HRP20171016T1 - VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ - Google Patents

VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ Download PDF

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Publication number
HRP20171016T1
HRP20171016T1 HRP20171016TT HRP20171016T HRP20171016T1 HR P20171016 T1 HRP20171016 T1 HR P20171016T1 HR P20171016T T HRP20171016T T HR P20171016TT HR P20171016 T HRP20171016 T HR P20171016T HR P20171016 T1 HRP20171016 T1 HR P20171016T1
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Croatia
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formulation
receptor
formulation according
buffered
solution
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HRP20171016TT
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English (en)
Inventor
Peter Sondermann
Thomas Pohl
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Suppremol Gmbh
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Publication of HRP20171016T1 publication Critical patent/HRP20171016T1/hr
Publication of HRP20171016T8 publication Critical patent/HRP20171016T8/hr

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    • 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
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P17/10Anti-acne agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
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    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
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    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • AHUMAN NECESSITIES
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    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
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    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Cell Biology (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Emergency Medicine (AREA)
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Claims (14)

1. Formulacija koja sadrži topljivi receptor Fcγ (sFcγR) u vodenoj puferiranoj otopini, naznačena time što je koncentracija topljivog receptora Fcγ viša od 60 mg/ml, te što sadrži fiziološki prihvatljivu pufersku tvar.
2. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što se puferska tvar bira između histidina, citrata, fosfata ili bilo koje njihove kombinacije.
3. Formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što je receptor receptor FcγRII, po mogućnosti FcγRIIB.
4. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je koncentracija receptora Fcγ viša od 80 mg/ml, po mogućnosti viša od 100 mg/ml, poželjnije viša od 150 mg/ml, a najpoželjnije viša od 200 mg/ml.
5. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži dodatne tvari, koje se biraju između šećera, soli i detergenata.
6. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je receptor prisutna u otopljenom obliku ili formulacija sadrži receptor in a mikrokristalnom oblik.
7. Formulacija u skladu s patentnim zahtjevima 5 ili 6, naznačena time što je otopina puferirana citratom, a pH formulacije je podešen na 6,0 do 7,5.
8. Formulacija u skladu s patentnim zahtjevima 5 ili 6, naznačena time što je otopina puferirana histidinom, a pH joj je podešen na 5,2 do 5,9.
9. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time što sadrži receptor u kristalnom obliku.
10. Formulacija u skladu s bilo kojim od patentnih zahtjeva 6 i 9, naznačena time što je otopina puferirana citratom, a njezin pH je podešen na 5,2 do 5,9.
11. Formulacija u skladu s bilo kojim od patentnih zahtjeva 6 i 9, naznačena time što je otopina puferirana histidinom, a njezin pH je podešen na 6,0 do 7,5.
12. Farmaceutski pripravak, naznačen time što sadrži formulaciju u skladu s bilo kojim od patentnih zahtjeva 1 do 11, izborno u kombinaciji s farmaceutski prihvatljivim pomoćnim tvarima i/ili adjuvansima i/ili nosačima.
13. Farmaceutski pripravak u skladu s patentnim zahtjevom 12, namijenjen supkutanoj injekciji djelotvorne količine receptora Fcγ, naznačen time što je namijenjen upotrebi u sprječavanju ili liječenju autoimunih bolesti ili upalnih bolesti.
14. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 11 ili farmaceutski pripravak u skladu s patentnim zahtjevima 12 ili 13, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju autoimunih bolesti, osobito multiple skleroze, sistemnog eritematoznog lupusa, reumatoidnog artritisa, primarne imunosne trombocitopenije ili autoimune hemolitične anemije.
HRP20171016TT 2013-04-26 2017-07-04 VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ HRP20171016T8 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13002211.4A EP2796144A1 (en) 2013-04-26 2013-04-26 Highly concentrated Formulations of soluble Fc receptors
PCT/EP2014/001029 WO2014173510A1 (en) 2013-04-26 2014-04-16 HIGHLY CONCENTRATED FORMULATIONS OF SOLUBLE Fc RECEPTORS
EP14722097.4A EP2991667B1 (en) 2013-04-26 2014-04-16 Highly concentrated formulations of soluble fc gamma receptors

Publications (2)

Publication Number Publication Date
HRP20171016T1 true HRP20171016T1 (hr) 2017-10-06
HRP20171016T8 HRP20171016T8 (hr) 2017-12-15

Family

ID=48326051

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20171016TT HRP20171016T8 (hr) 2013-04-26 2017-07-04 VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ

Country Status (17)

Country Link
US (3) US10226504B2 (hr)
EP (2) EP2796144A1 (hr)
JP (2) JP6562901B2 (hr)
KR (1) KR20160036530A (hr)
CN (1) CN105555294B (hr)
AU (1) AU2014256510B2 (hr)
EA (1) EA033742B1 (hr)
ES (1) ES2632971T3 (hr)
HK (1) HK1223035A1 (hr)
HR (1) HRP20171016T8 (hr)
IL (1) IL242257B (hr)
MX (1) MX366110B (hr)
PH (1) PH12015502358B1 (hr)
PL (1) PL2991667T3 (hr)
PT (1) PT2991667T (hr)
SG (1) SG11201508621PA (hr)
WO (1) WO2014173510A1 (hr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2796144A1 (en) 2013-04-26 2014-10-29 SuppreMol GmbH Highly concentrated Formulations of soluble Fc receptors
JP6665414B2 (ja) * 2015-03-25 2020-03-13 東ソー株式会社 Fc結合性タンパク質の保存方法
RU2766340C1 (ru) * 2021-02-10 2022-03-15 Игорь Закванович Зайцев Пептидный толерогенный компаунд

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998031806A2 (en) * 1997-01-21 1998-07-23 Human Genome Sciences, Inc. Fc RECEPTORS AND POLYPEPTIDES
EP1006183A1 (en) * 1998-12-03 2000-06-07 Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. Recombinant soluble Fc receptors
DE10157290A1 (de) 2001-11-22 2003-06-05 Max Planck Gesellschaft Pharmazeutische Zusammensetzung enthaltend sFcRgamma IIb oder sFcRgamma III
ATE499384T1 (de) * 2005-12-13 2011-03-15 Suppremol Gmbh Multimere fc-rezeptor-polypeptide
CN101426527A (zh) * 2006-02-03 2009-05-06 米迪缪尼有限公司 蛋白质制剂
WO2007092772A2 (en) * 2006-02-03 2007-08-16 Medimmune, Inc. Protein formulations
WO2009158696A1 (en) * 2008-06-27 2009-12-30 Zymogenetics, Inc. SOLUBLE HYBRID Fcγ RECEPTORS AND RELATED METHODS
EP2161031A1 (en) * 2008-09-05 2010-03-10 SuppreMol GmbH Fc gamma receptor for the treatment of B cell mediated multiple sclerosis
CA2829629A1 (en) 2011-03-10 2012-09-13 Board Of Regents, The University Of Texas System Protein nanoparticle dispersions
US10028998B2 (en) * 2012-10-30 2018-07-24 Suppremol Gmbh Method for treating an inflammatory disease and/or an autoimmune disease with a soluble FcγRIIb
EP2796144A1 (en) 2013-04-26 2014-10-29 SuppreMol GmbH Highly concentrated Formulations of soluble Fc receptors
NZ719745A (en) * 2013-10-16 2018-10-26 Suppremol Gmbh Soluble fc gamma receptor for treatment of autoimmune bullous diseases

Also Published As

Publication number Publication date
US10226504B2 (en) 2019-03-12
JP2019203011A (ja) 2019-11-28
EP2991667A1 (en) 2016-03-09
MX366110B (es) 2019-06-26
EA033742B1 (ru) 2019-11-21
MX2015014814A (es) 2016-03-09
PH12015502358A1 (en) 2016-02-22
EP2991667B1 (en) 2017-04-12
HK1223035A1 (zh) 2017-07-21
US20160095895A1 (en) 2016-04-07
IL242257B (en) 2018-10-31
AU2014256510B2 (en) 2019-04-11
JP2016522812A (ja) 2016-08-04
US11266708B2 (en) 2022-03-08
HRP20171016T8 (hr) 2017-12-15
PT2991667T (pt) 2017-07-13
WO2014173510A1 (en) 2014-10-30
US20220296668A1 (en) 2022-09-22
ES2632971T3 (es) 2017-09-18
EP2796144A1 (en) 2014-10-29
PL2991667T3 (pl) 2017-09-29
JP6562901B2 (ja) 2019-08-21
CN105555294B (zh) 2019-04-09
SG11201508621PA (en) 2015-11-27
US20190231842A1 (en) 2019-08-01
PH12015502358B1 (en) 2016-02-22
KR20160036530A (ko) 2016-04-04
AU2014256510A1 (en) 2015-12-10
EA201592056A1 (ru) 2016-03-31
NZ714292A (en) 2020-11-27
JP6979427B2 (ja) 2021-12-15
CN105555294A (zh) 2016-05-04

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