SG11201804961UA - Formulations with reduced degradation of polysorbate - Google Patents

Formulations with reduced degradation of polysorbate

Info

Publication number
SG11201804961UA
SG11201804961UA SG11201804961UA SG11201804961UA SG11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA
Authority
SG
Singapore
Prior art keywords
polysorbate
international
formulations
san francisco
methods
Prior art date
Application number
SG11201804961UA
Inventor
Brian Connolly
Lydia Hamburg
Emily HOLZ
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of SG11201804961UA publication Critical patent/SG11201804961UA/en

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Classifications

    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 6 July 2017 (06.07.2017) WIPO I PCT (10) International Publication Number WO 2017/117311 Al 11111111111111011101111111111101011111011101110101111101110111011111111111110111111 (51) International Patent Classification: A61K 47/40 (2006.01) A61K 9/08 (2006.01) A61K 47/26 (2006.01) A61K 39/395 (2006.01) (21) International Application Number: PCT/US2016/069046 (22) International Filing Date: 28 December 2016 (28.12.2016) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/272,965 30 December 2015 (30.12.2015) US (71) Applicant all designated States except AL, AT, BA, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, NL, NO, PL, PT, RS, SE, SI, SK, SM, TR): GENENTECH, INC. [US/US]; 1 DNA Way, South San Francisco, CA 94080- 4990 (US). (71) Applicant (for AL, AT, BA, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR only): F. HOFFMANN-LA ROCHE AG [CH/CH]; Grenzacherstrasse 124, 4070 Basel (CH). (72) Inventors: CONNOLLY, Brian; c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). HAM- BURG, Lydia; c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). HOLZ, Emily; c/o Gen- entech, Inc., 1 DNA Way, South San Francisco, CA 94080 (US). (74) Agents: BASOL, Erol, C. et al.; Morrison & Foerster LLP, 755 Page Mill Road, Palo Alto, CA 94304-1018 (US). (81) Designated States (unless otherwise indicated, for every 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, 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. (84) Designated States (unless otherwise indicated, for every 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). Published: — with international search report (Art. 21(3)) W O 20 17117 / 3 11 Al (54) Title: FORMULATIONS WITH REDUCED DEGRADATION OF POLYSORBATE (57) : The invention provides methods for making such formulations and methods of using such formulations. The inven- tion further provides methods of reducing polysorbate degradation, methods of reducing the amount of visible and sub-visible particles in an aqueous formulation, and methods of disaggregating polysorbate degradation products comprising adding a cyclodex - trin to a formula comprising polysorbate and a polypeptide. The invention also provides aqueous formulations comprising a poly- peptide, a polysorbate, and a cyclodextrin with reduced polysorbate degradation.
SG11201804961UA 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate SG11201804961UA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562272965P 2015-12-30 2015-12-30
PCT/US2016/069046 WO2017117311A1 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Publications (1)

Publication Number Publication Date
SG11201804961UA true SG11201804961UA (en) 2018-07-30

Family

ID=57868354

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201804961UA SG11201804961UA (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Country Status (11)

Country Link
US (3) US10525137B2 (en)
EP (1) EP3397287A1 (en)
JP (2) JP7008023B2 (en)
KR (1) KR20180098625A (en)
CN (2) CN108472379B (en)
AU (2) AU2016380988B2 (en)
BR (1) BR112018010945A2 (en)
CA (1) CA3007419A1 (en)
IL (2) IL299759A (en)
SG (1) SG11201804961UA (en)
WO (1) WO2017117311A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016380988B2 (en) 2015-12-30 2022-07-21 Genentech, Inc. Formulations with reduced degradation of polysorbate
EP3560945A1 (en) 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
CA3130457A1 (en) * 2019-03-05 2020-09-10 Regeneron Pharmaceuticals, Inc. Human serum albumin in formulations
CA3143663A1 (en) 2019-06-17 2020-12-24 Intas Pharmaceuticals Ltd. A stable formulation of cetrorelix
CN114040754A (en) * 2019-06-28 2022-02-11 基因泰克公司 Compositions and methods for stabilizing liquid protein formulations
KR20220157386A (en) * 2020-03-20 2022-11-29 글락소스미스클라인 인털렉츄얼 프로퍼티 디벨로프먼트 리미티드 Detection method of polysorbate
WO2023117858A1 (en) 2021-12-20 2023-06-29 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations

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