[go: up one dir, main page]

MX2021015789A - Reduccion de la viscosidad de formulaciones farmaceuticas. - Google Patents

Reduccion de la viscosidad de formulaciones farmaceuticas.

Info

Publication number
MX2021015789A
MX2021015789A MX2021015789A MX2021015789A MX2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A
Authority
MX
Mexico
Prior art keywords
pharmaceutical formulations
reducing viscosity
viscosity
acetyl
reducing
Prior art date
Application number
MX2021015789A
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=MX2021015789(A) "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 MX2021015789A publication Critical patent/MX2021015789A/es

Links

Classifications

    • 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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (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)

Abstract

Se proporciona un método para reducir la viscosidad de una formulación farmacéutica que utiliza una concentración de reducción de la viscosidad de un excipiente seleccionado del grupo que consiste en la n-acetil arginina, n-acetil lisina, n-acetil prolina y mezclas de los mismos en combinación con una proteína terapéutica. También se proporciona una formulación farmacéutica estable.
MX2021015789A 2014-10-23 2017-04-21 Reduccion de la viscosidad de formulaciones farmaceuticas. MX2021015789A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23

Publications (1)

Publication Number Publication Date
MX2021015789A true MX2021015789A (es) 2022-01-27

Family

ID=54427875

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2017005243A MX388858B (es) 2014-10-23 2015-10-22 Reducción de la viscosidad de formulaciones farmacéuticas
MX2021015789A MX2021015789A (es) 2014-10-23 2017-04-21 Reduccion de la viscosidad de formulaciones farmaceuticas.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2017005243A MX388858B (es) 2014-10-23 2015-10-22 Reducción de la viscosidad de formulaciones farmacéuticas

Country Status (17)

Country Link
US (3) US11813328B2 (es)
EP (2) EP3909611B1 (es)
JP (3) JP2017531682A (es)
KR (1) KR102534017B1 (es)
CN (2) CN107206070B (es)
AU (2) AU2015335743B2 (es)
BR (1) BR112017008125B1 (es)
CA (1) CA2964786C (es)
CL (2) CL2017000984A1 (es)
EA (3) EA033444B1 (es)
ES (1) ES2964713T3 (es)
IL (2) IL287947B2 (es)
MA (1) MA54716A (es)
MX (2) MX388858B (es)
SG (1) SG11201703152RA (es)
WO (1) WO2016065181A1 (es)
ZA (1) ZA201702762B (es)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11813328B2 (en) 2014-10-23 2023-11-14 Amgen Inc. Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins
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
US12257343B2 (en) 2017-04-28 2025-03-25 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
AU2018258676B2 (en) * 2017-04-28 2024-09-19 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
BR112019026711A2 (pt) 2017-06-16 2020-06-30 Zealand Pharma A/S regimes de dosagem para a administração de análogos de peptídeo semelhante a glucagon- 2 (glp-2)
JP6577683B2 (ja) * 2017-09-22 2019-09-18 旭化成ファーマ株式会社 安定性に優れるテリパラチド含有液状医薬組成物
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
CA3105261A1 (en) 2018-07-05 2020-01-09 Bayer Aktiengesellschaft Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody
AU2019329686A1 (en) 2018-08-27 2020-12-03 Regeneron Pharmaceuticals, Inc. Use of raman spectroscopy in downstream purification
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
MX2021012782A (es) * 2019-04-23 2021-11-25 Amgen Inc El uso de polivinilpirrolidona (pvp) de bajo peso molecular para reducir la viscosidad de formulaciones de proteinas de alta concentracion.
JOP20220183A1 (ar) * 2020-02-13 2023-01-30 Amgen Inc صياغات أجسام مضادة ضد tslp بشرية وطرائق علاج مرض التهابي
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
MX2023010457A (es) * 2021-03-09 2023-09-14 Gi Innovation Inc Formulacion de proteina de fusion que incluye el dominio extracelular de la subunidad alfa del receptor fc de ige.
WO2022217021A1 (en) * 2021-04-09 2022-10-13 Avantor Performance Materials, Llc Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
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
ATE238807T1 (de) 1997-11-07 2003-05-15 Chiron Corp 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
CA2403962C (en) 2000-03-31 2009-12-15 Kirin Beer Kabushiki Kaisha Powdery preparation for transmucosal administration comprising a medicine of high molecular weight and exhibiting an improved storage stability
PT1343518E (pt) 2000-11-07 2009-08-03 Novartis Vaccines & Diagnostic Composições de interferão estabilizadas
RS51829B (sr) 2001-08-23 2012-02-29 Genmab A/S. Ljudska antitela specifična za interleukin 15 (il-15)
US20030180287A1 (en) 2002-02-27 2003-09-25 Immunex Corporation Polypeptide formulation
WO2004055164A2 (en) 2002-12-13 2004-07-01 Abgenix, Inc. System and method for stabilizing antibodies with histidine
CA2512174A1 (en) 2003-01-30 2004-08-12 Christian B. Allan Anti-integrin .alpha..nu..beta.3 antibody formulations and uses thereof
SI2335725T1 (sl) * 2003-04-04 2017-01-31 Genentech, Inc. Visokokoncentrirane formulacije protiteles in proteinov
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
CA2589860A1 (en) 2005-01-24 2006-08-03 Amgen Inc. Humanized anti-amyloid antibody
US8003108B2 (en) 2005-05-03 2011-08-23 Amgen Inc. Sclerostin epitopes
US7592429B2 (en) 2005-05-03 2009-09-22 Ucb Sa Sclerostin-binding antibody
EP1977763A4 (en) * 2005-12-28 2010-06-02 Chugai Pharmaceutical Co Ltd ANTIBODY-CONTAINING STABILIZING PREPARATION
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
US7547684B2 (en) 2006-05-11 2009-06-16 Isis Pharmaceuticals, Inc. 5′-modified bicyclic nucleic acid analogs
JP5059119B2 (ja) 2006-12-14 2012-10-24 シェーリング コーポレイション 操作された抗tslp抗体
WO2008155365A1 (en) 2007-06-20 2008-12-24 Irm Llc 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
KR20210049186A (ko) 2007-11-30 2021-05-04 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
RU2537139C2 (ru) * 2008-01-15 2014-12-27 Эбботт Гмбх Унд Ко.Кг Порошковые белковые композиции и способы их получения
TWI445716B (zh) 2008-09-12 2014-07-21 Rinat Neuroscience Corp 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
JP6084036B2 (ja) * 2009-11-17 2017-02-22 イプセン ファルマ ソシエテ パール アクシオン サンプリフィエIpsen Pharma S.A.S. hGHとrhIGF−1の組合せのための配合物
TR201903403T4 (tr) 2010-02-04 2019-04-22 Csl Behring Ag İmmünoglobulin preparatı.
AU2011219715B2 (en) * 2010-02-26 2014-12-11 Novo Nordisk A/S Stable antibody containing compositions
US20130171128A1 (en) * 2010-03-02 2013-07-04 Amgen Inc. Reducing viscosity of pharmaceutical formulations
MX2012012743A (es) 2010-05-03 2012-11-23 Genentech Inc Composiciones y metodos utiles para reducir la viscosidad de formulaciones que contienen proteina.
UY33679A (es) 2010-10-22 2012-03-30 Esbatech 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
CA2853823C (en) * 2011-10-28 2016-12-20 Integritybio Inc. Protein formulations containing amino acids
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
US11813328B2 (en) 2014-10-23 2023-11-14 Amgen Inc. Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins
DK3763384T3 (da) 2014-12-03 2024-09-23 Csl Behring Ag Farmaceuitisk produkt med øget stabilitet, omfattende immunoglobuliner
IL307684B2 (en) 2016-09-29 2025-04-01 Amgen Inc Low viscosity antigen binding proteins and methods for preparing 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
AU2015335743A1 (en) 2017-05-04
US20170333559A1 (en) 2017-11-23
AU2021200990A1 (en) 2021-03-11
JP2017531682A (ja) 2017-10-26
MA54716A (fr) 2021-11-17
CN114569716A (zh) 2022-06-03
JP7411615B2 (ja) 2024-01-11
CA2964786A1 (en) 2016-04-28
EP3909611A1 (en) 2021-11-17
IL287947B1 (en) 2024-04-01
KR20170071518A (ko) 2017-06-23
BR112017008125A2 (pt) 2018-06-19
IL287947B2 (en) 2024-08-01
EP3909611B1 (en) 2023-08-30
US12318447B2 (en) 2025-06-03
IL251726B (en) 2021-12-01
CN107206070A (zh) 2017-09-26
US11813328B2 (en) 2023-11-14
US20250345421A1 (en) 2025-11-13
JP2020037559A (ja) 2020-03-12
ZA201702762B (en) 2022-12-21
MX388858B (es) 2025-03-20
AU2015335743B2 (en) 2020-12-24
WO2016065181A1 (en) 2016-04-28
IL251726A0 (en) 2017-06-29
EA033444B1 (ru) 2019-10-31
JP2022009223A (ja) 2022-01-14
EA201991447A1 (ru) 2019-11-29
EP3209332A1 (en) 2017-08-30
EA202191513A1 (ru) 2021-11-30
MX2017005243A (es) 2017-08-18
AU2021200990B2 (en) 2023-02-16
KR102534017B1 (ko) 2023-05-19
US20240066124A1 (en) 2024-02-29
CL2017000984A1 (es) 2018-01-05
EA038462B1 (ru) 2021-08-31
EA201790787A1 (ru) 2017-08-31
CL2019002190A1 (es) 2019-11-22
EP3209332B1 (en) 2021-05-26
ES2964713T3 (es) 2024-04-09
BR112017008125B1 (pt) 2023-11-21
JP6965321B2 (ja) 2021-11-10
CA2964786C (en) 2023-10-17
CN107206070B (zh) 2022-01-18
SG11201703152RA (en) 2017-05-30
IL287947A (en) 2022-01-01

Similar Documents

Publication Publication Date Title
MX2021015789A (es) Reduccion de la viscosidad de formulaciones farmaceuticas.
MX2018007703A (es) Inhibidores de la interaccion de menina-linaje leucemico mixto.
CL2016002772A1 (es) Composiciones de insulina de rápida acción
MY191581A (en) Anti-pd-1 antibodies
MX2019013670A (es) Formulaciones de anticuerpos y proteinas.
EA202090632A1 (ru) Способы и композиции для лечения расстройств с использованием фоллистатиновых полипептидов
AR100215A1 (es) Conjugados de anticuerpo-fármaco anti-ptk7
MX2017005575A (es) Formulacion farmaceutica de anticuerpos anti-tnf alfa.
EA202090683A3 (ru) Способы и композиции для лечения рака
EA201692254A1 (ru) Иммуномодулирующие прогениторные (имп) клетки
CL2015002897A1 (es) Inhibidores de bace1
BR112016020181A8 (pt) composições de ácido lipoico éster colina e métodos de uso.
TN2014000498A1 (en) Pharmaceutical formulation
CO2017001601A2 (es) Derivados de 1-acetil-4-((pirazin-2-il) amino)-1,2,3,4-tetrahydroquinolina-6 carboxamida como inhibidores de bromodominio
MX2016015261A (es) Dispersion solida de allisartan isoproxilo y su composicion.
PH12016501434A1 (en) Compositions for use in the treatment of allergic conditions
GEAP201914292A (en) Pharmaceutical formulations of vildagliptin
PH12018502139A1 (en) Phosphaplatin liquid formulations
PH12017501979A1 (en) Pharmaceutical compound
MX2021001361A (es) Composicion liquida de fibrinogeno humano.
UA106905U (uk) Фармацевтична композиція
UA93017U (uk) Препарат "нановулін-врх"
UA93153U (uk) Кисломолочний продукт з композицією хлорофілвмісних прянощів
MX2017016679A (es) Esteres de lactama esteroidal y derivados de acido bis(2-cloroetil)aminofenoxi propanoico.
PL406972A1 (pl) Sposób otrzymywania kompozycji zawierającej klotrimazol oraz kompozycja farmaceutyczna uzyskana tym sposobem