TR201900350T4 - Kandesartan sileksetil ve amlodipin içeren bir farmasötik bileşim. - Google Patents
Kandesartan sileksetil ve amlodipin içeren bir farmasötik bileşim. Download PDFInfo
- Publication number
- TR201900350T4 TR201900350T4 TR2019/00350T TR201900350T TR201900350T4 TR 201900350 T4 TR201900350 T4 TR 201900350T4 TR 2019/00350 T TR2019/00350 T TR 2019/00350T TR 201900350 T TR201900350 T TR 201900350T TR 201900350 T4 TR201900350 T4 TR 201900350T4
- Authority
- TR
- Turkey
- Prior art keywords
- candesartan cilexetil
- composition
- pharmaceutical composition
- amlodipine
- composition containing
- Prior art date
Links
- GHOSNRCGJFBJIB-UHFFFAOYSA-N Candesartan cilexetil Chemical compound C=12N(CC=3C=CC(=CC=3)C=3C(=CC=CC=3)C3=NNN=N3)C(OCC)=NC2=CC=CC=1C(=O)OC(C)OC(=O)OC1CCCCC1 GHOSNRCGJFBJIB-UHFFFAOYSA-N 0.000 title abstract 4
- 229960004349 candesartan cilexetil Drugs 0.000 title abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- HTIQEAQVCYTUBX-UHFFFAOYSA-N amlodipine Chemical compound CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl HTIQEAQVCYTUBX-UHFFFAOYSA-N 0.000 title 1
- 229960000528 amlodipine Drugs 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 5
- 239000002202 Polyethylene glycol Substances 0.000 abstract 2
- 239000008187 granular material Substances 0.000 abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 229920001223 polyethylene glycol Polymers 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 239000002552 dosage form Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 238000005550 wet granulation Methods 0.000 abstract 1
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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- General Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Kandesartan sileksetil ve amiodipin veya bunun farmasötik olarak kabul edilebilir tuzunu içeren bir kombinasyonlu farmasötik bileşim, bu tür bir bileşimin ve bu tür bir bileşimi içeren birim dozaj formunun hazırlanmasına yönelik bir prosestir. Bileşim, kandesartan sileksetil ila polietilen glikol ağırlık oranının 5:1 ila 2:1 aralığında olduğu, kandesartan sileksetil, polietilen glikol ve diğer eksipiyanları içeren bir granülattan ve amiodipin veya bunun farmasötik olarak kabul edilebilir bir tuzunu ve eksipiyanları içeren toz karışımın ekstragranüler fazından oluşur. Bileşim, ıslak granülasyon yoluyla hazırlanan granülat ile ekstragranüler fazın karıştırılması yoluyla hazırlanır.
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 (1)
Publication Number | Publication Date |
---|---|
TR201900350T4 true TR201900350T4 (tr) | 2019-02-21 |
Family
ID=50030379
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TR2019/00350T TR201900350T4 (tr) | 2012-12-21 | 2013-12-19 | Kandesartan sileksetil ve amlodipin içeren bir farmasötik bileşim. |
Country Status (19)
Country | Link |
---|---|
EP (1) | EP2934488B1 (tr) |
AU (1) | AU2013365715B2 (tr) |
BR (1) | BR112015014875A2 (tr) |
EA (1) | EA030704B1 (tr) |
ES (1) | ES2706067T3 (tr) |
HK (1) | HK1213808A1 (tr) |
HR (1) | HRP20190049T1 (tr) |
HU (1) | HUE042194T2 (tr) |
MX (1) | MX2015008032A (tr) |
MY (1) | MY185947A (tr) |
PH (1) | PH12015501301B1 (tr) |
PL (2) | PL236001B1 (tr) |
PT (1) | PT2934488T (tr) |
RS (1) | RS58214B1 (tr) |
SG (1) | SG11201504473XA (tr) |
TR (1) | TR201900350T4 (tr) |
UA (1) | UA115257C2 (tr) |
WO (1) | WO2014097209A1 (tr) |
ZA (1) | ZA201505192B (tr) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3236950B1 (en) * | 2014-12-24 | 2022-11-23 | KRKA, d.d., Novo mesto | Pharmaceutical composition comprising candesartan or pharmaceutically acceptable salts or esters thereof and amlodipine or pharmaceutically acceptable salts thereof |
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 (tr) | 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 |
WO2008065097A2 (en) | 2006-11-28 | 2008-06-05 | Laboratorios Liconsa, S.A. | Stabilized solid pharmaceutical composition of candesartan cilexetil |
JP5139515B2 (ja) | 2007-04-25 | 2013-02-06 | テバ ファーマシューティカル インダストリーズ リミティド | 医薬賦形剤複合体 |
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 |
DK2165702T3 (da) | 2008-09-17 | 2012-03-05 | Helm Ag | Stabile og let opløselige sammensætninger af candesartancilexetil fremstillet ved vådgranulering |
NZ596395A (en) | 2009-04-30 | 2013-06-28 | Takeda Pharmaceutical | Stable solid benzimidazole derivative preparation having optimized dissolution property |
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 SG SG11201504473XA patent/SG11201504473XA/en unknown
- 2013-12-19 WO PCT/IB2013/061138 patent/WO2014097209A1/en active Application Filing
- 2013-12-19 EA EA201591097A patent/EA030704B1/ru unknown
- 2013-12-19 ES ES13826632T patent/ES2706067T3/es active Active
- 2013-12-19 EP EP13826632.5A patent/EP2934488B1/en active Active
- 2013-12-19 PT PT13826632T patent/PT2934488T/pt unknown
- 2013-12-19 UA UAA201507042A patent/UA115257C2/uk unknown
- 2013-12-19 MY MYPI2015001480A patent/MY185947A/en unknown
- 2013-12-19 BR BR112015014875A patent/BR112015014875A2/pt active Search and Examination
- 2013-12-19 HU HUE13826632A patent/HUE042194T2/hu unknown
- 2013-12-19 MX MX2015008032A patent/MX2015008032A/es active IP Right Grant
- 2013-12-19 AU AU2013365715A patent/AU2013365715B2/en active Active
- 2013-12-19 RS RS20190047A patent/RS58214B1/sr unknown
- 2013-12-19 PL PL13826632T patent/PL2934488T3/pl unknown
-
2015
- 2015-06-08 PH PH12015501301A patent/PH12015501301B1/en unknown
- 2015-07-20 ZA ZA2015/05192A patent/ZA201505192B/en unknown
-
2016
- 2016-02-19 HK HK16101894.7A patent/HK1213808A1/zh unknown
-
2019
- 2019-01-08 HR HRP20190049TT patent/HRP20190049T1/hr unknown
Also Published As
Publication number | Publication date |
---|---|
HUE042194T2 (hu) | 2019-06-28 |
RS58214B1 (sr) | 2019-03-29 |
ES2706067T3 (es) | 2019-03-27 |
AU2013365715B2 (en) | 2017-10-05 |
PH12015501301A1 (en) | 2015-08-24 |
MY185947A (en) | 2021-06-14 |
HK1213808A1 (zh) | 2016-07-15 |
BR112015014875A2 (pt) | 2017-07-11 |
UA115257C2 (uk) | 2017-10-10 |
EA201591097A1 (ru) | 2015-10-30 |
PL236001B1 (pl) | 2020-11-30 |
EP2934488A1 (en) | 2015-10-28 |
PH12015501301B1 (en) | 2015-08-24 |
PT2934488T (pt) | 2019-01-29 |
HRP20190049T1 (hr) | 2019-02-22 |
PL402191A1 (pl) | 2014-06-23 |
AU2013365715A1 (en) | 2015-06-18 |
SG11201504473XA (en) | 2015-07-30 |
EP2934488B1 (en) | 2018-10-17 |
ZA201505192B (en) | 2016-07-27 |
WO2014097209A1 (en) | 2014-06-26 |
PL2934488T3 (pl) | 2019-04-30 |
EA030704B1 (ru) | 2018-09-28 |
MX2015008032A (es) | 2015-10-30 |
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