HUE031058T2 - Eljárás szilárd gyógyszerkészítmény elõállítására - Google Patents
Eljárás szilárd gyógyszerkészítmény elõállítására Download PDFInfo
- Publication number
- HUE031058T2 HUE031058T2 HUE05730288A HUE05730288A HUE031058T2 HU E031058 T2 HUE031058 T2 HU E031058T2 HU E05730288 A HUE05730288 A HU E05730288A HU E05730288 A HUE05730288 A HU E05730288A HU E031058 T2 HUE031058 T2 HU E031058T2
- Authority
- HU
- Hungary
- Prior art keywords
- salt
- carbonate
- perindopril
- hydrate
- indapamide
- Prior art date
Links
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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Indole Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Claims (4)
- wsvv < V í > w V ww V'f V í1. Eljárás psrindöpilt vagy amtak Sálát tmtairnezo szilárd gyógynzerkészlímény előáll fuisáro, amely magában foglalja (i> perindopril vagy annak sójának száraz összekeverését legalább egy szervetlen karbogáitak legalább egy -vivdany&ggak és adott esetben egyéb összetevőkkel, ás lii) az. íi) lépésben kapok keverék száraz feldolgozását a klváut szilárd tormává. •1* Az k igénypoit sgéftnb eljárás, ahöí a kfehmény a geAhdpgH! fété-bittlÁamlm sóját tastalmazza,1. Az 1, vagy 2> igényimet szerimj átjárás^ ahol a szerveliep karbonát Mtrimm -karbonát:. rrátrtum'AMprgétpkarbopA^ tnagBézium-tobonái Mleltalr-kásbönli vagy káiotBrn" -h IdrogémAatiíopák
- 4. Az 1-3. Igénypontok bármelyike szerint? eljárás, ahol perindoprll vagy annak sójának a szervptles tinói aránya 1 és 0,3-:0,9 kbxöti és előnyösen l és (l50-0A3 közötti, I. Az 1*4, Igénypontok: bármelyike szerinti eg áráig áhol. a vlvóanyag míkrcArtstfe lyos eol|nlozs laktoz vagy ezek. keveréke.
- 6. Az? 5. igénypont szénné eljárás, ahol a mikrokristályos celmióz nedvességtartalma 0,3 - S,0 toipegÓA előnyösen 0,3 - 1.5 mmeg.%, ?. Azt 5. vagy 4. igénypont szerint· eljárás« ahol a lakióz vízmentes laldoz.5, Az I-?. igénypontok hárrndytke szerinti eljárás, ahol az (U) lépest a keverék közvetlen összesajtoiásáva! végezzük.
- 9, Az. i-S igénypontok bármelyike szerintí eljárás,, ahol a készítmény indapamidot vág)·' annak hidrátját is lartaltnazza 10. A 9. igénypont szerinti eljárás, ahol a hidrát îndupaadd-hontihidrát. I k Λ 9. vagy 10. igénypont szedni! eljárás« ahoi az Indapamid vagy annak hidrába részecskéinek térfogat .sz.onnti vO 'A'á?mk mórom kisebb, mint Sörön. ! 2. A 11, igAtyponf: szeAatl ellátás, ahol az iodapaanrl vagy artttak hidratjá .tészeém kémek térfogat: szerint! fi) óá-ápak mérete kisebb, mim ?(>gm, 13:. Psrioílopnlt vagy annák sóját ládáimazó szilárd gyigyszerkiszftmbpy, amely magában foglal fáj perlbdpprüt vagy 8mfa.k sójáé flf) 0,3 - SjOtőreegiA nodvességtarialmó mlkrökristályos eejkdózi és yÍAhkBies nakfóxl, fel legalább: egy sz^ryeíien karbppátot, Ato! pbAndopflI vagy annak sdjlpak: a széA5étlóh jmxbó·· Pálhoz vtszóbyttbö mél arittya I és 0,1-0:9 közötti, és gi) adpii: ésvÁteo egyéb összetevőké ü 14, A 13, igénypont szerinti készitrp|py. ahol % perindogttl vagy aooak: tójának a: szervetlen karbonáthoz víszonyltol! mól aránya X és 0.30-0,13 közötti I §·< A 13.. vagy Li 4, tgédypgûl mmiïúv MsallmlaVj ah©! a · Étitek#islâi^s«. asliötéz:. nedvesaégiartalma 03 - 13 têmagkk W.< Ä 13. Igaayp-aat késaltoényS: amaly iovsbM: hdapamidot vagy aaaak hid·? álját tarlalmaaaa. la, A. Kkigénypont aacrimi kësaibnémg ahoi aa iadapsMid vagy aaaak bLdraba xé-sgeeakéla^k térflïgal sagHgb 3íl334askjBdíbie klsaMg bliat kûgrg.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200410019845 DE102004019845A1 (de) | 2004-03-29 | 2004-03-29 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
DE102004059521A DE102004059521A1 (de) | 2004-12-09 | 2004-12-09 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
Publications (1)
Publication Number | Publication Date |
---|---|
HUE031058T2 true HUE031058T2 (hu) | 2017-06-28 |
Family
ID=34963866
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HUE05730288A HUE031058T2 (hu) | 2004-03-29 | 2005-03-29 | Eljárás szilárd gyógyszerkészítmény elõállítására |
Country Status (14)
Country | Link |
---|---|
US (2) | US20070172524A1 (hu) |
EP (1) | EP1729739B1 (hu) |
JP (1) | JP4948392B2 (hu) |
CY (1) | CY1118180T1 (hu) |
DK (1) | DK1729739T3 (hu) |
EA (1) | EA011712B1 (hu) |
ES (1) | ES2603856T3 (hu) |
HR (1) | HRP20161602T1 (hu) |
HU (1) | HUE031058T2 (hu) |
LT (1) | LT1729739T (hu) |
NO (1) | NO20064934L (hu) |
PL (1) | PL1729739T3 (hu) |
PT (1) | PT1729739T (hu) |
WO (1) | WO2005094793A1 (hu) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2603856T3 (es) | 2004-03-29 | 2017-03-01 | Les Laboratoires Servier | Procedimiento para preparar una composición farmacéutica sólida |
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 |
PL1948224T3 (pl) * | 2005-11-17 | 2014-10-31 | Silverstone Pharma Est | Trwały preparat amorficznych soli peryndoprylu, sposób ich wytwarzania, zwłaszcza wytwarzania w skali przemysłowej oraz ich zastosowanie w terapii nadciśnienia |
EP1815857A1 (en) | 2006-02-02 | 2007-08-08 | LEK Pharmaceuticals D.D. | A pharmaceutical composition comprising perindopril |
CA2647705A1 (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 |
US20070264330A1 (en) * | 2006-05-15 | 2007-11-15 | Bo Ragnar-Tolf | Pharmaceutical formulations of pimavanserin |
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 |
JP2010516700A (ja) * | 2007-01-18 | 2010-05-20 | エヴォルヴァ エスアー | 置換1,3−ジオキサンおよびそれらの使用 |
SI22543A (sl) | 2007-06-27 | 2008-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nove soli perindoprila |
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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US4508729A (en) * | 1979-12-07 | 1985-04-02 | Adir | Substituted iminodiacids, their preparation and pharmaceutical compositions containing them |
US4350704A (en) * | 1980-10-06 | 1982-09-21 | Warner-Lambert Company | Substituted acyl derivatives of octahydro-1H-indole-2-carboxylic acids |
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US4743450A (en) * | 1987-02-24 | 1988-05-10 | Warner-Lambert Company | Stabilized compositions |
FR2620699B1 (fr) * | 1987-09-17 | 1990-06-01 | Adir | Procede de synthese d'alpha amino acides n alkyles et de leurs esters. application a la synthese de carboxyalkyl dipeptides |
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 |
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SI9111842A (sl) * | 1991-11-25 | 1998-04-30 | Krka | Stabilna formulacija soli enalaprila, postopek za njeno pripravo in njena uporaba |
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FR2807430B1 (fr) * | 2000-04-11 | 2002-05-17 | Adir | Nouveau procede de synthese des esters de la n-[(s)-1- carboxybutyl]-(s)-alanine et application a la synthese du perindopril |
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FR2811318B1 (fr) * | 2000-07-06 | 2002-08-23 | Adir | Nouvelle forme cristalline gamma du sel de tert-butylamine du perindopril, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
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SI1603558T1 (sl) * | 2003-02-28 | 2008-12-31 | Servier S A Lab | Postopek za pripravo perindoprila in njegovih soli |
DK1635792T3 (da) * | 2003-06-26 | 2009-06-15 | Teva Pharma | Stabile farmaceutiske sammensætninger af 2-aza-bicyklo-3.3.0-oktan-3-carboxylsyrederivater |
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ES2334900T3 (es) * | 2003-09-01 | 2010-03-17 | Les Laboratoires Servier | Nuevo procedimiento de sintesis de esteres de n-((s)-1-carboxibutil)-(s)-alanina y su aplicacion a la sintesis de perindopril. |
GB2394660A (en) * | 2003-12-17 | 2004-05-05 | Niche Generics Ltd | Stabilisation of pharmaceutical compositions comprising ACE inhibitor by absence of acidic excipients having large specific surface area, eg silicon dioxide |
ES2603856T3 (es) | 2004-03-29 | 2017-03-01 | Les Laboratoires Servier | Procedimiento para preparar una composición farmacéutica sólida |
SI21800A (sl) * | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
-
2005
- 2005-03-29 ES ES05730288.7T patent/ES2603856T3/es active Active
- 2005-03-29 JP JP2007505484A patent/JP4948392B2/ja not_active Expired - Fee Related
- 2005-03-29 DK DK05730288.7T patent/DK1729739T3/en active
- 2005-03-29 EA EA200601608A patent/EA011712B1/ru not_active IP Right Cessation
- 2005-03-29 EP EP05730288.7A patent/EP1729739B1/en not_active Revoked
- 2005-03-29 LT LTEP05730288.7T patent/LT1729739T/lt unknown
- 2005-03-29 PL PL05730288T patent/PL1729739T3/pl unknown
- 2005-03-29 HU HUE05730288A patent/HUE031058T2/hu unknown
- 2005-03-29 WO PCT/EP2005/003277 patent/WO2005094793A1/en active Application Filing
- 2005-03-29 PT PT57302887T patent/PT1729739T/pt unknown
- 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
Also Published As
Publication number | Publication date |
---|---|
LT1729739T (lt) | 2016-11-10 |
NO20064934L (no) | 2006-10-27 |
PT1729739T (pt) | 2016-12-01 |
CY1118180T1 (el) | 2017-06-28 |
JP4948392B2 (ja) | 2012-06-06 |
WO2005094793A1 (en) | 2005-10-13 |
EP1729739A1 (en) | 2006-12-13 |
DK1729739T3 (en) | 2016-10-31 |
EP1729739B1 (en) | 2016-09-28 |
ES2603856T3 (es) | 2017-03-01 |
EA011712B1 (ru) | 2009-04-28 |
HRP20161602T1 (hr) | 2016-12-30 |
PL1729739T3 (pl) | 2017-04-28 |
US20070172524A1 (en) | 2007-07-26 |
US20100172995A1 (en) | 2010-07-08 |
EA200601608A1 (ru) | 2007-02-27 |
JP2007530623A (ja) | 2007-11-01 |
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