MX2014011289A - Procedimiento de elaboracion de microcapsulas entericas de alginato por gelacion ionica que contienen diclofenac o una de sus sales y composicion farmaceutica multiparticulada que las contiene. - Google Patents

Procedimiento de elaboracion de microcapsulas entericas de alginato por gelacion ionica que contienen diclofenac o una de sus sales y composicion farmaceutica multiparticulada que las contiene.

Info

Publication number
MX2014011289A
MX2014011289A MX2014011289A MX2014011289A MX2014011289A MX 2014011289 A MX2014011289 A MX 2014011289A MX 2014011289 A MX2014011289 A MX 2014011289A MX 2014011289 A MX2014011289 A MX 2014011289A MX 2014011289 A MX2014011289 A MX 2014011289A
Authority
MX
Mexico
Prior art keywords
salts
pharmaceutical composition
diclofenac
composition containing
via ionic
Prior art date
Application number
MX2014011289A
Other languages
English (en)
Other versions
MX354454B (es
Inventor
Mario Atilio Los
Original Assignee
Bagó S A Lab
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 Bagó S A Lab filed Critical Bagó S A Lab
Publication of MX2014011289A publication Critical patent/MX2014011289A/es
Publication of MX354454B publication Critical patent/MX354454B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

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

Abstract

Procedimiento de elaboración de microcápsulas entéricas sin recubrimiento, que contienen diclofenac o una de sus sales con actividad antiinflamatoria satisfactoria y baja agresividad gástrica; y una composición farmacéutica que las contiene. El procedimiento comprende a) preparar una mezcla en agua-etanol con una sal de alginato, agregar diclofenac o una de sus sales previamente disuelto con un tensioactivo y bicarbonato sódico; b) agregar la solución anterior sobre una solución con una sal de calcio; c) resuspender las microcápsulas obtenidas y aisladas en solución acuosa de la sal de alginato; y d) aislar, secar y tamizar por mallas de 1000 y 250 micrones las microcápsulas obtenidas; y seleccionar la fracción comprendida entre ambas mallas. La composición farmacéutica se puede presentar como cápsulas de uso oral, comprimidos, comprimidos masticables, o polvo para suspensión en agua.
MX2014011289A 2012-03-20 2012-03-20 Procedimiento de elaboracion de microcapsulas entericas de alginato por gelacion ionica que contienen diclofenac o una de sus sales y composicion farmaceutica multiparticulada que las contiene. MX354454B (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2012/054904 WO2013139377A1 (en) 2012-03-20 2012-03-20 Method for producing enteric alginate microcapsules via ionic gelation containing diclofenac or one of the salts thereof and multiparticled pharmaceutical composition containing them

Publications (2)

Publication Number Publication Date
MX2014011289A true MX2014011289A (es) 2015-02-17
MX354454B MX354454B (es) 2018-03-06

Family

ID=45855800

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2014011289A MX354454B (es) 2012-03-20 2012-03-20 Procedimiento de elaboracion de microcapsulas entericas de alginato por gelacion ionica que contienen diclofenac o una de sus sales y composicion farmaceutica multiparticulada que las contiene.

Country Status (14)

Country Link
US (2) US9668978B2 (es)
EP (1) EP2827843B1 (es)
CN (1) CN104244927B (es)
AR (1) AR090187A1 (es)
CA (1) CA2899664C (es)
CL (2) CL2014002465A1 (es)
ES (1) ES2584403T3 (es)
MX (1) MX354454B (es)
PH (1) PH12014501981B1 (es)
PL (1) PL2827843T3 (es)
SG (1) SG11201505320TA (es)
UA (1) UA112345C2 (es)
WO (1) WO2013139377A1 (es)
ZA (1) ZA201406886B (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2017012643A (es) * 2015-03-31 2018-08-01 Laboratorios Bago S A Procedimiento de elaboracion de pellets entericos que contienen un inhibidor de la bomba protonica y composiciones farmaceuticas multiparticuladas que los contienen.
WO2017084680A1 (en) * 2015-11-17 2017-05-26 Rontis Hellas S.A. Pharmaceutical composition containing a non-steroidal antiinflammatory drug and a proton pump inhibitor
CN109498571B (zh) * 2018-11-19 2019-09-10 朗天药业(湖北)有限公司 一种艾司奥美拉唑钠缓释微球及其制备方法
TW202126301A (zh) 2019-10-04 2021-07-16 愛爾蘭商席歐拉斯製藥有限公司 小兒懸浮調配物
CN112494450A (zh) * 2020-12-12 2021-03-16 海南海神同洲制药有限公司 化学药专用口腔崩解片包覆结构及其制备方法
CN115317464B (zh) * 2022-09-01 2023-08-08 苏州弘森药业股份有限公司 一种双氯芬酸钾微胶囊及其制备方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0520119A1 (de) 1991-06-17 1992-12-30 Spirig Ag Pharmazeutische Präparate Neue orale Diclofenaczubereitung
NZ253999A (en) 1992-08-05 1996-07-26 Faulding F H & Co Ltd Pelletised substained release medicament
ES2068762B1 (es) 1993-07-21 1995-12-01 Lipotec Sa Un nuevo preparado farmaceutico para mejorar la biodisponibilidad de drogas de dificil absorcion y procedimiento para su obtencion.
US6096344A (en) * 1995-07-28 2000-08-01 Advanced Polymer Systems, Inc. Bioerodible porous compositions
SE9600070D0 (sv) * 1996-01-08 1996-01-08 Astra Ab New oral pharmaceutical dosage forms
US7687542B2 (en) * 1996-05-17 2010-03-30 Kowa Pharmaeuticals America, Inc. Rapidly bioavailable tablet and capsule formulations of diclofenac
US6544556B1 (en) * 2000-09-11 2003-04-08 Andrx Corporation Pharmaceutical formulations containing a non-steroidal antiinflammatory drug and a proton pump inhibitor
AR044398A1 (es) 2004-05-19 2005-09-14 Bago Sa Labor Procedimiento para la elaboracion de microcapsulas recubiertas que contienen agentes farmacologicamente activos y composiciones farmaceuticas conteniendo dichas microcapsulas".

Also Published As

Publication number Publication date
PH12014501981A1 (en) 2014-11-24
MX354454B (es) 2018-03-06
PL2827843T3 (pl) 2016-11-30
EP2827843B1 (en) 2016-05-25
US9668978B2 (en) 2017-06-06
CA2899664A1 (en) 2013-09-26
ZA201406886B (en) 2015-06-24
ES2584403T3 (es) 2016-09-27
EP2827843A1 (en) 2015-01-28
US20150072000A1 (en) 2015-03-12
AR090187A1 (es) 2014-10-22
CN104244927A (zh) 2014-12-24
SG11201505320TA (en) 2015-08-28
CA2899664C (en) 2019-07-09
US9918941B2 (en) 2018-03-20
WO2013139377A1 (en) 2013-09-26
CL2014002465A1 (es) 2015-05-08
CN104244927B (zh) 2017-03-15
UA112345C2 (uk) 2016-08-25
PH12014501981B1 (en) 2014-11-24
US20170172934A1 (en) 2017-06-22
CL2016003348A1 (es) 2018-03-23

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