NZ565020A - Solid dosage forms of valsartan and amlodipine and method of making the same - Google Patents

Solid dosage forms of valsartan and amlodipine and method of making the same

Info

Publication number
NZ565020A
NZ565020A NZ565020A NZ56502006A NZ565020A NZ 565020 A NZ565020 A NZ 565020A NZ 565020 A NZ565020 A NZ 565020A NZ 56502006 A NZ56502006 A NZ 56502006A NZ 565020 A NZ565020 A NZ 565020A
Authority
NZ
New Zealand
Prior art keywords
valsartan
solid dosage
amlodipine
blended
dosage form
Prior art date
Application number
NZ565020A
Other languages
English (en)
Inventor
Yatindra Joshi
Robert Frank Wagner
Madhusudhan Pudipeddi
Gangadhar Sunkara
Ping Li
Original Assignee
Novartis Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37758280&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NZ565020(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of NZ565020A publication Critical patent/NZ565020A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/06Antiarrhythmics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
NZ565020A 2005-08-17 2006-08-15 Solid dosage forms of valsartan and amlodipine and method of making the same NZ565020A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US70908305P 2005-08-17 2005-08-17
PCT/US2006/031699 WO2007022113A2 (en) 2005-08-17 2006-08-15 Solid dosage forms of valsartan and amlodipine and method of making the same

Publications (1)

Publication Number Publication Date
NZ565020A true NZ565020A (en) 2011-07-29

Family

ID=37758280

Family Applications (1)

Application Number Title Priority Date Filing Date
NZ565020A NZ565020A (en) 2005-08-17 2006-08-15 Solid dosage forms of valsartan and amlodipine and method of making the same

Country Status (22)

Country Link
US (3) US20080171086A1 (enExample)
EP (1) EP1917002A2 (enExample)
JP (2) JP2009504744A (enExample)
KR (3) KR20120135356A (enExample)
CN (1) CN101237859A (enExample)
AR (1) AR055120A1 (enExample)
AU (2) AU2006279670A1 (enExample)
BR (1) BRPI0614790A2 (enExample)
CA (1) CA2617367A1 (enExample)
EC (1) ECSP088188A (enExample)
GT (1) GT200600371A (enExample)
IL (1) IL189021A0 (enExample)
MA (1) MA29734B1 (enExample)
MX (1) MX2008002267A (enExample)
NO (1) NO20081310L (enExample)
NZ (1) NZ565020A (enExample)
PE (1) PE20070420A1 (enExample)
RU (2) RU2008109913A (enExample)
TN (1) TNSN08071A1 (enExample)
TW (1) TW200740432A (enExample)
WO (1) WO2007022113A2 (enExample)
ZA (1) ZA200800397B (enExample)

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TR200703568A1 (tr) * 2007-05-24 2008-07-21 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Valsartan formülasyonları
WO2009061713A1 (en) 2007-11-06 2009-05-14 Novartis Ag Dual-acting pharmaceutical compositions based on superstructures of angiotensin receptor antagonist/blocker (arb) and neutral endopeptidase (nep) inhibitor
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EP2291233B1 (en) 2008-05-09 2019-09-04 Atacama Labs Oy Method for dry granulation
JO3239B1 (ar) 2008-09-22 2018-03-08 Novartis Ag تركيبات جالينية من مركبات عضوية
DE102008051783A1 (de) * 2008-10-17 2010-04-22 Tiefenbacher Pharmachemikalien Alfred E. Tiefenbacher Gmbh & Co. Kg Valsartan enthaltende Tablette
WO2010104485A2 (en) * 2009-03-11 2010-09-16 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Valsartan formulations
CN101926798B (zh) * 2009-06-26 2013-09-18 北京德众万全药物技术开发有限公司 一种含有氨氯地平和缬沙坦的分散片
US20120107397A1 (en) * 2009-07-03 2012-05-03 Hetero Research Foundation Pharmaceutical compositions of valsartan
CN101647797B (zh) * 2009-09-18 2011-06-08 海南锦瑞制药股份有限公司 一种含有苯磺酸氨氯地平和缬沙坦的药物组合物及其制备方法
CN102091069A (zh) * 2009-12-11 2011-06-15 浙江华海药业股份有限公司 缬沙坦和氨氯地平的复方制剂及其制备方法
CN101897675B (zh) * 2010-02-10 2012-11-21 温士顿医药股份有限公司 含有凡尔沙坦或其药学上可接受的盐的固体剂型口服医药组成物
CN101843615A (zh) * 2010-06-25 2010-09-29 包丽昕 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法
TR201102067A1 (tr) 2011-03-03 2012-09-21 Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Valsartan ve amlodipin kombinasyonları.
CN102283837A (zh) * 2011-07-29 2011-12-21 江苏省药物研究所有限公司 缬沙坦和氨氯地平复方的固体制剂的制备方法
CN102697778B (zh) * 2012-06-21 2014-04-30 上海医药集团股份有限公司 缬沙坦氨氯地平复方固体制剂及其制备方法
WO2013191668A1 (en) 2012-06-22 2013-12-27 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Compositions preventing hypertension comprising soluplus
WO2014058047A1 (ja) * 2012-10-12 2014-04-17 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
CN103006649B (zh) * 2012-12-27 2014-06-25 石家庄市华新药业有限责任公司 一种复方制剂缬沙坦氨氯地平片(ⅰ)及其制备方法
CZ2013783A3 (cs) 2013-10-08 2015-04-15 Zentiva, K. S Stabilní farmaceutická kompozice obsahující amlodipin a valsartan
MX380070B (es) * 2015-07-08 2025-03-11 Cj Healthcare Corp Una composición farmacéutica que comprende amlodipino, valsartán y rosuvastatina.
CN105232551A (zh) * 2015-11-19 2016-01-13 哈尔滨圣吉药业股份有限公司 一种缬沙坦/苯磺酸氨氯地平复方制剂及其制备方法
CN106176744A (zh) * 2016-07-13 2016-12-07 精华制药集团股份有限公司 缬沙坦氨氯地平胶囊在制备治疗脑中风的药物中的应用
ES3035030T3 (en) 2016-10-07 2025-08-28 Silvergate Pharmaceuticals Inc Amlodipine formulations
EP3522888A4 (en) * 2016-10-10 2020-06-10 Alembic Pharmaceuticals Limited STABLE PHARMACEUTICAL COMPOSITION WITH TELMISARTAN AND AMLODIPINE BESYLATE
CN109498626A (zh) * 2017-09-14 2019-03-22 北京万全德众医药生物技术有限公司 一种稳定的复方制剂缬沙坦氨氯地平处方及其制备方法
US10799453B2 (en) 2018-04-11 2020-10-13 Silvergate Pharmaceuticals, Inc. Amlodipine formulations
CN109260160A (zh) * 2018-08-30 2019-01-25 天津仁生医药科技有限公司 一种缬沙坦氨氯地平片剂及其制备方法
CN109010338B (zh) * 2018-09-13 2021-09-21 合肥合源药业有限公司 一种缬沙坦氨氯地平片的制备方法及缬沙坦氨氯地平片
CN109157526A (zh) * 2018-09-13 2019-01-08 合肥合源药业有限公司 一种缬沙坦氨氯地平复方制剂及其制备工艺
CN109394712B (zh) * 2018-11-23 2019-11-12 海南妙音春制药有限公司 一种缬沙坦氨氯地平复方片剂及其制备方法
WO2025162195A1 (zh) * 2024-01-30 2025-08-07 上海汇伦医药股份有限公司 包衣复方片剂
CN120392682A (zh) * 2024-01-30 2025-08-01 上海汇伦医药股份有限公司 速释组合物
CN119925284B (zh) * 2025-04-09 2025-07-11 杭州沐源生物医药科技有限公司 一种含有厄贝沙坦和氨氯地平的药物组合物及制备方法

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Also Published As

Publication number Publication date
CN101237859A (zh) 2008-08-06
GT200600371A (es) 2007-03-21
US20080171086A1 (en) 2008-07-17
KR20120078751A (ko) 2012-07-10
AR055120A1 (es) 2007-08-08
TNSN08071A1 (en) 2009-07-14
PE20070420A1 (es) 2007-05-21
AU2006279670A1 (en) 2007-02-22
EP1917002A2 (en) 2008-05-07
ECSP088188A (es) 2008-03-26
KR20120135356A (ko) 2012-12-12
JP2009504744A (ja) 2009-02-05
RU2008109913A (ru) 2009-09-27
NO20081310L (no) 2008-05-16
ZA200800397B (en) 2009-03-25
KR20080034159A (ko) 2008-04-18
IL189021A0 (en) 2008-08-07
WO2007022113A2 (en) 2007-02-22
MX2008002267A (es) 2008-03-27
JP2013091660A (ja) 2013-05-16
US20120177733A1 (en) 2012-07-12
CA2617367A1 (en) 2007-02-22
US20100303906A1 (en) 2010-12-02
WO2007022113A3 (en) 2007-05-10
TW200740432A (en) 2007-11-01
MA29734B1 (fr) 2008-09-01
AU2010227062A1 (en) 2010-11-04
BRPI0614790A2 (pt) 2011-04-12
RU2012131668A (ru) 2014-01-27

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