PL402191A1 - Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję - Google Patents
Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycjęInfo
- Publication number
- PL402191A1 PL402191A1 PL402191A PL40219112A PL402191A1 PL 402191 A1 PL402191 A1 PL 402191A1 PL 402191 A PL402191 A PL 402191A PL 40219112 A PL40219112 A PL 40219112A PL 402191 A1 PL402191 A1 PL 402191A1
- Authority
- PL
- Poland
- Prior art keywords
- composition
- candesartan cilexetil
- unit dosage
- amlodipine
- preparation
- 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
- A61K31/41—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
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Kompozycja składa się z granulatu zawierającego kandesartan cyleksetylu, glikol polietylenowy oraz substancje pomocnicze, w którym stosunek wagowy kandesartanu cyleksetylu do glikolu polietylenowego zawiera się w zakresie od 5:1 do 2:1 oraz z fazy zewnątrzgranularnej stanowiącej mieszankę proszkową, zawierającą amlodypinę lub jej farmaceutycznie akceptowalną sól oraz substancje pomocnicze. Kompozycję wytwarza się mieszając wytworzony drogą granulacji na mokro granulat z fazą zewnątrzgranularną. Z kompozycji według wynalazku przygotowuje się jednostkowe postaci dawkowania.
Priority Applications (20)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL402191A PL236001B1 (pl) | 2012-12-21 | 2012-12-21 | Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję |
| HK16101894.7A HK1213808B (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| RS20190047A RS58214B1 (sr) | 2012-12-21 | 2013-12-19 | Farmaceutski sastav koji sadrži kandesartan cileksetil i amlodipin |
| HRP20190049TT HRP20190049T1 (hr) | 2012-12-21 | 2013-12-19 | Farmaceutski pripravak koji sadrži kandesartan cileksetil i amlodipin |
| EA201591097A EA030704B1 (ru) | 2012-12-21 | 2013-12-19 | Фармацевтическая композиция, содержащая кандесартана цилексетил и амлодипин |
| BR112015014875A BR112015014875A2 (pt) | 2012-12-21 | 2013-12-19 | composição farmacêutica que contém candesartana cilexetila e anlodipina |
| SG11201504473XA SG11201504473XA (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| AU2013365715A AU2013365715B2 (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| UAA201507042A UA115257C2 (uk) | 2012-12-21 | 2013-12-19 | Фармацевтична композиція у формі твердої суміші, що містить кандесартану цилексетил та амлодипін |
| ES13826632T ES2706067T3 (es) | 2012-12-21 | 2013-12-19 | Una composición farmacéutica que contiene candesartán cilexetilo y amlodipino |
| MX2015008032A MX374106B (es) | 2012-12-21 | 2013-12-19 | Una composicion farmaceutica que contiene candesartan cilexetilo y amlodipina. |
| TR2019/00350T TR201900350T4 (tr) | 2012-12-21 | 2013-12-19 | Kandesartan sileksetil ve amlodipin içeren bir farmasötik bileşim. |
| PL13826632T PL2934488T3 (pl) | 2012-12-21 | 2013-12-19 | Kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu i amlodypinę |
| EP13826632.5A EP2934488B1 (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| MYPI2015001480A MY185947A (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| PT13826632T PT2934488T (pt) | 2012-12-21 | 2013-12-19 | Composição farmacêutica contendo candesartan cilexetil e amlodipina |
| PCT/IB2013/061138 WO2014097209A1 (en) | 2012-12-21 | 2013-12-19 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| HUE13826632A HUE042194T2 (hu) | 2012-12-21 | 2013-12-19 | Kandeszartán-cilexetilt és amlodipint tartalamazó gyógyszerkészítmény |
| PH12015501301A PH12015501301A1 (en) | 2012-12-21 | 2015-06-08 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
| ZA2015/05192A ZA201505192B (en) | 2012-12-21 | 2015-07-20 | A pharmaceutical composition containing candesartan cilexetil and amlodipine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL402191A PL236001B1 (pl) | 2012-12-21 | 2012-12-21 | Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| PL402191A1 true PL402191A1 (pl) | 2014-06-23 |
| PL236001B1 PL236001B1 (pl) | 2020-11-30 |
Family
ID=50030379
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL402191A PL236001B1 (pl) | 2012-12-21 | 2012-12-21 | Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję |
| PL13826632T PL2934488T3 (pl) | 2012-12-21 | 2013-12-19 | Kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu i amlodypinę |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL13826632T PL2934488T3 (pl) | 2012-12-21 | 2013-12-19 | Kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu i amlodypinę |
Country Status (18)
| Country | Link |
|---|---|
| EP (1) | EP2934488B1 (pl) |
| AU (1) | AU2013365715B2 (pl) |
| BR (1) | BR112015014875A2 (pl) |
| EA (1) | EA030704B1 (pl) |
| ES (1) | ES2706067T3 (pl) |
| HR (1) | HRP20190049T1 (pl) |
| HU (1) | HUE042194T2 (pl) |
| MX (1) | MX374106B (pl) |
| MY (1) | MY185947A (pl) |
| PH (1) | PH12015501301A1 (pl) |
| PL (2) | PL236001B1 (pl) |
| PT (1) | PT2934488T (pl) |
| RS (1) | RS58214B1 (pl) |
| SG (1) | SG11201504473XA (pl) |
| TR (1) | TR201900350T4 (pl) |
| UA (1) | UA115257C2 (pl) |
| WO (1) | WO2014097209A1 (pl) |
| ZA (1) | ZA201505192B (pl) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI3236950T1 (sl) * | 2014-12-24 | 2023-04-28 | Krka, D.D., Novo Mesto | Farmacevtski sestavek, ki obsega kandesartan ali njegove farmacevtsko sprejemljive soli ali estre in amlodipin ali njegove farmacevtsko sprejemljive soli |
| CN104721159A (zh) * | 2015-03-24 | 2015-06-24 | 浙江康乐药业股份有限公司 | 一种苯磺酸氨氯地平片及其制备方法 |
| KR101710441B1 (ko) * | 2015-12-28 | 2017-02-28 | 신풍제약주식회사 | 안정성 및 용출성이 향상된 정제 |
| EP3219309A1 (en) * | 2016-03-17 | 2017-09-20 | K.H.S. Pharma Holding GmbH | Fixed dosed pharmaceutical composition comprising amlodipine, candesartan cilexetil and hydrochlorothiazide for the treatment of hypertension |
| US10350171B2 (en) | 2017-07-06 | 2019-07-16 | Dexcel Ltd. | Celecoxib and amlodipine formulation and method of making the same |
| EP4374855A1 (en) * | 2022-11-22 | 2024-05-29 | KRKA, D.D., Novo Mesto | Pharmaceutical dosage form of candesartan and indapamide |
Family Cites Families (18)
| 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 |
| GB8608335D0 (en) | 1986-04-04 | 1986-05-08 | Pfizer Ltd | Pharmaceutically acceptable salts |
| US5196444A (en) | 1990-04-27 | 1993-03-23 | Takeda Chemical Industries, Ltd. | 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof |
| TW284688B (pl) | 1991-11-20 | 1996-09-01 | Takeda Pharm Industry Co Ltd | |
| PL189666B1 (pl) | 1998-04-09 | 2005-09-30 | Adamed Sp Z Oo | Sposób otrzymywania benzenosulfonianu amlodypiny |
| HU226642B1 (en) | 2001-12-17 | 2009-05-28 | Egis Gyogyszergyar Nyilvanosan | Amlodipine bezylate tablets having extended stability and process for producing the same |
| WO2004075825A2 (en) | 2003-02-28 | 2004-09-10 | Ranbaxy Laboratories Limited | Dosage forms of amlodipine and processes for their preparation |
| US20100041644A1 (en) | 2006-11-28 | 2010-02-18 | Laboratorios Liconsa, S. A. | Stabilized solid pharmaceutical composition of candesartan cilexetil |
| MX2009011493A (es) | 2007-04-25 | 2009-11-09 | Teva Pharma | Complejo de excipiente farmaceutico. |
| EP2050440A1 (en) | 2007-10-18 | 2009-04-22 | Krka | Stable solid pharmaceutical composition comprising candesartan or pharmaceutically acceptable forms thereof |
| EP2106789A1 (en) * | 2008-03-31 | 2009-10-07 | KRKA, tovarna zdravil, d.d., Novo mesto | Pharmaceutical composition comprising candesartan |
| EP2165702B1 (en) | 2008-09-17 | 2011-11-16 | Helm AG | Stable and readily dissolved compositions of candesartan cilexetil prepared with wet granulation |
| CA2760073A1 (en) | 2009-04-30 | 2010-11-04 | Takeda Pharmaceutical Company Limited | Solid preparation |
| CN101966181A (zh) * | 2010-07-08 | 2011-02-09 | 王丽燕 | 包含坎地沙坦和氨氯地平的口服固体制剂及其新应用 |
| CN102743381B (zh) * | 2011-04-22 | 2014-08-27 | 重庆市力扬医药开发有限公司 | 一种稳定的坎地沙坦酯氨氯地平药物组合物及其制备方法 |
| CN102764258B (zh) | 2011-10-21 | 2013-09-25 | 四川百利药业有限责任公司 | 一种坎地沙坦酯氨氯地平复方片的制备方法 |
| CN102670603B (zh) * | 2012-04-29 | 2017-10-31 | 浙江华海药业股份有限公司 | 含有坎地沙坦酯和苯磺酸氨氯地平的口服片剂及其制备方法 |
| CN102688236B (zh) * | 2012-06-06 | 2014-03-26 | 石药集团中诺药业（石家庄）有限公司 | 一种坎地沙坦酯氨氯地平片剂组合物及其制备方法 |
-
2012
- 2012-12-21 PL PL402191A patent/PL236001B1/pl unknown
-
2013
- 2013-12-19 TR TR2019/00350T patent/TR201900350T4/tr unknown
- 2013-12-19 UA UAA201507042A patent/UA115257C2/uk unknown
- 2013-12-19 MY MYPI2015001480A patent/MY185947A/en unknown
- 2013-12-19 AU AU2013365715A patent/AU2013365715B2/en not_active Ceased
- 2013-12-19 SG SG11201504473XA patent/SG11201504473XA/en unknown
- 2013-12-19 PT PT13826632T patent/PT2934488T/pt unknown
- 2013-12-19 EA EA201591097A patent/EA030704B1/ru unknown
- 2013-12-19 RS RS20190047A patent/RS58214B1/sr unknown
- 2013-12-19 WO PCT/IB2013/061138 patent/WO2014097209A1/en not_active Ceased
- 2013-12-19 HU HUE13826632A patent/HUE042194T2/hu unknown
- 2013-12-19 EP EP13826632.5A patent/EP2934488B1/en active Active
- 2013-12-19 HR HRP20190049TT patent/HRP20190049T1/hr unknown
- 2013-12-19 ES ES13826632T patent/ES2706067T3/es active Active
- 2013-12-19 PL PL13826632T patent/PL2934488T3/pl unknown
- 2013-12-19 BR BR112015014875A patent/BR112015014875A2/pt active Search and Examination
- 2013-12-19 MX MX2015008032A patent/MX374106B/es active IP Right Grant
-
2015
- 2015-06-08 PH PH12015501301A patent/PH12015501301A1/en unknown
- 2015-07-20 ZA ZA2015/05192A patent/ZA201505192B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EA201591097A1 (ru) | 2015-10-30 |
| BR112015014875A2 (pt) | 2017-07-11 |
| RS58214B1 (sr) | 2019-03-29 |
| PL236001B1 (pl) | 2020-11-30 |
| HK1213808A1 (en) | 2016-07-15 |
| PH12015501301B1 (en) | 2015-08-24 |
| EA030704B1 (ru) | 2018-09-28 |
| UA115257C2 (uk) | 2017-10-10 |
| EP2934488A1 (en) | 2015-10-28 |
| AU2013365715B2 (en) | 2017-10-05 |
| EP2934488B1 (en) | 2018-10-17 |
| WO2014097209A1 (en) | 2014-06-26 |
| PH12015501301A1 (en) | 2015-08-24 |
| SG11201504473XA (en) | 2015-07-30 |
| PT2934488T (pt) | 2019-01-29 |
| HRP20190049T1 (hr) | 2019-02-22 |
| AU2013365715A1 (en) | 2015-06-18 |
| PL2934488T3 (pl) | 2019-04-30 |
| ZA201505192B (en) | 2016-07-27 |
| MX374106B (es) | 2025-03-05 |
| ES2706067T3 (es) | 2019-03-27 |
| TR201900350T4 (tr) | 2019-02-21 |
| MX2015008032A (es) | 2015-10-30 |
| HUE042194T2 (hu) | 2019-06-28 |
| MY185947A (en) | 2021-06-14 |
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