JP2012503020A - 有機化合物のガレヌス製剤 - Google Patents

有機化合物のガレヌス製剤 Download PDF

Info

Publication number
JP2012503020A
JP2012503020A JP2011528052A JP2011528052A JP2012503020A JP 2012503020 A JP2012503020 A JP 2012503020A JP 2011528052 A JP2011528052 A JP 2011528052A JP 2011528052 A JP2011528052 A JP 2011528052A JP 2012503020 A JP2012503020 A JP 2012503020A
Authority
JP
Japan
Prior art keywords
component
fixed dose
oral pharmaceutical
pharmaceutical formulation
dose oral
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Withdrawn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
JP2011528052A
Other languages
English (en)
Japanese (ja)
Other versions
JP2012503020A5 (enExample
Inventor
バラッツァ，ステファン
フランク ワグナー，ロバート
ビッパグンタ，スーダ
Original Assignee
ノバルティス アーゲー
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=42040192&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2012503020(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ノバルティス アーゲー filed Critical ノバルティス アーゲー
Publication of JP2012503020A publication Critical patent/JP2012503020A/ja
Publication of JP2012503020A5 publication Critical patent/JP2012503020A5/ja
Withdrawn legal-status Critical Current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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K31/435—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
    • 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
    • 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
    • A61K9/2072—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
    • 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
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (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)
  • Diabetes (AREA)
  • Hospice & Palliative Care (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Psychiatry (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2011528052A 2008-09-22 2009-09-22 有機化合物のガレヌス製剤 Withdrawn JP2012503020A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US9894508P 2008-09-22 2008-09-22
US61/098,945 2008-09-22
PCT/US2009/057750 WO2010033954A2 (en) 2008-09-22 2009-09-22 Galenical formulations of organic compounds

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2014252210A Division JP2015091830A (ja) 2008-09-22 2014-12-12 有機化合物のガレヌス製剤

Publications (2)

Publication Number Publication Date
JP2012503020A true JP2012503020A (ja) 2012-02-02
JP2012503020A5 JP2012503020A5 (enExample) 2014-05-01

Family

ID=42040192

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2011528052A Withdrawn JP2012503020A (ja) 2008-09-22 2009-09-22 有機化合物のガレヌス製剤
JP2014252210A Pending JP2015091830A (ja) 2008-09-22 2014-12-12 有機化合物のガレヌス製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2014252210A Pending JP2015091830A (ja) 2008-09-22 2014-12-12 有機化合物のガレヌス製剤

Country Status (21)

Country Link
US (1) US8613949B2 (enExample)
EP (1) EP2328564A2 (enExample)
JP (2) JP2012503020A (enExample)
KR (1) KR20110060942A (enExample)
CN (1) CN102159195A (enExample)
AR (1) AR073384A1 (enExample)
AU (1) AU2009292908B2 (enExample)
BR (1) BRPI0919350A2 (enExample)
CA (1) CA2736257A1 (enExample)
CL (1) CL2011000594A1 (enExample)
CO (1) CO6351711A2 (enExample)
EC (1) ECSP11010999A (enExample)
IL (1) IL211571A0 (enExample)
JO (1) JO3239B1 (enExample)
MA (1) MA32719B1 (enExample)
MX (1) MX2011002988A (enExample)
MY (1) MY153610A (enExample)
PE (1) PE20110293A1 (enExample)
RU (2) RU2011115712A (enExample)
TW (1) TW201016217A (enExample)
WO (1) WO2010033954A2 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2382969A1 (en) * 2010-04-30 2011-11-02 Sanovel Ilac Sanayi ve Ticaret A.S. Multicoated Aliskiren formulations
CN102247344A (zh) * 2011-05-30 2011-11-23 北京阜康仁生物制药科技有限公司 一种新型降血压组合物
CN103070863A (zh) * 2011-10-25 2013-05-01 河南省健康伟业生物医药研究股份有限公司 阿利吉仑和氨氯地平/左旋氨氯地平的口服固体制剂的制备新工艺
US20180338922A1 (en) * 2017-05-26 2018-11-29 Esperion Therapeutics, Inc. Fixed dose formulations

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006059217A1 (en) * 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Stable solid dosage forms of amlodipine besylate and processes for their preparation
WO2007022113A2 (en) * 2005-08-17 2007-02-22 Novartis Ag Solid dosage forms of valsartan and amlodipine and method of making the same
WO2008061622A1 (en) * 2006-11-07 2008-05-29 Novartis Ag Crystalline forms of aliskiren hemifumarate

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003032954A1 (en) 2001-10-17 2003-04-24 Dr. Reddy's Laboratories Ltd. Stabilized pharmaceutical formulations containing amlodipine maleate
HU226642B1 (en) 2001-12-17 2009-05-28 Egis Gyogyszergyar Nyilvanosan Amlodipine bezylate tablets having extended stability and process for producing the same
KR20100137026A (ko) * 2002-05-17 2010-12-29 노파르티스 아게 레닌 억제제, 칼슘 채널 차단제 및 이뇨제를 포함하는 약제학적 조성물
DE10223282B3 (de) 2002-05-24 2004-02-05 Orga Kartensysteme Gmbh Verfahren, Computerprogramm und Computersystem für einen prepaid Telekommunikationsdienst
FR2853904B1 (fr) 2003-04-15 2007-11-16 Air Liquide Procede de production de liquides hydrocarbones mettant en oeuvre un procede fischer-tropsch
RU2426532C2 (ru) * 2004-03-17 2011-08-20 Новартис Аг Применение органических соединений
MY144477A (en) * 2004-03-17 2011-09-30 Novartis Ag Galenic formulations of organic compounds
PL1814527T5 (pl) * 2004-11-05 2021-08-02 Boehringer Ingelheim International Gmbh Dwuwarstwowa tabletka zawierająca telmisartan i amlodypinę
US20060116435A1 (en) * 2004-12-01 2006-06-01 Housel Tyler L High strength polyurethane foam
PE20120542A1 (es) * 2006-06-27 2012-05-14 Novartis Ag Formas de dosificacion solidas de valsartan, amlodipina e hidroclorotiazida y metodo para elaborarlas
US20080161320A1 (en) 2006-09-11 2008-07-03 Xiong Cai Fused bicyclic pyrimidines as ptk inhibitors containing a zinc binding moiety

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006059217A1 (en) * 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Stable solid dosage forms of amlodipine besylate and processes for their preparation
WO2007022113A2 (en) * 2005-08-17 2007-02-22 Novartis Ag Solid dosage forms of valsartan and amlodipine and method of making the same
WO2008061622A1 (en) * 2006-11-07 2008-05-29 Novartis Ag Crystalline forms of aliskiren hemifumarate

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
JPN5012000856; ＡＮＯＮＹＭＯＵＳ: 'ＡＮ　ＡＳＳＥＳＳＭＥＮＴ　ＯＦ　ＬＯＮＧ　ＴＥＲＭ　ＳＡＦＥＴＹ　ＯＦ　ＴＨＥ　ＣＯＭＢＩＮＡＴＩＯＮ　ＯＦ　ＡＬＩＳＫＩＲＥＮ　／　ＡＭＬＯＤＩＰＩＮＥ　以下備考' ＣＬＩＮＩＣＡＬＴＲＩＡＬＳ．ＧＯＶ　［ＯＮＬＩＮＥ］ , 20061208 *
JPN6013062304; Ｉｎｔ．Ｊ．Ｃｌｉｎ．Ｐｒａｃｔ． ６０（１１）, 2006, ｐ．１３４３-１３５６ *

Also Published As

Publication number Publication date
JP2015091830A (ja) 2015-05-14
RU2014140552A (ru) 2015-06-20
TW201016217A (en) 2010-05-01
IL211571A0 (en) 2011-05-31
RU2011115712A (ru) 2012-10-27
WO2010033954A2 (en) 2010-03-25
US20110165240A1 (en) 2011-07-07
BRPI0919350A2 (pt) 2015-12-29
US8613949B2 (en) 2013-12-24
JO3239B1 (ar) 2018-03-08
CO6351711A2 (es) 2011-12-20
CN102159195A (zh) 2011-08-17
AU2009292908A1 (en) 2010-03-25
CL2011000594A1 (es) 2011-08-05
WO2010033954A3 (en) 2010-10-21
MY153610A (en) 2015-02-27
MX2011002988A (es) 2011-04-11
AU2009292908B2 (en) 2012-07-26
CA2736257A1 (en) 2010-03-25
EP2328564A2 (en) 2011-06-08
MA32719B1 (fr) 2011-10-02
AR073384A1 (es) 2010-11-03
ECSP11010999A (es) 2011-06-30
KR20110060942A (ko) 2011-06-08
PE20110293A1 (es) 2011-05-17

Similar Documents

Publication Publication Date Title
BR112012028035B1 (pt) formulação de liberação imediata
EP3791867A1 (en) Medicament-containing hollow particle
AU2008309058A1 (en) Galenical formulations of Aliskiren and Valsartan
KR20100059912A (ko) 알리스키렌 및 발사르탄의 제약 조합물
JP2015091830A (ja) 有機化合物のガレヌス製剤
US20110177166A1 (en) Galenical Formulation Comprising Aliskiren and Process for its Preparation by Melt Extrusion Granulation
TWI436760B (zh) 阿利克侖之蓋崙（ｇａｌｅｎｉｃａｌ）調配物
US20120003308A1 (en) Pharmaceutical Composition Comprising Aliskiren
TWI810656B (zh) 二氟甲基鳥氨酸及舒林酸（ｓｕｌｉｎｄａｃ），固定劑量組合調配物
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

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120924

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20120924

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20131217

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20140314

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20140812

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20141212

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20141219

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20150119

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20150116