CO6160302A2 - Formulaciones farmaceuticas - Google Patents

Formulaciones farmaceuticas

Info

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
Application number
CO09036680A
Other languages
English (en)
Inventor
Yi Gao
R Ju Tzuchi
Hauiliang Wu
Nicole Nguyen
Dennis Lee
Original Assignee
Abbott Lab
Fournier Lab Ireland Ltd
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 Abbott Lab, Fournier Lab Ireland Ltd filed Critical Abbott Lab
Publication of CO6160302A2 publication Critical patent/CO6160302A2/es

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
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Diabetes (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.
CO09036680A 2006-10-12 2009-04-13 Formulaciones farmaceuticas CO6160302A2 (es)

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2722093C (en) * 2008-05-30 2015-04-28 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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1829541A1 (en) * 2002-12-17 2007-09-05 Abbott GmbH & Co. KG Formulation comprising fenofibric acid or a physiologically acceptable salt thereof
US7259186B2 (en) * 2002-12-17 2007-08-21 Abbott Laboratories Salts of fenofibric acid and pharmaceutical formulations thereof
MXPA05005736A (es) * 2002-12-17 2005-08-16 Abbott Gmbh & Co Kg Formulacion que comprende acido fenofibrico, una sal fisiologicamente aceptable o derivado del mismo.
EP1559419A1 (en) * 2004-01-23 2005-08-03 Fournier Laboratories Ireland Limited Pharmaceutical formulations comprising metformin and a fibrate, and processes for their obtention
EP2074992B1 (en) * 2005-04-08 2015-05-20 Abbott Laboratories Oral pharmaceutical formulations comprising salts of fenofibric acid

Also Published As

Publication number Publication date
ZA200902488B (en) 2010-10-27
IL198160A0 (en) 2009-12-24
SG175570A1 (en) 2011-11-28
JP2010506855A (ja) 2010-03-04
AU2007307641A1 (en) 2008-04-17
ECSP099251A (es) 2009-06-30
EA200900531A1 (ru) 2009-12-30
KR20090119959A (ko) 2009-11-23
WO2008046052A1 (en) 2008-04-17
MX2009003815A (es) 2009-09-07
CN101677981A (zh) 2010-03-24
EP2081563A1 (en) 2009-07-29
CA2672686A1 (en) 2008-04-17

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