WO2002102376A8 - ORALLY DELIVERABLE PHARMACEUTICAL COMPOSITION COMPRISING AN ACTIVE COMPOUND HAVING AN AMINOSULFONYL GROUP (cox-2 INHIBITOR), A POLYETHYLENE GLYCOL AND A FREE-RADICAL SCAVENGING ANTIOXIDANT - Google Patents

ORALLY DELIVERABLE PHARMACEUTICAL COMPOSITION COMPRISING AN ACTIVE COMPOUND HAVING AN AMINOSULFONYL GROUP (cox-2 INHIBITOR), A POLYETHYLENE GLYCOL AND A FREE-RADICAL SCAVENGING ANTIOXIDANT

Info

Publication number
WO2002102376A8
WO2002102376A8 PCT/US2002/011690 US0211690W WO02102376A8 WO 2002102376 A8 WO2002102376 A8 WO 2002102376A8 US 0211690 W US0211690 W US 0211690W WO 02102376 A8 WO02102376 A8 WO 02102376A8
Authority
WO
WIPO (PCT)
Prior art keywords
polyethylene glycol
pharmaceutical composition
cox
inhibitor
free
Prior art date
Application number
PCT/US2002/011690
Other languages
French (fr)
Other versions
WO2002102376A1 (en
Inventor
Ping Gao
Tiehua Huang
Russell H Robins
Juliane M Bauer
Jane E Guido
Andrew M Brugger
Aziz Karim
Fred Hassan
James C Forbes
Original Assignee
Pharmacia Corp
Ping Gao
Tiehua Huang
Russell H Robins
Juliane M Bauer
Jane E Guido
Andrew M Brugger
Aziz Karim
Fred Hassan
James C Forbes
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26962690&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002102376(A8) "Global patent litigation datasetā€ by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to KR10-2003-7013653A priority Critical patent/KR20040012761A/en
Priority to EA200301018A priority patent/EA006677B1/en
Priority to JP2003504963A priority patent/JP2004529986A/en
Priority to NZ528716A priority patent/NZ528716A/en
Priority to BR0208947-5A priority patent/BR0208947A/en
Priority to MXPA03009410A priority patent/MXPA03009410A/en
Priority to EP02723846A priority patent/EP1494666A1/en
Application filed by Pharmacia Corp, Ping Gao, Tiehua Huang, Russell H Robins, Juliane M Bauer, Jane E Guido, Andrew M Brugger, Aziz Karim, Fred Hassan, James C Forbes filed Critical Pharmacia Corp
Priority to AU2002254609A priority patent/AU2002254609B2/en
Priority to IL15820002A priority patent/IL158200A0/en
Priority to CA002444356A priority patent/CA2444356A1/en
Publication of WO2002102376A1 publication Critical patent/WO2002102376A1/en
Publication of WO2002102376A8 publication Critical patent/WO2002102376A8/en
Priority to NO20034627A priority patent/NO20034627L/en
Priority to HK05100590A priority patent/HK1068278A1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D231/00—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings
    • C07D231/02—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings
    • C07D231/10—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
    • C07D231/12—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring carbon atoms
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g.Ā sulfadiazine
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D261/00—Heterocyclic compounds containing 1,2-oxazole or hydrogenated 1,2-oxazole rings
    • C07D261/02—Heterocyclic compounds containing 1,2-oxazole or hydrogenated 1,2-oxazole rings not condensed with other rings
    • C07D261/06—Heterocyclic compounds containing 1,2-oxazole or hydrogenated 1,2-oxazole rings not condensed with other rings having two or more double bonds between ring members or between ring members and non-ring members
    • C07D261/08—Heterocyclic compounds containing 1,2-oxazole or hydrogenated 1,2-oxazole rings not condensed with other rings having two or more double bonds between ring members or between ring members and non-ring members with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D413/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings
    • C07D413/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

Abstract

An orally deliverable pharmaceutical composition is provided comprising an aminosulfonyl-comprising drug, for example a selective cyclooxygenase-2 inhibitory drug such as celecoxib, and a solvent liquid comprising a polyethylene glycol and one or more free radical-scavenging antioxidants. At least a substantial part of the drug is in dissolved form in the solvent liquid. The composition has rapid-onset properties and is useful in treatment of cyclooxygenase-2 mediated conditions and disorders.
PCT/US2002/011690 2001-04-17 2002-04-12 ORALLY DELIVERABLE PHARMACEUTICAL COMPOSITION COMPRISING AN ACTIVE COMPOUND HAVING AN AMINOSULFONYL GROUP (cox-2 INHIBITOR), A POLYETHYLENE GLYCOL AND A FREE-RADICAL SCAVENGING ANTIOXIDANT WO2002102376A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CA002444356A CA2444356A1 (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant
EP02723846A EP1494666A1 (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant
JP2003504963A JP2004529986A (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), polyethylene glycol and a free radical scavenging antioxidant
NZ528716A NZ528716A (en) 2001-04-17 2002-04-12 Stabilized oral pharmaceutical composition
BR0208947-5A BR0208947A (en) 2001-04-17 2002-04-12 Stabilized oral pharmaceutical composition
MXPA03009410A MXPA03009410A (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant.
AU2002254609A AU2002254609B2 (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (COX-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant
KR10-2003-7013653A KR20040012761A (en) 2001-04-17 2002-04-12 Stabilized oral pharmaceutical composition
EA200301018A EA006677B1 (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant
IL15820002A IL158200A0 (en) 2001-04-17 2002-04-12 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycol and a free-radical scavenging antioxidant
NO20034627A NO20034627L (en) 2001-04-17 2003-10-16 Orally dispensable pharmaceutical composition comprising an active compound with an aminosulfonyl group (cox-2 inhibitor), a polyethylene glycologist, a free radical-removing antioxidant
HK05100590A HK1068278A1 (en) 2001-04-17 2005-01-21 Orally deliverable pharmaceutical composition comprising an active compound having an aminosulfonyl group, a polyethylene glycol and an antioxidant

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US28458901P 2001-04-17 2001-04-17
US60/284,589 2001-04-17
US35795902P 2002-02-19 2002-02-19
US60/357,959 2002-02-19

Publications (2)

Publication Number Publication Date
WO2002102376A1 WO2002102376A1 (en) 2002-12-27
WO2002102376A8 true WO2002102376A8 (en) 2003-04-24

Family

ID=26962690

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2002/011690 WO2002102376A1 (en) 2001-04-17 2002-04-12 ORALLY DELIVERABLE PHARMACEUTICAL COMPOSITION COMPRISING AN ACTIVE COMPOUND HAVING AN AMINOSULFONYL GROUP (cox-2 INHIBITOR), A POLYETHYLENE GLYCOL AND A FREE-RADICAL SCAVENGING ANTIOXIDANT
PCT/US2002/012013 WO2002083655A1 (en) 2001-04-17 2002-04-17 Prodrugs of cox-2 inhibitors

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2002/012013 WO2002083655A1 (en) 2001-04-17 2002-04-17 Prodrugs of cox-2 inhibitors

Country Status (22)

Country Link
US (5) US20030105144A1 (en)
EP (2) EP1494666A1 (en)
JP (2) JP2004529986A (en)
KR (1) KR20040012761A (en)
CN (1) CN1292746C (en)
AR (1) AR033466A1 (en)
AT (1) ATE370938T1 (en)
AU (1) AU2002254609B2 (en)
BR (1) BR0208947A (en)
CA (2) CA2444356A1 (en)
CZ (1) CZ20032793A3 (en)
DE (1) DE60221977T2 (en)
EA (1) EA006677B1 (en)
ES (1) ES2289139T3 (en)
HK (1) HK1068278A1 (en)
IL (1) IL158200A0 (en)
MX (1) MXPA03009410A (en)
NO (1) NO20034627L (en)
NZ (1) NZ528716A (en)
PE (1) PE20021108A1 (en)
PL (1) PL367180A1 (en)
WO (2) WO2002102376A1 (en)

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