MX2018013243A - Composicion farmaceutica antineoplasica estable que comprende temozolomida y un metodo para preparar la composicion. - Google Patents

Composicion farmaceutica antineoplasica estable que comprende temozolomida y un metodo para preparar la composicion.

Info

Publication number
MX2018013243A
MX2018013243A MX2018013243A MX2018013243A MX2018013243A MX 2018013243 A MX2018013243 A MX 2018013243A MX 2018013243 A MX2018013243 A MX 2018013243A MX 2018013243 A MX2018013243 A MX 2018013243A MX 2018013243 A MX2018013243 A MX 2018013243A
Authority
MX
Mexico
Prior art keywords
composition
temozolomide
preparing
pharmaceutical composition
polysaccharide
Prior art date
Application number
MX2018013243A
Other languages
English (en)
Inventor
Mikalai Yurkshtovich
Dzmitry Veyeunik
Valiantsina Alinouskaya
Atrakhimovich Natalia
Halouchyk Lryna
Beliaev Sergey
Yurkshtovich Tatjana
Bychkouski Pavel
Fedulau Aliaksandr
Trukhachova Tatsiana
Original Assignee
Double Bond Pharmaceutical AB
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 Double Bond Pharmaceutical AB filed Critical Double Bond Pharmaceutical AB
Publication of MX2018013243A publication Critical patent/MX2018013243A/es

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
    • A61K31/41—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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic 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
    • 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
    • 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
    • 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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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
    • A61K9/14—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Abstract

Se describe una composición farmacéutica antineoplásica estable que comprende Temozolomida, fosfato de polisacárido de alta sustitución en forma de sal y fosfato de polisacárido de alta sustitución en forma ácida, en particular en una relación en peso de 5 a 20% de Temozolomida hasta 30 a 80% de polisacárido en forma de sal, el resto hasta el 100% es polisacárido en forma ácida. El nivel de 5-aminomidazol-4-carboxamida está por debajo del 0.5% en peso de Temozolomida tanto en la composición como la formulación descrita. También se describe un hidrogel para administración intratecal que se obtiene al poner en contacto la composición con agua estéril, un método de fabricación de la composición y usos de la composición y el gel.
MX2018013243A 2016-05-02 2017-04-28 Composicion farmaceutica antineoplasica estable que comprende temozolomida y un metodo para preparar la composicion. MX2018013243A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EA201640026 2016-05-02
SE1600150 2016-05-02
PCT/SE2017/050418 WO2017192088A1 (en) 2016-05-02 2017-04-28 Stable anti-neoplastic pharmaceutical composition comprising temozolomide and method of preparing the composition

Publications (1)

Publication Number Publication Date
MX2018013243A true MX2018013243A (es) 2019-07-10

Family

ID=60203568

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018013243A MX2018013243A (es) 2016-05-02 2017-04-28 Composicion farmaceutica antineoplasica estable que comprende temozolomida y un metodo para preparar la composicion.

Country Status (12)

Country Link
US (1) US10806732B2 (es)
EP (1) EP3452017B1 (es)
CN (1) CN107334766A (es)
AU (1) AU2017261137B2 (es)
BR (1) BR112018072603B1 (es)
CA (1) CA3022174C (es)
DK (1) DK3452017T3 (es)
ES (1) ES2776900T3 (es)
HU (1) HUE049403T2 (es)
MX (1) MX2018013243A (es)
PL (1) PL3452017T3 (es)
WO (1) WO2017192088A1 (es)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL205936B1 (pl) * 2002-02-22 2010-06-30 Schering Corp Farmaceutyczny preparat zawierający termozolomid oraz sposób jego wytwarzania
JP2008521911A (ja) 2004-12-02 2008-06-26 シェーリング コーポレイション 癌の処置において髄腔内にテモゾロミド処方物を使用する方法
CN100588399C (zh) * 2005-09-01 2010-02-10 天津帝士力投资控股集团有限公司 一种注射用替莫唑胺冻干粉针剂及其制备方法
WO2008116053A2 (en) * 2007-03-20 2008-09-25 Trustees Of Tufts College Fap-activated chemotherapeutic compounds, and methods of use thereof
WO2011036676A2 (en) * 2009-09-23 2011-03-31 Ashwini Nangia Stable cocrystals of temozolomide
RU2442586C1 (ru) * 2009-11-11 2012-02-20 Учреждение Белорусского государственного университета "Научно-исследовательский институт физико-химических проблем" (НИИ ФХП БГУ) Гидрогелевый противоопухолевый препарат
US20120283304A1 (en) * 2009-12-23 2012-11-08 Sahaj Life Sciences Pvt. Ltd. Formulations of Temozolomide for Parenteral Administration
WO2012045009A2 (en) * 2010-09-30 2012-04-05 Normoxys, Inc. Polyphosphate and pyrophosphate derivative of saccharides
KR20140087846A (ko) * 2012-12-31 2014-07-09 주식회사 삼양바이오팜 테모졸로미드를 포함하는 안정성이 개선된 약제학적 조성물 및 이의 제조방법
CN104274412A (zh) * 2013-07-01 2015-01-14 北京恒瑞康达医药科技发展有限公司 一种含有替莫唑胺、其药学上可接受的盐或其他衍生物的药物制剂
US20160199392A1 (en) * 2015-01-13 2016-07-14 Autotelic Llc Method for individualized drug therapy
CN104721155B (zh) * 2015-04-07 2017-09-29 齐鲁制药(海南)有限公司 一种替莫唑胺冻干粉制剂及其制备方法

Also Published As

Publication number Publication date
PL3452017T3 (pl) 2020-08-10
ES2776900T3 (es) 2020-08-03
EP3452017A1 (en) 2019-03-13
CN107334766A (zh) 2017-11-10
US10806732B2 (en) 2020-10-20
CA3022174C (en) 2024-01-02
HUE049403T2 (hu) 2020-09-28
DK3452017T3 (da) 2020-04-06
BR112018072603B1 (pt) 2023-12-26
AU2017261137B2 (en) 2022-10-27
AU2017261137A1 (en) 2018-11-15
BR112018072603A2 (pt) 2019-04-30
CA3022174A1 (en) 2017-11-09
WO2017192088A1 (en) 2017-11-09
US20190142824A1 (en) 2019-05-16
EP3452017B1 (en) 2020-02-19

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