SG11201804961UA - Formulations with reduced degradation of polysorbate - Google Patents
Formulations with reduced degradation of polysorbateInfo
- 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
Links
Classifications
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- 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
-
- 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
- A61K47/06—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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
Landscapes
- 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.
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)
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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-
2016
- 2016-12-28 AU AU2016380988A patent/AU2016380988B2/en active Active
- 2016-12-28 CN CN201680076936.XA patent/CN108472379B/en active Active
- 2016-12-28 JP JP2018534668A patent/JP7008023B2/en active Active
- 2016-12-28 CN CN202210627963.9A patent/CN115400220A/en active Pending
- 2016-12-28 EP EP16829373.6A patent/EP3397287A1/en active Pending
- 2016-12-28 IL IL299759A patent/IL299759A/en unknown
- 2016-12-28 SG SG11201804961UA patent/SG11201804961UA/en unknown
- 2016-12-28 BR BR112018010945A patent/BR112018010945A2/en not_active Application Discontinuation
- 2016-12-28 WO PCT/US2016/069046 patent/WO2017117311A1/en active Application Filing
- 2016-12-28 US US15/393,147 patent/US10525137B2/en active Active
- 2016-12-28 CA CA3007419A patent/CA3007419A1/en active Pending
- 2016-12-28 KR KR1020187021584A patent/KR20180098625A/en unknown
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BR112018010945A2 (en) | 2018-12-04 |
CN115400220A (en) | 2022-11-29 |
US20170189536A1 (en) | 2017-07-06 |
KR20180098625A (en) | 2018-09-04 |
CN108472379A (en) | 2018-08-31 |
IL299759A (en) | 2023-03-01 |
US20200215195A1 (en) | 2020-07-09 |
US10933141B2 (en) | 2021-03-02 |
EP3397287A1 (en) | 2018-11-07 |
US20220040312A1 (en) | 2022-02-10 |
AU2016380988A1 (en) | 2018-07-05 |
JP2022036977A (en) | 2022-03-08 |
US10525137B2 (en) | 2020-01-07 |
CA3007419A1 (en) | 2017-07-06 |
IL259646B2 (en) | 2023-06-01 |
AU2022256163A1 (en) | 2022-11-24 |
JP7008023B2 (en) | 2022-01-25 |
WO2017117311A1 (en) | 2017-07-06 |
AU2016380988B2 (en) | 2022-07-21 |
IL259646A (en) | 2018-07-31 |
CN108472379B (en) | 2022-06-21 |
JP2019504056A (en) | 2019-02-14 |
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