DK2370065T3 - Farmaceutisk lægemiddelform indeholdende nifedipin eller nisoldipin og en angiotensin-ii antagonist og/eller et diuretikum - Google Patents
Farmaceutisk lægemiddelform indeholdende nifedipin eller nisoldipin og en angiotensin-ii antagonist og/eller et diuretikum Download PDFInfo
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- DK2370065T3 DK2370065T3 DK09755847.2T DK09755847T DK2370065T3 DK 2370065 T3 DK2370065 T3 DK 2370065T3 DK 09755847 T DK09755847 T DK 09755847T DK 2370065 T3 DK2370065 T3 DK 2370065T3
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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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Claims (26)
1. Farmaceutisk lægemiddelform indeholdende en aktivstofkombination af nifedipin eller nisoldipin og i det mindste en angiotensin-II antagonist og/eller i det mindste et diuretikum, kendetegnet ved, at kernen er et osmotisk udløsningssystem, kendetegnet ved, at skallen på det osmotiske udløsningssystem består af celluloseacetat eller af en blanding af celluloseacetat og polyethylenglykol, samt endvidere kendetegnet ved, at der befinder sig nifedipin eller nisoldipin i kernen, og angiotensin-II antagonisten og/eller diuretikummet befinder sig i et kappeovertræk omkring kernen, og kendetegnet ved, at kappeovertrækket indeholder i det mindste en filmdannende polymer, der er egnet til en hurtig udløsning af aktivstoffer, idet den filmdannende polymer er delvist hydrolyseret polyvinylalkohol, og endvidere kendetegnet ved, at der udløses i det mindste 85 % af nifedipinen eller nisoldipinen (baseret på den deklarerede samlede mængde af det pågældende aktivstof) over en periode på 24 timer, 5 til 17 % af nifedipinen eller nisoldipinen inden for 4 timer og 43 til 80 % af nifedipinen eller nisoldipinen inden for 12 timer ifølge USP-udløsningsfremgangsmåden med apparatur 2 (paddle) , og der udløses i det mindste 60 % af angiotensin-II antagonisten og/eller af diuretikummet (baseret på den deklarerede samlede mængde af det pågældende aktivstof) inden for 30 minutter ifølge USP-udløsningsfremgangsmåden med apparatur 2 (paddle) ved 75 omdrejninger pr. minut i 900 ml egnet medie.
2. Farmaceutisk lægemiddelform ifølge krav 1, idet angiotensin-II antagonisten er udvalgt af gruppen candesartan, losartan, telmisartan, irbesartan, embursartan, eprosartan, valsartan eller olmesartan, idet candesartan anvendes i form af diuretikummet og olmesartan i form af Olmesartan medoxomil.
3. Farmaceutisk lægemiddelform ifølge krav 1, idet angiotensin-II antagonisten er udvalgt af gruppen azilsartan, candesartan, losartan, telmisartan, irbesartan, embursartan, eprosartan, valsartan eller olmesartan, idet candesartan anvendes i form af Candesartan cilexetil og olmesartan i form af Olmesartan medoxomil.
4. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 3, idet diuretikummet er udvalgt af gruppen acetazolamid, dichlorphenamid, methazolamid, furosemid, torasemid, bumetanid, etacrynsyre, piretanid, amilorid, triamteren, spironolacton, kaliumcanreonat, eplerenon, hydrochlorothiazid, chlorthalidon, xipamid, metolazon, mefrusid eller indapamid.
5. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 4, kendetegnet ved, at nifedipin eller nisoldipin anvendes i en minimumsdosis på 5 mg og en maksimal dosis på 90 mg, og angiotensin-II antagonist anvendes i en minimumsdosis på 2 mg og en maksimal dosis på 500 mg, og/eller diuretikummet anvendes i en minimumsdosis på 0,5 mg og en maksimal dosis på 500 mg.
6. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 5, kendetegnet ved, at andelen af angiotensin-II antagonisten og/eller diuretikummet i kappeovertrækket er 10 til 50 % baseret på kappeovertrækkets tørvægt.
7. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 6, kendetegnet ved, at kappeovertrækkets vægt i lægemiddelformen ifølge opfindelsen er 20 til 300 mg.
8. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 7, kendetegnet ved, at kappeovertrækkets tykkelse er 50 til 1500 ym.
9. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 8, kendetegnet ved, at angiotensin II antagonisten er candesartan.
10. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 8, kendetegnet ved, at angiotensin II antagonisten er Candesartan cilexetil.
11. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 20 mg, og at Candesartan cilexetil er indeholdt i en mængde på 4 mg.
12. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 20 mg, og at Candesartan cilexetil er indeholdt i en mængde på 8 mg.
13. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 20 mg, og at Candesartan cilexetil er indeholdt i en mængde på 16 mg.
14. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 20 mg, og at Candesartan cilexetil er indeholdt i en mængde på 32 mg.
15. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 30 mg, og at Candesartan cilexetil er indeholdt i en mængde på 4 mg.
16. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 30 mg, og at Candesartan cilexetil er indeholdt i en mængde på 8 mg.
17. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 30 mg, og at Candesartan cilexetil er indeholdt i en mængde på 16 mg.
18. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 30 mg, og at Candesartan cilexetil er indeholdt i en mængde på 32 mg.
19. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 60 mg, og at Candesartan cilexetil er indeholdt i en mængde på 4 mg.
20. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 60 mg, og at Candesartan cilexetil er indeholdt i en mængde på 8 mg.
21. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 60 mg, og at Candesartan cilexetil er indeholdt i en mængde på 16 mg.
22. Farmaceutisk lægemiddelform ifølge krav 10, kendetegnet ved, at nifedipin er indeholdt i en mængde på 60 mg, og at Candesartan cilexetil er indeholdt i en mængde på 32 mg.
23. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 22, kendetegnet ved, at det osmotiske udløsningssystem er et osmotisk etkammersystem.
24. Farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 22, kendetegnet ved, at det osmotiske udløsningssystem er et osmotisk tokammersystem.
25. Farmaceutisk lægemiddelform ifølge krav 24, kendetegnet ved, at det osmotiske udløsningssystem er et osmotisk tokammersystem omfattende en kerne med et aktivstoflag indeholdende • 5 til 50 % at aktivstoffet nifedipin eller nisoldipin, • 40 til 95 % af en eller flere osmotisk aktive polymerer, og et osmoselag indeholdende • 40 til 90 % af en eller flere osmotisk aktive polymerer, • 5 til 40 % af et osmotisk aktivt tilsætningsstof Samt en kapsling bestående af et vandgennemtrængeligt, for bestanddelene i kernen uigennemtrængeligt materiale med i det mindste en åbning.
26. Fremgangsmåde til fremstilling af en farmaceutisk lægemiddelform ifølge et eller flere af kravene 1 til 25, kendetegnet ved, at en vandig laksuspension indeholdende i det mindste en angiotensin-II antagonist og/eller i det mindste et diuretikum, i det mindste en filmdannende polymer og i givet fald yderligere hjælpestoffer sprøjtes på kernen ved en indblæsningslufttemperatur på 40 til 70°C.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102008059206A DE102008059206A1 (de) | 2008-11-27 | 2008-11-27 | Pharmazeutische Darreichungsform enthaltend Nifedipin oder Nisoldipin und einen Angiotensin-II Antagonisten und/oder ein Diuretikum |
| PCT/EP2009/008232 WO2010060564A1 (de) | 2008-11-27 | 2009-11-19 | Pharmazeutische darreichungsform enthaltend nifedipin oder nisoldipin und einen angiotensin-ii antagonisten und/oder ein diuretikum |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2370065T3 true DK2370065T3 (da) | 2016-08-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09755847.2T DK2370065T3 (da) | 2008-11-27 | 2009-11-19 | Farmaceutisk lægemiddelform indeholdende nifedipin eller nisoldipin og en angiotensin-ii antagonist og/eller et diuretikum |
Country Status (36)
| Country | Link |
|---|---|
| US (1) | US9993432B2 (da) |
| EP (1) | EP2370065B1 (da) |
| JP (2) | JP2012509918A (da) |
| KR (1) | KR101418632B1 (da) |
| CN (2) | CN102227216A (da) |
| AR (1) | AR073423A1 (da) |
| AU (1) | AU2009319362B2 (da) |
| BR (1) | BRPI0922306A2 (da) |
| CA (1) | CA2744515C (da) |
| CL (1) | CL2011001091A1 (da) |
| CO (1) | CO6382107A2 (da) |
| CR (1) | CR20110260A (da) |
| CU (1) | CU24065B1 (da) |
| CY (1) | CY1118183T1 (da) |
| DE (1) | DE102008059206A1 (da) |
| DK (1) | DK2370065T3 (da) |
| DO (1) | DOP2011000137A (da) |
| EA (1) | EA025485B1 (da) |
| EC (1) | ECSP11011052A (da) |
| ES (1) | ES2585731T3 (da) |
| HR (1) | HRP20160987T1 (da) |
| HU (1) | HUE029085T2 (da) |
| IL (1) | IL212599A (da) |
| MX (1) | MX2011005023A (da) |
| MY (1) | MY160000A (da) |
| NZ (1) | NZ593045A (da) |
| PA (1) | PA8849701A1 (da) |
| PE (2) | PE20142192A1 (da) |
| PL (1) | PL2370065T3 (da) |
| PT (1) | PT2370065T (da) |
| SI (1) | SI2370065T1 (da) |
| SV (1) | SV2011003905A (da) |
| TW (1) | TWI484957B (da) |
| UA (1) | UA103347C2 (da) |
| UY (1) | UY32260A (da) |
| WO (1) | WO2010060564A1 (da) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2210595A1 (en) * | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
| CN102274223B (zh) * | 2010-06-12 | 2012-10-24 | 重庆市力扬医药开发有限公司 | 含替米沙坦和氨氯地平的复方制剂 |
| WO2012080833A2 (en) * | 2010-12-13 | 2012-06-21 | Purdue Pharma L.P. | Controlled release dosage forms |
| DE102011007272A1 (de) | 2011-04-13 | 2012-10-18 | Bayer Pharma Aktiengesellschaft | Verzweigte 3-Phenylpropionsäure-Derivate und ihre Verwendung |
| JP5934610B2 (ja) * | 2011-08-30 | 2016-06-15 | 第一三共ヘルスケア株式会社 | イブプロフェンを含有するフィルムコーティング製剤 |
| WO2013098831A2 (en) * | 2011-09-23 | 2013-07-04 | Emcure Pharmaceuticals Limited | Controlled release formulations of nisoldipine |
| US9216169B2 (en) | 2011-12-23 | 2015-12-22 | Tianjin Institute Of Pharmaceutical Research | Pharmaceutical composition comprising candesartan or ester thereof and chlortalidone, and use thereof |
| JP6231553B2 (ja) | 2012-05-07 | 2017-11-15 | バイエル ファーマ アクチエンゲゼルシャフト | ニフェジピンおよびカンデサルタン・シレキセチルを含む医薬投与形を製造する方法 |
| JP6304675B2 (ja) * | 2012-07-18 | 2018-04-04 | 国立大学法人北陸先端科学技術大学院大学 | 炭酸脱水酵素阻害剤のスクリーニング方法 |
| SG11201500582UA (en) * | 2012-08-17 | 2015-04-29 | Hoffmann La Roche | Combination therapies for melanoma comprising administering cobimetinib and vemurafinib |
| JP5790965B2 (ja) * | 2012-10-12 | 2015-10-07 | 味の素株式会社 | カルシウム拮抗薬／アンジオテンシンｉｉ受容体拮抗薬含有医薬製剤の製造方法 |
| EP3043778B1 (en) * | 2013-09-13 | 2017-09-06 | Bayer Pharma Aktiengesellschaft | Pharmaceutical compositions containing refametinib |
| CN104758289B (zh) * | 2015-03-09 | 2019-05-03 | 西安力邦制药有限公司 | 一种含美托法宗的复方降压药物组合及其应用 |
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| BR112019015368A2 (pt) | 2017-01-25 | 2020-03-10 | The George Institute for Global Health | Composições para o tratamento de hipertensão |
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