BRPI0812561A2 - Formulação liofilizada estável preparada, formulação reconstituída estável, método para preparar formulação reconstituída estável e para tratar indivíduo - Google Patents

Formulação liofilizada estável preparada, formulação reconstituída estável, método para preparar formulação reconstituída estável e para tratar indivíduo

Info

Publication number
BRPI0812561A2
BRPI0812561A2 BRPI0812561-9A2A BRPI0812561A BRPI0812561A2 BR PI0812561 A2 BRPI0812561 A2 BR PI0812561A2 BR PI0812561 A BRPI0812561 A BR PI0812561A BR PI0812561 A2 BRPI0812561 A2 BR PI0812561A2
Authority
BR
Brazil
Prior art keywords
stable
formulation
reconstituted formulation
prepared
preparing
Prior art date
Application number
BRPI0812561-9A2A
Other languages
English (en)
Inventor
Barbara Horsey O'connor
Shaun E Buckley
David J Burke
Sherwood Russ Lehrman
Original Assignee
Elan Pharm 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
Application filed by Elan Pharm Inc filed Critical Elan Pharm Inc
Publication of BRPI0812561A2 publication Critical patent/BRPI0812561A2/pt

Links

Classifications

    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
BRPI0812561-9A2A 2007-06-14 2008-06-13 Formulação liofilizada estável preparada, formulação reconstituída estável, método para preparar formulação reconstituída estável e para tratar indivíduo BRPI0812561A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US92913307P 2007-06-14 2007-06-14
US12/138,075 US20090208492A1 (en) 2007-06-14 2008-06-12 Lyophilized Immunoglobulin Formulations and Methods of Preparation
PCT/US2008/066990 WO2008157409A1 (en) 2007-06-14 2008-06-13 Lyophilized immunoglobulin formulations and methods of preparation

Publications (1)

Publication Number Publication Date
BRPI0812561A2 true BRPI0812561A2 (pt) 2014-10-29

Family

ID=40156638

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0812561-9A2A BRPI0812561A2 (pt) 2007-06-14 2008-06-13 Formulação liofilizada estável preparada, formulação reconstituída estável, método para preparar formulação reconstituída estável e para tratar indivíduo

Country Status (15)

Country Link
US (1) US20090208492A1 (pt)
EP (1) EP2167126A4 (pt)
JP (1) JP2010530003A (pt)
KR (1) KR20100038100A (pt)
CN (1) CN101827608A (pt)
AU (1) AU2008265930A1 (pt)
BR (1) BRPI0812561A2 (pt)
CA (1) CA2691855A1 (pt)
CO (1) CO6251275A2 (pt)
EA (1) EA201000018A1 (pt)
EC (1) ECSP099837A (pt)
IL (1) IL202660A0 (pt)
MA (1) MA31519B1 (pt)
MX (1) MX2009013558A (pt)
WO (1) WO2008157409A1 (pt)

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CN106075449A (zh) 2005-07-14 2016-11-09 尼奥塞蒂克斯公司 用于局部脂肪组织治疗的持续释放的增强性脂肪分解性制剂
PT2993186T (pt) 2008-03-14 2019-11-29 Biocon Ltd Anticorpo monoclonal e um método do mesmo
US9132084B2 (en) 2009-05-27 2015-09-15 Neothetics, Inc. Methods for administration and formulations for the treatment of regional adipose tissue
MX2011013722A (es) * 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
PL3721904T3 (pl) * 2009-11-20 2022-01-31 Biocon Limited Formulacje przeciwciała t1h
GB2487868B (en) * 2010-01-15 2014-12-10 Neothetics Inc Lyophilized cake formulations
SI3409289T1 (sl) * 2010-02-26 2020-12-31 Novo Nordisk A/S Stabilni sestavki, ki vsebujejo protitelo
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
RU2012153786A (ru) 2010-05-28 2014-07-10 Ново Нордиск А/С Стабильные многодозовые композиции, содержащие антитело и консервант
PL2616090T3 (pl) * 2010-09-17 2023-12-18 Takeda Pharmaceutical Company Limited Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego
BR112013012994A2 (pt) 2010-11-24 2016-09-13 Lithera Inc formulações monoterapêuticas de beta-agonista de longa duração, lipofílicas e seletivas e métodos para o tratamento cosmético da adiposidade e saliência de contorno
WO2012135408A1 (en) * 2011-03-31 2012-10-04 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
JP6265970B2 (ja) * 2012-03-26 2018-01-24 サノフイ 安定なＩｇＧ４に基づく結合剤の製剤
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
US11576863B2 (en) 2013-03-15 2023-02-14 Takeda Pharmaceutical Company Limited Formulation of an antibody and use thereof
US10189899B2 (en) 2013-07-23 2019-01-29 Biocon Limited Use of a CD6 binding partner and method based thereon
US20210322549A1 (en) * 2015-07-17 2021-10-21 Coherus Biosciences, Inc. Stable Aqueous Formulations of Natalizumab
KR102740598B1 (ko) 2015-09-07 2024-12-09 모찌다 세이야쿠 가부시끼가이샤 알긴산 동결 건조 제제
CN108025072A (zh) * 2015-09-22 2018-05-11 辉瑞公司 制备治疗用蛋白质制剂的方法和由这种方法生产的抗体制剂
CN110022855B (zh) * 2016-10-07 2024-07-16 瑞泽恩制药公司 室温稳定的冻干蛋白质
KR102514528B1 (ko) 2016-10-21 2023-03-27 바이오콘 리미티드 루푸스 치료를 위한 단일클론항체 및 이의 치료방법
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
SG11202009874QA (en) * 2018-04-10 2020-11-27 Dr Reddys Laboratories Ltd Antibody formulation
US12024561B2 (en) * 2018-04-10 2024-07-02 Dr. Reddy's Laboratories Limited Stable antibody formulation
CN112292146A (zh) 2018-04-10 2021-01-29 雷迪博士实验室有限公司 治疗性抗体的稳定的制剂
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
EA202191403A1 (ru) * 2018-11-21 2021-08-09 Ридженерон Фармасьютикалз, Инк. Композиция с высокой концентрацией белка
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
CN112538111B (zh) * 2020-12-09 2022-04-29 深圳市亚辉龙生物科技股份有限公司 新冠病毒单链抗体及质控品和制备方法
EP4720125A1 (en) 2023-05-30 2026-04-08 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
EP4762093A1 (en) 2023-08-14 2026-06-24 Paragon Therapeutics, Inc. Alpha 4 beta 7 integrin binding proteins and methods of use

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6306404B1 (en) * 1998-07-14 2001-10-23 American Cyanamid Company Adjuvant and vaccine compositions containing monophosphoryl lipid A
ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
CN103040732B (zh) * 2003-02-10 2015-04-01 伊兰药品公司 免疫球蛋白制剂及其制备方法
US20060008415A1 (en) * 2004-06-25 2006-01-12 Protein Design Labs, Inc. Stable liquid and lyophilized formulation of proteins

Also Published As

Publication number Publication date
EP2167126A4 (en) 2012-03-07
CN101827608A (zh) 2010-09-08
EP2167126A1 (en) 2010-03-31
AU2008265930A1 (en) 2008-12-24
IL202660A0 (en) 2011-08-01
MX2009013558A (es) 2010-03-08
KR20100038100A (ko) 2010-04-12
WO2008157409A8 (en) 2010-03-11
ECSP099837A (es) 2010-01-29
CO6251275A2 (es) 2011-02-21
US20090208492A1 (en) 2009-08-20
MA31519B1 (fr) 2010-07-01
EA201000018A1 (ru) 2010-06-30
JP2010530003A (ja) 2010-09-02
WO2008157409A1 (en) 2008-12-24
CA2691855A1 (en) 2008-12-24

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE AS 5A, 6A E 7A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2329 DE 25-08-2015 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.

B350 Update of information on the portal [chapter 15.35 patent gazette]