WO2009047802A3 - Novel colon targeted modified release bioadhesive formulation of 5-amino salicylic acid or its salts and metabolites thereof - Google Patents

Novel colon targeted modified release bioadhesive formulation of 5-amino salicylic acid or its salts and metabolites thereof Download PDF

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Publication number
WO2009047802A3
WO2009047802A3 PCT/IN2008/000654 IN2008000654W WO2009047802A3 WO 2009047802 A3 WO2009047802 A3 WO 2009047802A3 IN 2008000654 W IN2008000654 W IN 2008000654W WO 2009047802 A3 WO2009047802 A3 WO 2009047802A3
Authority
WO
WIPO (PCT)
Prior art keywords
metabolites
salicylic acid
modified release
salts
amino salicylic
Prior art date
Application number
PCT/IN2008/000654
Other languages
French (fr)
Other versions
WO2009047802A2 (en
Inventor
Shirish Kumar Kulkarni
Rajesh Kulkarni
Pandarinath Jadhav
Umesh Badhe
Sushma Gupta
Original Assignee
Lupin Limited
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 Lupin Limited filed Critical Lupin Limited
Priority to JP2010528531A priority Critical patent/JP2011500553A/en
Publication of WO2009047802A2 publication Critical patent/WO2009047802A2/en
Publication of WO2009047802A3 publication Critical patent/WO2009047802A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a colon targeted modified release bioadhesive pharmaceutical composition of 5-amino salicylic acid or a pharmaceutically acceptable salt or enantiomer or polymorph or metabolites thereof, one or more hydrophilic or hydrophobic release controlling agent (s) and pharmaceutical acceptable excipient (s), and the process of preparing it.
PCT/IN2008/000654 2007-10-10 2008-10-08 Novel colon targeted modified release bioadhesive formulation of 5-amino salicylic acid or its salts and metabolites thereof WO2009047802A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2010528531A JP2011500553A (en) 2007-10-10 2008-10-08 Controlled release bioadhesive formulation targeting 5-colon of 5-aminosalicylic acid or its salts or metabolites

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1394KO2007 2007-10-10
IN1394/KOL/2007 2007-10-10

Publications (2)

Publication Number Publication Date
WO2009047802A2 WO2009047802A2 (en) 2009-04-16
WO2009047802A3 true WO2009047802A3 (en) 2009-09-24

Family

ID=40276174

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2008/000654 WO2009047802A2 (en) 2007-10-10 2008-10-08 Novel colon targeted modified release bioadhesive formulation of 5-amino salicylic acid or its salts and metabolites thereof

Country Status (2)

Country Link
JP (1) JP2011500553A (en)
WO (1) WO2009047802A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8920838B2 (en) 2006-08-03 2014-12-30 Horizon Pharma Ag Delayed-release glucocorticoid treatment of rheumatoid disease

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2359812C (en) 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
WO2011045775A1 (en) * 2009-10-16 2011-04-21 Ranbaxy Laboratories Limited A delayed release pharmaceutical composition of mesalamine
WO2011102504A1 (en) 2010-02-22 2011-08-25 第一三共株式会社 Sustained-release solid preparation for oral use
TW201200165A (en) * 2010-02-22 2012-01-01 Daiichi Sankyo Co Ltd Oral solid extended release dosage form
KR101767288B1 (en) * 2010-03-31 2017-08-10 모찌다 세이야쿠 가부시끼가이샤 Easily dosable solid preparation
EP2425826A1 (en) * 2010-09-01 2012-03-07 Disphar International B.V. Mesalazine tablet having improved dissolution
CA2847614C (en) 2011-09-30 2018-10-23 Mochida Pharmaceutical Co., Ltd. Easily dosable solid preparation
CN104768552A (en) 2012-09-03 2015-07-08 第一三共株式会社 Hydromorphone hydrochloride-containing oral sustained-release pharmaceutical composition
LT2959892T (en) * 2013-02-22 2020-12-10 Zeria Pharmaceutical Co., Ltd. Enteric coated tablet
EP3162362A1 (en) 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Optimized high-dose tablet of mesalazine
US20210077415A1 (en) * 2018-01-03 2021-03-18 Ferring B.V. Oral liquid pharmaceutical compositions of aminosalicylates
MX2021002686A (en) * 2018-09-06 2021-08-11 Fachhochschule Nordwestschweiz Controlled drug release formulation.
EP3662895A1 (en) 2018-12-07 2020-06-10 Tillotts Pharma AG A process for manufacturing reducing sugar-free 5-asa tablet cores
IT201800011120A1 (en) * 2018-12-14 2020-06-14 Dpl Pharma S P A SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR THE ADMINISTRATION OF MESALAZINE OR ITS DERIVATIVES

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992016206A1 (en) * 1991-03-15 1992-10-01 Norwich Eaton Pharmaceuticals Inc. The use of 5-aminosalicylic acid in the treatment of irritable bowel syndrome - diarrheal phase or type (ibs-d)
US20050090473A1 (en) * 2003-09-03 2005-04-28 John Devane Formulations and methods of treating inflammatory bowel disease
US20060223787A1 (en) * 2003-09-03 2006-10-05 John Devane Modified release formulations and methods of treating inflammatory bowel disease

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0624962A (en) * 1992-07-09 1994-02-01 Green Cross Corp:The Enteric sustained release solid pharmaceutical preparation
FR2752843B1 (en) * 1996-08-30 1998-10-16 Sod Conseils Rech Applic CROSSLINKED COPOLYMERS BASED ON POLYCARBOXYLIC POLYMERS AND THEIR USE AS SUPPORTS OF PHARMACEUTICAL COMPOSITIONS
GB0025208D0 (en) * 2000-10-13 2000-11-29 Euro Celtique Sa Delayed release pharmaceutical formulations
WO2005030173A1 (en) * 2003-09-25 2005-04-07 Ranbaxy Laboratories Limited Colon-specific drug delivery using interpolymer complexations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992016206A1 (en) * 1991-03-15 1992-10-01 Norwich Eaton Pharmaceuticals Inc. The use of 5-aminosalicylic acid in the treatment of irritable bowel syndrome - diarrheal phase or type (ibs-d)
US20050090473A1 (en) * 2003-09-03 2005-04-28 John Devane Formulations and methods of treating inflammatory bowel disease
US20060223787A1 (en) * 2003-09-03 2006-10-05 John Devane Modified release formulations and methods of treating inflammatory bowel disease

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HARDY J G ET AL: "GASTROINTESTINAL TRANSIT OF AN ENTERIC-COATED DELAYED-RELEASE 5- AMINOSALICYLIC ACID TABLET", ALIMENTARY PHARMACOLOGY & THERAPEUTICS, BLACKWELL SCIENTIFIC PUBLICATIONS LTD., CAMBRIDGE, GB, vol. 1, no. 3, 1 June 1987 (1987-06-01), pages 209 - 216, XP000569271, ISSN: 0269-2813 *
SHIRE US INC: ""Lialda" (mesalamine) delayed release tablets"", INTERNET ARTICLE, 16 January 2007 (2007-01-16), XP002533219, Retrieved from the Internet <URL:http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf> [retrieved on 20090620] *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8920838B2 (en) 2006-08-03 2014-12-30 Horizon Pharma Ag Delayed-release glucocorticoid treatment of rheumatoid disease

Also Published As

Publication number Publication date
WO2009047802A2 (en) 2009-04-16
JP2011500553A (en) 2011-01-06

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