AU2013229990B2 - Controlled-release solid dosage forms of mesalamine - Google Patents

Controlled-release solid dosage forms of mesalamine Download PDF

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Publication number
AU2013229990B2
AU2013229990B2 AU2013229990A AU2013229990A AU2013229990B2 AU 2013229990 B2 AU2013229990 B2 AU 2013229990B2 AU 2013229990 A AU2013229990 A AU 2013229990A AU 2013229990 A AU2013229990 A AU 2013229990A AU 2013229990 B2 AU2013229990 B2 AU 2013229990B2
Authority
AU
Australia
Prior art keywords
solid dosage
mini
certain embodiments
mesalamine
dosage form
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.)
Ceased
Application number
AU2013229990A
Other languages
English (en)
Other versions
AU2013229990A1 (en
Inventor
Craig Michael Bowe
John Christopher Carter
Stephen Paul Levine
Dana Elaine Moseson
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.)
Santarus Inc
Original Assignee
Santarus Inc
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 Santarus Inc filed Critical Santarus Inc
Publication of AU2013229990A1 publication Critical patent/AU2013229990A1/en
Application granted granted Critical
Publication of AU2013229990B2 publication Critical patent/AU2013229990B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/2072—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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2013229990A 2012-03-07 2013-03-06 Controlled-release solid dosage forms of mesalamine Ceased AU2013229990B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261607726P 2012-03-07 2012-03-07
US61/607,726 2012-03-07
PCT/US2013/029291 WO2013134348A1 (en) 2012-03-07 2013-03-06 Controlled-release solid dosage forms of mesalamine

Publications (2)

Publication Number Publication Date
AU2013229990A1 AU2013229990A1 (en) 2014-09-18
AU2013229990B2 true AU2013229990B2 (en) 2017-07-06

Family

ID=47884617

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013229990A Ceased AU2013229990B2 (en) 2012-03-07 2013-03-06 Controlled-release solid dosage forms of mesalamine

Country Status (6)

Country Link
US (2) US10071058B2 (enExample)
EP (1) EP2822542A1 (enExample)
JP (1) JP6566638B2 (enExample)
AU (1) AU2013229990B2 (enExample)
CA (1) CA2866276A1 (enExample)
WO (1) WO2013134348A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140141075A1 (en) * 2012-11-21 2014-05-22 Warner Chilcott Company, Llc 5-aminosalicylic acid capsule formulation
CN109195584A (zh) * 2015-09-16 2019-01-11 国家科学研究中心 用于治疗恶性肿瘤和/或防止肿瘤复发的胶凝组合物
CA3021066C (en) 2016-04-19 2024-04-09 Ferring B.V. Oral pharmaceutical compositions of nicotinamide
CA3021071A1 (en) * 2016-04-19 2017-10-26 Ferring B.V. Oral pharmaceutical compositions of mesalazine
JP2018052909A (ja) * 2016-05-16 2018-04-05 日本製紙株式会社 化粧用組成物
KR20210054539A (ko) 2018-08-31 2021-05-13 옵코 아일랜드 글로벌 홀딩스 리미티드 비타민 d의 소아용 투여 형태, 이의 제조 및 사용
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
US11975011B2 (en) * 2020-11-03 2024-05-07 Atoz Pharmaceuticals Pvt Ltd Matrix mesalamine extended release minitablets and its process thereof
EP4472640A1 (en) * 2022-02-04 2024-12-11 Intact Therapeutics, Inc. Mesalamine pharmaceutical formulations and methods of use thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003032952A1 (en) * 2001-10-15 2003-04-24 Ferring Bv Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease
EP1547601A1 (en) * 2003-12-23 2005-06-29 Ferring B.V. Coating method
US20090017110A1 (en) * 2005-05-31 2009-01-15 Capricorn Pharma Inc. Modified release formulations of anti-irritability drugs
WO2011045775A1 (en) * 2009-10-16 2011-04-21 Ranbaxy Laboratories Limited A delayed release pharmaceutical composition of mesalamine

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
ITMI991316A1 (it) * 1999-06-14 2000-12-14 Cip Ninety Two 92 S A Composizioni farmaceutiche orali a rilascio modificato di mesalazina
AR034813A1 (es) * 2001-07-20 2004-03-17 Novartis Ag Composiciones farmaceuticas y uso de las mismas
SE0102887D0 (sv) * 2001-08-29 2001-08-29 Astrazeneca Ab New formulation
US8916546B2 (en) * 2003-08-29 2014-12-23 Therapeutic Research Llc Materials and methods for treatment and diagnosis of disorders associated with oxidative stress
US7737133B2 (en) * 2003-09-03 2010-06-15 Agi Therapeutics Ltd. Formulations and methods of treating inflammatory bowel disease
ZA200806496B (en) * 2006-01-27 2009-12-30 Eurand Inc Drug delivery systems comprising weakly basic drugs and organic acids
EP2392321A1 (en) * 2007-06-13 2011-12-07 Jay Pravda Combined composition for rectal administration for the treatment of inflammatory bowel disease
WO2010040021A1 (en) * 2008-10-03 2010-04-08 Salix Pharmaceuticals, Ltd. Compositions and methods for the treatment of bowel diseases with granulated mesalamine
US20120128764A1 (en) * 2009-02-23 2012-05-24 Aptalis Pharmatech, Inc. Controlled-release compositions comprising a proton pump inhibitor
JP2014517843A (ja) * 2011-05-24 2014-07-24 テバ ファーマシューティカル インダストリーズ リミティド 医薬組成物用の圧縮コア

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003032952A1 (en) * 2001-10-15 2003-04-24 Ferring Bv Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease
EP1547601A1 (en) * 2003-12-23 2005-06-29 Ferring B.V. Coating method
US20090017110A1 (en) * 2005-05-31 2009-01-15 Capricorn Pharma Inc. Modified release formulations of anti-irritability drugs
WO2011045775A1 (en) * 2009-10-16 2011-04-21 Ranbaxy Laboratories Limited A delayed release pharmaceutical composition of mesalamine

Also Published As

Publication number Publication date
US20150056275A1 (en) 2015-02-26
US20190231699A1 (en) 2019-08-01
JP2015509539A (ja) 2015-03-30
WO2013134348A1 (en) 2013-09-12
EP2822542A1 (en) 2015-01-14
US10071058B2 (en) 2018-09-11
US10555907B2 (en) 2020-02-11
JP6566638B2 (ja) 2019-08-28
CA2866276A1 (en) 2013-09-12
AU2013229990A1 (en) 2014-09-18

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Legal Events

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired