AR044265A1 - Una forma de dosificacion que contiene (s) - pantoprazol como ingrediente activo - Google Patents

Una forma de dosificacion que contiene (s) - pantoprazol como ingrediente activo

Info

Publication number
AR044265A1
AR044265A1 ARP040101559A ARP040101559A AR044265A1 AR 044265 A1 AR044265 A1 AR 044265A1 AR P040101559 A ARP040101559 A AR P040101559A AR P040101559 A ARP040101559 A AR P040101559A AR 044265 A1 AR044265 A1 AR 044265A1
Authority
AR
Argentina
Prior art keywords
dosage form
pantoprazole
tablet
pellet
magnesium
Prior art date
Application number
ARP040101559A
Other languages
English (en)
Inventor
Dietrich Rango Dr
Anstett Isabel Dr
Schiller Marc Dr
Hartmut Ney
Schafer-Preuss Sabine Dr
Hartmann Manfred Dr
Original Assignee
Altana Pharma Ag
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 Altana Pharma Ag filed Critical Altana Pharma Ag
Publication of AR044265A1 publication Critical patent/AR044265A1/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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Landscapes

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

Abstract

Formas de dosificación para la administración oral de la sal de magnesio de (S)-pantoprazol. Reivindicación 1: Una forma de dosificación para la administración oral de la sal de magnesio de (S)-pantoprazol, caracterizada porque comprende una cantidad terapéuticamente efectiva de la sal de magnesio de (S)-pantoprazol conjuntamente con excipientes farmacéuticamente aceptables. Reivindicación 2: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es una forma de dosificación sólida en forma de tableta o pella. Reivindicación 3: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es una forma de dosificación de liberación retardada que comprende una capa entérica soluble en condiciones neutras o alcalinas y al menos una capa intermedia (capa de subrecubrimiento). Reivindicación 5: Una forma de dosificación de acuerdo con la reivindicación 1, caracterizada porque es un medicamento oralmente administrable en la forma de pella o tableta que es resistente a jugo gástrico, y donde cada pella o tableta consiste de un núcleo en el cual el compuesto activo o su sal tolerada fisiológicamente se encuentra mezclado con un ligante, relleno y, opcionalmente, un miembro seleccionado del grupo formado por otro agente auxiliar para la formación de tabletas y un compuesto inorgánico básico tolerado fisiológicamente; una capa intermedia inerte soluble en agua que rodea el núcleo y una capa exterior resistente a jugo gástrico, donde el compuesto activo es (S)-pantoprazol magnésico dihidrato, el ligante es polivinilpirrolidona y/o hidroxipropilmetilcelulosa y, opcionalmente, el relleno es manitol. Reivindicación 28: Un método para la profilaxis o el tratamiento de una condición clínica en un mamífero, tal como un humano, para la cual está indicada un inhibidor de bomba protónica, método caracterizado porque comprende la administración de una cantidad terapéuticamente efectiva de (S)-pantoprazol magnésico en una forma de dosificación de acuerdo con cualquiera de las reivindicaciones 1 a 27. Reivindicación 29: Un método de tratamiento de acuerdo con la reivindicación 28, caracterizado porque la condición clínica se selecciona del grupo formado por úlcera gástrica benigna, enfermedad de reflujo gastro-esofágico, síndrome de Zollinger-Ellison, úlcera duodenal, úlcera duodenal asociada con Helicobacter pylori, profilaxis de úlcera gástrica o duodenal asociado con NSAID en pacientes con un riesgo aumentado de complicación gastroduodenal que requieran un tratamiento continuo con NSAID y una terapia de combinación con antibióticos en la erradicación de Helicobacter pylori.
ARP040101559A 2003-05-08 2004-05-07 Una forma de dosificacion que contiene (s) - pantoprazol como ingrediente activo AR044265A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP03010368 2003-05-08
EP04001759 2004-01-28

Publications (1)

Publication Number Publication Date
AR044265A1 true AR044265A1 (es) 2005-09-07

Family

ID=33436113

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP040101559A AR044265A1 (es) 2003-05-08 2004-05-07 Una forma de dosificacion que contiene (s) - pantoprazol como ingrediente activo

Country Status (11)

Country Link
US (2) US20060216346A1 (es)
EP (1) EP1624870B1 (es)
JP (1) JP4800926B2 (es)
AR (1) AR044265A1 (es)
AU (1) AU2004237364B2 (es)
CA (1) CA2524979C (es)
CL (1) CL2004000984A1 (es)
ES (1) ES2392687T3 (es)
PE (1) PE20050150A1 (es)
TW (1) TW200503785A (es)
WO (1) WO2004098577A2 (es)

Families Citing this family (11)

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Publication number Priority date Publication date Assignee Title
CL2004000983A1 (es) 2003-05-08 2005-03-04 Altana Pharma Ag Composicion farmaceutica oral en forma de tableta que comprende a pantoprazol magnetico dihidratado, en donde la forma de tableta esta compuesto por un nucleo, una capa intermedia y una capa exterior; y uso de la composicion farmaceutica en ulceras y
PE20050150A1 (es) 2003-05-08 2005-03-22 Altana Pharma Ag Una forma de dosificacion que contiene (s)-pantoprazol como ingrediente activo
US20050147663A1 (en) * 2003-07-17 2005-07-07 Mohan Mailatur S. Method of treatment for improved bioavailability
WO2005009410A2 (en) * 2003-07-17 2005-02-03 Dr. Reddy's Laboratories, Inc. Pharmaceutical compositions having a swellable coating
TWI372066B (en) * 2003-10-01 2012-09-11 Wyeth Corp Pantoprazole multiparticulate formulations
PT1746980E (pt) 2004-05-07 2012-01-25 Nycomed Gmbh Forma de dosagem farmacêutica compreendendo granulados assim como o seu processo de fabrico
EP2081546A2 (en) * 2006-10-17 2009-07-29 Ranbaxy Laboratories Limited Multiple unit tablet compositions of benzimidazole compounds
WO2016174664A1 (en) 2015-04-29 2016-11-03 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US10537562B2 (en) * 2016-10-06 2020-01-21 Jubilant Generics Limited Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof
US11291654B2 (en) * 2018-09-13 2022-04-05 Syneurx International (Taiwan) Corp. Formulations of cycloserine compounds and applications thereof

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CL2004000983A1 (es) 2003-05-08 2005-03-04 Altana Pharma Ag Composicion farmaceutica oral en forma de tableta que comprende a pantoprazol magnetico dihidratado, en donde la forma de tableta esta compuesto por un nucleo, una capa intermedia y una capa exterior; y uso de la composicion farmaceutica en ulceras y
TWI372066B (en) 2003-10-01 2012-09-11 Wyeth Corp Pantoprazole multiparticulate formulations
PT1746980E (pt) 2004-05-07 2012-01-25 Nycomed Gmbh Forma de dosagem farmacêutica compreendendo granulados assim como o seu processo de fabrico
JP4563077B2 (ja) 2004-05-28 2010-10-13 株式会社ロッテ キャンディ及びその製造方法

Also Published As

Publication number Publication date
CA2524979C (en) 2012-08-14
WO2004098577A3 (en) 2004-12-09
JP2006525287A (ja) 2006-11-09
JP4800926B2 (ja) 2011-10-26
AU2004237364A1 (en) 2004-11-18
TW200503785A (en) 2005-02-01
US8758817B2 (en) 2014-06-24
PE20050150A1 (es) 2005-03-22
US20110171303A1 (en) 2011-07-14
ES2392687T3 (es) 2012-12-12
WO2004098577A2 (en) 2004-11-18
CL2004000984A1 (es) 2005-03-04
AU2004237364B2 (en) 2010-02-18
US20060216346A1 (en) 2006-09-28
EP1624870A2 (en) 2006-02-15
EP1624870B1 (en) 2012-08-08
CA2524979A1 (en) 2004-11-18

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