KR20110063684A - 알리스키렌을 포함하는 생약 제형 및 용융 압출 과립화에 의한 그의 제조 방법 - Google Patents

알리스키렌을 포함하는 생약 제형 및 용융 압출 과립화에 의한 그의 제조 방법 Download PDF

Info

Publication number
KR20110063684A
KR20110063684A KR1020117009209A KR20117009209A KR20110063684A KR 20110063684 A KR20110063684 A KR 20110063684A KR 1020117009209 A KR1020117009209 A KR 1020117009209A KR 20117009209 A KR20117009209 A KR 20117009209A KR 20110063684 A KR20110063684 A KR 20110063684A
Authority
KR
South Korea
Prior art keywords
dosage form
oral dosage
solid oral
aliskiren
pharmaceutically acceptable
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
KR1020117009209A
Other languages
English (en)
Korean (ko)
Inventor
인드라지트 고쉬
제임스 코왈스키
제니퍼 스나이더
웨이-친 통
수드하 비파군타
Original Assignee
노파르티스 아게
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
Application filed by 노파르티스 아게 filed Critical 노파르티스 아게
Publication of KR20110063684A publication Critical patent/KR20110063684A/ko
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61P25/28—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Psychiatry (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020117009209A 2008-09-24 2009-09-23 알리스키렌을 포함하는 생약 제형 및 용융 압출 과립화에 의한 그의 제조 방법 Withdrawn KR20110063684A (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US9959508P 2008-09-24 2008-09-24
US61/099,595 2008-09-24
US16179909P 2009-03-20 2009-03-20
US61/161,799 2009-03-20

Publications (1)

Publication Number Publication Date
KR20110063684A true KR20110063684A (ko) 2011-06-13

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020117009209A Withdrawn KR20110063684A (ko) 2008-09-24 2009-09-23 알리스키렌을 포함하는 생약 제형 및 용융 압출 과립화에 의한 그의 제조 방법

Country Status (19)

Country Link
US (1) US20110177166A1 (enExample)
EP (1) EP2328562A1 (enExample)
JP (1) JP2012503665A (enExample)
KR (1) KR20110063684A (enExample)
CN (1) CN102164584A (enExample)
AR (1) AR073651A1 (enExample)
AU (1) AU2009296718A1 (enExample)
BR (1) BRPI0919077A2 (enExample)
CA (1) CA2736259A1 (enExample)
CL (1) CL2011000614A1 (enExample)
CO (1) CO6351712A2 (enExample)
EC (1) ECSP11010998A (enExample)
MA (1) MA32722B1 (enExample)
MX (1) MX2011003077A (enExample)
PE (1) PE20110925A1 (enExample)
RU (1) RU2011116122A (enExample)
TW (1) TW201016210A (enExample)
WO (1) WO2010036686A1 (enExample)
ZA (1) ZA201101686B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102348452A (zh) * 2009-03-20 2012-02-08 诺瓦提斯公司 缬沙坦和阿利吉仑的固定剂量组合的盖仑制剂
EP2382967A1 (de) * 2010-04-21 2011-11-02 ratiopharm GmbH Aliskiren in Form einer festen Dispersion
TWI736135B (zh) * 2013-03-01 2021-08-11 美商英塞特控股公司 吡唑并嘧啶衍生物治療PI3Kδ相關病症之用途
FR3055800B1 (fr) * 2016-09-15 2020-06-26 Unither Pharmaceuticals Composition solide a ingestion rapide et deglutition facilitee, sous forme de particules solides non agglomerees, comprenant deux differents types de particules
KR102898913B1 (ko) * 2020-09-04 2025-12-10 상하이 파마슈티컬스 홀딩 컴퍼니 리미티드 질소 함유 포화 헤테로사이클릭 화합물의 응용

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY144477A (en) * 2004-03-17 2011-09-30 Novartis Ag Galenic formulations of organic compounds
AR050615A1 (es) * 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral
US20080075772A1 (en) * 2006-04-13 2008-03-27 Lawrence Solomon Pharmaceutical compositions having novel scoring patterns and methods of using those compositions
US8119841B2 (en) * 2006-11-07 2012-02-21 Novartis Ag Crystalline forms of aliskiren hemifumarate
EP1972335A1 (en) * 2007-03-23 2008-09-24 Krka Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
AR066168A1 (es) * 2007-09-28 2009-07-29 Novartis Ag Formulaciones galenicas de compuestos organicos
WO2009040427A1 (en) * 2007-09-28 2009-04-02 Novartis Ag Galenical formulations of organic compounds
EP2062874B1 (en) * 2007-11-20 2014-12-17 KRKA, tovarna zdravil, d.d., Novo mesto Process and intermediates for the preparation of aliskiren

Also Published As

Publication number Publication date
JP2012503665A (ja) 2012-02-09
MA32722B1 (fr) 2011-10-02
US20110177166A1 (en) 2011-07-21
BRPI0919077A2 (pt) 2015-12-15
RU2011116122A (ru) 2012-10-27
AR073651A1 (es) 2010-11-24
CL2011000614A1 (es) 2011-11-04
MX2011003077A (es) 2011-08-03
CN102164584A (zh) 2011-08-24
WO2010036686A1 (en) 2010-04-01
AU2009296718A1 (en) 2010-04-01
ECSP11010998A (es) 2011-06-30
PE20110925A1 (es) 2012-01-13
EP2328562A1 (en) 2011-06-08
CO6351712A2 (es) 2011-12-20
ZA201101686B (en) 2012-01-25
CA2736259A1 (en) 2010-04-01
TW201016210A (en) 2010-05-01

Similar Documents

Publication Publication Date Title
AU2008309058B2 (en) Galenical formulations of Aliskiren and Valsartan
CN1705471A (zh) 地非司罗分散片
KR101434906B1 (ko) Ｎｓａｉｄ 및 파라세타몰을 포함하는 조성물
US20110177166A1 (en) Galenical Formulation Comprising Aliskiren and Process for its Preparation by Melt Extrusion Granulation
EA030982B1 (ru) Твердая галеновая форма с высоким содержанием фексофенадина и способ ее получения
CN103200935A (zh) 包含2-甲基丙硫代酸s-[2-([[1-(2-乙基丁基)-环己基]-羰基]氨基)苯基]酯和交联羧甲基纤维素钠的组合物
JP2015091830A (ja) 有機化合物のガレヌス製剤
TWI436760B (zh) 阿利克侖之蓋崙（ｇａｌｅｎｉｃａｌ）調配物
WO2002024168A1 (fr) Procede de production d'une dispersion solide medicinale
JP7862402B2 (ja) リジニラゾールの固形錠剤剤形
JP2021167306A (ja) 崩壊性粒子の製造方法
US20120003308A1 (en) Pharmaceutical Composition Comprising Aliskiren
JP2012520895A (ja) バルサルタンおよびアリスキレンの一定用量の組合せのガレヌス製剤
Di Pretoro DEVELOPMENT OF AN ORAL MULTIPLE-UNIT DOSAGE FORM CONTAINING A HIGH LOAD OF 5-AMINOSALICYLIC ACID
HK1226312A1 (en) A composition comprising s-[2-( [ [1-(2-ethylbutyl) -cyclohexyl] -carbonyl]amino)phenyl] 2-thylpropanethioate and croscarmellosesodium

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20110422

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PC1203 Withdrawal of no request for examination
WITN Application deemed withdrawn, e.g. because no request for examination was filed or no examination fee was paid