RU2011116122A - Галеновая композиция, включающая алискирен и способ ее получения экструзионной грануляцией из расплава - Google Patents
Галеновая композиция, включающая алискирен и способ ее получения экструзионной грануляцией из расплава Download PDFInfo
- Publication number
- RU2011116122A RU2011116122A RU2011116122/15A RU2011116122A RU2011116122A RU 2011116122 A RU2011116122 A RU 2011116122A RU 2011116122/15 A RU2011116122/15 A RU 2011116122/15A RU 2011116122 A RU2011116122 A RU 2011116122A RU 2011116122 A RU2011116122 A RU 2011116122A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- oral dosage
- solid oral
- aliskiren
- pharmaceutically acceptable
- Prior art date
Links
- UXOWGYHJODZGMF-QORCZRPOSA-N Aliskiren Chemical compound COCCCOC1=CC(C[C@@H](C[C@H](N)[C@@H](O)C[C@@H](C(C)C)C(=O)NCC(C)(C)C(N)=O)C(C)C)=CC=C1OC UXOWGYHJODZGMF-QORCZRPOSA-N 0.000 title claims abstract 20
- 229960004601 aliskiren Drugs 0.000 title claims abstract 20
- 238000001125 extrusion Methods 0.000 title claims abstract 8
- 238000007909 melt granulation Methods 0.000 title claims abstract 5
- 239000000203 mixture Substances 0.000 title claims abstract 5
- 238000004519 manufacturing process Methods 0.000 title claims 2
- 241000125974 Galene <Rhodophyta> Species 0.000 title 1
- 239000006186 oral dosage form Substances 0.000 claims abstract 22
- 239000007787 solid Substances 0.000 claims abstract 22
- 150000003839 salts Chemical class 0.000 claims abstract 21
- 239000004072 C09CA03 - Valsartan Substances 0.000 claims abstract 8
- 238000005469 granulation Methods 0.000 claims abstract 8
- 230000003179 granulation Effects 0.000 claims abstract 8
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims abstract 8
- 229960004699 valsartan Drugs 0.000 claims abstract 8
- 238000000034 method Methods 0.000 claims abstract 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract 7
- 229920000642 polymer Polymers 0.000 claims abstract 6
- 238000002844 melting Methods 0.000 claims abstract 4
- 230000008018 melting Effects 0.000 claims abstract 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000013543 active substance Substances 0.000 claims abstract 2
- 239000001913 cellulose Substances 0.000 claims abstract 2
- 229920002678 cellulose Polymers 0.000 claims abstract 2
- 239000002552 dosage form Substances 0.000 claims abstract 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract 2
- 239000000463 material Substances 0.000 claims 7
- 239000008187 granular material Substances 0.000 claims 5
- 238000002156 mixing Methods 0.000 claims 5
- 239000003826 tablet Substances 0.000 claims 5
- 206010002383 Angina Pectoris Diseases 0.000 claims 3
- 206010003210 Arteriosclerosis Diseases 0.000 claims 3
- 206010007558 Cardiac failure chronic Diseases 0.000 claims 3
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 3
- 208000007342 Diabetic Nephropathies Diseases 0.000 claims 3
- 208000032781 Diabetic cardiomyopathy Diseases 0.000 claims 3
- 206010019233 Headaches Diseases 0.000 claims 3
- 206010019280 Heart failures Diseases 0.000 claims 3
- 206010020772 Hypertension Diseases 0.000 claims 3
- 208000007177 Left Ventricular Hypertrophy Diseases 0.000 claims 3
- 208000018262 Peripheral vascular disease Diseases 0.000 claims 3
- 208000001647 Renal Insufficiency Diseases 0.000 claims 3
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 3
- 208000010877 cognitive disease Diseases 0.000 claims 3
- 208000033679 diabetic kidney disease Diseases 0.000 claims 3
- 231100000869 headache Toxicity 0.000 claims 3
- 201000006370 kidney failure Diseases 0.000 claims 3
- 208000010125 myocardial infarction Diseases 0.000 claims 3
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims 2
- 208000006011 Stroke Diseases 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- 206010022437 insomnia Diseases 0.000 claims 2
- 239000000155 melt Substances 0.000 claims 2
- 238000012216 screening Methods 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000007941 film coated tablet Substances 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
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 |
|---|---|
| RU2011116122A true RU2011116122A (ru) | 2012-10-27 |
Family
ID=41323516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2011116122/15A RU2011116122A (ru) | 2008-09-24 | 2009-09-23 | Галеновая композиция, включающая алискирен и способ ее получения экструзионной грануляцией из расплава |
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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR075880A1 (es) * | 2009-03-20 | 2011-05-04 | Novartis Ag | Formulaciones galenicas de compuestos organicos que comprenden alisquireno y valsartan. uso. metodo. |
| EP2382967A1 (de) * | 2010-04-21 | 2011-11-02 | ratiopharm GmbH | Aliskiren in Form einer festen Dispersion |
| TWI657090B (zh) * | 2013-03-01 | 2019-04-21 | 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 |
| CN114129569A (zh) * | 2020-09-04 | 2022-03-04 | 上海医药集团股份有限公司 | 一种含氮的饱和杂环化合物的应用 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20110121A1 (es) * | 2004-03-17 | 2011-02-28 | Novartis Ag | Composiciones farmaceuticas de aliskiren |
| 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 |
| PE20081157A1 (es) * | 2006-11-07 | 2008-09-26 | Novartis Ag | Forma cristalina de hemifumarato de alisquireno |
| 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 |
-
2009
- 2009-09-22 AR ARP090103629A patent/AR073651A1/es unknown
- 2009-09-23 AU AU2009296718A patent/AU2009296718A1/en not_active Abandoned
- 2009-09-23 TW TW098132133A patent/TW201016210A/zh unknown
- 2009-09-23 US US13/120,182 patent/US20110177166A1/en not_active Abandoned
- 2009-09-23 CN CN2009801373641A patent/CN102164584A/zh active Pending
- 2009-09-23 MX MX2011003077A patent/MX2011003077A/es not_active Application Discontinuation
- 2009-09-23 CA CA2736259A patent/CA2736259A1/en not_active Abandoned
- 2009-09-23 EP EP09792885A patent/EP2328562A1/en not_active Withdrawn
- 2009-09-23 PE PE2011000667A patent/PE20110925A1/es not_active Application Discontinuation
- 2009-09-23 KR KR1020117009209A patent/KR20110063684A/ko not_active Withdrawn
- 2009-09-23 RU RU2011116122/15A patent/RU2011116122A/ru not_active Application Discontinuation
- 2009-09-23 JP JP2011529177A patent/JP2012503665A/ja active Pending
- 2009-09-23 WO PCT/US2009/057993 patent/WO2010036686A1/en not_active Ceased
- 2009-09-23 BR BRPI0919077A patent/BRPI0919077A2/pt not_active IP Right Cessation
-
2011
- 2011-03-04 ZA ZA2011/01686A patent/ZA201101686B/en unknown
- 2011-03-23 CL CL2011000614A patent/CL2011000614A1/es unknown
- 2011-03-25 CO CO11036970A patent/CO6351712A2/es not_active Application Discontinuation
- 2011-04-20 MA MA33785A patent/MA32722B1/fr unknown
- 2011-04-21 EC EC2011010998A patent/ECSP11010998A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ECSP11010998A (es) | 2011-06-30 |
| ZA201101686B (en) | 2012-01-25 |
| TW201016210A (en) | 2010-05-01 |
| JP2012503665A (ja) | 2012-02-09 |
| MA32722B1 (fr) | 2011-10-02 |
| WO2010036686A1 (en) | 2010-04-01 |
| AR073651A1 (es) | 2010-11-24 |
| PE20110925A1 (es) | 2012-01-13 |
| KR20110063684A (ko) | 2011-06-13 |
| EP2328562A1 (en) | 2011-06-08 |
| US20110177166A1 (en) | 2011-07-21 |
| CA2736259A1 (en) | 2010-04-01 |
| BRPI0919077A2 (pt) | 2015-12-15 |
| MX2011003077A (es) | 2011-08-03 |
| CN102164584A (zh) | 2011-08-24 |
| CO6351712A2 (es) | 2011-12-20 |
| CL2011000614A1 (es) | 2011-11-04 |
| AU2009296718A1 (en) | 2010-04-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20140110 |