WO2003011224A3 - Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same - Google Patents

Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same Download PDF

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Publication number
WO2003011224A3
WO2003011224A3 PCT/US2002/024262 US0224262W WO03011224A3 WO 2003011224 A3 WO2003011224 A3 WO 2003011224A3 US 0224262 W US0224262 W US 0224262W WO 03011224 A3 WO03011224 A3 WO 03011224A3
Authority
WO
WIPO (PCT)
Prior art keywords
lapachone
beta
pharmaceutically acceptable
carrier molecule
pharmaceutical compositions
Prior art date
Application number
PCT/US2002/024262
Other languages
French (fr)
Other versions
WO2003011224A2 (en
Inventor
Zhiwei Jiang
Dasharatha G Reddy
Original Assignee
Cyclis Pharmaceuticals Inc
Zhiwei Jiang
Dasharatha G Reddy
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
Priority to EP02753423A priority Critical patent/EP1420777A4/en
Priority to AU2002313713A priority patent/AU2002313713B2/en
Priority to CA002455567A priority patent/CA2455567A1/en
Priority to US10/343,091 priority patent/US7074824B2/en
Application filed by Cyclis Pharmaceuticals Inc, Zhiwei Jiang, Dasharatha G Reddy filed Critical Cyclis Pharmaceuticals Inc
Priority to KR1020047001569A priority patent/KR100734341B1/en
Priority to JP2003516456A priority patent/JP2005507861A/en
Priority to IL16010802A priority patent/IL160108A0/en
Priority to NZ531335A priority patent/NZ531335A/en
Priority to BR0211613-8A priority patent/BR0211613A/en
Priority to EA200400242A priority patent/EA007075B1/en
Priority to MXPA04000994A priority patent/MXPA04000994A/en
Publication of WO2003011224A2 publication Critical patent/WO2003011224A2/en
Publication of WO2003011224A3 publication Critical patent/WO2003011224A3/en
Priority to US11/140,838 priority patent/US20050245599A1/en
Priority to IL192937A priority patent/IL192937A0/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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Abstract

Beta-lapachone, which is poorly soluble in most pharmaceutically acceptable solvents, has demonstrated significant antineoplastic activity against human cancer lines. The present invention overcomes this significant limitation by teaching novel pharmaceutical compositions comprising a therapeutically effective amount of Beta-lapachone, or a derivative or analog thereof, and a pharmaceutically acceptable solubilizing carrier molecule, which may be at water-solubilizing carrier molecule such as hydroxypropyl-β-cyclodextrin, or an oil-based solubilizing carrier molecule, for enhancing the solubility of Beta-lapachone in aqueous solution. The therapeutically effective amount of Beta-lapachone, or a derivative or analog thereof, may be complexed with the pharmaceutically acceptable solubilizing carrier molecule in aqueous solution. The novel pharmaceutical compositions may be administered with a second anticancer agent or in combination with radiation therapy. A formulation of Beta-lapachone or a derivative or analog thereof, complexed with a pharmaceutically acceptable solubilizing carrier molecule, wherein the complex can be freeze-dried and when subsequently reconstituted in aqueous solution is substantially soluble is also disclosed. Emulsions of Beta-Lapachone in a pharmaceutically acceptable fat emulsion vehicle are also provided. Also disclosed are methods for treating cancer by administering to a patient the novel pharmaceutical compositions and formulations. Pharmaceutical kits are also provided.
PCT/US2002/024262 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same WO2003011224A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
JP2003516456A JP2005507861A (en) 2001-07-31 2002-07-31 Pharmaceutical compositions comprising β-lapachone, or derivatives or analogs thereof, and methods of use thereof
CA002455567A CA2455567A1 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
US10/343,091 US7074824B2 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
NZ531335A NZ531335A (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
KR1020047001569A KR100734341B1 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
AU2002313713A AU2002313713B2 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
IL16010802A IL160108A0 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone or derivatives or analogs thereof, and methods of using same
EP02753423A EP1420777A4 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
BR0211613-8A BR0211613A (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone or derivatives or analogs thereof, and processes for their use
EA200400242A EA007075B1 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
MXPA04000994A MXPA04000994A (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same.
US11/140,838 US20050245599A1 (en) 2001-07-31 2005-05-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
IL192937A IL192937A0 (en) 2001-07-31 2008-07-21 Pharmaceutical compositions containing beta-lapachone or derivatives or analogs thereof, and methods of using same

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US30893501P 2001-07-31 2001-07-31
US60/308,935 2001-07-31
US09/975,776 US6962944B2 (en) 2001-07-31 2001-10-10 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same
US09/975,776 2001-10-10

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09/975,776 Continuation-In-Part US6962944B2 (en) 2001-07-31 2001-10-10 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/140,838 Continuation US20050245599A1 (en) 2001-07-31 2005-05-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same

Publications (2)

Publication Number Publication Date
WO2003011224A2 WO2003011224A2 (en) 2003-02-13
WO2003011224A3 true WO2003011224A3 (en) 2003-05-08

Family

ID=26976533

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/024262 WO2003011224A2 (en) 2001-07-31 2002-07-31 Pharmaceutical compositions containing beta-lapachone, or derivatives or analogs thereof, and methods of using same

Country Status (13)

Country Link
US (1) US6962944B2 (en)
EP (1) EP1420777A4 (en)
JP (1) JP2005507861A (en)
KR (1) KR100734341B1 (en)
CN (1) CN1561209A (en)
AU (1) AU2002313713B2 (en)
BR (1) BR0211613A (en)
CA (1) CA2455567A1 (en)
EA (1) EA007075B1 (en)
IL (2) IL160108A0 (en)
MX (1) MXPA04000994A (en)
NZ (1) NZ531335A (en)
WO (1) WO2003011224A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9308180B2 (en) 2005-08-31 2016-04-12 Abraxis Bioscience, Llc Compositions and methods for preparation of poorly water soluble drugs with increased stability

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US20040241094A1 (en) * 2001-09-13 2004-12-02 Hesson Chung Oily paclitaxel composition and formulation for chemoembolization and preparation method thereof
WO2003090710A1 (en) * 2002-04-23 2003-11-06 Case Western Reserve University Lapachone delivery systems, compositions and uses related thereto
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US7361691B2 (en) 2002-12-02 2008-04-22 Arqule, Inc. Method of treating cancers using β-lapachone or analogs or derivatives thereof
JP2007512378A (en) * 2003-11-26 2007-05-17 アークル インコーポレイテッド Use of β-lapachone to protect against radiation damage
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KR101405823B1 (en) 2007-12-24 2014-06-12 주식회사 케이티앤지생명과학 Pharmaceutical Composition for the Treatment and Prevention of glaucoma
KR20090071829A (en) * 2007-12-28 2009-07-02 주식회사 머젠스 Pharmaceutical composition for treatment and prevention of kidney diseases
KR20090073381A (en) * 2007-12-31 2009-07-03 주식회사 머젠스 Pharmaceutical composition for the treatment and prevention of cardiac disease
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WO2019143192A1 (en) * 2018-01-18 2019-07-25 (주)나디안바이오 Composition comprising dunnione as effective ingredient for prevention or alleviation of hair loss
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Also Published As

Publication number Publication date
US6962944B2 (en) 2005-11-08
US20030091639A1 (en) 2003-05-15
KR100734341B1 (en) 2007-07-03
CN1561209A (en) 2005-01-05
EP1420777A4 (en) 2009-03-04
IL192937A0 (en) 2009-02-11
EA200400242A1 (en) 2004-12-30
WO2003011224A2 (en) 2003-02-13
EA007075B1 (en) 2006-06-30
NZ531335A (en) 2007-08-31
MXPA04000994A (en) 2005-02-17
EP1420777A2 (en) 2004-05-26
AU2002313713B2 (en) 2007-03-29
IL160108A0 (en) 2004-06-20
CA2455567A1 (en) 2003-02-13
JP2005507861A (en) 2005-03-24
BR0211613A (en) 2004-11-09
KR20040054667A (en) 2004-06-25

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