AR072826A1 - Granulos con alto contenido de ibuprofeno sodico, su preparacion y uso en la preparacion de formas de administracion solidas no efervescentes. proceso. composicion. formulacion. - Google Patents

Granulos con alto contenido de ibuprofeno sodico, su preparacion y uso en la preparacion de formas de administracion solidas no efervescentes. proceso. composicion. formulacion.

Info

Publication number
AR072826A1
AR072826A1 ARP090102755A ARP090102755A AR072826A1 AR 072826 A1 AR072826 A1 AR 072826A1 AR P090102755 A ARP090102755 A AR P090102755A AR P090102755 A ARP090102755 A AR P090102755A AR 072826 A1 AR072826 A1 AR 072826A1
Authority
AR
Argentina
Prior art keywords
weight
granules
parts
sodium ibuprofen
dry
Prior art date
Application number
ARP090102755A
Other languages
English (en)
Original Assignee
Albemarle Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41259057&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR072826(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Albemarle Corp filed Critical Albemarle Corp
Publication of AR072826A1 publication Critical patent/AR072826A1/es

Links

Classifications

    • 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
    • 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
    • A61K9/1611—Inorganic 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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/14—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
    • A61K9/2009—Inorganic 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
    • A61K9/2004—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
    • 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)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicacion 1: Un proceso para preparar gránulos de ibuprofeno sodico dihidratado de alta fluidez y altamente dispersables, caracterizado porque comprende: (a) juntar en un granulador de alto corte (o alta velocidad) los siguientes componentes (i) al menos 80 partes en peso sobre una base seca de ibuprofeno sodico dihidratado, (ii) 1 a 4 partes en peso sobre una base seca de carbonato de sodio, (iii) 1 a 15 partes en peso sobre una base seca de polivinilpirrolidona no entrecruzada, y (iv) 8 a 12 partes en peso de agua en base al peso total de (i), (ii), (iii), y (iv) para formar una mezcla humeda; b) granular dicha mezcla humeda en dicho granulador de alto corte para formar gránulos humedos; c) secar los gránulos humedos para formar gránulos secos con un contenido de humedad en el rango de aproximadamente 12,5 a 15% en peso, a determinarse mediante la medicion de la pérdida de peso a 110sC; y d) eliminar mediante tamizado los gránulos secos que tengan un tamano de partícula superiora malla 16. Reivindicacion 4: Un proceso como el de cualquiera de las reivindicaciones 1-3. caracterizado porque la granulacion se realiza a una temperatura en el rango de aproximadamente 15 a aproximadamente 35sC, usando enfriamiento, si fuera necesario, para eliminar el exceso de calor generado durante la granulacion. Reivindicacion 9: Una composicion de gránulos altamente dispersables y con alta fluidez que tiene un alto contenido de ibuprofeno sodico dihidratado, caracterizada porque está formada por componentes en forma de polvo, dichos componentes comprenden (i) 80 a 98 partes en peso de ibuprofeno sodico dihidratado sobre una base seca, (ii) 1 a 4 partes en peso de carbonato de sodio anhidro sobre una base seca, y (iii) 1 a 15 partes en peso de polivinilpirrolidona no entrecruzada sobre una base seca. Reivindicacion 13: Una composicion de gránulos humedos que tiene un alto contenido de ibuprofeno sodico dihidratado, caracterizada porque está formada por componentes en forma de polvo, dichos componentes comprenden (i) ibuprofeno sodico dihidratado en una cantidad de al menos 80% en peso sobre una base seca, (ii) carbonato de sodio anhidro en una cantidad en el rango de 1 a 4% en peso sobre una base seca, (iii) polivinilpirrolidona no entrecruzada en una cantidad en el rango de 1 a 15% en peso sobre una base seca, y (iv) agua en una cantidad en el rango de 8 a 12% en peso en base al peso total de (i), (ii), (iii), y (iv). Reivindicacion 15: Una formulacion de ibuprofeno sodico dihidratado adaptada para la preparacion de formas de administracion solidas utilizando una prensa rotativa, caracterizada porque está formada por componentes que comprenden: a) aproximadamente 40 a aproximadamente 100% en peso de una composicion de gránulos como la de cualquiera de las reivindicaciones 9-11; b) 0 a aproximadamente 25% en peso de una celulosa microcristalina, hidrogeno fostato de calcio, o ambos; c) 0 a aproximadamente 8% en peso de crospovidona o croscarmelosa sodica; d) 0 a aproximadamente 0,5% en peso de sílice coloidal; e) 0 a aproximadamente 10% en peso almidon; y f) 0 a aproximadamente 2% en peso de ácido esteárico, estearato de magnesio, o ambos. Reivindicacion 20: Una forma de administracion solida caracterizada porque es formada a partir de una formulacion como la de cualquiera de las reivindicaciones 15-19. Reivindicacion 21: Una forma de administracion que consta de una cápsula dura caracterizada porque contiene una composicion de gránulos como la de cualquiera de las reivindicaciones 9-11.
ARP090102755A 2008-07-21 2009-07-20 Granulos con alto contenido de ibuprofeno sodico, su preparacion y uso en la preparacion de formas de administracion solidas no efervescentes. proceso. composicion. formulacion. AR072826A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US8244508P 2008-07-21 2008-07-21

Publications (1)

Publication Number Publication Date
AR072826A1 true AR072826A1 (es) 2010-09-22

Family

ID=41259057

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP090102755A AR072826A1 (es) 2008-07-21 2009-07-20 Granulos con alto contenido de ibuprofeno sodico, su preparacion y uso en la preparacion de formas de administracion solidas no efervescentes. proceso. composicion. formulacion.

Country Status (10)

Country Link
US (2) US9629806B2 (es)
EP (1) EP2309988B1 (es)
JP (1) JP5553830B2 (es)
CN (1) CN102099017A (es)
AR (1) AR072826A1 (es)
BR (1) BRPI0916344A2 (es)
CA (1) CA2730005C (es)
CL (1) CL2009001613A1 (es)
MX (1) MX337488B (es)
WO (1) WO2010011522A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010011522A1 (en) 2008-07-21 2010-01-28 Albemarle Corporation High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
US9629809B2 (en) 2008-07-21 2017-04-25 Si Group, Inc. High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
CA2894272A1 (en) * 2012-12-14 2014-06-19 Si Group, Inc. High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
WO2015016256A1 (ja) * 2013-07-30 2015-02-05 ライオン株式会社 錠剤

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Also Published As

Publication number Publication date
CA2730005A1 (en) 2010-01-28
WO2010011522A1 (en) 2010-01-28
US10391072B2 (en) 2019-08-27
US20170181992A1 (en) 2017-06-29
JP2011528712A (ja) 2011-11-24
EP2309988B1 (en) 2015-11-25
CA2730005C (en) 2017-06-13
US9629806B2 (en) 2017-04-25
EP2309988A1 (en) 2011-04-20
US20110182984A1 (en) 2011-07-28
MX337488B (es) 2016-03-08
BRPI0916344A2 (pt) 2020-07-21
CL2009001613A1 (es) 2010-07-19
CN102099017A (zh) 2011-06-15
JP5553830B2 (ja) 2014-07-16
MX2011000709A (es) 2011-02-24

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