CN109310642B - 美沙拉嗪的口服药物组合物 - Google Patents

美沙拉嗪的口服药物组合物 Download PDF

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Publication number
CN109310642B
CN109310642B CN201780031230.6A CN201780031230A CN109310642B CN 109310642 B CN109310642 B CN 109310642B CN 201780031230 A CN201780031230 A CN 201780031230A CN 109310642 B CN109310642 B CN 109310642B
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China
Prior art keywords
mesalamine
unit dose
drug product
release
dose drug
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Expired - Fee Related
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CN201780031230.6A
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English (en)
Chinese (zh)
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CN109310642A (zh
Inventor
A.C.Y.梁
V.丁加里
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Ferring BV
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Ferring BV
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    • 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
    • A61K9/20—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
    • A61K9/2004—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
    • A61K9/28—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
    • 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
    • A61K9/2806—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
    • 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
    • A61K9/0012—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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201780031230.6A 2016-04-19 2017-04-18 美沙拉嗪的口服药物组合物 Expired - Fee Related CN109310642B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662324416P 2016-04-19 2016-04-19
US62/324416 2016-04-19
PCT/US2017/028067 WO2017184566A1 (en) 2016-04-19 2017-04-18 Oral pharmaceutical compositions of mesalazine

Publications (2)

Publication Number Publication Date
CN109310642A CN109310642A (zh) 2019-02-05
CN109310642B true CN109310642B (zh) 2021-07-20

Family

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Family Applications (1)

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CN201780031230.6A Expired - Fee Related CN109310642B (zh) 2016-04-19 2017-04-18 美沙拉嗪的口服药物组合物

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 (8)

* 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
CA3021066C (en) 2016-04-19 2024-04-09 Ferring B.V. Oral pharmaceutical compositions of nicotinamide
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
CA3136081A1 (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
US20220125733A1 (en) * 2020-10-23 2022-04-28 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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020098235A1 (en) * 2000-11-20 2002-07-25 Dittmar Gregory Paul Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
US20030152627A1 (en) * 2001-01-31 2003-08-14 Thomas Beckert Multi-particulate form of medicament, comprising at least two differently coated forms of pellet
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
WO2013134348A1 (en) * 2012-03-07 2013-09-12 Santarus, Inc. Controlled-release solid dosage forms of mesalamine

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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.
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
CA2746767A1 (en) 2008-12-17 2010-07-08 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
WO2013144176A1 (en) 2012-03-30 2013-10-03 Laboratorios Del Dr. Esteve, S.A. Controlled release formulatin comprising mesalamine
CA2876540C (en) 2012-06-15 2022-11-29 Conaris Research Institute Ag A pharmaceutical composition containing nicotinic acid and/or nicotinamide and/or tryptophan for positively influencing the intestinal microbiota
US20140178468A1 (en) 2012-12-24 2014-06-26 Ranbaxy Laboratories Limited Multiparticulate extended-release composition of mesalamine
US9763887B2 (en) * 2013-03-15 2017-09-19 Allergan Pharmaceuticals International Limited Mesalamine pharmaceutical composition with multiple dosage elements for reduced delivery variability
ES2788866T3 (es) 2013-12-13 2020-10-23 Conaris Res Institute Ag Una composición farmacéutica que contiene ácido nicotínico y/o nicotinamida para su uso en influir beneficiosamente en los niveles de lípidos en sangre mediante la modificación de la microbiota intestinal
CA2932504A1 (en) 2013-12-13 2015-06-18 Conaris Research Institute Ag A pharmaceutical composition containing combinations of nicotinamide and 5-aminosalicylic acid for beneficially influencing the intestinal microbiota and/or treating gastrointestinal inflammation
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

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US20020098235A1 (en) * 2000-11-20 2002-07-25 Dittmar Gregory Paul Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
US20030152627A1 (en) * 2001-01-31 2003-08-14 Thomas Beckert Multi-particulate form of medicament, comprising at least two differently coated forms of pellet
WO2013134348A1 (en) * 2012-03-07 2013-09-12 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

Also Published As

Publication number Publication date
US20190105275A1 (en) 2019-04-11
CN109310642A (zh) 2019-02-05
BR112018071370A2 (pt) 2019-02-05
EP3445340A1 (en) 2019-02-27
RU2744576C2 (ru) 2021-03-11
CA3021071A1 (en) 2017-10-26
KR20180133503A (ko) 2018-12-14
US20210220281A1 (en) 2021-07-22
RU2018137359A (ru) 2020-05-19
US10874617B2 (en) 2020-12-29
MX387731B (es) 2025-03-18
KR102381586B1 (ko) 2022-04-04
MX2018012618A (es) 2019-06-24
WO2017184566A1 (en) 2017-10-26
AU2017252410A1 (en) 2018-11-01
AR108231A1 (es) 2018-08-01
TW201740932A (zh) 2017-12-01
RU2018137359A3 (enExample) 2020-07-03
JP2019513800A (ja) 2019-05-30

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