes and their uses |
CN102665764A (zh) * | 2009-12-22 | 2012-09-12 | Fmc有限公司 | 可用作可再压实药物赋形剂的微晶纤维素和碳酸钙组合物 |
PL227900B1 (pl) | 2012-11-15 | 2018-01-31 | Adamed Spolka Z Ograniczona Odpowiedzialnoscia | Kompozycja farmaceutyczna zawierająca inhibitor ACE i bloker kanałów wapniowych, sposób jej wytwarzania i jednostka dawkowania zawierająca tę kompozycję |
WO2016178591A2 (en) | 2015-05-05 | 2016-11-10 | Gene Predit, Sa | Genetic markers and treatment of male obesity |
CN109700774A (zh) * | 2019-03-05 | 2019-05-03 | 上药东英(江苏)药业有限公司 | 一种培哚普利叔丁胺片及其粉末直压工艺 |
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JPS63225322A (ja) * | 1987-02-24 | 1988-09-20 | パーク・デービス・アンド・コンパニー | 安定化された組成物 |
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SI21800A (sl) * | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
-
2005
- 2005-03-29 WO PCT/EP2005/003277 patent/WO2005094793A1/en active Application Filing
- 2005-03-29 ES ES05730288.7T patent/ES2603856T3/es active Active
- 2005-03-29 EP EP05730288.7A patent/EP1729739B1/en not_active Revoked
- 2005-03-29 PL PL05730288T patent/PL1729739T3/pl unknown
- 2005-03-29 DK DK05730288.7T patent/DK1729739T3/en active
- 2005-03-29 LT LTEP05730288.7T patent/LT1729739T/lt unknown
- 2005-03-29 JP JP2007505484A patent/JP4948392B2/ja not_active Expired - Fee Related
- 2005-03-29 HU HUE05730288A patent/HUE031058T2/en unknown
- 2005-03-29 PT PT57302887T patent/PT1729739T/pt unknown
- 2005-03-29 EA EA200601608A patent/EA011712B1/ru not_active IP Right Cessation
- 2005-03-29 US US10/599,154 patent/US20070172524A1/en not_active Abandoned
-
2006
- 2006-10-27 NO NO20064934A patent/NO20064934L/no not_active Application Discontinuation
-
2009
- 2009-06-03 US US12/477,727 patent/US20100172995A1/en not_active Abandoned
-
2016
- 2016-11-03 CY CY20161101118T patent/CY1118180T1/el unknown
- 2016-11-30 HR HRP20161602TT patent/HRP20161602T1/hr unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS63225322A (ja) * | 1987-02-24 | 1988-09-20 | パーク・デービス・アンド・コンパニー | 安定化された組成物 |
US5350582A (en) * | 1991-11-25 | 1994-09-27 | Krka, Tovarna Zdravil, P.O. | Stable formulation of enalapril salt, a process for the preparation thereof and the use thereof |
JP2001523646A (ja) * | 1997-11-19 | 2001-11-27 | アディール エ コンパニー | 微小循環障害を処置するためのアンギオテンシン変換酵素阻害剤と利尿剤との合剤 |
WO2003059388A1 (en) * | 2002-01-15 | 2003-07-24 | Delta Hf. | Formulations of quinapril and related ace inhibitors |
WO2003075842A2 (en) * | 2002-03-08 | 2003-09-18 | Teva Pharmeceuticals Usa, Inc. | Stable formulations of angiotensin converting enzyme (ace) inhibitors |
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Publication number | Publication date |
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HUE031058T2 (en) | 2017-06-28 |
NO20064934L (no) | 2006-10-27 |
PL1729739T3 (pl) | 2017-04-28 |
EA200601608A1 (ru) | 2007-02-27 |
HRP20161602T1 (hr) | 2016-12-30 |
JP4948392B2 (ja) | 2012-06-06 |
CY1118180T1 (el) | 2017-06-28 |
PT1729739T (pt) | 2016-12-01 |
WO2005094793A1 (en) | 2005-10-13 |
LT1729739T (lt) | 2016-11-10 |
ES2603856T3 (es) | 2017-03-01 |
DK1729739T3 (en) | 2016-10-31 |
EA011712B1 (ru) | 2009-04-28 |
EP1729739B1 (en) | 2016-09-28 |
EP1729739A1 (en) | 2006-12-13 |
US20070172524A1 (en) | 2007-07-26 |
US20100172995A1 (en) | 2010-07-08 |
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