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DK3368017T3 - Optimeret mesalazinholdig højdosistablet - Google Patents

Optimeret mesalazinholdig højdosistablet Download PDF

Info

Publication number
DK3368017T3
DK3368017T3 DK16787790.1T DK16787790T DK3368017T3 DK 3368017 T3 DK3368017 T3 DK 3368017T3 DK 16787790 T DK16787790 T DK 16787790T DK 3368017 T3 DK3368017 T3 DK 3368017T3
Authority
DK
Denmark
Prior art keywords
mesalazine
optimized
high dose
containing high
dose tablet
Prior art date
Application number
DK16787790.1T
Other languages
English (en)
Inventor
Rudolph Wilhelm
Markus Pröls
Roland Greinwald
Tanju Nacak
Original Assignee
Dr Falk Pharma Gmbh
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 Dr Falk Pharma Gmbh filed Critical Dr Falk Pharma Gmbh
Application granted granted Critical
Publication of DK3368017T3 publication Critical patent/DK3368017T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/606Salicylic acid; Derivatives thereof having amino groups
    • 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
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK16787790.1T 2015-10-30 2016-10-21 Optimeret mesalazinholdig højdosistablet DK3368017T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15192269.7A EP3162362A1 (de) 2015-10-30 2015-10-30 Optimierte mesalazinhaltige hochdosistablette
PCT/EP2016/075427 WO2017072050A1 (de) 2015-10-30 2016-10-21 Optimierte mesalazinhaltige hochdosistablette

Publications (1)

Publication Number Publication Date
DK3368017T3 true DK3368017T3 (da) 2019-12-16

Family

ID=54476727

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16787790.1T DK3368017T3 (da) 2015-10-30 2016-10-21 Optimeret mesalazinholdig højdosistablet

Country Status (21)

Country Link
US (1) US11135159B2 (da)
EP (2) EP3162362A1 (da)
JP (1) JP6872135B2 (da)
KR (1) KR102701506B1 (da)
CN (2) CN108348472A (da)
AU (1) AU2016347352B2 (da)
CA (1) CA3001435A1 (da)
CY (1) CY1122473T1 (da)
DK (1) DK3368017T3 (da)
EA (1) EA201890828A1 (da)
ES (1) ES2761319T3 (da)
HK (1) HK1255193A1 (da)
HR (1) HRP20192184T1 (da)
HU (1) HUE046593T2 (da)
LT (1) LT3368017T (da)
MX (1) MX2018005358A (da)
PL (1) PL3368017T3 (da)
PT (1) PT3368017T (da)
RS (1) RS59748B1 (da)
SI (1) SI3368017T1 (da)
WO (1) WO2017072050A1 (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUA20162293A1 (it) * 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
TR201722039A2 (tr) * 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Mesalazi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari
EP3662895A1 (en) * 2018-12-07 2020-06-10 Tillotts Pharma AG A process for manufacturing reducing sugar-free 5-asa tablet cores
IT201800011120A1 (it) 2018-12-14 2020-06-14 Dpl Pharma S P A Composizioni farmaceutiche orali solide per la somministrazione di mesalazina o suoi derivati
KR102104507B1 (ko) * 2019-08-23 2020-04-24 브릿지바이오테라퓨틱스(주) 팔미토일-l-프롤릴-l-프롤릴-글리실-l-타이로신 나트륨을 포함하는 약제학적 제제 및 이의 제조방법
WO2022047730A1 (en) * 2020-09-04 2022-03-10 Shanghai Pharmaceuticals Holding Co., Ltd. Methods to treat inflammatory bowel disease
CN115957330B (zh) * 2022-12-16 2025-05-02 扬子江药业集团有限公司 一种肠溶层及其制备方法、口服制剂

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3151196A1 (de) 1981-12-23 1983-06-30 Kurt Heinz Prof. Dr. 7800 Freiburg Bauer Verfahren zur herstellung von gut loeslichen 5-aminosalicylsaeure-arzneimittelzubereitungen
US5686105A (en) * 1993-10-19 1997-11-11 The Procter & Gamble Company Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery
DE19732903A1 (de) 1997-07-30 1999-02-04 Falk Pharma Gmbh Pellet-Formulierung zur Behandlung des Intestinaltraktes
JP2002535353A (ja) * 1999-01-29 2002-10-22 ロザン ファルマ ゲゼルシャフトミットベシュレンクテルハフツンク 医薬品組成物
ITMI991316A1 (it) 1999-06-14 2000-12-14 Cip Ninety Two 92 S A Composizioni farmaceutiche orali a rilascio modificato di mesalazina
US20030114527A1 (en) * 2001-08-31 2003-06-19 Karnachi Anees Abdulquadar Pharmaceutical composition
CA2444814C (en) * 2001-10-24 2009-06-09 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
DE60133319T3 (de) * 2001-11-23 2021-08-05 Allergan pharmaceuticals International Ltd. Mehrfach beschichete pharmazeutische dosierungsform
EP1519717B1 (en) * 2002-07-05 2010-09-29 Temrel Limited Controlled release composition
EP1615619A2 (en) 2003-04-23 2006-01-18 Ferring B.V. Sachet for a pharmaceutical composition
MY157620A (en) * 2006-01-31 2016-06-30 Cytochroma Dev Inc A granular material of a solid water-soluble mixed metal compound capable of binding phosphate
JP2011500553A (ja) * 2007-10-10 2011-01-06 ルピン・リミテッド 5−アミノサリチル酸またはその塩もしくは代謝産物の新規な結腸を標的とする調節放出性生体接着性製剤
US20090162434A1 (en) * 2007-12-21 2009-06-25 Disphar International Bv Mesalazine tablet
CN102036658A (zh) * 2008-05-23 2011-04-27 香港大学 治疗流感的联合疗法
US9463163B2 (en) * 2009-10-16 2016-10-11 Sun Pharmaceutical Industries Limited Delayed release pharmaceutical composition of mesalamine
EP2425826A1 (en) * 2010-09-01 2012-03-07 Disphar International B.V. Mesalazine tablet having improved dissolution
EP2468264A1 (en) * 2010-12-27 2012-06-27 Laboratorios Liconsa, S.A. Oral pharmaceutical tablet for controled release of mesalazine and process for obtaining it
CN105025888B (zh) * 2013-02-22 2018-10-12 志瑞亚新药工业株式会社 肠溶片
EP3542791A1 (en) * 2013-10-29 2019-09-25 Tillotts Pharma AG A delayed release drug formulation
IN2014MU00097A (da) * 2014-01-10 2015-08-21 Cadila Healthcare Ltd

Also Published As

Publication number Publication date
EP3368017A1 (de) 2018-09-05
CN108348472A (zh) 2018-07-31
PT3368017T (pt) 2020-01-06
ES2761319T3 (es) 2020-05-19
KR102701506B1 (ko) 2024-09-02
MX2018005358A (es) 2018-06-06
SI3368017T1 (sl) 2020-01-31
HK1255193A1 (zh) 2019-08-09
US11135159B2 (en) 2021-10-05
CA3001435A1 (en) 2017-05-04
US20180311155A1 (en) 2018-11-01
JP2018531960A (ja) 2018-11-01
HRP20192184T1 (hr) 2020-03-06
KR20180077246A (ko) 2018-07-06
EP3162362A1 (de) 2017-05-03
CY1122473T1 (el) 2021-01-27
CN117180218A (zh) 2023-12-08
AU2016347352A1 (en) 2018-05-10
EP3368017B1 (de) 2019-11-06
PL3368017T3 (pl) 2020-04-30
EA201890828A1 (ru) 2018-11-30
LT3368017T (lt) 2020-01-27
RS59748B1 (sr) 2020-02-28
AU2016347352B2 (en) 2021-09-09
JP6872135B2 (ja) 2021-05-19
WO2017072050A1 (de) 2017-05-04
HUE046593T2 (hu) 2020-03-30

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