FI90204B - Förfarande för framställning av en injekterbar melfalansammansättning - Google Patents

Förfarande för framställning av en injekterbar melfalansammansättning Download PDF

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Publication number
FI90204B
FI90204B FI885358A FI885358A FI90204B FI 90204 B FI90204 B FI 90204B FI 885358 A FI885358 A FI 885358A FI 885358 A FI885358 A FI 885358A FI 90204 B FI90204 B FI 90204B
Authority
FI
Finland
Prior art keywords
melphalan
component
hydrochloride
citrate
diluent
Prior art date
Application number
FI885358A
Other languages
English (en)
Finnish (fi)
Other versions
FI885358A (sv
FI90204C (sv
FI885358A0 (sv
Inventor
Stephen William Poole
Timothy Paul Stanley
Geoffrey Divall
Terence William Packham
Joseph Knight
Original Assignee
Wellcome Found
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 Wellcome Found filed Critical Wellcome Found
Publication of FI885358A0 publication Critical patent/FI885358A0/sv
Publication of FI885358A publication Critical patent/FI885358A/sv
Priority to FI924668A priority Critical patent/FI102275B1/sv
Publication of FI90204B publication Critical patent/FI90204B/sv
Application granted granted Critical
Publication of FI90204C publication Critical patent/FI90204C/sv

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Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Catalysts (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Steroid Compounds (AREA)

Claims (4)

1. Förfarande för framställning av en injekterbar melfalansammansättning, kännetecknat därav, 5 att man formulerar som tvä skilda komponenter a) frystorkad melfalanhydroklorid och b) ett lösnings/utspädningsmedel, som omfattar 0,05 - 5 vikt/volym-% sitrat, 40 - 80 volym-% propylenglykol och 0,1 - 10 volym-% etanol. 10
2. Förfarande enligt patentkravet 1, känne tecknat därav, att komponenten (a) kan innehälla ett ohydroxylerat ämne som bildar matrix och som finns 0,1 - 99 vikt-% av komponenten (a).
3. Förfarande enligt patentkravet 2, k ä n n e -15 tecknat därav, att det ohydroxylerade ämnet som bildar matrix är polyvinylpyrrolidon.
4. Förfarande enligt nägot av patentkraven 1-3, kännetecknat därav, att sitratet är aikaiime-tallsitrat. 20
FI885358A 1987-11-19 1988-11-18 Förfarande för framställning av en injekterbar melfalansammansättning FI90204C (sv)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FI924668A FI102275B1 (sv) 1987-11-19 1992-10-15 Förfarande för framställning av väsentligen ren melfalanhydroklorid

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8727157 1987-11-19
GB878727157A GB8727157D0 (en) 1987-11-19 1987-11-19 Pharmaceutical formulations

Publications (4)

Publication Number Publication Date
FI885358A0 FI885358A0 (sv) 1988-11-18
FI885358A FI885358A (sv) 1989-05-20
FI90204B true FI90204B (sv) 1993-09-30
FI90204C FI90204C (sv) 1994-01-10

Family

ID=10627252

Family Applications (2)

Application Number Title Priority Date Filing Date
FI885358A FI90204C (sv) 1987-11-19 1988-11-18 Förfarande för framställning av en injekterbar melfalansammansättning
FI924668A FI102275B1 (sv) 1987-11-19 1992-10-15 Förfarande för framställning av väsentligen ren melfalanhydroklorid

Family Applications After (1)

Application Number Title Priority Date Filing Date
FI924668A FI102275B1 (sv) 1987-11-19 1992-10-15 Förfarande för framställning av väsentligen ren melfalanhydroklorid

Country Status (22)

Country Link
US (1) US4997651A (sv)
EP (1) EP0317281B1 (sv)
JP (1) JP2693191B2 (sv)
KR (1) KR970002607B1 (sv)
AT (1) ATE83922T1 (sv)
AU (1) AU619781B2 (sv)
CA (1) CA1341114C (sv)
DE (1) DE3877151T2 (sv)
DK (1) DK172794B1 (sv)
ES (1) ES2052745T3 (sv)
FI (2) FI90204C (sv)
GB (1) GB8727157D0 (sv)
GR (1) GR3007287T3 (sv)
HK (1) HK108994A (sv)
HU (3) HU203197B (sv)
IE (1) IE63996B1 (sv)
IL (1) IL88419A (sv)
LV (1) LV10179B (sv)
NZ (2) NZ227004A (sv)
PT (1) PT89028B (sv)
SG (1) SG73894G (sv)
ZA (1) ZA888674B (sv)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5407672A (en) * 1993-04-08 1995-04-18 Cornell Research Foundation, Inc. Enhancing the anti-tumor effect of melphalan with L-amino acid oxidase
US5695751A (en) * 1993-04-08 1997-12-09 Cornell Research Foundation, Inc. Enhancing delivery of large neutral amino acid drugs
US6020004A (en) * 1997-04-17 2000-02-01 Amgen Inc. Biodegradable microparticles for the sustained delivery of therapeutic drugs
US5980904A (en) * 1998-11-18 1999-11-09 Amway Corporation Skin whitening composition containing bearberry extract and a reducing agent
GB2386066A (en) * 2002-02-28 2003-09-10 Norbrook Lab Ltd Long-acting parasiticidal composition with improved bioavailability comprising a salicylanilide, a further anti-parasitic compound & a polymeric species
CN1674917A (zh) * 2002-06-24 2005-09-28 研究发展基金会 用姜黄素治疗人多发性骨髓瘤
WO2006046934A2 (en) 2003-08-26 2006-05-04 Research Development Foundation Osteoclastogenesis inhibitors and uses thereof
US7872050B2 (en) * 2005-03-14 2011-01-18 Yaupon Therapeutics Inc. Stabilized compositions of volatile alkylating agents and methods of using thereof
US8501818B2 (en) 2005-03-14 2013-08-06 Ceptaris Therapeutics, Inc. Stabilized compositions of alkylating agents and methods of using same
PL2273876T3 (pl) 2008-03-27 2019-09-30 Helsinn Healthcare Sa Stabilizowane kompozycje środków alkilujących i sposoby ich zastosowania
AR066943A1 (es) * 2008-06-10 2009-09-23 Eriochem Sa Una composicion farmaceutica de melfalano
US11020363B2 (en) 2009-05-29 2021-06-01 Cydex Pharmaceuticals, Inc. Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
CN106389307A (zh) * 2009-05-29 2017-02-15 锡德克斯药物公司 包含环糊精衍生物的可注射美法仑组合物及其制备和使用方法
AR077384A1 (es) * 2010-07-05 2011-08-24 Eriochem Sa Una formulacion farmaceutica inyectable de melfalano.
US8921596B2 (en) * 2010-11-04 2014-12-30 Emcure Pharmaceuticals, Ltd. Process for the preparation of melphalan hydrochloride
EP2701720B1 (en) * 2011-04-28 2017-07-12 Oncopeptides AB Lyophilized preparation of cytotoxic dipeptides
JP6284945B2 (ja) * 2012-10-26 2018-02-28 オンコペプティデス エービーＯｎｃｏｐｅｐｔｉｄｅｓ ＡＢ メルファランフルフェナミドの凍結乾燥製剤
EP2970102B1 (en) 2013-03-11 2019-05-08 Biophore India Pharmaceuticals Pvt. Ltd. An improved process for the synthesis of melphalan and the hydrochloride salt
ITMI20130896A1 (it) * 2013-05-31 2014-12-01 Farmabios Spa Processo di purificazione di melphalan
US10576101B2 (en) 2015-03-06 2020-03-03 Leadiant Biosciences Sa Roneparstat combined therapy of multiple myeloma
US10537520B2 (en) * 2015-06-30 2020-01-21 Leiutis Pharmaceuticals Pvt. Ltd. Stable liquid formulations of melphalan
US11752135B2 (en) * 2018-03-29 2023-09-12 Project Pharmaceutics Gmbh Liquid pharmaceutical formulation
US10682326B1 (en) 2019-06-03 2020-06-16 Shilpa Medicare Limited Stable melphalan liquid injectable formulations

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB750155A (en) * 1953-03-17 1956-06-13 Nat Res Dev Substituted alanines
US3032585A (en) * 1954-12-03 1962-05-01 Nat Res Dev Process for the production of p-bis-(2-chloroethyl)-aminophenylalanine
DE1292660B (de) * 1963-04-24 1969-04-17 Ural Polytechnitscheskij I Im Verfahren zur Herstellung von p-(Bis-ª‰-chloraethyl-amino)-phenylalanin-hydrochlorid
US4029778A (en) * 1969-01-23 1977-06-14 Aktiebolaget Leo Cortical steroid nitrogen mustard compositions and treatment therewith
RO57195A2 (sv) * 1970-11-30 1974-09-01
FR2285855A1 (fr) * 1974-09-25 1976-04-23 Kohjin Co Composition therapeutique lyophilisee a base de sel de cyclocytidine et son procede de preparation
JPS59186924A (ja) * 1983-04-08 1984-10-23 Kureha Chem Ind Co Ltd ヒト免疫グロブリン結合抗腫瘍剤
US4696814A (en) * 1985-08-21 1987-09-29 Warner-Lambert Company Parenteral phenytoin compositions
JPS62192357A (ja) * 1986-02-19 1987-08-22 Kureha Chem Ind Co Ltd Ｎ−フタロイル−ｐ−ニトロ−Ｌ−フエニルアラニンの製造方法

Also Published As

Publication number Publication date
FI102275B (sv) 1998-11-13
GB8727157D0 (en) 1987-12-23
HU9100335D0 (en) 1991-08-28
IL88419A (en) 1993-03-15
IE63996B1 (en) 1995-06-28
DE3877151D1 (de) 1993-02-11
EP0317281A3 (en) 1989-08-09
HU207286B (en) 1993-03-29
HU910336D0 (en) 1991-08-28
FI924668A (fi) 1992-10-15
FI885358A (sv) 1989-05-20
GR3007287T3 (sv) 1993-07-30
CA1341114C (en) 2000-10-10
KR970002607B1 (ko) 1997-03-06
HU206671B (en) 1992-12-28
FI90204C (sv) 1994-01-10
HK108994A (en) 1994-10-14
DK646688A (da) 1989-05-20
ES2052745T3 (es) 1994-07-16
DE3877151T2 (de) 1993-07-15
NZ227004A (en) 1992-11-25
LV10179A (lv) 1994-10-20
AU619781B2 (en) 1992-02-06
FI924668A0 (fi) 1992-10-15
FI885358A0 (sv) 1988-11-18
HU203197B (en) 1991-06-28
JPH01153628A (ja) 1989-06-15
KR890007729A (ko) 1989-07-05
AU2574888A (en) 1989-05-25
PT89028B (pt) 1993-02-26
FI102275B1 (sv) 1998-11-13
NZ239867A (en) 1992-11-25
ZA888674B (en) 1990-07-25
PT89028A (pt) 1988-12-01
IL88419A0 (en) 1989-06-30
US4997651A (en) 1991-03-05
IE883447L (en) 1989-05-19
HUT48198A (en) 1989-05-29
JP2693191B2 (ja) 1997-12-24
SG73894G (en) 1994-11-25
EP0317281B1 (en) 1992-12-30
ATE83922T1 (de) 1993-01-15
DK172794B1 (da) 1999-07-19
EP0317281A2 (en) 1989-05-24
LV10179B (en) 1995-06-20
DK646688D0 (da) 1988-11-18

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FG Patent granted

Owner name: THE WELLCOME FOUNDATION LIMITED

MA Patent expired