TR201802935T4 - Stabil sıvı antikor formülasyonu. - Google Patents

Stabil sıvı antikor formülasyonu. Download PDF

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TR201802935T4
TR201802935T4 TR2018/02935T TR201802935T TR201802935T4 TR 201802935 T4 TR201802935 T4 TR 201802935T4 TR 2018/02935 T TR2018/02935 T TR 2018/02935T TR 201802935 T TR201802935 T TR 201802935T TR 201802935 T4 TR201802935 T4 TR 201802935T4
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liquid composition
antibody
composition according
liquid
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TR2018/02935T
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Vijay Badkar Advait
Kristen Bohack Leigh
Roger King Kevin
Lea Lary Alanta
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Pfizer
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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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Urology & Nephrology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Abstract

Mevcut buluş genellikle antikorlar içeren farmasötik formülasyonların alanı ile ilgilidir. Spesifik olarak mevcut buluş, stabil sıvı bir antikor formülasyonu ve bunun farmasötik preparasyonu ve kullanımı ile ilgilidir. Bu buluş, insancıllaştırılmış bir anti-NGF antikoru içeren bir sıvı formülasyon ile örneklendirilir.

Description

Tarifname içerisinde atifta bulunulan patent dökümanlari: Tarifnamede belirtilen patentlestirilmemis literatür: o HONGO et al. Hybridoma, 2000, ° Fundamental lmmunology. Raven . KABAT. Sequences of Proteins of o CHOTHIA ; LESK. 1. Mol. Biol., - CHOTHIA et al. Nature, 1989, vol.
° SHAW et al. 1 Immunol., 1987, vol.
- BROWN et al. Cancer Res., 1987, ° RIECHMANN et al. Nature, 1988, ° VERHOEYEN et al. Science, 1988, ° JONES et al. Nature, 1986, vol. 321, ° WARD et al. Nature, 1989, vol. 341, 0 BIRD et al. Science, 1988, vol. 242, ° HUSTON et al. Proc. Natl. Acad. o KABAT et al. Sequences of Proteins of lmmunological Interest. National o CHOTHIA et al. Nature, 1989, vol.
° AL-LAZIKANI et al. J. Molec. Biol., o WINTER et al. Nature, 1991, vol.
- LOBUGLIO et al. Proc. Nat. Acad.
° Remington, The Science and Practice of Pharmacy. Mack Publishing, 2000 ° KARLSSON, R. ROOS ; H.
FAGERSTAM ; L. PETERSSON, B. Methods Enzymology, 1994, vol. 6, 99-110 [0159] - KARLIN ; ALTSCHUL. Proc. Natl. 2268 [0142] o KARLIN ; ALTSCHUL. Proc. Natl. 5877 [0142] o ALTSCHUL et al. .1. Mol. Biol., o TORELLIS; ROBOTTI. Comput. o PEARSON ; LIPMAN. Proc. Natl.
. Remington”s Phannaceutical Sciences. Mack Publishing Co, 1990 - KARLSSON, R. ; ROOS, H. ; FAGERSTAM, L. ; PETERSSON,B.
Methods Enzymology, 1994, vol. 6, 99- 1 10 [0195] SEKILLERDEKI YAZILARIN ANLAMLARI A =Trehaloz B :Sukroz C = %Agregasyon D :Süre (hafta) E : %Parçalanina F = Dondurma eritme döngüsü H :Oksidasyon 3 NF 9 w 0 v N 0 vmrövumî . omwwwmvwwmowmrwrvvNFOFwovw ..EmeoFiw 4. ov 485& m . m 1:59: om .:5msom JEBEQNX

Claims (1)

ISTEMLER
1. Asagidakileri içeren bir sivi anti-NGF antikoru kompozisyonu: bir antikor, bir tonisite ajani bir tampon, bir kiskaçlama ajani, bir surfektan; burada adi geçen kompozisyonun pH°si, 5.8 ila 6.8 arasindadir, buradaki surfektan, polisorbat 20”dir, buradaki tampon, histidindir, buradaki tonisite ajani, trehalozdur ve buradaki antikor, SEK.KIM.NO.:1°e ait bir degisken agir zincir sekansi ve SEK.KIM.NO.:2”ye ait bir degisken hafif zincir sekansi içerir. Istein l”e göre sivi kompozisyon; buradaki tonisite ajani, trehaloz dihidrattir. Istem 2,ye göre sivi kompozisyon; buradaki trehaloz dihidrat konsantrasyonu, l mg/ml ila 100 mg/ml arasindadir. 1 ila 3 istemlerinden birine göre sivi kompozisyon; buradaki polisorbat 20 konsantrasyonu, 0.01 ila 0.15 mg/ml arasindadir. 1 ila 4 istemlerinden birine göre sivi kompozisyon; buradaki histidin tamponu konsantrasyonu, 1.0 ila 15 mM arasindadir. 1 ila 5 istemlerinden birine göre SlVl kompozisyon; buradaki kiskaçlama ajani, EDTA”dir. Istem 6”ya göre sivi kompozisyon; buradaki EDTA konsantrasyonu, 0.01 ila 0.1 mg/ml arasindadir. 1 ila 7 istemlerinden birine göre sivi kompozisyon; buradaki antikor konsantrasyonu, 50 mg/ml°den az veya buna esittir. 1 ila 8 istemlerinden birine göre olup ayrica bir antioksidan ajan ve/Veya bir prezervatif ajan da içeren sivi kompozisyon. 1 ila 9 istemlerinden birine göre olup, sunlari içeren sivi anti- NGF kompozisyonu: 0.5 ing/inl ila 50 ing/inl antikor, 1.0 mM ila 15 mM histidin tamponu, 1 mg/inl ila 100 mg/ml trehaloz dihidrat, 0.01 ila 0.15 mg/ml polisorbat 20, 0.01 ila 0.] mg/ml EDTA, burada adi geçen kompozisyonun pH”si, 5.8 ila 6.8 arasindadir. 1 ila 10 istemlerinden birine göre sivi kompozisyon; buradaki antikor, bir insan veya insancillastirilmis antikordur. 1 ila 11 istemlerinden birine göre sivi kompozisyon; buradaki 1 ila 112 istemlerinden birine göre sivi kompozisyon; buradaki antikor, insan NGF”sine 2 nM”den az veya buna esit bir KD ile baglanir. 1 ila 13 istemlerindeii birine göre sivi koinpozisyon; buradaki antikor, SEK.KIM.NO.:16°ya ait bir agir zincir amino asit sekansi ve SEK.KIM.NO.:17'ye ait bir hafif zincir amino asit sekansi içerir. 1 ila 114 istemlerinden birine göre sivi kompozisyon; buradaki kompozisyon liyofilize edilmesi ve liyofilizasyona tabi tutulmamistir. 1 ila 15 istemlerinden birine göre sivi kompozisyon; buradaki kompozisyon, birçok dondurma eritme döngüsünden sonra antikor agregasyonuna dirençlidir. 1 ila 15 istemleriiiden birine göre sivi kompozisyon; buradaki kompozisyon, 40°C°1ik bir sicaklikta en az 26 haftalik bir süre boyunca depolanabilir ve burada: (a) kompozisyonun antikorunda %10”dan az agregasyon artisi, (b) kompozisyonun antikorunda %10”dan az oksidasyon artisi (c) kompozisyonun antikorunda %10”dan az aktivite düsüsü 1 ila 17 istemlerinden birine göre sivi kompozisyon; buradaki kompozisyon, 40°C”lik bir sicaklikta en az 26 haftalik bir sure boyunca depolanabilir ve buradaki koinpozisyonun antikorunda Bir memelide agri tedavisinde kullanim için 1 ila 18 istemlerinden birine göre sivi kompozisyon. Istem 19”a göre kullanim için sivi kompozisyon; buradaki koinpozisyonun uygulanma paterni, bir doz koinpozisyonun sekiz haftada bir uygulanmasini kapsar. Istem 20”ye göre kullanim için sivi kompozisyon; buradaki doz hacmi, 2.5 m1`den az veya buna esittir. Istem 20 yada istein 21 ”e göre kullanim için sivi kompozisyon; buradaki doz, 50 mg°den az veya buiia esit antikor içerir. 20 ila 22 istenilerinden birine göre kullanim için sivi kompozisyon; buradaki doz uygulamasi, intravenöz veya subkütandir.
TR2018/02935T 2008-09-19 2009-09-18 Stabil sıvı antikor formülasyonu. TR201802935T4 (tr)

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EP (2) EP2331090B1 (tr)
JP (1) JP5642683B2 (tr)
KR (1) KR101355750B1 (tr)
CN (1) CN102159204B (tr)
AU (1) AU2009294214B2 (tr)
BR (1) BRPI0917888A2 (tr)
CA (1) CA2736864C (tr)
DK (1) DK2331090T3 (tr)
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PL (1) PL2331090T3 (tr)
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