ZA201702762B - Reducing viscosity of pharmaceutical formulations - Google Patents

Reducing viscosity of pharmaceutical formulations

Info

Publication number
ZA201702762B
ZA201702762B ZA2017/02762A ZA201702762A ZA201702762B ZA 201702762 B ZA201702762 B ZA 201702762B ZA 2017/02762 A ZA2017/02762 A ZA 2017/02762A ZA 201702762 A ZA201702762 A ZA 201702762A ZA 201702762 B ZA201702762 B ZA 201702762B
Authority
ZA
South Africa
Prior art keywords
pharmaceutical formulations
reducing viscosity
viscosity
reducing
formulations
Prior art date
Application number
ZA2017/02762A
Other languages
English (en)
Inventor
Christopher James Sloey
Sekhar Kanapuram
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54427875&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ZA201702762(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of ZA201702762B publication Critical patent/ZA201702762B/en

Links

Classifications

    • 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
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/16Organic 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
    • 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
    • A61K47/16Organic 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 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ZA2017/02762A 2014-10-23 2017-04-19 Reducing viscosity of pharmaceutical formulations ZA201702762B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23
PCT/US2015/056972 WO2016065181A1 (en) 2014-10-23 2015-10-22 Reducing viscosity of pharmaceutical formulations

Publications (1)

Publication Number Publication Date
ZA201702762B true ZA201702762B (en) 2022-12-21

Family

ID=54427875

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA2017/02762A ZA201702762B (en) 2014-10-23 2017-04-19 Reducing viscosity of pharmaceutical formulations

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3909611B1 (enExample)
JP (3) JP2017531682A (enExample)
KR (1) KR102534017B1 (enExample)
CN (2) CN107206070B (enExample)
AU (2) AU2015335743B2 (enExample)
BR (1) BR112017008125B1 (enExample)
CA (1) CA2964786C (enExample)
CL (2) CL2017000984A1 (enExample)
EA (3) EA038462B1 (enExample)
ES (1) ES2964713T3 (enExample)
IL (2) IL287947B2 (enExample)
MA (1) MA54716A (enExample)
MX (2) MX388858B (enExample)
SG (1) SG11201703152RA (enExample)
WO (1) WO2016065181A1 (enExample)
ZA (1) ZA201702762B (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112017008125B1 (pt) 2014-10-23 2023-11-21 Amgen Inc. Método para a redução da viscosidade de formulações farmacêuticas, formulações farmacêuticas, método de preparação de um pó liofilizado, pó liofilizado e método para reconstituição de um pó liofilizado
WO2018067987A1 (en) * 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
JP7377596B2 (ja) * 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
MA48461A (fr) 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
ES3036143T3 (en) * 2017-04-28 2025-09-15 Amgen Inc N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
SG11202003754YA (en) 2017-05-16 2020-05-28 Bhamis Research Laboratory Pvt Ltd High concentration protein formulations with reduced viscosity
IL299864B2 (en) 2017-06-16 2024-06-01 Zealand Pharma As Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues
EP3685849A4 (en) * 2017-09-22 2021-12-22 Asahi Kasei Pharma Corporation LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY
WO2019106206A1 (en) 2017-12-01 2019-06-06 Fyb 202 Project Gmbh Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody
CN112543627A (zh) 2018-07-05 2021-03-23 拜耳公司 新型稳定的高浓度抗FXIa抗体制剂
JP2021535739A (ja) 2018-08-27 2021-12-23 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 下流精製でのラマン分光法の使用
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
JP7739182B2 (ja) * 2019-04-23 2025-09-16 アムジエン・インコーポレーテツド 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン(pvp)の使用
IL295042A (en) * 2020-02-13 2022-09-01 Amgen Inc Formulations of human anti-tslp antibodies and methods of treating inflammatory disease
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
CN116963721A (zh) * 2021-03-09 2023-10-27 Gi 医诺微新 包含IgE Fc受体的α亚基的胞外结构域的融合蛋白的制剂
KR20230167123A (ko) * 2021-04-09 2023-12-07 아반토 퍼포먼스 머티리얼즈, 엘엘씨 성능-강화 부형제 및 생물학적 제형의 점성을 낮추고 안정성을 높이는 방법
WO2025175164A1 (en) * 2024-02-16 2025-08-21 Regeneron Pharmaceuticals, Inc. Methods of producing concentrated formulated drug substances comprising proteins, and concentrated formulated drug substance made by the methods

Family Cites Families (49)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5078997A (en) 1988-07-13 1992-01-07 Cetus Corporation Pharmaceutical composition for interleukin-2 containing physiologically compatible stabilizers
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
DE69814133T2 (de) * 1997-11-07 2004-04-01 Chiron Corp. (N.D.Ges.D. Staates Delaware), Emeryville Zusammensetzung um die löslichkeit von igf-i zu erhöhen
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
US6159485A (en) * 1999-01-08 2000-12-12 Yugenic Limited Partnership N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use
AU4458401A (en) * 2000-03-31 2001-10-15 Kirin Brewery Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability
PL209928B1 (pl) 2000-11-07 2011-11-30 Novartis Vaccines & Diagnostic Kompozycja farmaceutyczna zawierająca biologicznie aktywny IFN-β i mannitol, wstępnie napełniona strzykawka zawierająca tę kompozycję oraz sposób wytwarzania preparatu IFN-β
MXPA04001486A (es) 2001-08-23 2004-10-27 Genmab As Anticuerpos humanos especificos para interleucina 15 (il-15).
CA2476934C (en) 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
AU2003293543A1 (en) 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
EP1589996A4 (en) 2003-01-30 2009-01-21 Medimmune Inc ANTI-INTEGRIN ALPHA BETA 3 ANTIBODY FORMULATIONS AND ITS USES
PT1610820E (pt) 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
US8084032B2 (en) 2004-01-21 2011-12-27 Ajinomoto Co., Inc. Purification method which prevents denaturation of an antibody
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2006081171A1 (en) 2005-01-24 2006-08-03 Amgen Inc. Humanized anti-amyloid antibody
US7592429B2 (en) 2005-05-03 2009-09-22 Ucb Sa Sclerostin-binding antibody
US8003108B2 (en) 2005-05-03 2011-08-23 Amgen Inc. Sclerostin epitopes
EP1977763A4 (en) * 2005-12-28 2010-06-02 Chugai Pharmaceutical Co Ltd STABILIZER PREPARATION CONTAINING ANTIBODIES
CN101426527A (zh) * 2006-02-03 2009-05-06 米迪缪尼有限公司 蛋白质制剂
GB0603683D0 (en) 2006-02-23 2006-04-05 Novartis Ag Organic compounds
CA2651453C (en) 2006-05-11 2014-10-14 Isis Pharmaceuticals, Inc. 5'-modified bicyclic nucleic acid analogs
KR20090088950A (ko) 2006-12-14 2009-08-20 쉐링 코포레이션 가공된 항-tslp 항체
US8101182B2 (en) 2007-06-20 2012-01-24 Novartis Ag Methods and compositions for treating allergic diseases
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
TWI629064B (zh) * 2007-11-30 2018-07-11 艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
EP2249809A1 (en) * 2008-01-15 2010-11-17 Abbott GmbH & Co. KG Powdered protein compositions and methods of making same
TWI516501B (zh) 2008-09-12 2016-01-11 禮納特神經系統科學公司 Pcsk9拮抗劑類
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
JP2011067202A (ja) * 2009-08-31 2011-04-07 Sanyo Chem Ind Ltd タンパク質水溶液の安定化剤、この安定化剤を含有するタンパク質水溶液及びタンパク質の安定化方法
US20120270782A1 (en) * 2009-11-17 2012-10-25 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
CA2788863C (en) 2010-02-04 2020-07-07 Reinhard Franz Bolli Immunoglobulin preparation
CA2789061A1 (en) * 2010-02-26 2011-09-01 Henrik Parshad Stable antibody containing compositions
WO2011109415A2 (en) * 2010-03-02 2011-09-09 Amgen Inc. Reducing viscosity of pharmaceutical formulations
RU2012151500A (ru) * 2010-05-03 2014-06-10 Дженентек, Инк. Композиции и способы, пригодные для снижения вязкости белковосодержащих составов
AR083495A1 (es) 2010-10-22 2013-02-27 Esbatech Alcon Biomed Res Unit Anticuerpos estables y solubles
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
EP2735315B1 (en) 2011-07-19 2019-10-02 Chugai Seiyaku Kabushiki Kaisha Stable protein-containing preparation containing argininamide or valinamide
BR112014010186A2 (pt) * 2011-10-28 2017-05-02 Integritybio Inc formulação farmacêutica estável, kit, composição farmacêutica, método para preparar uma formulação farmacêutica, e, método para tratar um humano ou animal
EA039663B1 (ru) 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
US20150150982A1 (en) 2012-06-12 2015-06-04 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
US20150004174A1 (en) 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
TWI694836B (zh) 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
BR112017008125B1 (pt) 2014-10-23 2023-11-21 Amgen Inc. Método para a redução da viscosidade de formulações farmacêuticas, formulações farmacêuticas, método de preparação de um pó liofilizado, pó liofilizado e método para reconstituição de um pó liofilizado
EP3763384B1 (en) 2014-12-03 2024-08-28 CSL Behring AG Pharmaceutical product with increased stability comprising immunoglobulins
US11059908B2 (en) 2016-09-29 2021-07-13 Amgen Inc. Low-viscosity antigen binding proteins and methods of making them
WO2018067987A1 (en) 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法

Also Published As

Publication number Publication date
JP7411615B2 (ja) 2024-01-11
EP3209332A1 (en) 2017-08-30
KR102534017B1 (ko) 2023-05-19
MA54716A (fr) 2021-11-17
BR112017008125A2 (pt) 2018-06-19
IL251726A0 (en) 2017-06-29
CL2017000984A1 (es) 2018-01-05
US11813328B2 (en) 2023-11-14
JP2017531682A (ja) 2017-10-26
US20250345421A1 (en) 2025-11-13
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
EA038462B1 (ru) 2021-08-31
US20170333559A1 (en) 2017-11-23
JP2020037559A (ja) 2020-03-12
CN107206070B (zh) 2022-01-18
BR112017008125B1 (pt) 2023-11-21
EA201790787A1 (ru) 2017-08-31
ES2964713T3 (es) 2024-04-09
EP3909611A1 (en) 2021-11-17
SG11201703152RA (en) 2017-05-30
IL287947B2 (en) 2024-08-01
IL251726B (en) 2021-12-01
EP3909611B1 (en) 2023-08-30
MX2021015789A (es) 2022-01-27
JP2022009223A (ja) 2022-01-14
AU2015335743A1 (en) 2017-05-04
US20240066124A1 (en) 2024-02-29
US12318447B2 (en) 2025-06-03
AU2021200990A1 (en) 2021-03-11
AU2015335743B2 (en) 2020-12-24
JP6965321B2 (ja) 2021-11-10
WO2016065181A1 (en) 2016-04-28
CL2019002190A1 (es) 2019-11-22
CN114569716A (zh) 2022-06-03
CN107206070A (zh) 2017-09-26
IL287947A (en) 2022-01-01
EA033444B1 (ru) 2019-10-31
IL287947B1 (en) 2024-04-01
MX2017005243A (es) 2017-08-18
EA202191513A1 (ru) 2021-11-30
KR20170071518A (ko) 2017-06-23
EP3209332B1 (en) 2021-05-26
MX388858B (es) 2025-03-20
CA2964786A1 (en) 2016-04-28
CA2964786C (en) 2023-10-17

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