BR112013003573A2 - comprimido de mesalazina tendo dissolução melhorada conforme antecedentes da invenção - Google Patents

comprimido de mesalazina tendo dissolução melhorada conforme antecedentes da invenção

Info

Publication number
BR112013003573A2
BR112013003573A2 BR112013003573A BR112013003573A BR112013003573A2 BR 112013003573 A2 BR112013003573 A2 BR 112013003573A2 BR 112013003573 A BR112013003573 A BR 112013003573A BR 112013003573 A BR112013003573 A BR 112013003573A BR 112013003573 A2 BR112013003573 A2 BR 112013003573A2
Authority
BR
Brazil
Prior art keywords
mesalazine
tablet
background
improved dissolution
tablet core
Prior art date
Application number
BR112013003573A
Other languages
English (en)
Inventor
Hendrik Cornelis De Fluiter
Original Assignee
Disphar Internat 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43416492&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112013003573(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Disphar Internat Bv filed Critical Disphar Internat Bv
Publication of BR112013003573A2 publication Critical patent/BR112013003573A2/pt

Links

Classifications

    • 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
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61K9/20—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
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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

comprimido de mesalazina tendo dissolução melhorada conforme antecedentes da invenção. a invenção proporciona um método para a preparação de um comprimido de revestimento entérico de mesalazina, constituído por : (i) uma composição que compreende a granulação de mesalazina, um sal farmacêuticamente aceitável, ou um éster em granulados de mesalazina, (ii) marcando uma composição de núcleos de comprimidos que compreende a mesalazina granulada obtida em (i) para se obter um núcleo do comprimido e (iii) revestimento do núcleo do comprimido obtido em (ii) com pelo menos uma camada intermediária e um revestimento entérico; onde a dureza do núcleo do comprimido é controlada para estar compreendida entre 80 n e 105 n e a camada intermediária representa menos de 2% em peso do comprimido.
BR112013003573A 2010-09-01 2011-09-01 comprimido de mesalazina tendo dissolução melhorada conforme antecedentes da invenção BR112013003573A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10174940A EP2425826A1 (en) 2010-09-01 2010-09-01 Mesalazine tablet having improved dissolution
PCT/EP2011/065155 WO2012028698A1 (en) 2010-09-01 2011-09-01 Mesalazine tablet having improved dissolution

Publications (1)

Publication Number Publication Date
BR112013003573A2 true BR112013003573A2 (pt) 2016-06-07

Family

ID=43416492

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013003573A BR112013003573A2 (pt) 2010-09-01 2011-09-01 comprimido de mesalazina tendo dissolução melhorada conforme antecedentes da invenção

Country Status (12)

Country Link
US (1) US20130183434A1 (pt)
EP (2) EP2425826A1 (pt)
JP (1) JP6059143B2 (pt)
CN (2) CN103108629A (pt)
AU (2) AU2011298350A1 (pt)
BR (1) BR112013003573A2 (pt)
CA (1) CA2808170C (pt)
ES (1) ES2669570T3 (pt)
HU (1) HUE037197T2 (pt)
PL (1) PL2611429T3 (pt)
RU (1) RU2610435C2 (pt)
WO (1) WO2012028698A1 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102871980B (zh) * 2012-10-17 2014-03-05 扬子江药业集团有限公司 一种s-泮托拉唑或其盐的肠溶片及其制备方法
US20140141075A1 (en) 2012-11-21 2014-05-22 Warner Chilcott Company, Llc 5-aminosalicylic acid capsule formulation
AU2014219726B2 (en) * 2013-02-22 2018-03-15 Zeria Pharmaceutical Co., Ltd. Enteric coated tablet
EP3162362A1 (de) * 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Optimierte mesalazinhaltige hochdosistablette
ITUA20162293A1 (it) 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
WO2022245307A1 (en) * 2021-05-21 2022-11-24 Ilko Ilac Sanayi Ve Ticaret A.S. Composition of mesalazine enteric tablet formulation
CN115990142A (zh) * 2021-10-20 2023-04-21 华益泰康药业股份有限公司 一种治疗结肠炎的肠溶片剂

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4539198A (en) 1983-07-07 1985-09-03 Rowell Laboratories, Inc. Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range
GB8812490D0 (en) 1988-05-26 1988-06-29 Agricultural & Food Res Delayed release formulations
WO1998006385A1 (de) * 1996-08-15 1998-02-19 Losan Pharma Gmbh Gut schluckbare orale arzneiform
WO1998026767A2 (en) * 1996-12-17 1998-06-25 Poli Industria Chimica S.P.A. Site-specific controlled release dosage formulation for mesalamine
US5862951A (en) 1997-01-29 1999-01-26 The Procter & Gamble Company Replacement fluid cartridge for a positive displacement pump and method of making the cartridge
CN1148171C (zh) * 1998-04-17 2004-05-05 大正制药株式会社 多单元缓释片剂
ITMI991316A1 (it) * 1999-06-14 2000-12-14 Cip Ninety Two 92 S A Composizioni farmaceutiche orali a rilascio modificato di mesalazina
IT1318625B1 (it) * 2000-07-14 2003-08-27 Roberto Valducci Formulazioni farmaceutiche solide orali a rilascio multifasicoph-dipendente.
RU2286156C2 (ru) * 2001-10-15 2006-10-27 Ферринг Бв Способ приготовления фармацевтической композиции, включающей в себя 5-аминосалициловую кислоту, для применения в лечении неспецифического язвенного колита и болезни крона
US9149439B2 (en) 2005-03-21 2015-10-06 Sandoz Ag Multi-particulate, modified-release composition
JP5041774B2 (ja) 2006-09-22 2012-10-03 日本ケミファ株式会社 メサラジンを有効成分として含有する徐放性錠剤
US20090036414A1 (en) * 2007-08-02 2009-02-05 Mutual Pharmaceutical Company, Inc. Mesalamine Formulations
WO2009047802A2 (en) * 2007-10-10 2009-04-16 Lupin Limited Novel colon targeted modified release bioadhesive formulation of 5-amino salicylic acid or its salts and metabolites thereof
US20090162434A1 (en) * 2007-12-21 2009-06-25 Disphar International Bv Mesalazine tablet

Also Published As

Publication number Publication date
RU2013106945A (ru) 2014-10-10
JP6059143B2 (ja) 2017-01-11
EP2425826A1 (en) 2012-03-07
WO2012028698A1 (en) 2012-03-08
RU2610435C2 (ru) 2017-02-10
CN103108629A (zh) 2013-05-15
AU2016210591A1 (en) 2016-08-18
CA2808170C (en) 2019-02-12
US20130183434A1 (en) 2013-07-18
ES2669570T3 (es) 2018-05-28
CN105560204A (zh) 2016-05-11
EP2611429B1 (en) 2018-02-21
JP2013536827A (ja) 2013-09-26
AU2011298350A1 (en) 2013-02-28
PL2611429T3 (pl) 2018-08-31
EP2611429A1 (en) 2013-07-10
CA2808170A1 (en) 2012-03-08
HUE037197T2 (hu) 2018-08-28

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2477 DE 26-06-2018 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.