SG11201903521XA - Pharmaceutical formulations and methods of making the same - Google Patents
Pharmaceutical formulations and methods of making the sameInfo
- 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
Links
- 238000000034 method Methods 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 108010008165 Etanercept Proteins 0.000 abstract 2
- 241000219492 Quercus Species 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 229960000403 etanercept Drugs 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 1
- 230000008520 organization Effects 0.000 abstract 1
- 102220240796 rs553605556 Human genes 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
-
- 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
- A61K47/16—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
- A61K47/26—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
- 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
-
- 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]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
- C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/32—Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662411458P | 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 (14)
Country | Link |
---|---|
US (4) | US20180110856A1 (en) |
EP (1) | EP3528787A4 (en) |
JP (3) | JP6884858B2 (en) |
KR (2) | KR102413592B1 (en) |
CN (2) | CN109982685B (en) |
AU (1) | AU2017345490B2 (en) |
BR (1) | BR112019007858A2 (en) |
CA (1) | CA3040899A1 (en) |
CL (1) | CL2019001053A1 (en) |
EA (1) | EA201990998A1 (en) |
IL (1) | IL266132B (en) |
MX (1) | MX2019004580A (en) |
SG (1) | SG11201903521XA (en) |
WO (1) | WO2018075818A1 (en) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2006259664A1 (en) | 2005-06-14 | 2006-12-28 | Amgen Inc. | Self-buffering protein formulations |
AU2017345490B2 (en) * | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
GB201911461D0 (en) * | 2019-08-09 | 2019-09-25 | Arecor Ltd | Novel composition |
US20230146593A1 (en) | 2020-03-12 | 2023-05-11 | Amgen Inc. | Method for treatment and prophylaxis of crs in patients comprising a combination of bispecific antibodies binding to cds x cancer cell and tnf alpha or il-6 inhibitor |
EP4007164A4 (en) | 2020-05-12 | 2022-11-23 | NEC Corporation | Distortion compensation device and distortion compensation method |
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AU2017345490A1 (en) | 2019-05-09 |
WO2018075818A1 (en) | 2018-04-26 |
JP2021120393A (en) | 2021-08-19 |
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JP2019533679A (en) | 2019-11-21 |
IL266132B (en) | 2021-12-01 |
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EP3528787A4 (en) | 2020-05-06 |
CN109982685A (en) | 2019-07-05 |
KR20190071760A (en) | 2019-06-24 |
KR102413592B1 (en) | 2022-06-27 |
EA201990998A1 (en) | 2019-11-29 |
JP2024010026A (en) | 2024-01-23 |
KR102446838B1 (en) | 2022-09-26 |
CL2019001053A1 (en) | 2019-08-02 |
EP3528787A1 (en) | 2019-08-28 |
AU2017345490B2 (en) | 2022-07-07 |
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CA3040899A1 (en) | 2018-04-26 |
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