ES2525648T3 - Formulaciones galénicas que comprenden Aliskiren - Google Patents
Formulaciones galénicas que comprenden Aliskiren Download PDFInfo
- Publication number
- ES2525648T3 ES2525648T3 ES10702092.7T ES10702092T ES2525648T3 ES 2525648 T3 ES2525648 T3 ES 2525648T3 ES 10702092 T ES10702092 T ES 10702092T ES 2525648 T3 ES2525648 T3 ES 2525648T3
- Authority
- ES
- Spain
- Prior art keywords
- aliskiren
- minitableta
- coating
- core
- galenic formulations
- 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.)
- Active
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
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
-
- 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
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Hospice & Palliative Care (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Vascular Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Una forma de dosificación unitaria sólida para administración oral en Ia forma de una minitableta que tiene un núcleo y un recubrimiento externo, en donde: - el núcleo comprende una cantidad terapéuticamente efectiva de Aliskiren, o una sal farmacéuticamente aceptable del mismo, y - el recubrimiento exterior es en forma de una película de revestimiento que comprende un material de enmascaramiento del sabor seleccionado de entre poliacrilatos, y/o un componente de recubrimiento de liberación modificada seleccionado a partir de derivados de celulosa, copolímeros acrílicos, y mezclas de los mismos, en donde dicha minitableta tiene un tamaño de entre 1 mm y 4 mm, y en donde dicha minitableta contiene entre aproximadamente 2 mg y aproximadamente 4 mg de Aliskiren.
Description
E10702092
28-11-2014
Tabla 3 Relación de la media geométrica y 90% de CI de SSP de la Variante A
- Variante A / Referencia
- Pt estimada
- 90% de CI
- Cmáx (ng/mL)
- 1,499 1,181 -1,901
- AUC0-t (ng.h/mL)
- 1,164 1,004 -1,350
- AUC0-inf (ng.h/mL)
- 1,168 1,010 -1,350
Tabla 4 Valores de la media geométrica de Cmax y AUC de SSP de la solución de SPP100 de 75 mg
- Dos cápsulas de SPP de 37,5 mg (referencia)
- Solución de SPP de 75 mg
- Media geométrica
- Media geométrica
- Cmax (ng/mL)
- 28 15
- AUC0-inf (ng.h/mL)
- 225 158
La biodisponibilidad de la formulación de acuerdo con la presente invención tenía una biodisponibilidad comparable a la tableta de Aliskiren comercializada (referencia), así como la formulación de cápsula, y una biodisponibilidad mucho mejor comparada con la formulación líquida.
Tabla 5 Farmacocinéticas en pacientes pediátricos
- Grupo de edad (años)
- Dosis Día Cmáx (ng/mL) Tmáx* (h) AUCtau (ng.h/mL) AI T1/2 (h)
- 12 -17
- Media 136 1,0 391 - --
- DE
- 1 133 0,5, 3,0 264 - -
- % de CV
- 97 68 - -
- 2 mg/kg
- Media
- 279 1,0 846 2,1 40
- DE
- 8 358 0,5, 3,0 804 1,3 5,0
- % de CV
- 128 95 62 13
- Media
- 424 1,8 1801 - --
- DE
- 1 189 0,5, 4,0 811 - -
- % de CV
- 44 45 - -
20
E10702092
28-11-2014
(continuación)
- Grupo de edad (años)
- Dosis Día Cmáx (ng/mL) Tmáx* (h) AUCtau (ng.h/mL) AI T1/2 (h)
- 12-17
- 6 mg/kg
- Media
- 486 2,0 2089 1,3 42
- DE
- 8 301 0,5, 3,0 1003 0,6 6,5
- % de CV
- 62 48 50 16
- Media
- 39 0,5 149 - --
- DE
- 1 21 0,5, 3,0 74 - -
- % de CV
- 53 49 - -
- 2 mg/kg
- 6 -11
- Media 48 0,5 240 1,5 40
- DE
- 8 39 0,5, 1,0 183 0,5 6,6
- % de CV
- 81 76 31 16
- Media
- 323 1,3 1841 - --
- DE
- 1 55 1,0, 1,5 1168 - -
- % de CV
- 17 63 - -
- 6 mg/kg
- Media
- 259 0,8 956 0,5 36
- DE
- 8 274 0,5, 1,0 568 0,0 0,7
- % de CV
- 106 59 0 2
- * Mediana (min, máx.)
21
Claims (1)
-
imagen1 imagen2
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09151496 | 2009-01-28 | ||
EP09151496 | 2009-01-28 | ||
PCT/EP2010/050886 WO2010086312A1 (en) | 2009-01-28 | 2010-01-27 | Galenic formulations of organic compounds |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2525648T3 true ES2525648T3 (es) | 2014-12-26 |
Family
ID=40770648
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES10702092.7T Active ES2525648T3 (es) | 2009-01-28 | 2010-01-27 | Formulaciones galénicas que comprenden Aliskiren |
Country Status (28)
Country | Link |
---|---|
US (1) | US20110287100A1 (es) |
EP (1) | EP2391345B1 (es) |
JP (1) | JP2012516299A (es) |
KR (1) | KR20110117199A (es) |
CN (1) | CN102300558A (es) |
AR (1) | AR075179A1 (es) |
AU (1) | AU2010209787B2 (es) |
BR (1) | BRPI1007452A2 (es) |
CA (1) | CA2749531A1 (es) |
CL (1) | CL2011001817A1 (es) |
CO (1) | CO6400184A2 (es) |
EC (1) | ECSP11011289A (es) |
ES (1) | ES2525648T3 (es) |
HK (1) | HK1161125A1 (es) |
IL (1) | IL213918A0 (es) |
MA (1) | MA33060B1 (es) |
MX (1) | MX2011007779A (es) |
MY (1) | MY153852A (es) |
NZ (1) | NZ593622A (es) |
PE (1) | PE20110943A1 (es) |
PL (1) | PL2391345T3 (es) |
PT (1) | PT2391345E (es) |
RU (1) | RU2535090C2 (es) |
SG (1) | SG172226A1 (es) |
TN (1) | TN2011000307A1 (es) |
TW (1) | TWI468191B (es) |
WO (1) | WO2010086312A1 (es) |
ZA (1) | ZA201104489B (es) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP5822758B2 (ja) * | 2011-03-02 | 2015-11-24 | 第一三共ヘルスケア株式会社 | 速溶性防湿フィルムコーティング製剤及びその製造方法 |
EP2596802A1 (en) * | 2011-11-23 | 2013-05-29 | PLS-Design GmbH | Pharmaceutical composition for treatment of allergic reactions |
AU2017215530B2 (en) * | 2016-02-03 | 2019-09-12 | Novartis Ag | Galenic formulations of organic compounds |
US20210308054A1 (en) * | 2018-08-10 | 2021-10-07 | Kissei Pharmaceutical Co., Ltd. | Sucroferric oxyhydroxide-containing granules and pharmaceutical composition |
CA3129395A1 (en) | 2019-02-22 | 2020-08-27 | Catalent U.K. Swindon Zydis Limited | Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen |
AU2020225818A1 (en) * | 2019-02-22 | 2021-10-14 | Catalent U.K. Swindon Zydis Limited | Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension |
WO2021011538A1 (en) * | 2019-07-15 | 2021-01-21 | R.P. Scherer Technologies, Llc | Capsule dosage forms, methods of preparation and methods of use thereof |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MY119161A (en) | 1994-04-18 | 2005-04-30 | Novartis Ag | Delta-amino-gamma-hydroxy-omega-aryl-alkanoic acid amides with enzyme especially renin inhibiting activities |
DE19842753A1 (de) * | 1998-09-18 | 2000-03-23 | Bayer Ag | Agitationsunabhängige pharmazeutische Retardzubereitungen und Verfahren zu ihrer Herstellung |
US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
AR034813A1 (es) * | 2001-07-20 | 2004-03-17 | Novartis Ag | Composiciones farmaceuticas y uso de las mismas |
US20040266743A1 (en) * | 2003-05-09 | 2004-12-30 | Pharmacia Corporation | Combination of an aldosterone receptor antagonist and a renin inhibitor |
PE20142101A1 (es) * | 2004-03-17 | 2014-12-27 | Novartis Ag | Composiciones farmaceuticas de aliskiren |
WO2005105054A1 (en) * | 2004-04-15 | 2005-11-10 | Dr. Reddy's Laboratories Ltd. | Dosage form having polymorphic stability |
CA2580862A1 (en) * | 2004-10-08 | 2006-04-20 | Novartis Ag | Use of renin inhibitors for the prevention or treatment of diastolic dysfunction or diastolic heart failure |
AU2008309059A1 (en) * | 2007-09-28 | 2009-04-09 | Novartis Ag | Pharmaceutical combination of Aliskiren and Valsartan |
-
2010
- 2010-01-27 ES ES10702092.7T patent/ES2525648T3/es active Active
- 2010-01-27 NZ NZ593622A patent/NZ593622A/en not_active IP Right Cessation
- 2010-01-27 EP EP10702092.7A patent/EP2391345B1/en not_active Not-in-force
- 2010-01-27 US US13/145,454 patent/US20110287100A1/en not_active Abandoned
- 2010-01-27 AR ARP100100193A patent/AR075179A1/es unknown
- 2010-01-27 PT PT107020927T patent/PT2391345E/pt unknown
- 2010-01-27 CN CN2010800057033A patent/CN102300558A/zh active Pending
- 2010-01-27 PE PE2011001391A patent/PE20110943A1/es not_active Application Discontinuation
- 2010-01-27 WO PCT/EP2010/050886 patent/WO2010086312A1/en active Application Filing
- 2010-01-27 PL PL10702092T patent/PL2391345T3/pl unknown
- 2010-01-27 TW TW99102290A patent/TWI468191B/zh not_active IP Right Cessation
- 2010-01-27 CA CA2749531A patent/CA2749531A1/en not_active Abandoned
- 2010-01-27 RU RU2011135417/15A patent/RU2535090C2/ru not_active IP Right Cessation
- 2010-01-27 JP JP2011546822A patent/JP2012516299A/ja active Pending
- 2010-01-27 MX MX2011007779A patent/MX2011007779A/es not_active Application Discontinuation
- 2010-01-27 SG SG2011044450A patent/SG172226A1/en unknown
- 2010-01-27 BR BRPI1007452A patent/BRPI1007452A2/pt not_active IP Right Cessation
- 2010-01-27 AU AU2010209787A patent/AU2010209787B2/en not_active Ceased
- 2010-01-27 MA MA34114A patent/MA33060B1/fr unknown
- 2010-01-27 MY MYPI2011003186A patent/MY153852A/en unknown
- 2010-01-27 KR KR1020117019809A patent/KR20110117199A/ko not_active Application Discontinuation
-
2011
- 2011-06-16 TN TN2011000307A patent/TN2011000307A1/fr unknown
- 2011-06-17 ZA ZA2011/04489A patent/ZA201104489B/en unknown
- 2011-07-04 IL IL213918A patent/IL213918A0/en unknown
- 2011-07-27 CL CL2011001817A patent/CL2011001817A1/es unknown
- 2011-07-28 CO CO11095153A patent/CO6400184A2/es not_active Application Discontinuation
- 2011-08-26 EC EC2011011289A patent/ECSP11011289A/es unknown
-
2012
- 2012-02-27 HK HK12101945.0A patent/HK1161125A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
EP2391345B1 (en) | 2014-09-03 |
TN2011000307A1 (en) | 2012-12-17 |
PT2391345E (pt) | 2014-12-03 |
CL2011001817A1 (es) | 2012-01-13 |
CN102300558A (zh) | 2011-12-28 |
CA2749531A1 (en) | 2010-08-05 |
RU2535090C2 (ru) | 2014-12-10 |
TWI468191B (zh) | 2015-01-11 |
SG172226A1 (en) | 2011-07-28 |
BRPI1007452A2 (pt) | 2016-02-16 |
PL2391345T3 (pl) | 2015-03-31 |
AU2010209787A1 (en) | 2011-07-14 |
ZA201104489B (en) | 2012-02-29 |
TW201038300A (en) | 2010-11-01 |
ECSP11011289A (es) | 2011-09-30 |
JP2012516299A (ja) | 2012-07-19 |
US20110287100A1 (en) | 2011-11-24 |
MY153852A (en) | 2015-03-31 |
AU2010209787B2 (en) | 2013-06-06 |
NZ593622A (en) | 2013-12-20 |
MX2011007779A (es) | 2011-08-12 |
HK1161125A1 (en) | 2012-08-24 |
AR075179A1 (es) | 2011-03-16 |
MA33060B1 (fr) | 2012-02-01 |
WO2010086312A1 (en) | 2010-08-05 |
EP2391345A1 (en) | 2011-12-07 |
KR20110117199A (ko) | 2011-10-26 |
CO6400184A2 (es) | 2012-03-15 |
RU2011135417A (ru) | 2013-03-10 |
IL213918A0 (en) | 2011-07-31 |
PE20110943A1 (es) | 2012-01-22 |
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