AR044264A1 - Una forma de dosificacion que contiene pantoprazol como ingrediente activo - Google Patents

Una forma de dosificacion que contiene pantoprazol como ingrediente activo

Info

Publication number
AR044264A1
AR044264A1 ARP040101558A ARP040101558A AR044264A1 AR 044264 A1 AR044264 A1 AR 044264A1 AR P040101558 A ARP040101558 A AR P040101558A AR P040101558 A ARP040101558 A AR P040101558A AR 044264 A1 AR044264 A1 AR 044264A1
Authority
AR
Argentina
Prior art keywords
dosage form
pantoprazole magnesium
tablet
pellet
form according
Prior art date
Application number
ARP040101558A
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=33436112&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR044264(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Altana Pharma Ag filed Critical Altana Pharma Ag
Publication of AR044264A1 publication Critical patent/AR044264A1/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
    • 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
    • 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
    • A61K9/14Particulate 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
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (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)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Formas de dosificación para la administración oral de la sal de magnesio de pantoprazol. Reivindicación 1: Una forma de dosificación para la administración oral de la sal de magnesio de pantoprazol, caracterizada porque comprende una cantidad terapéuticamente efectiva de la sal de magnesio de 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 pantoprazol magnesio 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 pantoprazol magnesio 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.
ARP040101558A 2003-05-08 2004-05-07 Una forma de dosificacion que contiene pantoprazol como ingrediente activo AR044264A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP03010328 2003-05-08
EP04001754 2004-01-28

Publications (1)

Publication Number Publication Date
AR044264A1 true AR044264A1 (es) 2005-09-07

Family

ID=33436112

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP040101558A AR044264A1 (es) 2003-05-08 2004-05-07 Una forma de dosificacion que contiene pantoprazol como ingrediente activo

Country Status (27)

Country Link
US (2) US20060240100A1 (es)
EP (2) EP1624869B1 (es)
JP (2) JP4878284B2 (es)
KR (2) KR101237742B1 (es)
AR (1) AR044264A1 (es)
AU (2) AU2004237363B2 (es)
BR (2) BRPI0410044B8 (es)
CA (1) CA2489140C (es)
CL (1) CL2004000983A1 (es)
CY (2) CY1113128T1 (es)
DK (2) DK1624869T3 (es)
EA (2) EA016824B1 (es)
ES (2) ES2396197T3 (es)
HK (1) HK1090546A1 (es)
HR (2) HRP20120754T1 (es)
IL (2) IL171365A (es)
MX (1) MXPA05000411A (es)
NO (1) NO337921B1 (es)
NZ (1) NZ543181A (es)
PE (1) PE20050199A1 (es)
PL (2) PL2316454T3 (es)
PT (2) PT2316454E (es)
RS (1) RS53443B (es)
SI (2) SI2316454T1 (es)
TW (1) TW200509992A (es)
WO (1) WO2004098594A2 (es)
ZA (1) ZA200508202B (es)

Families Citing this family (15)

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PE20050150A1 (es) 2003-05-08 2005-03-22 Altana Pharma Ag Una forma de dosificacion que contiene (s)-pantoprazol como ingrediente activo
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WO2007029124A2 (en) * 2005-05-13 2007-03-15 Combino Pharm, S.L. Formulations containing pantoprazole free acid and its salts
EP1747776A1 (en) * 2005-07-29 2007-01-31 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising granular pantoprazole
TWI519322B (zh) * 2008-04-15 2016-02-01 愛戴爾製藥股份有限公司 包含弱鹼性藥物及控制釋放劑型之組合物
WO2010018593A2 (en) * 2008-07-03 2010-02-18 Torrent Pharmaceuticals Ltd. Gastric acid resistant benzimidazole multiple unit tablet composition
MX2013000827A (es) * 2010-07-22 2013-06-28 Lupin Ltd Composicion de tableta de unidad multiple.
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ITMI20111168A1 (it) * 2011-06-27 2012-12-28 Professional Dietetics Srl Composizioni farmaceutiche comprendenti idrossipropilmetilcellulosa e/o acido ialuronico e loro uso
US20150209432A1 (en) * 2012-07-26 2015-07-30 Lupin Limited Pharmaceutical compositions of proton pump inhibitor
EP3288556A4 (en) 2015-04-29 2018-09-19 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
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AU2017339246B2 (en) * 2016-10-06 2020-07-23 Jubilant Generics Limited Delayed release pharmaceutical composition of pantoprazole and process for preparation thereof
WO2023214016A1 (en) * 2022-05-06 2023-11-09 Evonik Operations Gmbh Dosage form with drug release at ph 3 to 6 using double coating system with at least one release acceleration agent

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Also Published As

Publication number Publication date
EP2316454B1 (en) 2012-09-26
CA2489140A1 (en) 2004-11-18
AU2010200905A1 (en) 2010-04-01
EP2316454A1 (en) 2011-05-04
JP2006525286A (ja) 2006-11-09
BRPI0410044B8 (pt) 2021-05-25
PE20050199A1 (es) 2005-03-26
EA027734B1 (ru) 2017-08-31
AU2004237363B2 (en) 2009-12-10
AU2004237363A1 (en) 2004-11-18
PT2316454E (pt) 2012-12-06
KR20060010774A (ko) 2006-02-02
BR122016006880B1 (pt) 2020-11-10
EP1624869B1 (en) 2012-07-04
JP2011126912A (ja) 2011-06-30
CA2489140C (en) 2006-10-17
HRP20121005T1 (hr) 2013-01-31
BRPI0410044B1 (pt) 2019-05-07
DK2316454T3 (da) 2013-01-21
TW200509992A (en) 2005-03-16
PT1624869E (pt) 2012-09-18
RS53443B (en) 2014-12-31
WO2004098594A3 (en) 2004-12-09
EA200501697A1 (ru) 2006-06-30
ZA200508202B (en) 2006-12-27
MXPA05000411A (es) 2005-03-23
HRP20120754T1 (hr) 2012-11-30
KR20110104124A (ko) 2011-09-21
IL229510A (en) 2016-09-29
BRPI0410044A (pt) 2006-04-25
KR101237742B1 (ko) 2013-02-26
IL229510A0 (en) 2013-12-31
WO2004098594A2 (en) 2004-11-18
NZ543181A (en) 2009-10-30
US20090208571A1 (en) 2009-08-20
EA016824B1 (ru) 2012-07-30
ES2396197T3 (es) 2013-02-19
CY1113462T1 (el) 2016-06-22
RS20050818A (en) 2008-04-04
AU2010200905B2 (en) 2012-04-05
NO20055631L (no) 2005-11-29
BR122016006880B8 (pt) 2021-05-25
PL2316454T3 (pl) 2013-03-29
CL2004000983A1 (es) 2005-03-04
IL171365A (en) 2014-08-31
EP2316454B9 (en) 2013-01-02
NO337921B1 (no) 2016-07-11
DK1624869T3 (da) 2012-10-01
US20060240100A1 (en) 2006-10-26
EA201101119A1 (ru) 2011-12-30
CY1113128T1 (el) 2016-04-13
HK1090546A1 (en) 2006-12-29
JP5162689B2 (ja) 2013-03-13
US8703192B2 (en) 2014-04-22
SI2316454T1 (sl) 2013-01-31
EP1624869A2 (en) 2006-02-15
SI1624869T1 (sl) 2012-10-30
JP4878284B2 (ja) 2012-02-15
ES2390342T3 (es) 2012-11-12
PL1624869T3 (pl) 2012-11-30

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