CN101478956B - 缬沙坦、氨氯地平和氢氯噻嗪的固体剂型及制备该固体剂型的方法 - Google Patents

缬沙坦、氨氯地平和氢氯噻嗪的固体剂型及制备该固体剂型的方法 Download PDF

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Publication number
CN101478956B
CN101478956B CN200780024142XA CN200780024142A CN101478956B CN 101478956 B CN101478956 B CN 101478956B CN 200780024142X A CN200780024142X A CN 200780024142XA CN 200780024142 A CN200780024142 A CN 200780024142A CN 101478956 B CN101478956 B CN 101478956B
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solid dosage
amlodipine
sieves
valsartan
hydrochlorothiazide
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CN101478956A (zh
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Y·曹
Y·乔希
P·李
M·普迪派迪
A·E·罗伊斯
R·F·瓦格纳
J·朱
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Novartis AG
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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
    • A61K9/2004—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • 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
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Hospice & Palliative Care (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Psychiatry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN200780024142XA 2006-06-27 2007-06-26 缬沙坦、氨氯地平和氢氯噻嗪的固体剂型及制备该固体剂型的方法 Active CN101478956B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US80588306P 2006-06-27 2006-06-27
US60/805,883 2006-06-27
PCT/US2007/072097 WO2008002905A2 (en) 2006-06-27 2007-06-26 Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same

Related Child Applications (1)

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CN2013100435988A Division CN103169711A (zh) 2006-06-27 2007-06-26 缬沙坦、氨氯地平和氢氯噻嗪的固体剂型及制备该固体剂型的方法

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CN101478956A CN101478956A (zh) 2009-07-08
CN101478956B true CN101478956B (zh) 2013-03-20

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CN2013100435988A Pending CN103169711A (zh) 2006-06-27 2007-06-26 缬沙坦、氨氯地平和氢氯噻嗪的固体剂型及制备该固体剂型的方法

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Country Status (22)

Country Link
US (2) US20100003321A1 (enExample)
EP (1) EP2037893A2 (enExample)
JP (1) JP2009542709A (enExample)
KR (1) KR20090021191A (enExample)
CN (2) CN101478956B (enExample)
AR (1) AR061627A1 (enExample)
AU (1) AU2007265138A1 (enExample)
BR (1) BRPI0713785A2 (enExample)
CA (1) CA2654986A1 (enExample)
CL (1) CL2007001870A1 (enExample)
EC (1) ECSP088987A (enExample)
IL (1) IL195797A0 (enExample)
MA (1) MA30529B1 (enExample)
MX (1) MX2008016532A (enExample)
NO (1) NO20090314L (enExample)
NZ (1) NZ573295A (enExample)
PE (2) PE20080991A1 (enExample)
RU (1) RU2449786C2 (enExample)
TN (1) TNSN08538A1 (enExample)
TW (1) TW200808379A (enExample)
WO (1) WO2008002905A2 (enExample)
ZA (1) ZA200810053B (enExample)

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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
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CN101829111B (zh) * 2010-05-23 2014-12-17 浙江华海药业股份有限公司 含有缬沙坦的固体制剂及其制备方法
CN102716132B (zh) * 2011-03-29 2015-09-30 石药集团中奇制药技术（石家庄）有限公司 复方氨氯地平/缬沙坦/氢氯噻嗪片及其制备方法
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CN102846625A (zh) * 2012-10-18 2013-01-02 海口华仕联医药科技有限公司 一种稳定的缬沙坦、氨氯地平和氢氯噻嗪的药物组合及其制备方法
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US11813275B2 (en) 2013-04-05 2023-11-14 Boehringer Ingelheim International Gmbh Pharmaceutical composition, methods for treating and uses thereof
HK1213818A1 (zh) 2013-04-05 2016-07-15 勃林格殷格翰国际有限公司 依帕列净的治疗用途
JP2016520564A (ja) 2013-04-18 2016-07-14 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 医薬組成物、治療方法及びその使用
CZ2013783A3 (cs) 2013-10-08 2015-04-15 Zentiva, K. S Stabilní farmaceutická kompozice obsahující amlodipin a valsartan
US20200316029A1 (en) * 2016-05-30 2020-10-08 Boehringer Ingelheim International Gmbh Fixed dose combination of telmisartan, hydrochlorothiazide and amlodipine
MX2019005435A (es) 2016-11-10 2019-07-10 Boehringer Ingelheim Int Composicion farmaceutica, metodos para tratamiento y sus usos.
AU2017400276B2 (en) 2017-02-27 2024-01-11 Idorsia Pharmaceuticals Ltd Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
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CL2007001870A1 (es) 2008-06-13
ECSP088987A (es) 2009-01-30
KR20090021191A (ko) 2009-02-27
WO2008002905A3 (en) 2008-12-11
US8475839B2 (en) 2013-07-02
NZ573295A (en) 2012-01-12
CA2654986A1 (en) 2008-01-03
WO2008002905A2 (en) 2008-01-03
PE20120542A1 (es) 2012-05-14
PE20080991A1 (es) 2008-09-05
AR061627A1 (es) 2008-09-10
IL195797A0 (en) 2009-09-01
AU2007265138A1 (en) 2008-01-03
HK1133818A1 (en) 2010-04-09
EP2037893A2 (en) 2009-03-25
CN101478956A (zh) 2009-07-08
NO20090314L (no) 2009-01-26
JP2009542709A (ja) 2009-12-03
RU2009102273A (ru) 2010-08-10
RU2449786C2 (ru) 2012-05-10
ZA200810053B (en) 2009-11-25
MA30529B1 (fr) 2009-06-01
TW200808379A (en) 2008-02-16
TNSN08538A1 (en) 2010-04-14
US20120164218A1 (en) 2012-06-28
BRPI0713785A2 (pt) 2012-10-30
US20100003321A1 (en) 2010-01-07
MX2008016532A (es) 2009-01-19
CN103169711A (zh) 2013-06-26

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