AR036797A1 - Un metodo para preparar una composicion farmaceutica que comprende acido 5-aminosalicilico para utilizar en el tratamiento de colitis ulcerosa y enfermedades de crohn - Google Patents

Un metodo para preparar una composicion farmaceutica que comprende acido 5-aminosalicilico para utilizar en el tratamiento de colitis ulcerosa y enfermedades de crohn

Info

Publication number
AR036797A1
AR036797A1 ARP020103823A ARP020103823A AR036797A1 AR 036797 A1 AR036797 A1 AR 036797A1 AR P020103823 A ARP020103823 A AR P020103823A AR P020103823 A ARP020103823 A AR P020103823A AR 036797 A1 AR036797 A1 AR 036797A1
Authority
AR
Argentina
Prior art keywords
pharmaceutically acceptable
solvent
granules
treatment
binder
Prior art date
Application number
ARP020103823A
Other languages
English (en)
Inventor
Jepsen Svenn Kluver
Original Assignee
Ferring Bv
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
Priority claimed from PCT/DK2001/000677 external-priority patent/WO2003032952A1/en
Application filed by Ferring Bv filed Critical Ferring Bv
Publication of AR036797A1 publication Critical patent/AR036797A1/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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (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

Reivindicación 1: Un método para la preparación de gránulos que comprende ácido 5-aminosalicílico (5-ASA) o una sal o éster farmacéuticamente aceptable del mismo y un aglutinante farmacéuticamente aceptable que comprende: (a) disolver el aglutinante farmacéuticamente aceptable en un solvente, (b) mezclar el aglutinante disuelto con 5-ASA para formar una masa húmeda, (c) extruir la masa húmeda en gránulos, y (d) secar los gránulos al evaporarse el solvente, caracterizado porque el solvente está comprendido por al menos el 50% p/p de agua. Reivindicación 18: Un método para la preparación de comprimidos de liberación prolongada, útil para el tratamiento de colitis ulcerosa o enfermedad de Crohn, que comprende los pasos de (a) mezclar ácido 5-aminosalicílico o una sal o éster farmacéuticamente aceptable del mismo y un aglutinante farmacéuticamente aceptable en un solvente que comprende al menos el 50% p/p de agua, y extruir luego la mezcla producida para proveer gránulos al evaporarse el solvente, (b) aplicar sobre dichos gránulos una composición de recubrimiento que comprende una solución de un material de recubrimiento farmacéuticamente aceptable en un solvente orgánico para proveer así gránulos recubiertos al evaporarse el solvente, (c) mezclar los gránulos recubiertos con uno o más excipientes para comprimidos farmacéuticamente aceptables, y (d) formar comprimidos a partir de la mezcla resultante.
ARP020103823A 2001-10-15 2002-10-11 Un metodo para preparar una composicion farmaceutica que comprende acido 5-aminosalicilico para utilizar en el tratamiento de colitis ulcerosa y enfermedades de crohn AR036797A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32883101P 2001-10-15 2001-10-15
PCT/DK2001/000677 WO2003032952A1 (en) 2001-10-15 2001-10-15 Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease

Publications (1)

Publication Number Publication Date
AR036797A1 true AR036797A1 (es) 2004-10-06

Family

ID=41795791

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP020103823A AR036797A1 (es) 2001-10-15 2002-10-11 Un metodo para preparar una composicion farmaceutica que comprende acido 5-aminosalicilico para utilizar en el tratamiento de colitis ulcerosa y enfermedades de crohn

Country Status (4)

Country Link
US (3) US8282955B2 (es)
AR (1) AR036797A1 (es)
EG (1) EG24584A (es)
MY (1) MY137570A (es)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2359812C (en) * 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
US8282955B2 (en) 2001-10-15 2012-10-09 Ferring B.V. Method for the preparation of a pharmaceutical composition comprising 5-aminosalicylic acid for use in treatment of ulcerative colitis and Crohn's disease
US20070042143A1 (en) * 2003-04-23 2007-02-22 Ferring B.V. Sachet for a pharmaceutical composition
EP1547601A1 (en) 2003-12-23 2005-06-29 Ferring B.V. Coating method
US20090028944A1 (en) * 2007-07-16 2009-01-29 Balaji Sathurappan Pharmaceutical compositions comprising mesalamine
US20090036414A1 (en) * 2007-08-02 2009-02-05 Mutual Pharmaceutical Company, Inc. Mesalamine Formulations
US9078824B2 (en) * 2007-09-24 2015-07-14 The Procter & Gamble Company Composition and method of stabilized sensitive ingredient
US20090169622A1 (en) * 2007-12-27 2009-07-02 Roxane Laboratories, Inc. Delayed-release oral pharmaceutical composition for treatment of colonic disorders
EP2340812A1 (en) 2009-12-18 2011-07-06 Ferring International Center S.A. Granules for pharmaceutical preparations, methods and apparatus for their production
ITUA20162293A1 (it) 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
US20220125733A1 (en) * 2020-10-23 2022-04-28 Atoz Pharmaceuticals Pvt Ltd Nongranulated compressed tablets of mesalamine, and process of preparation thereof

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Also Published As

Publication number Publication date
US20130195980A1 (en) 2013-08-01
MY137570A (en) 2009-02-27
US20030138495A1 (en) 2003-07-24
US20140193492A1 (en) 2014-07-10
EG24584A (en) 2009-11-16
US8697135B2 (en) 2014-04-15
US8282955B2 (en) 2012-10-09

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