EP1214073A2 - Use of dexrazoxane for treating psoriasis - Google Patents

Use of dexrazoxane for treating psoriasis

Info

Publication number
EP1214073A2
EP1214073A2 EP00960646A EP00960646A EP1214073A2 EP 1214073 A2 EP1214073 A2 EP 1214073A2 EP 00960646 A EP00960646 A EP 00960646A EP 00960646 A EP00960646 A EP 00960646A EP 1214073 A2 EP1214073 A2 EP 1214073A2
Authority
EP
European Patent Office
Prior art keywords
dexrazoxane
medicament
calculated
injection
infusion
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP00960646A
Other languages
German (de)
English (en)
French (fr)
Inventor
Iervant Zarmanian
Jadranka Rogan-Grgas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cyathus Exquirere Pharmaforschungs GmbH
Original Assignee
Cyathus Exquirere Pharmaforschungs GmbH
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 Cyathus Exquirere Pharmaforschungs GmbH filed Critical Cyathus Exquirere Pharmaforschungs GmbH
Publication of EP1214073A2 publication Critical patent/EP1214073A2/en
Withdrawn legal-status Critical Current

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/08—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
    • A61K47/30—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
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61K9/2027—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
    • A61K9/20—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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics

Definitions

  • This invention relates to pharmaceutical compositions based on l,2-bis(3,5- dioxopiperazin-l-yl)-propane and pharmaceutically acceptable salts thereof.
  • Step 1 is topical treatment
  • step 2 is phototherapy
  • step 3 is systemic treatment.
  • Medicines currently prescribed for systemic treatment are the immunosuppressants methotrexate and cyclosporine A, hydroxyurea and retinoids.
  • razoxane was not developed further and today is not recommended for treatment of psoriasis. Hitherto, therefore, the known facts about razoxane have been that it cannot be used both safely and effectively to treat psoriasis.
  • a new pharmaceutical composition for treatment of psoriasis contains as active compound dexrazoxane, or a pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable carrier and/or excipient.
  • the invention also includes a method of treating psoriasis in a patient, comprising administering to the patient a therapeutically effective amount of dexrazoxane, the d- isomer of l,2-bis(3,5-dioxopiperazin-l-yl)-propane, a compound of formula
  • PASI Psoriasis Area and Severity Index
  • the method may comprise administering the dexrazoxane by injection or infusion (or by other internal administration route, for example oral) at a daily dosage of, for example, between 250mg and 1750mg, and in one suitable protocol comprises administering the dexrazoxane at increasing dosages, for example at a first daily dosage for an initial period of up to e.g. 5 days, a second daily dosage for a second period of up to e.g. 5 days and a third daily dosage for a third period of up to e.g. five days.
  • the initial, second and third periods may be spaced apart and preferably are one or two days long; one of the initial, second and third periods is dispensed with in some treatment protocols.
  • the first daily dosage is usually from about 250mg to about 750mg (e.g. about 500mg)
  • the second daily dosage is usually from about 750mg to 1250mg (e.g. about lOOOmg)
  • the third daily dosage is usually from about 1250mg to 1750mg (e.g. about 1500mg).
  • administering dexrazoxane involve administering the dexrazoxane at intervals, for example with an interval between administration periods of from 5 to 20 days, more usually from 8 to 16 days and most preferably of from 10 to 14 days, e.g. 12 days.
  • an administration period may last two successive days, on each of which dexrazoxane is administered.
  • single day administration periods may be used, or administration periods of more than two days, in which case dexrazoxane may be administered on all of the days or only some of them.
  • the dosage may be varied, for example increased, over the course of the treatment.
  • the dosage may be increased after the first administration period of the protocol described in the previous paragraph if the patient's initial response is not adequate.
  • an adult is administered a dose of from about 250mg to about 750mg on each day of an initial two day administration period, after which the dose may be maintained or increased (e.g. to about 750mg to about 1250 mg).
  • the dosage may be maintained or, if necessary increased (or even decreased) for the third administration period.
  • the dosage is conveniently, but not necessarily, altered in steps of 500mg.
  • dexrazoxane weights and weight percentages specified in this application refer to dexrazoxane hydrochloride, i.e. they relate to dexrazoxane as the hydrochloride salt. If an alternative form is used appropriate adjustments should be made on the basis of the relative molecular weights of the two forms. Similarly, dosages must be suitably adjusted for the treatment of children.
  • the dexrazoxane is administered intravenously or otherwise by injection or infusion.
  • the solutions for injection or infusion are made by reconstituting lyophilised dexrazoxane just prior to administration.
  • the lyophihsate may be packaged in an amount corresponding to the unit dosage to be used and packages containing about 250mg, from about 750 mg to about 1250 mg or about 1250 mg to about 1750 mg are each included in the invention.
  • the invention also includes the use of dexrazoxane to manufacture liquid dexrazoxane preparations in ready to use form, and the administration of such ready to use liquid formulations (solutions).
  • the topical formulations may by way of example contain conventional carriers.
  • the ointments may contain water and one or more hydrophobic carriers selected from liquid paraffin, polyoxyethylene alkyl ether, propylene glycol and white vaseline.
  • the carrier compositions of the creams are typically based on water and white vaseline, in combination with glycerol and more minor components, e.g. one or more of glycerinemonostearate, PEG- glycerinemonostearate and cetylstearyl alcohol.
  • the gels may by way of example be formulated using isopropyl alcohol and water, suitably in combination with minor components, for example one or more of glycerol and hydroxyethyl cellulose.
  • Concurrent diseases were grade II hypertension and chronic cholecystopancreatitis.
  • the patient complained about itching all over the body (resulting in insomnia) and pain in the large joints (mainly knees).
  • the skin on the back, buttocks, chest and arms was covered with a erythematous papular and pustular rash with a white coating (desquamation).
  • a similar though less intense rash was seen on the legs.
  • the patient's general status, the haematological and biochemical profiles were within normal.
  • the mean reduction in PASI was 65%, with a maximum reduction of 88%, and one resistant case.
  • the tolerability of the treatment was excellent, and no serious adverse events were reported.
  • the therapy with Cardioxane resulted in better and faster relief of symptoms associated with psoriatic arthritis, when compared to treatment with cyclosporine A (which is the standard treatment in this indication and had been used previously in the clinic).
  • a solution for infusion is prepared:
  • a cream of the following composition is prepared:

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP00960646A 1999-09-10 2000-09-08 Use of dexrazoxane for treating psoriasis Withdrawn EP1214073A2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
AT155899 1999-09-10
AT155899 1999-09-10
US18380600P 2000-02-22 2000-02-22
US183806P 2000-02-22
PCT/EP2000/008879 WO2001019358A2 (en) 1999-09-10 2000-09-08 Use dexrazoxane for treating psoriasis

Publications (1)

Publication Number Publication Date
EP1214073A2 true EP1214073A2 (en) 2002-06-19

Family

ID=25596169

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00960646A Withdrawn EP1214073A2 (en) 1999-09-10 2000-09-08 Use of dexrazoxane for treating psoriasis

Country Status (16)

Country Link
EP (1) EP1214073A2 (cs)
KR (1) KR20020035131A (cs)
CN (1) CN1378451A (cs)
AU (1) AU7286500A (cs)
BG (1) BG106428A (cs)
BR (1) BR0013921A (cs)
CA (1) CA2384685A1 (cs)
CZ (1) CZ2002729A3 (cs)
EE (1) EE04871B1 (cs)
HR (1) HRPK20020201B1 (cs)
HU (1) HUP0202791A3 (cs)
MX (1) MXPA02002486A (cs)
PL (1) PL354980A1 (cs)
RU (1) RU2002106874A (cs)
SK (1) SK2802002A3 (cs)
WO (1) WO2001019358A2 (cs)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021053523A1 (en) * 2019-09-18 2021-03-25 Tryp Therapeutics Compositions and methods to improve the therapeutic benefit of bis-dioxopiperazines

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1234935A (en) * 1967-07-03 1971-06-09 Nat Res Dev Piperazine derivatives
US3941790A (en) * 1967-07-03 1976-03-02 National Research Development Corporation Bis diketopiperazines
US4963679A (en) * 1988-02-17 1990-10-16 Erbamont, Inc. Process for preparing bis (3,5-dioxopiperazinyl) alkanes or alkenes
JPH09503749A (ja) * 1993-07-23 1997-04-15 エルエックスアール バイオテクノロジー インコーポレイテッド アポトーシスおよび関連した状態の処置方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0119358A2 *

Also Published As

Publication number Publication date
WO2001019358A3 (en) 2001-10-04
AU7286500A (en) 2001-04-17
BR0013921A (pt) 2002-05-14
EE04871B1 (et) 2007-08-15
HRP20020201A2 (en) 2003-06-30
CN1378451A (zh) 2002-11-06
SK2802002A3 (en) 2003-02-04
CA2384685A1 (en) 2001-03-22
HUP0202791A3 (en) 2003-02-28
HUP0202791A2 (hu) 2003-01-28
RU2002106874A (ru) 2003-11-20
KR20020035131A (ko) 2002-05-09
PL354980A1 (en) 2004-03-22
MXPA02002486A (es) 2004-09-10
HRPK20020201B1 (en) 2004-08-31
CZ2002729A3 (cs) 2002-07-17
BG106428A (en) 2003-04-30
WO2001019358A2 (en) 2001-03-22
EE200200128A (et) 2003-04-15

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