WO2010064258A3 - Pharmaceutical formulations of pegylated interferon - Google Patents

Pharmaceutical formulations of pegylated interferon Download PDF

Info

Publication number
WO2010064258A3
WO2010064258A3 PCT/IN2009/000688 IN2009000688W WO2010064258A3 WO 2010064258 A3 WO2010064258 A3 WO 2010064258A3 IN 2009000688 W IN2009000688 W IN 2009000688W WO 2010064258 A3 WO2010064258 A3 WO 2010064258A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulations
pegylated interferon
pegylated
formulations
pharmaceutically acceptable
Prior art date
Application number
PCT/IN2009/000688
Other languages
French (fr)
Other versions
WO2010064258A2 (en
Inventor
Sorab Mody Rustom
Kumar Mishra Ashok
Hanuman D Mallubhotla
Dinesh Mahalingam
Dhruti Tamhane
Ramesh Kumar Shanmugam
Bhavesh Vats
Arpita Shah
Original Assignee
Intas Biopharmaceuticals 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 Intas Biopharmaceuticals Limited filed Critical Intas Biopharmaceuticals Limited
Publication of WO2010064258A2 publication Critical patent/WO2010064258A2/en
Publication of WO2010064258A3 publication Critical patent/WO2010064258A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Abstract

The present invention provides stable pharmaceutical formulations of pegylated interferons comprising pegylated interferon alfa conjugates and pharmaceutically acceptable excipients. The formulations of the invention are in the form of lyophilized powder.
PCT/IN2009/000688 2008-12-01 2009-11-30 Pharmaceutical formulations of interferon conjugates WO2010064258A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2077/MUM/2008 2008-12-01
IN2077MU2008 2008-12-01

Publications (2)

Publication Number Publication Date
WO2010064258A2 WO2010064258A2 (en) 2010-06-10
WO2010064258A3 true WO2010064258A3 (en) 2010-11-11

Family

ID=42233685

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2009/000688 WO2010064258A2 (en) 2008-12-01 2009-11-30 Pharmaceutical formulations of interferon conjugates

Country Status (1)

Country Link
WO (1) WO2010064258A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015535238A (en) 2012-10-26 2015-12-10 ルピン・リミテッドＬｕｐｉｎ Ｌｉｍｉｔｅｄ Stable pharmaceutical composition of pegylated interferon α-2b
WO2017117617A2 (en) * 2016-01-03 2017-07-06 Bernkrant Keith Smart weapon holster
CN113797318B (en) * 2021-10-26 2023-06-30 深圳科兴药业有限公司 Interferon composition and preparation method and application thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005084303A2 (en) * 2004-03-01 2005-09-15 Enzon Pharmaceuticals, Inc. Interferon-beta polymer conjugates
US20060051320A1 (en) * 2004-08-12 2006-03-09 Schering Corporation Stable pegylated interferon formulation
WO2008062481A2 (en) * 2006-11-24 2008-05-29 Cadila Healthcare Limited Formulations of peg-interferon alpha conjugates
WO2008107908A1 (en) * 2007-03-05 2008-09-12 Cadila Healthcare Limited Compositions comprising peg- interferon alpha conjugates and raffinose as cryoprotectant

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005084303A2 (en) * 2004-03-01 2005-09-15 Enzon Pharmaceuticals, Inc. Interferon-beta polymer conjugates
US20060051320A1 (en) * 2004-08-12 2006-03-09 Schering Corporation Stable pegylated interferon formulation
WO2008062481A2 (en) * 2006-11-24 2008-05-29 Cadila Healthcare Limited Formulations of peg-interferon alpha conjugates
WO2008107908A1 (en) * 2007-03-05 2008-09-12 Cadila Healthcare Limited Compositions comprising peg- interferon alpha conjugates and raffinose as cryoprotectant

Also Published As

Publication number Publication date
WO2010064258A2 (en) 2010-06-10

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