AT7729U2 - Pharmazeutische zusammensetzungen enthaltend amlodipinmaleat - Google Patents
Pharmazeutische zusammensetzungen enthaltend amlodipinmaleat Download PDFInfo
- Publication number
- AT7729U2 AT7729U2 AT0093303U AT9332003U AT7729U2 AT 7729 U2 AT7729 U2 AT 7729U2 AT 0093303 U AT0093303 U AT 0093303U AT 9332003 U AT9332003 U AT 9332003U AT 7729 U2 AT7729 U2 AT 7729U2
- Authority
- AT
- Austria
- Prior art keywords
- amlodipinmaleat
- pharmaceutical compositions
- compositions containing
- microns
- amlodipine maleate
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- TZNOWAJJWCGILX-BTJKTKAUSA-N (z)-but-2-enedioic acid;3-o-ethyl 5-o-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Chemical compound OC(=O)\C=C/C(O)=O.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl TZNOWAJJWCGILX-BTJKTKAUSA-N 0.000 abstract 2
- 229960000528 amlodipine Drugs 0.000 abstract 2
- 239000002245 particle Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 1
- 239000002002 slurry Substances 0.000 abstract 1
Classifications
-
- 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
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Hospice & Palliative Care (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Vorgesehen wird eine pharmazeutische Amlodipinmaleat-Zusammensetzung mit guter Stabilität bei Formulierung mit einem pH innerhalb des Bereichs von 5,5 bis 7, gemessen als eine 20 Gew.-% wässrige Aufschlämmung. Die Stabilität kann auch unterstützt werden durch Herstellung der pharmazeutischen Zusammensetzung aus Amlodipinmaleatteilchen mit einer durchschnittlichen Teilchengröße von mehr als 20 Mikron, vorzugsweise mehr als 100 Mikron.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25856200P | 2000-12-29 | 2000-12-29 | |
| US80934601A | 2001-03-16 | 2001-03-16 | |
| AT0063401U AT5874U1 (de) | 2000-12-29 | 2001-08-09 | Pharmazeutische zubereitungen enthaltend amlodipinmaleat |
| BE2001/0706A BE1014449A6 (nl) | 2000-12-29 | 2001-11-05 | Farmaceutische verbindingen omvattende amlodipine maleaat. |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AT7729U2 true AT7729U2 (de) | 2005-08-25 |
| AT7729U3 AT7729U3 (de) | 2006-01-15 |
Family
ID=29740874
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT0063401U AT5874U1 (de) | 2000-12-29 | 2001-08-09 | Pharmazeutische zubereitungen enthaltend amlodipinmaleat |
| AT01970353T ATE320244T1 (de) | 2000-12-29 | 2001-08-15 | Pharmazeutische zusammensetzungen mit amlodipinmaleat |
| AT0093303U AT7729U3 (de) | 2000-12-29 | 2003-12-29 | Pharmazeutische zusammensetzungen enthaltend amlodipinmaleat |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT0063401U AT5874U1 (de) | 2000-12-29 | 2001-08-09 | Pharmazeutische zubereitungen enthaltend amlodipinmaleat |
| AT01970353T ATE320244T1 (de) | 2000-12-29 | 2001-08-15 | Pharmazeutische zusammensetzungen mit amlodipinmaleat |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US6919087B2 (de) |
| EP (1) | EP1309317B1 (de) |
| CN (1) | CN1268322C (de) |
| AP (1) | AP2003002819A0 (de) |
| AT (3) | AT5874U1 (de) |
| AU (1) | AU2001290354B2 (de) |
| BE (1) | BE1014449A6 (de) |
| BR (1) | BR0116556A (de) |
| CA (1) | CA2433035C (de) |
| DE (2) | DE60118008T2 (de) |
| DK (3) | DK1309317T3 (de) |
| EA (1) | EA008101B1 (de) |
| ES (1) | ES2258549T3 (de) |
| FI (1) | FI6787U1 (de) |
| HR (1) | HRP20030527A2 (de) |
| IL (1) | IL156691A0 (de) |
| IS (1) | IS6833A (de) |
| MA (1) | MA26968A1 (de) |
| MX (1) | MXPA03005883A (de) |
| NO (1) | NO20032517L (de) |
| NZ (1) | NZ526505A (de) |
| PL (1) | PL362668A1 (de) |
| PT (1) | PT1309317E (de) |
| RS (1) | RS53303A (de) |
| UA (1) | UA78500C2 (de) |
| WO (1) | WO2002053134A1 (de) |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002053540A1 (en) * | 2000-12-29 | 2002-07-11 | Pfizer Limited | Aspartate derivative of amlodipine as calcium channel antagonist |
| GB2371862B (en) * | 2000-12-29 | 2004-07-14 | Bioorg Bv | Reference standards for determining the purity or stability of amlodipine maleate and processes therefor |
| US20030027848A1 (en) * | 2001-06-15 | 2003-02-06 | Anne Billotte | Stabilized formulations |
| GB0114709D0 (en) * | 2001-06-15 | 2001-08-08 | Pfizer Ltd | Stabilised formulations of amlodipine maleate |
| WO2003032954A1 (en) * | 2001-10-17 | 2003-04-24 | Dr. Reddy's Laboratories Ltd. | Stabilized pharmaceutical formulations containing amlodipine maleate |
| US20030180354A1 (en) * | 2001-10-17 | 2003-09-25 | Dr. Reddy's Laboratories Limited | Amlodipine maleate formulations |
| WO2003055467A1 (en) * | 2001-12-18 | 2003-07-10 | Synthon B.V. | Simvastatin dosage forms |
| US20040072879A1 (en) * | 2002-10-10 | 2004-04-15 | Dr. Reddy's Laboratories Limited | Crystalline 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine maleate salt (Amlodipine) |
| DK1435239T3 (da) * | 2002-12-31 | 2006-07-31 | Cimex Pharma Ag | Stabiliseret og let forarbejdeligt granulat af amlodipin--maleat |
| CA2559670A1 (en) * | 2003-04-14 | 2004-10-28 | Gabor Pragai | Stable amlodipine maleate formulations |
| KR100604034B1 (ko) * | 2003-10-08 | 2006-07-24 | 주식회사유한양행 | 암로디핀 유리염기를 함유한 구강 속붕해정 및 그의 조성물 |
| EA013053B1 (ru) * | 2004-11-05 | 2010-02-26 | Бёрингер Ингельхайм Интернациональ Гмбх | Двуслойная таблетка, содержащая телмисартан и амлодипин |
| EP1833466A1 (de) * | 2004-12-28 | 2007-09-19 | Ranbaxy Laboratories Limited | Verfahren zur herstelulng von stabilen pharmazeutischen soliden dosierformen von atorvastatin und amlodipin |
| KR100825039B1 (ko) | 2005-01-21 | 2008-04-24 | 대원제약주식회사 | 안정성이 개선된 암로디핀 말레이트염 정제 |
| US10130624B2 (en) * | 2005-03-15 | 2018-11-20 | Lupin Limited | Pharmaceutical compositions of amlodipine and benazepril |
| WO2007020079A2 (en) * | 2005-08-17 | 2007-02-22 | Synthon B.V. | Orally disintegratable simvastatin tablets |
| AU2005336956A1 (en) * | 2005-09-28 | 2007-04-12 | Teva Pharmaceutical Industries Ltd. | Stable combinations of amlodipine besylate and benazepril hydrochloride |
| PT1797885E (pt) * | 2005-09-28 | 2008-05-20 | Teva Pharma | Combinações estáveis de besilato de amlodipina e cloridrato de benazepril |
| US8158146B2 (en) * | 2005-09-28 | 2012-04-17 | Teva Pharmaceutical Industries Ltd. | Stable combinations of amlodipine besylate and benazepril hydrochloride |
| KR100689862B1 (ko) | 2005-10-04 | 2007-03-09 | 삼익제약주식회사 | 말레인산암로디핀을 포함하는 조성물 및 그의 제조 방법 |
| KR100795313B1 (ko) | 2006-09-05 | 2008-01-21 | 현대약품 주식회사 | 암로디핀 베실레이트를 포함하는 약학 조성물 |
| CN101161241B (zh) * | 2006-10-10 | 2010-05-26 | 扬子江药业集团上海海尼药业有限公司 | 苯磺酸氨氯地平片的制备工艺 |
| WO2008065485A2 (en) * | 2006-10-19 | 2008-06-05 | Torrent Pharmaceuticals Limited | Stable pharmaceutical compositions of a calcium channel blocker and an ace inhibitor |
| RU2009128039A (ru) * | 2006-12-22 | 2011-01-27 | Дженентек, Инк. (Us) | Антагонисты dr6 и способы их применения в лечении неврологических нарушений |
| HU230877B1 (hu) * | 2008-09-30 | 2018-11-29 | EGIS Gyógyszergyár NyR | Stabil kombinációs gyógyszerkészítmény |
| CN102292085B (zh) | 2009-01-23 | 2017-01-18 | 韩美科学株式会社 | 包含氨氯地平和氯沙坦的固体药物组合物及其制备方法 |
| TWI461213B (zh) * | 2009-11-05 | 2014-11-21 | Fmc Corp | 作為藥物賦形劑之微晶纖維素及磷酸鈣之組合物 |
| CN103054862B (zh) * | 2013-01-08 | 2014-09-17 | 江苏万高药业有限公司 | 一种含有马来酸氨氯地平的快速释放的口服固体制剂 |
| WO2018067959A1 (en) | 2016-10-07 | 2018-04-12 | Silvergate Pharmaceuticals, Inc. | Amlodipine formulations |
| US10799453B2 (en) | 2018-04-11 | 2020-10-13 | Silvergate Pharmaceuticals, Inc. | Amlodipine formulations |
| CN111728948A (zh) * | 2020-08-19 | 2020-10-02 | 湖北潜龙药业有限公司 | 一种苯磺酸氨氯地平片的制备工艺 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK161312C (da) | 1982-03-11 | 1991-12-09 | Pfizer | Analogifremgangsmaade til fremstilling af 2-aminoalkoxymethyl-4-phenyl-6-methyl-1,4-dihydropyridin-3,5-dicarboxylsyreestere eller syreadditionssalte deraf samt phthalimidoderivater til anvendelse som udgangsmateriale ved fremgangsmaaden |
| GB8306666D0 (en) | 1983-03-10 | 1983-04-13 | Pfizer Ltd | Therapeutic agents |
| US4687662A (en) * | 1985-08-30 | 1987-08-18 | Warner-Lambert Company | Therapeutic effervescent composition |
| GB8608335D0 (en) | 1986-04-04 | 1986-05-08 | Pfizer Ltd | Pharmaceutically acceptable salts |
| US4983740A (en) | 1986-08-04 | 1991-01-08 | Adir Et Compagnie | Process for 1,4-dihydropyridine compounds |
| GB8710493D0 (en) | 1987-05-02 | 1987-06-03 | Pfizer Ltd | Dihydropyridines |
| US5155120A (en) | 1991-01-14 | 1992-10-13 | Pfizer Inc | Method for treating congestive heart failure |
| WO1993006082A1 (en) | 1991-09-13 | 1993-04-01 | Merck & Co., Inc. | Process for the preparation of 4-substituted-1,4-dihydropyridines |
| WO1993010779A1 (en) * | 1991-11-26 | 1993-06-10 | Sepracor, Inc. | Methods and compositions for treating hypertension, angina and other disorders using optically pure (-) amlodipine |
| US6057344A (en) | 1991-11-26 | 2000-05-02 | Sepracor, Inc. | Methods for treating hypertension, and angina using optically pure (-) amlodipine |
| AT399718B (de) * | 1992-04-16 | 1995-07-25 | Lek Tovarna Farmacevtskih | Inklusionskomplexe von optisch aktiven und racemischen 1,4-dihydropyridinen mit methyl-beta- cyclodextrin oder anderen cyclodextrinderivaten, ein verfahren zur herstellung von optisch aktiven dihydropyridinen und deren inklusionskomplexen und diese komplexe enthaltende pharmazeutische formulierungen |
| US5389654A (en) | 1992-11-26 | 1995-02-14 | Lek, Tovarna, Farmacevtskih In Kemicnih . . . | 3-ethyl 5-methyl(±)2-[2-(N-tritylamino)ethoxymethyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-6-methyl-3,5-pyridinedicarboxylate |
| GB9317773D0 (en) * | 1993-08-26 | 1993-10-13 | Pfizer Ltd | Therapeutic compound |
| WO1995034299A1 (en) * | 1994-06-10 | 1995-12-21 | Telor Ophthalmic Pharmaceuticals, Inc. | Inhibition of intraoperative miosis/production of mydriasis by calcium channel blockers |
| US5585115A (en) * | 1995-01-09 | 1996-12-17 | Edward H. Mendell Co., Inc. | Pharmaceutical excipient having improved compressability |
| HU222497B1 (hu) * | 1996-12-18 | 2003-07-28 | Chinoin Gyógyszer és Vegyészeti Termékek Gyára Rt. | Enalapril-maleátot tartalmazó stabilizált gyógyszerkészítmény és eljárás előállítására |
| HU221810B1 (hu) | 1997-08-12 | 2003-01-28 | EGIS Gyógyszergyár Rt. | Eljárás amlodipin-bezilát előállítására és az eljárás intermedierjei |
| ZA9810320B (en) | 1997-11-14 | 2000-05-11 | Gea Farmaceutisk Fabrik As | Process for the preparation of 1,4-dihydropyridines and novel compounds of use for such purpose. |
| PL189666B1 (pl) | 1998-04-09 | 2005-09-30 | Adamed Sp Z Oo | Sposób otrzymywania benzenosulfonianu amlodypiny |
| JP3719874B2 (ja) * | 1998-04-24 | 2005-11-24 | サンスター株式会社 | 口腔用組成物 |
| GB9812413D0 (en) | 1998-06-10 | 1998-08-05 | Glaxo Group Ltd | Compound and its use |
| ES2151850B1 (es) | 1998-10-26 | 2001-08-16 | Esteve Quimica Sa | Intermedio para la sintesis de amlodipino para su obtencion y utilizacion correspondiente. |
| GB9827387D0 (en) | 1998-12-11 | 1999-02-03 | Smithkline Beecham Plc | Novel process |
| GB9827431D0 (en) | 1998-12-11 | 1999-02-03 | Smithkline Beecham Plc | Novel compound |
| GB0008332D0 (en) * | 2000-04-04 | 2000-05-24 | Pfizer Ltd | Treament |
| GB0020842D0 (en) * | 2000-08-23 | 2000-10-11 | Pfizer Ltd | Therapeutic compositions |
-
2001
- 2001-08-09 AT AT0063401U patent/AT5874U1/de not_active IP Right Cessation
- 2001-08-15 IL IL15669101A patent/IL156691A0/xx unknown
- 2001-08-15 CN CNB018216692A patent/CN1268322C/zh not_active Expired - Fee Related
- 2001-08-15 CA CA002433035A patent/CA2433035C/en not_active Expired - Fee Related
- 2001-08-15 HR HR20030527A patent/HRP20030527A2/hr not_active Application Discontinuation
- 2001-08-15 DE DE60118008T patent/DE60118008T2/de not_active Expired - Fee Related
- 2001-08-15 AP APAP/P/2003/002819A patent/AP2003002819A0/en unknown
- 2001-08-15 UA UA2003077117A patent/UA78500C2/uk unknown
- 2001-08-15 NZ NZ526505A patent/NZ526505A/en unknown
- 2001-08-15 BR BR0116556-9A patent/BR0116556A/pt not_active IP Right Cessation
- 2001-08-15 PL PL01362668A patent/PL362668A1/xx not_active Application Discontinuation
- 2001-08-15 PT PT01970353T patent/PT1309317E/pt unknown
- 2001-08-15 WO PCT/NL2001/000606 patent/WO2002053134A1/en not_active Ceased
- 2001-08-15 EA EA200300740A patent/EA008101B1/ru not_active IP Right Cessation
- 2001-08-15 ES ES01970353T patent/ES2258549T3/es not_active Expired - Lifetime
- 2001-08-15 DK DK01970353T patent/DK1309317T3/da active
- 2001-08-15 AU AU2001290354A patent/AU2001290354B2/en not_active Ceased
- 2001-08-15 AT AT01970353T patent/ATE320244T1/de not_active IP Right Cessation
- 2001-08-15 MX MXPA03005883A patent/MXPA03005883A/es active IP Right Grant
- 2001-08-15 RS YU53303A patent/RS53303A/sr unknown
- 2001-08-15 EP EP01970353A patent/EP1309317B1/de not_active Expired - Lifetime
- 2001-08-27 US US09/938,816 patent/US6919087B2/en not_active Expired - Fee Related
- 2001-10-08 DE DE20116428U patent/DE20116428U1/de not_active Ceased
- 2001-11-05 BE BE2001/0706A patent/BE1014449A6/nl not_active IP Right Cessation
-
2003
- 2003-05-26 MA MA27179A patent/MA26968A1/fr unknown
- 2003-05-30 IS IS6833A patent/IS6833A/is unknown
- 2003-06-04 NO NO20032517A patent/NO20032517L/no not_active Application Discontinuation
- 2003-12-12 DK DK200300346U patent/DK200300346U4/da not_active IP Right Cessation
- 2003-12-12 DK DK200300347U patent/DK200300347U3/da not_active IP Right Cessation
- 2003-12-17 FI FI20030475U patent/FI6787U1/fi active IP Right Grant
- 2003-12-29 AT AT0093303U patent/AT7729U3/de not_active IP Right Cessation
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