BR112016020877A8 - uso de ondansetron, uso de um núcleo compreendendo uma matriz polímera não iônica e forma de dosagem sólida - Google Patents

uso de ondansetron, uso de um núcleo compreendendo uma matriz polímera não iônica e forma de dosagem sólida

Info

Publication number
BR112016020877A8
BR112016020877A8 BR112016020877A BR112016020877A BR112016020877A8 BR 112016020877 A8 BR112016020877 A8 BR 112016020877A8 BR 112016020877 A BR112016020877 A BR 112016020877A BR 112016020877 A BR112016020877 A BR 112016020877A BR 112016020877 A8 BR112016020877 A8 BR 112016020877A8
Authority
BR
Brazil
Prior art keywords
ondansetron
core
amount
dosage form
matrix
Prior art date
Application number
BR112016020877A
Other languages
English (en)
Other versions
BR112016020877A2 (pt
BR112016020877B1 (pt
Inventor
Raday Gilead
Goldberg Guy
Fathi Reza
Original Assignee
Redhill Biopharma Ltd
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=54067752&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016020877(A8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Redhill Biopharma Ltd filed Critical Redhill Biopharma Ltd
Publication of BR112016020877A2 publication Critical patent/BR112016020877A2/pt
Publication of BR112016020877A8 publication Critical patent/BR112016020877A8/pt
Publication of BR112016020877B1 publication Critical patent/BR112016020877B1/pt

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs 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
    • 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
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

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

Abstract

formas de dosagem sólida de liberação prolongada de ondansetron para tratar quaisquer sintomas dentre náusea, vômito ou diarreia. um método de tratamento de um paciente compreende administrar oralmente uma forma de dosagem oral sólida compreendendo um núcleo compreendendo uma matriz polimérica não iônica, uma primeira quantidade de ondansetron dispersa dentro da matriz, e um sal disperso dentro da matriz, em que a primeira quantidade de ondansetron varia de cerca de 9 mg a cerca de 28 mg; um primeiro revestimento de vedação circundando o núcleo, em que o primeiro revestimento de vedação é compreendido de uma matriz polimérica não iônica; e uma camada de fármaco de liberação imediata circundando o primeiro revestimento de vedação e compreendendo um polímero não iônico e uma segunda quantidade de ondansetron dispersa nela, em que a segunda quantidade de ondansetron varia de cerca de 3 mg a cerca de 8 mg, em que a liberação de ondansetron da forma de dosagem oral sólida provê a exposição a ondansetron durante um período mínimo de 16 horas a fim de resultar em uma redução na frequência de vômito, náusea, diarreia, ou uma combinação dos mesmos.
BR112016020877-3A 2014-03-11 2015-03-11 Uso de ondansetron, uso de um núcleo compreendendo uma matriz polímera não iônica e comprimido BR112016020877B1 (pt)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201461951092P 2014-03-11 2014-03-11
US201461951074P 2014-03-11 2014-03-11
US201461951112P 2014-03-11 2014-03-11
US61/951,074 2014-03-11
US61/951,092 2014-03-11
US61/951,112 2014-03-11
US201462040136P 2014-08-21 2014-08-21
US62/040,136 2014-08-21
PCT/IB2015/000997 WO2015136377A2 (en) 2014-03-11 2015-03-11 Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms

Publications (3)

Publication Number Publication Date
BR112016020877A2 BR112016020877A2 (pt) 2017-08-15
BR112016020877A8 true BR112016020877A8 (pt) 2021-07-20
BR112016020877B1 BR112016020877B1 (pt) 2022-11-29

Family

ID=54067752

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016020877-3A BR112016020877B1 (pt) 2014-03-11 2015-03-11 Uso de ondansetron, uso de um núcleo compreendendo uma matriz polímera não iônica e comprimido

Country Status (17)

Country Link
US (3) US9675588B2 (pt)
EP (1) EP3116500B1 (pt)
JP (1) JP6461186B2 (pt)
KR (1) KR20160132057A (pt)
CN (1) CN106456611B (pt)
AU (1) AU2015228545B2 (pt)
BR (1) BR112016020877B1 (pt)
CA (1) CA2941829C (pt)
CL (1) CL2016002251A1 (pt)
IL (1) IL247698B (pt)
MX (1) MX2016011734A (pt)
PH (1) PH12016501756B1 (pt)
RU (1) RU2706708C2 (pt)
SG (1) SG11201607511WA (pt)
UA (1) UA121209C2 (pt)
WO (1) WO2015136377A2 (pt)
ZA (1) ZA201606276B (pt)

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AU2016272089B2 (en) 2015-06-03 2021-02-18 Triastek, Inc. Dosage forms and use thereof
EP3573602A4 (en) * 2017-01-26 2020-09-16 Triastek, Inc. DOSAGE FORMS OF CONTROLLED RELEASE AT SPECIFIC GASTROINTESTINAL SITES
JP7315383B2 (ja) * 2019-06-27 2023-07-26 株式会社Ｓｃｒｅｅｎホールディングス インクジェット用水性組成物及び固体製剤
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Also Published As

Publication number Publication date
AU2015228545A1 (en) 2016-09-22
IL247698B (en) 2020-08-31
CA2941829C (en) 2021-11-02
IL247698A0 (en) 2016-11-30
US20150258029A1 (en) 2015-09-17
WO2015136377A2 (en) 2015-09-17
UA121209C2 (uk) 2020-04-27
US9675588B2 (en) 2017-06-13
EP3116500A4 (en) 2017-10-25
JP2017507966A (ja) 2017-03-23
KR20160132057A (ko) 2016-11-16
US10668050B2 (en) 2020-06-02
SG11201607511WA (en) 2016-10-28
AU2015228545B2 (en) 2020-03-12
CA2941829A1 (en) 2015-09-17
PH12016501756A1 (en) 2016-11-07
US20200253933A1 (en) 2020-08-13
RU2016139474A3 (pt) 2018-10-26
CL2016002251A1 (es) 2017-11-03
EP3116500B1 (en) 2023-09-13
PH12016501756B1 (en) 2016-11-07
WO2015136377A3 (en) 2016-01-14
JP6461186B2 (ja) 2019-01-30
RU2706708C2 (ru) 2019-11-20
MX2016011734A (es) 2017-02-13
BR112016020877A2 (pt) 2017-08-15
EP3116500A2 (en) 2017-01-18
RU2016139474A (ru) 2018-04-11
ZA201606276B (en) 2019-04-24
BR112016020877B1 (pt) 2022-11-29
CN106456611B (zh) 2021-07-20
US20170258768A1 (en) 2017-09-14
CN106456611A (zh) 2017-02-22

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