CO6160302A2 - Formulaciones farmaceuticas - Google Patents
Formulaciones farmaceuticasInfo
- Publication number
- CO6160302A2 CO6160302A2 CO09036680A CO09036680A CO6160302A2 CO 6160302 A2 CO6160302 A2 CO 6160302A2 CO 09036680 A CO09036680 A CO 09036680A CO 09036680 A CO09036680 A CO 09036680A CO 6160302 A2 CO6160302 A2 CO 6160302A2
- Authority
- CO
- Colombia
- Prior art keywords
- salt
- acid
- temperature
- potassium phosphate
- phosphate buffer
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 150000003839 salts Chemical class 0.000 abstract 6
- MQOBSOSZFYZQOK-UHFFFAOYSA-N fenofibric acid Chemical compound C1=CC(OC(C)(C)C(O)=O)=CC=C1C(=O)C1=CC=C(Cl)C=C1 MQOBSOSZFYZQOK-UHFFFAOYSA-N 0.000 abstract 4
- 229960000701 fenofibric acid Drugs 0.000 abstract 4
- 238000000034 method Methods 0.000 abstract 4
- 239000008057 potassium phosphate buffer Substances 0.000 abstract 4
- 239000002253 acid Substances 0.000 abstract 3
- 239000000872 buffer Substances 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 239000012738 dissolution medium Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 229920001477 hydrophilic polymer Polymers 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 239000001509 sodium citrate Substances 0.000 abstract 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 abstract 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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; 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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/28—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
1.- Un proceso para seleccionar una formulación robusta de sal de ácido fenofíbrico que comprende estos pasos: (a) Creación de una forma de dosis oral con liberación modificada que comprenda: (i) una sal de ácido fenofíbrico; (ii) un polímero hidrofílico; y (iii) opcionalmente, uno o varios excipientes farmacéuticamente aceptables; y (b) Elección de una forma de dosis del paso (a) que por lo menos tenga una de las propiedades siguientes: (i) La velocidad de liberación de ácido fenofíbrico de la forma de dosis es considerablemente independiente de la fuerza iónica de los medios de disolución; (ii) La diferencia entre la cantidad de sal de ácido fenofíbrico disuelta en 0.5, 1, 2, 4, 6 u 8 horas en (A) 900 ml de tampón fosfato de potasio 0.05 M a un pH de 6.0 y una temperatura de 37° C y (B) 900 ml de tampón fosfato de potasio 0.3 M a un pH de 6.0 y una temperatura de 37° C, no es superior a cerca del 25 %; o (iii) La diferencia entre tiempos de desintegración en (A) 900 ml de tampón fosfato de potasio 0.05 M a un pH de 6.0 y una temperatura de 37° C y (B) 900 ml de tampón fosfato de potasio 0.3 M a un pH de 6.0 y una temperatura de 37° C, es inferior a cerca de 475 minutos. 2.- El proceso de la reivindicación 1, en donde la sal de ácido fenofíbrico tiene una solubilidad acuosa superior a cerca de 16.1 mg/ml. 3.- El proceso de la reivindicación 1, en donde la sal de ácido fenofíbrico tiene una solubilidad acuosa superior a cerca de 19.0 mg/ml. 4.- El proceso de la reivindicación 1, en donde la sal de ácido fenofíbrico tiene una velocidad de disolución intrínseca superior a cerca de 7.09 mg/min/cm2 en 400 ml de tampón citrato de sodio 50 mM a un pH de 6.8.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US82925506P | 2006-10-12 | 2006-10-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6160302A2 true CO6160302A2 (es) | 2010-05-20 |
Family
ID=38961056
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO09036680A CO6160302A2 (es) | 2006-10-12 | 2009-04-13 | Formulaciones farmaceuticas |
Country Status (14)
| Country | Link |
|---|---|
| EP (1) | EP2081563A1 (es) |
| JP (1) | JP2010506855A (es) |
| KR (1) | KR20090119959A (es) |
| CN (1) | CN101677981A (es) |
| AU (1) | AU2007307641A1 (es) |
| CA (1) | CA2672686A1 (es) |
| CO (1) | CO6160302A2 (es) |
| EA (1) | EA200900531A1 (es) |
| EC (1) | ECSP099251A (es) |
| IL (1) | IL198160A0 (es) |
| MX (1) | MX2009003815A (es) |
| SG (1) | SG175570A1 (es) |
| WO (1) | WO2008046052A1 (es) |
| ZA (1) | ZA200902488B (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8435564B2 (en) * | 2008-05-30 | 2013-05-07 | Ucb Pharma, S.A. | Pharmaceutical compositions comprising brivaracetam |
| CN102304103A (zh) * | 2011-06-03 | 2012-01-04 | 郑州泰基鸿诺药物科技有限公司 | 一种非诺贝特酸盐、制备方法、药物组合物及应用 |
| CN102659570B (zh) * | 2012-05-17 | 2014-05-28 | 安润医药科技（苏州）有限公司 | 二氟非诺贝特酸及其在药学上可接受的盐，以及它们的制备方法和应用 |
| FR3050112B1 (fr) * | 2016-04-15 | 2020-09-04 | Soc Civ Immobiliere Gecinq | Utilisation de l'acide fenofibrique dans le traitement des maladies hepatiques |
| CN107496397A (zh) * | 2016-06-14 | 2017-12-22 | 重庆安格龙翔医药科技有限公司 | 一种二甲双胍与非诺贝酸的复合物及其制剂 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1832285A1 (en) * | 2002-12-17 | 2007-09-12 | Abbott GmbH & Co. KG | Formulation comprising fenofibric acid or a physiologically acceptable salt thereof |
| DE60313359T2 (de) * | 2002-12-17 | 2008-01-03 | Abbott Gmbh & Co. Kg | Fenofibratsäure enthaltende pharmazeutische zusammensetzung und deren physiologisch verträgliche salze und derivate |
| US7259186B2 (en) * | 2002-12-17 | 2007-08-21 | Abbott Laboratories | Salts of fenofibric acid and pharmaceutical formulations thereof |
| EP1559419A1 (en) * | 2004-01-23 | 2005-08-03 | Fournier Laboratories Ireland Limited | Pharmaceutical formulations comprising metformin and a fibrate, and processes for their obtention |
| CN102172347A (zh) * | 2005-04-08 | 2011-09-07 | 雅培制药有限公司 | 包含非诺贝酸和/或其盐的口服药物制剂 |
-
2007
- 2007-10-12 CA CA002672686A patent/CA2672686A1/en not_active Abandoned
- 2007-10-12 AU AU2007307641A patent/AU2007307641A1/en not_active Abandoned
- 2007-10-12 EA EA200900531A patent/EA200900531A1/ru unknown
- 2007-10-12 MX MX2009003815A patent/MX2009003815A/es not_active Application Discontinuation
- 2007-10-12 WO PCT/US2007/081267 patent/WO2008046052A1/en active Application Filing
- 2007-10-12 KR KR1020097007466A patent/KR20090119959A/ko not_active Application Discontinuation
- 2007-10-12 CN CN200780045748A patent/CN101677981A/zh active Pending
- 2007-10-12 JP JP2009532610A patent/JP2010506855A/ja active Pending
- 2007-10-12 ZA ZA200902488A patent/ZA200902488B/xx unknown
- 2007-10-12 EP EP07844238A patent/EP2081563A1/en not_active Withdrawn
- 2007-10-12 SG SG2011070588A patent/SG175570A1/en unknown
-
2009
- 2009-04-13 EC EC2009009251A patent/ECSP099251A/es unknown
- 2009-04-13 CO CO09036680A patent/CO6160302A2/es unknown
- 2009-04-16 IL IL198160A patent/IL198160A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN101677981A (zh) | 2010-03-24 |
| AU2007307641A1 (en) | 2008-04-17 |
| KR20090119959A (ko) | 2009-11-23 |
| MX2009003815A (es) | 2009-09-07 |
| IL198160A0 (en) | 2009-12-24 |
| EA200900531A1 (ru) | 2009-12-30 |
| EP2081563A1 (en) | 2009-07-29 |
| ZA200902488B (en) | 2010-10-27 |
| SG175570A1 (en) | 2011-11-28 |
| JP2010506855A (ja) | 2010-03-04 |
| ECSP099251A (es) | 2009-06-30 |
| CA2672686A1 (en) | 2008-04-17 |
| WO2008046052A1 (en) | 2008-04-17 |
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