SG11201903521XA - Pharmaceutical formulations and methods of making the same - Google Patents

Pharmaceutical formulations and methods of making the same

Info

Publication number
SG11201903521XA
SG11201903521XA SG11201903521XA SG11201903521XA SG11201903521XA SG 11201903521X A SG11201903521X A SG 11201903521XA SG 11201903521X A SG11201903521X A SG 11201903521XA SG 11201903521X A SG11201903521X A SG 11201903521XA SG 11201903521X A SG11201903521X A SG 11201903521XA
Authority
SG
Singapore
Prior art keywords
sast
international
120naci
100naci
passt
Prior art date
Application number
SG11201903521XA
Inventor
Monica Goss
Nicole Ball
Original Assignee
Amgen 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
Priority to US201662411458P priority Critical
Application filed by Amgen Inc filed Critical Amgen Inc
Priority to PCT/US2017/057472 priority patent/WO2018075818A1/en
Publication of SG11201903521XA publication Critical patent/SG11201903521XA/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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 TOILET 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 TOILET 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 TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/32Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property 1#11101111 0 11101 HOE 3E1 0 011101 1111011 Mil OFR 11110 1111 OEN Organization International Bureau (10) International Publication Number (43) International Publication Date ......0\"\" WO 2018/075818 Al 26 April 2018 (26.04.2018) WIP0 I PCT (51) International Patent A61K 9/08 (2006.01) A61K 31/70 (2006.01) A61K 47/42 (2017.01) (21) International Application (22) International Filing Date: (25) Filing Language: (26) Publication Language: (30) Priority Data: 62/411,458 (71) Applicant: AMGEN Drive, Thousand Oaks, California 91320-1799 (US). (72) Inventors: GOSS, bury Park, California _ Heatherglow Street, Classification: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, A61P 29/00 (2006.01) HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, CO7K 1/34 (2006.01) KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, C07K 14/705 (2006.01) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US2017/057472 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 19 October 2017 (19.10.2017) kind of regional protection available): ARIPO (BW, GH, English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, English 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, 21 October 2016 (21.10.2016) US 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, INC. [US/US]; One Amgen Center KM, ML, MR, NE, SN, TD, TG). Monica; 3050 Lodgewood Street, New- Declarations under Rule 4.17: 91320 (US). BALL, Nicole; 3260 — as to applicant's entitlement to apply for and be granted a Thousand Oaks, California 91360 patent (Rule 4.1700) Published: Karoline A.; Knobbe, Martens, 01- — with international search report (Art. 21(3)) Main Street, 14th Floor, Irvine, CA — with sequence listing part of description (Rule 5.2(a)) (unless otherwise indicated, for every available): AE, AG, AL, AM, BB, BG, BH, BN, BR, BW, BY, BZ, CR, CU, CZ, DE, DJ, DK, DM, DO, (US). = (74) Agent: DELANEY, = son & Bear, LLP, 2040 92614 (US). = (81) Designated States kind of national protection __ AO, AT, AU, AZ, BA, _ — CA, CH, CL, CN, CO, = = Figure 1: Percent HMW (peak B) as detected by SEC 25 20 15 to 41 O. 10 FORMULATIONS AND METHODS OF MAKING THE SAME Percent Peak B by SEC —i—PASST 4°C also relates to (54) Title: PHARMACEUTICAL = = = = = --M—SAST_100NaCI 4°C • 40°C —A— SAST_120NaCI 4 ° C = co • • 5 : • —41— PASST 25 ° C Z: .:A . — M — SAST_100NaCI 25°C ,, It SAST_120NaCI 25°C • ••• • PASST 40°C :.. • • g• • SAST_100NaCI 40°C • .:: • • •A• • SAST_120NaCI 40 ° C I ,.. .. 25°C d - -a-- 41 - ''' e. - r • 4 ° C • • • = _ = .... _ PSI GC 1-1 pc Ir) IN © ---.... Il © ei (57) : The invention 0 5 methods of removing buffer and of formulating pharmaceutical compositions of etanercept. 0 , 0 10 20 30 40 50 Time (weeks) relates to the formulation of pharmaceutical compositions of etanercept. The invention
SG11201903521XA 2016-10-21 2017-10-19 Pharmaceutical formulations and methods of making the same SG11201903521XA (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US201662411458P true 2016-10-21 2016-10-21
PCT/US2017/057472 WO2018075818A1 (en) 2016-10-21 2017-10-19 Pharmaceutical formulations and methods of making the same

Publications (1)

Publication Number Publication Date
SG11201903521XA true SG11201903521XA (en) 2019-05-30

Family

ID=61971152

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201903521XA SG11201903521XA (en) 2016-10-21 2017-10-19 Pharmaceutical formulations and methods of making the same

Country Status (9)

Country Link
US (3) US20180110856A1 (en)
KR (1) KR20190071760A (en)
CN (1) CN109982685A (en)
AU (1) AU2017345490A1 (en)
BR (1) BR112019007858A2 (en)
CA (1) CA3040899A1 (en)
IL (1) IL266132D0 (en)
SG (1) SG11201903521XA (en)
WO (1) WO2018075818A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112019007858A2 (en) 2016-10-21 2019-07-02 Amgen Inc pharmaceutical formulations and methods for producing the same

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