HRP20220105T1 - Formulacija metotreksata - Google Patents

Formulacija metotreksata Download PDF

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Publication number
HRP20220105T1
HRP20220105T1 HRP20220105TT HRP20220105T HRP20220105T1 HR P20220105 T1 HRP20220105 T1 HR P20220105T1 HR P20220105T T HRP20220105T T HR P20220105TT HR P20220105 T HRP20220105 T HR P20220105T HR P20220105 T1 HRP20220105 T1 HR P20220105T1
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HR
Croatia
Prior art keywords
preparation
buffer
methotrexate
flavor
liquid pharmaceutical
Prior art date
Application number
HRP20220105TT
Other languages
English (en)
Inventor
Michael FRODSHAM
Julie-Ann PENTON
Original Assignee
Therakind Ltd.
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.)
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Publication date
Application filed by Therakind Ltd. filed Critical Therakind Ltd.
Publication of HRP20220105T1 publication Critical patent/HRP20220105T1/hr

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    • 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
    • A61K31/495—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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Communicable Diseases (AREA)
  • Neurosurgery (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Postupak za pripravu tekućeg farmaceutskog pripravka, naznačen time, da obuhvaća dodavanje pufera u slobodnu kiselinu metotreksatata za uspostavljanje pH vrijednosti na 6,6 do 7 i dodavanje jednog ili više konzervansa, spojeva za pojačavanje okusa, sredstava za zaslađivanje i/ili ko-otapala, pri čemu se puferska snaga pripravka nalazi u rasponu od 0,05 M do 0,1 M.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da se pH vrijednost pripravka postavlja na 6,6; 6,7; 6,8; 6,9 ili 7.
3. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da puferska snaga pripravka iznosi 0,05 M.
4. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pufera jest natrijev citratni pufer ili fosfatni pufer.
5. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da tekući pripravak jest otopina ili suspenzija.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži jedan ili više konzervansa, pri čemu jedan ili više konzervansa sadrže etil parahidroksibenzoat i/ili metil parahidroksibenzoat.
7. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži jedan ili više spojeva za pojačavanje okusa i/ili sredstava za zaslađivanje, pri čemu jedan ili više spojeva za pojačavanje okusa i/ili sredstava za zaslađivanje sadrže okus naranče ili okus jagode i/ili sukralozu.
8. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži glicerol i/ili polietilen glikol.
9. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da se dodaje natrijev citratni pufer ili fosfatni pufer u 0,4 do 20 mg/ml slobodne kiseline metotreksata, pri čemu pripravak sadrži: PEG 400; etil parahidroksibenzoat; metil parahidroksibenzoat natrijevu sol; glicerol; okus naranče; i sukralozu.
10. Tekući farmaceutski pripravak, naznačen time, da se može pripraviti postupkom prema bilo kojem od prethodnih patentnih zahtjeva.
11. Tekući farmaceutski pripravak prema patentnom zahtjevu 10, naznačen time, da je za oralnu primjenu.
12. Pripravak prema patentnom zahtjevu 10 ili 11, naznačen time, da je za uporabu u liječenju, gdje se primjena vrši oralnim putem.
13. Pripravak prema patentnom zahtjevu 10 ili 11, naznačen time, da je za uporabu u postupku primjene metotreksata kod pacijenta kojemu je potrebno liječenje, dok obuhvaća oralnu primjenu za pacijenta terapijski učinkovite količine tekućeg farmaceutskog pripravka prema bilo kojem od patentnih zahtjeva 10 ili 11.
14. Pripravak za uporabu prema patentnom zahtjevu 12 ili 13, naznačen time, da je liječenje za psorijazu, psorijatički artritis, sustavni dermatomiozitis, seronegativni artritis, reumatoidni artritis odraslih, otporan juvenilni reumatoidni artritis, poliartritičke oblike aktivnog juvenilnog idiopatskog artritisa (JIA), bolest usadak protiv domaćina, mikozne fungoide, spondiloartropatiju, spondiloartropatije, ankilozni spondilitis, neoplazme, akutnu limfoblastnu leukemiju, profilaksu meningealne leukemije, rak dojke, rak mokraćnog mjehura, rak glave, rak vrata, ne-Hodgkinov limfom, osteogenski sarkom, sarkom mekog tkiva kod odraslih, horiokarcinom ili rak pluća, hemoblastoze, ili bilo koje maligne tumore ili stanja za koja je propisan metotreksat.
15. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 12 do 14, naznačen time, da pacijent je dijete.
HRP20220105TT 2014-10-29 2015-10-28 Formulacija metotreksata HRP20220105T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1419261.1A GB201419261D0 (en) 2014-10-29 2014-10-29 Formulations
EP15790211.5A EP3212237B1 (en) 2014-10-29 2015-10-28 Methotrexate formulation
PCT/GB2015/053231 WO2016067024A1 (en) 2014-10-29 2015-10-28 Methotrexate formulation

Publications (1)

Publication Number Publication Date
HRP20220105T1 true HRP20220105T1 (hr) 2022-04-15

Family

ID=52103589

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20220105TT HRP20220105T1 (hr) 2014-10-29 2015-10-28 Formulacija metotreksata

Country Status (20)

Country Link
US (3) US11129833B2 (hr)
EP (1) EP3212237B1 (hr)
JP (3) JP2017533274A (hr)
CN (2) CN116747190A (hr)
AU (1) AU2015340373A1 (hr)
CA (1) CA3002493C (hr)
CY (1) CY1125033T1 (hr)
DK (1) DK3212237T3 (hr)
ES (1) ES2908447T3 (hr)
GB (2) GB201419261D0 (hr)
HR (1) HRP20220105T1 (hr)
HU (1) HUE057717T2 (hr)
IL (1) IL251859A0 (hr)
LT (1) LT3212237T (hr)
PL (1) PL3212237T3 (hr)
PT (1) PT3212237T (hr)
RS (1) RS62971B1 (hr)
SI (1) SI3212237T1 (hr)
SM (1) SMT202200104T1 (hr)
WO (1) WO2016067024A1 (hr)

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Publication number Priority date Publication date Assignee Title
GB201419261D0 (en) 2014-10-29 2014-12-10 Therakind Ltd Formulations
CN107714653B (zh) * 2017-11-27 2022-01-28 济南新科医药科技有限公司 一种稳定的可溶性甲氨蝶呤颗粒剂
WO2019162756A2 (en) * 2018-02-20 2019-08-29 Ftf Pharma Private Limited Liquid pharmaceutical compositions of anticancer drugs
GB2591681A (en) * 2018-08-29 2021-08-04 Ftf Pharma Private Ltd Methotrexate pharmaceutical composition
CN110269939A (zh) * 2019-03-12 2019-09-24 武汉愔紫生物科技有限公司 一种治疗真菌分泌蛋白介导的炎症疾病标志物的药物、药物组合物、用途及其使用方法
JP7682512B2 (ja) * 2019-09-13 2025-05-26 アルデイラ セラピューティクス， インコーポレイテッド メトトレキサートの眼科用製剤
EP3854385A1 (en) * 2020-01-27 2021-07-28 ROS Therapeutics ApS Methotrexate dosage form
JP7856338B2 (ja) * 2021-07-30 2026-05-11 エピジェニクス セラピューティクス インコーポレーテッド クレミゾール製剤
CN115778897A (zh) * 2022-12-15 2023-03-14 深圳市贝美药业有限公司 一种稳定的甲氨蝶呤药物制剂及其制备方法

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Also Published As

Publication number Publication date
US20240024327A1 (en) 2024-01-25
GB2531940A (en) 2016-05-04
US11771701B2 (en) 2023-10-03
US12605385B2 (en) 2026-04-21
EP3212237A1 (en) 2017-09-06
JP2023103402A (ja) 2023-07-26
ES2908447T3 (es) 2022-04-29
GB201519049D0 (en) 2015-12-09
PL3212237T3 (pl) 2022-04-19
DK3212237T3 (da) 2022-03-07
JP2017533274A (ja) 2017-11-09
EP3212237B1 (en) 2022-01-05
US11129833B2 (en) 2021-09-28
JP2021138748A (ja) 2021-09-16
CA3002493A1 (en) 2016-05-06
PT3212237T (pt) 2022-04-14
LT3212237T (lt) 2022-02-25
GB201419261D0 (en) 2014-12-10
GB2531940B (en) 2017-04-26
CA3002493C (en) 2023-11-28
SMT202200104T1 (it) 2022-05-12
US20210386746A1 (en) 2021-12-16
CY1125033T1 (el) 2023-03-24
SI3212237T1 (sl) 2022-04-29
AU2015340373A1 (en) 2017-05-18
HUE057717T2 (hu) 2022-06-28
HK1243638A1 (zh) 2018-07-20
CN107106485A (zh) 2017-08-29
US20170312281A1 (en) 2017-11-02
IL251859A0 (en) 2017-06-29
WO2016067024A1 (en) 2016-05-06
RS62971B1 (sr) 2022-03-31
CN116747190A (zh) 2023-09-15

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