WO2006131566A3 - Oral ribavirin pharmaceutical compositions - Google Patents

Oral ribavirin pharmaceutical compositions Download PDF

Info

Publication number
WO2006131566A3
WO2006131566A3 PCT/EP2006/063070 EP2006063070W WO2006131566A3 WO 2006131566 A3 WO2006131566 A3 WO 2006131566A3 EP 2006063070 W EP2006063070 W EP 2006063070W WO 2006131566 A3 WO2006131566 A3 WO 2006131566A3
Authority
WO
WIPO (PCT)
Prior art keywords
ribavirin
bio
treatment
oral
absorption time
Prior art date
Application number
PCT/EP2006/063070
Other languages
French (fr)
Other versions
WO2006131566A2 (en
Inventor
Gerard Soula
Remi Meyrueix
Florence Guimberteau
Catherine Castan
Original Assignee
Flamel Tech Sa
Gerard Soula
Remi Meyrueix
Florence Guimberteau
Catherine Castan
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 Flamel Tech Sa, Gerard Soula, Remi Meyrueix, Florence Guimberteau, Catherine Castan filed Critical Flamel Tech Sa
Priority to JP2008515226A priority Critical patent/JP2009514784A/en
Priority to CA002609998A priority patent/CA2609998A1/en
Priority to EP06763633A priority patent/EP1888047A2/en
Publication of WO2006131566A2 publication Critical patent/WO2006131566A2/en
Publication of WO2006131566A3 publication Critical patent/WO2006131566A3/en

Links

Classifications

    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
    • 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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • 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
    • A61K9/2004—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
    • A61K9/2004—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

Abstract

The invention relates to oral pharmaceutical compositions for the prevention and/or the treatment of viral diseases. This invention also addresses methods of prevention and/or treatment of these viral diseases, using these oral compositions. One of the main problems considered in the present invention, is to enhance the efficiency of anti-viral treatments, especially against Hepatitis C by means of ribavirin, for example in combination with interferon. The oral ribavirin antiviral composition according to the invention increases the bio-absorption time of ribavirin, and thus improves the treatment of the patients. Said composition comprises at least one modified release form of ribavirin which bio-absorption time BAT is greater than the bio-absorption time BAT* of a reference* immediate release form of ribavirin administered at the same dose; BAT being preferably comprised between 2 and 15 hours and more preferably between 4 and 12 hours. Said composition is a reservoir type form or a matricial type form. Said composition is a gastric retentive system or a multiparticulate form.
PCT/EP2006/063070 2005-06-09 2006-06-09 Oral ribavirin pharmaceutical compositions WO2006131566A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2008515226A JP2009514784A (en) 2005-06-09 2006-06-09 Oral ribavirin pharmaceutical composition
CA002609998A CA2609998A1 (en) 2005-06-09 2006-06-09 Oral ribavirin pharmaceutical compositions
EP06763633A EP1888047A2 (en) 2005-06-09 2006-06-09 Oral ribavirin pharmaceutical compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IBPCT/IB2005/054434 2005-06-09
PCT/IB2005/054434 WO2006131790A2 (en) 2005-06-09 2005-06-09 Oral ribavirin pharmaceutical composition

Publications (2)

Publication Number Publication Date
WO2006131566A2 WO2006131566A2 (en) 2006-12-14
WO2006131566A3 true WO2006131566A3 (en) 2007-04-12

Family

ID=36791638

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/IB2005/054434 WO2006131790A2 (en) 2005-06-09 2005-06-09 Oral ribavirin pharmaceutical composition
PCT/EP2006/063070 WO2006131566A2 (en) 2005-06-09 2006-06-09 Oral ribavirin pharmaceutical compositions

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/IB2005/054434 WO2006131790A2 (en) 2005-06-09 2005-06-09 Oral ribavirin pharmaceutical composition

Country Status (4)

Country Link
EP (1) EP1888047A2 (en)
JP (1) JP2009514784A (en)
CA (1) CA2609998A1 (en)
WO (2) WO2006131790A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2945947B1 (en) * 2009-05-29 2011-07-29 Flamel Tech Sa FLOATING PHARMACEUTICAL COMPOSITIONS WITH CONTROLLED RELEASE
US20170151272A1 (en) * 2014-06-23 2017-06-01 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi A novel pharmaceutical composition of sofosbuvir and ribavirin
EA201692514A1 (en) * 2014-06-23 2017-04-28 Сановель Илач Санайи Ве Тиджарет А.Ш. PHARMACEUTICAL COMPOSITIONS ON THE BASIS OF SOFOSBUVIR AND RIBAVIRIN WITH MODIFIED FREEDOM
CN108354000B (en) * 2018-04-19 2021-12-28 西安工程大学 Slow-release and controlled-release microcapsule for fresh agricultural products and preparation method thereof

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6022562A (en) * 1994-10-18 2000-02-08 Flamel Technologies Medicinal and/or nutritional microcapsules for oral administration
US20030104056A1 (en) * 2000-10-13 2003-06-05 Rudnic Edward M. Delayed release anti-viral product, use and formulation thereof
US20040234601A1 (en) * 2001-10-09 2004-11-25 Valerie Legrand Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
US20050019406A1 (en) * 2002-09-19 2005-01-27 Three Rivers Pharmaceuticals, Llc Composition containing ribavirin and use thereof
WO2005016370A1 (en) * 2003-08-13 2005-02-24 Howard J. Smith & Associates Pty Ltd Method of treating viral infections

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2837100B1 (en) * 2002-03-18 2004-07-23 Flamel Tech Sa MODIFIED RELEASE MICROCAPSULE-BASED TABLETS

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6022562A (en) * 1994-10-18 2000-02-08 Flamel Technologies Medicinal and/or nutritional microcapsules for oral administration
US20030104056A1 (en) * 2000-10-13 2003-06-05 Rudnic Edward M. Delayed release anti-viral product, use and formulation thereof
US20040234601A1 (en) * 2001-10-09 2004-11-25 Valerie Legrand Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
US20050019406A1 (en) * 2002-09-19 2005-01-27 Three Rivers Pharmaceuticals, Llc Composition containing ribavirin and use thereof
WO2005016370A1 (en) * 2003-08-13 2005-02-24 Howard J. Smith & Associates Pty Ltd Method of treating viral infections

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; BEI, QINGSHENG: "Release-sustained pellet of ribavirin", XP002395861, retrieved from STN Database accession no. 2005:353828 *
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; TAO, XIUMEI ET AL: "Preparation of ribavirin sustained - release pellets by centrifugal granulation technology", XP002395860, retrieved from STN Database accession no. 2005:500395 *
ZHONGGUO YAOXUE ZAZHI (BEIJING, CHINA) , 39(12), 925-927 CODEN: ZYZAEU; ISSN: 1001-2494, 2004 *

Also Published As

Publication number Publication date
JP2009514784A (en) 2009-04-09
CA2609998A1 (en) 2006-12-14
WO2006131790A3 (en) 2007-07-05
EP1888047A2 (en) 2008-02-20
WO2006131790A2 (en) 2006-12-14
WO2006131566A2 (en) 2006-12-14

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