CA3021071A1 - Oral pharmaceutical compositions of mesalazine - Google Patents

Oral pharmaceutical compositions of mesalazine Download PDF

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Publication number
CA3021071A1
CA3021071A1 CA3021071A CA3021071A CA3021071A1 CA 3021071 A1 CA3021071 A1 CA 3021071A1 CA 3021071 A CA3021071 A CA 3021071A CA 3021071 A CA3021071 A CA 3021071A CA 3021071 A1 CA3021071 A1 CA 3021071A1
Authority
CA
Canada
Prior art keywords
mesalazine
unit dose
pharmaceutical product
minitablets
dose pharmaceutical
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3021071A
Other languages
English (en)
French (fr)
Inventor
Alfred Chi Yeh LIANG
Venkataramana DINGARI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ferring BV
Original Assignee
Ferring 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
Application filed by Ferring BV filed Critical Ferring BV
Publication of CA3021071A1 publication Critical patent/CA3021071A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2072—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61K9/2095—Tabletting processes
    • 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

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)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA3021071A 2016-04-19 2017-04-18 Oral pharmaceutical compositions of mesalazine Pending CA3021071A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662324416P 2016-04-19 2016-04-19
US62/324,416 2016-04-19
PCT/US2017/028067 WO2017184566A1 (en) 2016-04-19 2017-04-18 Oral pharmaceutical compositions of mesalazine

Publications (1)

Publication Number Publication Date
CA3021071A1 true CA3021071A1 (en) 2017-10-26

Family

ID=59298513

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3021071A Pending CA3021071A1 (en) 2016-04-19 2017-04-18 Oral pharmaceutical compositions of mesalazine

Country Status (13)

Country Link
US (2) US10874617B2 (enExample)
EP (1) EP3445340A1 (enExample)
JP (1) JP2019513800A (enExample)
KR (1) KR102381586B1 (enExample)
CN (1) CN109310642B (enExample)
AR (1) AR108231A1 (enExample)
AU (1) AU2017252410A1 (enExample)
BR (1) BR112018071370A2 (enExample)
CA (1) CA3021071A1 (enExample)
MX (1) MX387731B (enExample)
RU (1) RU2744576C2 (enExample)
TW (1) TW201740932A (enExample)
WO (1) WO2017184566A1 (enExample)

Families Citing this family (9)

* 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
BR112018071363A2 (pt) 2016-04-19 2019-02-05 Ferring Bv composições farmacêuticas orais de nicotinamida
TR201722039A2 (tr) * 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Mesalazi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari
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
WO2020227151A1 (en) * 2019-05-03 2020-11-12 Azora Therapeutics, Inc. Compositions comprising indigo and/or an indigo derivative and methods of use thereof
US20210236519A1 (en) * 2020-01-30 2021-08-05 Atoz Pharmaceuticals Pvt Ltd Controlled release dosage forms of 5-aminosalicylic acid and process thereof
US12636255B2 (en) * 2020-10-23 2026-05-26 Atoz Pharmaceuticals Pvt Ltd Nongranulated compressed tablets of mesalamine, and process of preparation thereof
EP4382099A1 (en) * 2022-12-05 2024-06-12 ADD Advanced Drug Delivery Technologies, Ltd. Drug loaded modified release pellets
CN120585777A (zh) * 2025-06-23 2025-09-05 齐鲁工业大学(山东省科学院) 一种美沙拉嗪微晶胶囊及其制备方法

Family Cites Families (23)

* Cited by examiner, † Cited by third party
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IT1246382B (it) * 1990-04-17 1994-11-18 Eurand Int Metodo per la cessione mirata e controllata di farmaci nell'intestino e particolarmente nel colon
US6458383B2 (en) 1999-08-17 2002-10-01 Lipocine, Inc. Pharmaceutical dosage form for oral administration of hydrophilic drugs, particularly low molecular weight heparin
IT1318625B1 (it) 2000-07-14 2003-08-27 Roberto Valducci Formulazioni farmaceutiche solide orali a rilascio multifasicoph-dipendente.
CA2359812C (en) * 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
JP5502254B2 (ja) * 2001-01-31 2014-05-28 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング 少なくとも２種類の異なる被覆ペレット形から成る多粒子剤形
US8048924B2 (en) 2001-08-29 2011-11-01 Biocon Limited Methods and compositions employing 4-aminophenylacetic acid compounds
US20040185097A1 (en) 2003-01-31 2004-09-23 Glenmark Pharmaceuticals Ltd. Controlled release modifying complex and pharmaceutical compositions thereof
US20080286344A1 (en) 2007-05-16 2008-11-20 Olivia Darmuzey Solid form
US20120093939A1 (en) 2008-12-17 2012-04-19 Altheus Therapeutics, Inc. Oral formulations
GB201003734D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Delayed prolonged drug delivery
GB201003731D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Immediate/delayed drug delivery
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
EP2822542A1 (en) * 2012-03-07 2015-01-14 Santarus, Inc. Controlled-release solid dosage forms of mesalamine
CN102579388A (zh) * 2012-03-10 2012-07-18 吉林化工学院 美沙拉秦结肠定位给药缓释片的制备
WO2013144176A1 (en) 2012-03-30 2013-10-03 Laboratorios Del Dr. Esteve, S.A. Controlled release formulatin comprising mesalamine
KR20150021071A (ko) 2012-06-15 2015-02-27 코나리스 리써치 인스티튜트 아게 니코틴산 및/또는 니코틴아미드 및/또는 트립토판을 포함하는 장내 세균총에 유익한 효능을 가진 약학 조성물
US20140178468A1 (en) 2012-12-24 2014-06-26 Ranbaxy Laboratories Limited Multiparticulate extended-release composition of mesalamine
AU2014239683B2 (en) * 2013-03-15 2018-05-17 Allergan Pharmaceuticals International Limited Mesalamine pharmaceutical composition with multiple dosage elements for reduced delivery variability
PT3079675T (pt) 2013-12-13 2020-03-05 Conaris Res Institute Ag Uma composição farmacêutica que contém ácido nicotínico e/ou nicotinamida para utilização para influenciar beneficamente os níveis de lípidos no sangue através da modificação da microbiota intestinal
KR20160088436A (ko) 2013-12-13 2016-07-25 코나리스 리써치 인스티튜트 아게 니코틴아미드 및 5-아미노살리실산의 조합을 포함하는, 장내 세균총에 유익한 영향을 미치거나 및/또는 위장 염증을 치료하기 위한 약학 조성물
US20160045442A1 (en) * 2014-08-13 2016-02-18 Cadila Healthcare Limited Stable pharmaceutical compositions of mesalamine
CN104257669A (zh) 2014-09-25 2015-01-07 合肥平光制药有限公司 一种用于向肠道递送水杨酸类药物的口服给药组合物
CN105687158B (zh) * 2016-01-21 2019-06-07 贝沃特医药技术(上海)有限公司 一种时间依赖释放机制的美沙拉嗪微粒制剂及其制备方法

Also Published As

Publication number Publication date
RU2018137359A3 (enExample) 2020-07-03
CN109310642A (zh) 2019-02-05
AR108231A1 (es) 2018-08-01
JP2019513800A (ja) 2019-05-30
KR20180133503A (ko) 2018-12-14
US20190105275A1 (en) 2019-04-11
KR102381586B1 (ko) 2022-04-04
MX2018012618A (es) 2019-06-24
BR112018071370A2 (pt) 2019-02-05
TW201740932A (zh) 2017-12-01
EP3445340A1 (en) 2019-02-27
RU2744576C2 (ru) 2021-03-11
US10874617B2 (en) 2020-12-29
US20210220281A1 (en) 2021-07-22
MX387731B (es) 2025-03-18
AU2017252410A1 (en) 2018-11-01
RU2018137359A (ru) 2020-05-19
CN109310642B (zh) 2021-07-20
WO2017184566A1 (en) 2017-10-26

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Effective date: 20220404