HUE029849T2 - Folyékony gyógyászati készítmény - Google Patents

Folyékony gyógyászati készítmény Download PDF

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Publication number
HUE029849T2
HUE029849T2 HUE14169753A HUE14169753A HUE029849T2 HU E029849 T2 HUE029849 T2 HU E029849T2 HU E14169753 A HUE14169753 A HU E14169753A HU E14169753 A HUE14169753 A HU E14169753A HU E029849 T2 HUE029849 T2 HU E029849T2
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HU
Hungary
Prior art keywords
suitably
liquid pharmaceutical
pharmaceutical composition
formulations
adalimumab
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HUE14169753A
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English (en)
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Rio Alessandra Del
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Ares Trading Sa
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774704&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HUE029849(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ares Trading Sa filed Critical Ares Trading Sa
Publication of HUE029849T2 publication Critical patent/HUE029849T2/hu

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/10—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
    • A61K47/06—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
    • A61K9/0019—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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs 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
    • 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
    • A61P19/08—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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (9)

  1. Fntyeteey gyógyászati kêsziimèzkY Szateàalml IglnypoftkF F Folyékony gyógyászati késztiafeny, amely tartalmaz: - 45 mg m h toi korttibeilll 55 mgdolog terméé koneeotrácakn aaaltmomabtk; - 5-44 mM nátdarmaeetát/ecetsav pufié;-rendszerű ·· 150-210 mM (rebatézí; ... 44-00 mM náiTkm-kiofddop - 0.9-04 mg4«; poilszorbáife(bat ás - linkkel óhoz való.? vizet; almi a készítmény 4- pH4a 5 J és 5,3 kSzOtíi; o argkänrnenies vagy legiáljebb (1,001 mM kormeniracirfean tartalmaz argókat: o amlnosuv akiól mentes vagy legfeljebb 05101 mM (összesített) kormentráciobmt tartalmaz egy va gy több am mesa vág o a gíPiszorbái-SO kivételével felíllelakOv zpyagífefei mentes: vagy legfeífebb 0,001 mM tÖsszesített) kooacmmoiobar tartalmaz egy vagy több rémktaktiv anyagot ia poltszorbát-SO kivitelével); ésAagy o Ibsziai-pufierektel (pl, nairnzvedlhklfogenfemziat. ólaáfeibm-bidrogén-ksziat) mentes vagy fegfelfebP 03)01 mM kramen akcióban tartalmaz íb szia tora Fér rendszert,
  2. 2, Az 1. igénypont szerinti felyékeny gyógyászati készítmény, ahol a készítmény tartalmaz: ·· 50 mg/mí adalimumabot; - 10 mM tfettimreaeetátkcetsav pof fez-rendszert : ··· 200 tnfef ufenkozt; - 50 mM náírkrm -kleddel; - 1.,0 mg/mi pobszorbát-fekat; és - Őrnek {.iához való) vizet; ahol a készmnány a pl kg a 5,2; Ô ΟΓρΟΖΟΜΟΟΟ tes; o ansfoosavakfoi. mentes; o a pohszitrbuuHO kivételével tebdetakuv srnmgoklnl mentes:; ésAagy o fo;o:iâmpefïenAtôi es foszilh-yniier rcrnt szerektől memes
  3. 3, Az I. igénypont szerinti folyékony' győgyászoli készítmény, ebei. a kcszuméry a fcóvetfeeze összetevőkből áll: 50 mg/ml aüalmmmab: .....10 mMI na;rumoac.nzv'ecetsar puffot-rendszer: - 200 mM infon: oz : - 50 re fvi nánlnm-kkfod: - 1 ,11 mg/mi poüsnufod-kíg és - (foiekeiöhoz való) víz; ahol a készítmény Hja 5,2,
  4. 4, Az !. igénypont szerinti, folyékony gyógyászati kaszáméig. elsői a készítmény ;ar,isósavaktól mentes,
  5. 5, Az előző igénypontok, bármelyike szerinti folyékony gyógyászati keszítntény, ahol a készitrnény ozrnoiaiitása 220: rnDsrn/kg és 400 rnOsadkg közötti, ti.
  6. Az előző igénypontok bármelyike szerinti folyékony gyógyászati készítménye almi a folyékony gyógyászati készitnfonyoen az arlaiinmmab proteiadegombolyodási (..unfolding b homérsékiete 20 fo: vagy nagyobb.
  7. 7. i:lasőanyag--eélbafotíafo eszköz, amely tartalmaz egy előző Igénypontok bármelyike szerinti folyékony gyógyászati készítményt.
  8. 8. Λ 7, Igénypont szerinti featéaayag-cérbaioftaiő eszköz, ahol a hatóanyag--eci fog attasé eszköz egy nota, ars puha, fon «kendő, injekciós toll vagy intravénás taszk, amely tartalmazza a. folyékony gyógyászati kóezámém z
  9. 9. Az l-O, Igénypontok bármelyike szerinti folyékony gyógyászati készítmény rsa-maszerr! izületi gyulladás, plkkelysőrnórhöz társaié izületi gyulladás, izületi merevseg-gel járó csigolyagyrdladás: fiiez looreo-kór·, Ozást--betegség. rekelyes vastagbéigynlia-das, enyhétől súlyosig repedő krónikus pikkelysömör ésfoagy ismeretlen eredeté, fonák kori Izületi gyulladás kezelésében történő alkalmazásra.
HUE14169753A 2014-05-23 2014-05-23 Folyékony gyógyászati készítmény HUE029849T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP14169753.2A EP2946765B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition

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HUE029849T2 true HUE029849T2 (hu) 2017-04-28

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HUE14169753A HUE029849T2 (hu) 2014-05-23 2014-05-23 Folyékony gyógyászati készítmény
HUE15722541A HUE040237T2 (hu) 2014-05-23 2015-05-15 Folyékony gyógyszerészeti készítmény

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US (7) US10426832B2 (hu)
EP (4) EP3050557A1 (hu)
JP (1) JP6334819B2 (hu)
KR (4) KR20230004960A (hu)
CN (2) CN109248315B (hu)
AU (3) AU2015263340B2 (hu)
BR (2) BR122021022508B1 (hu)
CA (2) CA3073703A1 (hu)
CY (1) CY1120681T1 (hu)
DK (2) DK2946765T3 (hu)
ES (3) ES2600488T3 (hu)
HR (2) HRP20161311T1 (hu)
HU (2) HUE029849T2 (hu)
IL (3) IL249115B (hu)
LT (2) LT2946765T (hu)
MX (1) MX361061B (hu)
NZ (1) NZ725360A (hu)
PL (2) PL2946765T3 (hu)
PT (2) PT2946765T (hu)
RS (2) RS55548B1 (hu)
RU (2) RU2020112952A (hu)
SG (3) SG11201608745QA (hu)
SI (2) SI2946765T1 (hu)
WO (1) WO2015177057A1 (hu)

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