SG11201902531QA - Liquid pharmaceutical composition - Google Patents

Liquid pharmaceutical composition

Info

Publication number
SG11201902531QA
SG11201902531QA SG11201902531QA SG11201902531QA SG11201902531QA SG 11201902531Q A SG11201902531Q A SG 11201902531QA SG 11201902531Q A SG11201902531Q A SG 11201902531QA SG 11201902531Q A SG11201902531Q A SG 11201902531QA SG 11201902531Q A SG11201902531Q A SG 11201902531QA
Authority
SG
Singapore
Prior art keywords
international
composition
rule
pct
liquid pharmaceutical
Prior art date
Application number
SG11201902531QA
Inventor
Jan Jezek
Luca Badiali
David Gerring
Original Assignee
Fresenius Kabi Deutschland Gmbh
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 Fresenius Kabi Deutschland Gmbh filed Critical Fresenius Kabi Deutschland Gmbh
Publication of SG11201902531QA publication Critical patent/SG11201902531QA/en

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property 111111111111111111111010111 01111101011H011H11111110111111111111111110111111111111 Organization 0 International Bureau (10) International Publication Number (43) International Publication Date ......0\"\" WO 2018/078162 Al 03 May 2018 (03.05.2018) WIP0 I PCT (51) International Patent Classification: A61K 9/00 (2006.01) A61K 9/08 (2006.01) Published: A61K 47/18 (2017.01) A61K 38/16 (2006.01) — with international search report (Art 21(3)) — before the expiration of the time limit for amending the (21) International Application Number: claims and to be republished in the event of receipt of PCT/EP2017/077793 amendments (Rule 48.2(h)) (22) International Filing Date: — with sequence listing part of description (Rule 5.2(a)) 30 October 2017 (30.10.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 16196625.4 31 October 2016 (31.10.2016) EP (71) Applicant: ARES TRADING S.A. [CH/CH]; Zone Indus- trielle de L'Ouriettaz, 1170 Aubonne (CH). (72) Inventors: JEZEK, Jan; 4 Jennings Road, Saffron Walden CB11 3NJ (GB). BADIALI, Luca; 11 The Elms, Milton, Cambridge CB24 6ZQ (GB). GERRING, David; 19 Can- telupe Road, Haslingfield, Cambridge CB23 1LU (GB). Designated States (unless otherwise indicated, for every (81) = kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, = CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, _ — DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, = = — — SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, — TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. = Designated States (unless otherwise indicated, for every (84) = kind of regional protection available): ARIPO (BW, GH, = = GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, _ UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, = _ TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, = = TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, = — KM, ML, MR, NE, SN, TD, TG). = under Rule 4.17: = Declarations — as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(0 1-1 ei 1-1 ot IN © (54) Title: LIQUID PHARMACEUTICAL COMPOSITION --.... ,1 (57) : The present invention relates to a novel protein formulation. In particular, the invention relates to a liquid pharmaceutical 0 composition of tocilizumab, a method of manufacturing the composition, a kit including the composition, a package including the N composition and to methods of treatment using the composition and/or package.
SG11201902531QA 2016-10-31 2017-10-30 Liquid pharmaceutical composition SG11201902531QA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16196625 2016-10-31
PCT/EP2017/077793 WO2018078162A1 (en) 2016-10-31 2017-10-30 Liquid pharmaceutical composition

Publications (1)

Publication Number Publication Date
SG11201902531QA true SG11201902531QA (en) 2019-05-30

Family

ID=57218780

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201902531QA SG11201902531QA (en) 2016-10-31 2017-10-30 Liquid pharmaceutical composition

Country Status (16)

Country Link
US (2) US11291725B2 (en)
EP (2) EP3964197A1 (en)
JP (2) JP2019536761A (en)
KR (1) KR20190078572A (en)
CN (1) CN110062620B (en)
AU (1) AU2017351805A1 (en)
BR (1) BR112019006853B1 (en)
CA (1) CA3040342A1 (en)
DK (1) DK3532029T3 (en)
ES (1) ES2882181T3 (en)
HU (1) HUE054858T2 (en)
MY (1) MY192532A (en)
RU (1) RU2019116756A (en)
SG (1) SG11201902531QA (en)
WO (1) WO2018078162A1 (en)
ZA (1) ZA201901736B (en)

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PE20091174A1 (en) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd LIQUID FORMULATION WITH HIGH CONCENTRATION OF ANTIBODY CONTENT
CN110062620B (en) * 2016-10-31 2023-12-05 德国费森尤斯卡比有限公司 liquid pharmaceutical composition
CA3117245A1 (en) * 2018-10-31 2020-05-07 Richter Gedeon Nyrt. Aqueous pharmaceutical formulations
IL293737A (en) * 2019-12-10 2022-08-01 Mitotech S A Polymer matrixes for different compositions of mitochondrially targeted antioxidants
WO2021180821A2 (en) * 2020-03-10 2021-09-16 Tiziana Life Sciences Plc Compositions of il-6/il-6r antibodies and methods of use thereof
WO2022006051A1 (en) * 2020-06-29 2022-01-06 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating covid-19 by inhalation
KR20220028972A (en) * 2020-08-31 2022-03-08 (주)셀트리온 Stable Pharmaceutical Formulation
US20230076072A1 (en) * 2021-08-24 2023-03-09 Oxford Biomedica Solutions Llc Adeno-associated virus formulations
WO2024043837A1 (en) * 2022-08-26 2024-02-29 Aslan Pharmaceuticals Pte Ltd High concentration anti-il13r antibody formulation
KR102554775B1 (en) 2023-02-07 2023-07-12 한국코러스 주식회사 Hyaluronidase formulation and which contains stabilizer for hyaluronidase

Family Cites Families (13)

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Publication number Priority date Publication date Assignee Title
DE122009000019I1 (en) 1991-04-25 2009-07-16 Chugai Seiyaku K K 5 1 RECOMBINED HUMAN ANTIBODIES AGAINST THE HUMAN INTERLEUKIN-6 RECEPTOR
AU2001277781A1 (en) 2000-08-11 2002-02-25 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
CN1638798A (en) 2002-02-14 2005-07-13 中外制药株式会社 Antibody-containing solution pharmaceuticals
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
JP2009034095A (en) * 2007-07-06 2009-02-19 Sanyo Chem Ind Ltd Stabilizer for aqueous solution containing protein, method for stabilizing aqueous solution containing protein and aqueous solution containing protein
NZ583999A (en) * 2007-08-27 2011-10-28 Biogenerix Ag Liquid formulation comprising g-csf, sugar alcohol, surfactant and an acetate
PE20091174A1 (en) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd LIQUID FORMULATION WITH HIGH CONCENTRATION OF ANTIBODY CONTENT
JO3417B1 (en) 2010-01-08 2019-10-20 Regeneron Pharma Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies
BR112013011305A2 (en) * 2010-11-08 2017-07-25 Chugai Pharmaceutical Co Ltd il-6 mediated dysfunction treatment method, rheumatoid arthritis treatment method, article of manufacture, method of inhibiting the progression of joint structural damage, pharmaceutical composition, juvenile idiopathic arthritis (jia) treatment method and treatment method giant cell arteritis (gca)
BR112014010186A2 (en) 2011-10-28 2017-05-02 Integritybio Inc stable pharmaceutical formulation, kit, pharmaceutical composition, method for preparing a pharmaceutical formulation, and method for treating a human or animal
PE20150190A1 (en) * 2012-06-21 2015-02-13 Ucb Pharma Sa PHARMACEUTICAL FORMULATION
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CN110062620B (en) * 2016-10-31 2023-12-05 德国费森尤斯卡比有限公司 liquid pharmaceutical composition

Also Published As

Publication number Publication date
ZA201901736B (en) 2020-11-25
DK3532029T3 (en) 2021-06-07
AU2017351805A1 (en) 2019-04-11
HUE054858T2 (en) 2021-10-28
BR112019006853B1 (en) 2021-08-24
JP2022166006A (en) 2022-11-01
CN110062620B (en) 2023-12-05
US11291725B2 (en) 2022-04-05
US20220175924A1 (en) 2022-06-09
EP3964197A1 (en) 2022-03-09
CA3040342A1 (en) 2018-05-03
MY192532A (en) 2022-08-26
EP3532029B1 (en) 2021-04-28
JP7473603B2 (en) 2024-04-23
KR20190078572A (en) 2019-07-04
RU2019116756A (en) 2020-11-30
JP2019536761A (en) 2019-12-19
WO2018078162A1 (en) 2018-05-03
CN110062620A (en) 2019-07-26
ES2882181T3 (en) 2021-12-01
RU2019116756A3 (en) 2021-02-26
US20190262450A1 (en) 2019-08-29
BR112019006853A2 (en) 2019-06-25
EP3532029A1 (en) 2019-09-04

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