CO6341546A2 - Proceso para la preparacion de una formulacion de polvo intermedia y una forma de dosificacion solida final bajo el uso de un paso de congelacion por rocio - Google Patents

Proceso para la preparacion de una formulacion de polvo intermedia y una forma de dosificacion solida final bajo el uso de un paso de congelacion por rocio

Info

Publication number
CO6341546A2
CO6341546A2 CO10143084A CO10143084A CO6341546A2 CO 6341546 A2 CO6341546 A2 CO 6341546A2 CO 10143084 A CO10143084 A CO 10143084A CO 10143084 A CO10143084 A CO 10143084A CO 6341546 A2 CO6341546 A2 CO 6341546A2
Authority
CO
Colombia
Prior art keywords
range
component
temperature
melting
mixture
Prior art date
Application number
CO10143084A
Other languages
English (en)
Inventor
Anne Faure
Jody Voorspoels
Filip Rene Irena Kiekens
Roel Jos M Mertens
Original Assignee
Gruenenthal Chemie
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 Gruenenthal Chemie filed Critical Gruenenthal Chemie
Publication of CO6341546A2 publication Critical patent/CO6341546A2/es

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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
    • 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
    • A61K9/145—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 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
    • A61K9/14—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
    • A61K9/14—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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se refiere a un proceso para preparar un polvo que comprende los pasos de proporcionar al menos un primer componente que esta en forma liquida a temperatura ambiente, que tiene en particular una consistencia líquida viscosa, como por ejemplo un aceite; o que tiene una consistencia cerosa a temperatura ambiente, en particular un )componente el cual es un sólido o semisólido a temperatura ambiente y que tiene un inicio de fusión en el intervalo de temperatura de 15°C a 40°C, proporcionando al menos un segundo componente que tiene una temperatura de fusión o intervalo de fusión en el intervalo de aproximadamente la temperatura ambiente hasta por debajo de la temperatura de degradación del primer componente, en particular en el intervalo de por encima de la temperatura ambiente hasta 120°C, de manera más particular en el intervalo de > 40°C hasta 120°C, de manera aún más particular en el intervalo de 50°C hasta 120°C, de manera aún más particular en el intervalo de 55°C hasta 120°C, formar una mezcla líquida homogénea que comprende al menos un primer al menos un segundo componente agitando y componente y calentando la mezcla a o manteniendo la mezcla a una temperatura en el intervalo encima de la temperatura de fusión o el intervalo de fusión del segundo componente y debajo de la temperatura de degradación del primer componente, en particular en el intervalo por encima de la temperatura de fusión o intervalo de fusión del segundo componente hasta 120°C, transferir la mezcla líquida a al menos una unidad de congelación por rocío por al menos una unidad de transferencia, la cual está adaptada para mantener la mezcla en su forma líquida durante su transferencia, congelar por rocío la mezcla, y aislar el polvo obtenido tras la congelación por rocío. Además, la presente invención se refiere a un proceso para la preparación de una forma de dosificación sólida que comprende el polvo resultante del proceso anterior.
CO10143084A 2008-05-09 2010-11-16 Proceso para la preparacion de una formulacion de polvo intermedia y una forma de dosificacion solida final bajo el uso de un paso de congelacion por rocio CO6341546A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08008749 2008-05-09

Publications (1)

Publication Number Publication Date
CO6341546A2 true CO6341546A2 (es) 2011-11-21

Family

ID=40050124

Family Applications (1)

Application Number Title Priority Date Filing Date
CO10143084A CO6341546A2 (es) 2008-05-09 2010-11-16 Proceso para la preparacion de una formulacion de polvo intermedia y una forma de dosificacion solida final bajo el uso de un paso de congelacion por rocio

Country Status (26)

Country Link
US (1) US9161917B2 (es)
EP (1) EP2273983B1 (es)
JP (1) JP5674641B2 (es)
KR (1) KR101690094B1 (es)
CN (1) CN102123701B (es)
AU (1) AU2009243681B2 (es)
BR (1) BRPI0912014A2 (es)
CA (1) CA2723438C (es)
CO (1) CO6341546A2 (es)
CY (1) CY1118085T1 (es)
DK (1) DK2273983T3 (es)
EC (1) ECSP10010613A (es)
ES (1) ES2599031T3 (es)
HR (1) HRP20161307T1 (es)
HU (1) HUE030803T2 (es)
IL (1) IL209044A (es)
LT (1) LT2273983T (es)
MX (1) MX2010012039A (es)
NZ (1) NZ588863A (es)
PL (1) PL2273983T3 (es)
PT (1) PT2273983T (es)
RU (1) RU2508092C2 (es)
SI (1) SI2273983T1 (es)
TW (1) TWI524904B (es)
WO (1) WO2009135680A1 (es)
ZA (1) ZA201007818B (es)

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WO2009135680A1 (en) 2009-11-12
CA2723438A1 (en) 2009-11-12
RU2508092C2 (ru) 2014-02-27
PL2273983T3 (pl) 2017-01-31
KR101690094B1 (ko) 2016-12-27
EP2273983A1 (en) 2011-01-19
US20110082214A1 (en) 2011-04-07
LT2273983T (lt) 2016-10-25
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JP5674641B2 (ja) 2015-02-25
ES2599031T3 (es) 2017-01-31
DK2273983T3 (en) 2016-09-19
MX2010012039A (es) 2010-11-30
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CN102123701B (zh) 2013-03-27
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RU2010149992A (ru) 2012-06-20
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US9161917B2 (en) 2015-10-20
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EP2273983B1 (en) 2016-07-20
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