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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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], 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)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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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PL1921919T3 (pl) 2005-07-14 2012-09-28 Lithera Inc Ulepszona lipolityczna formulacja o podtrzymywanym uwalnianiu do traktowania lokalnej tkanki tłuszczowej
BRPI0822447A2 (pt) 2008-03-14 2015-06-16 Biocon Ltd Anticorpo monoclonal e 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
KR20120027031A (ko) * 2009-06-18 2012-03-20 와이어쓰 엘엘씨 소형 모듈 면역제약용 동결건조 제제
BR112012012080B1 (pt) * 2009-11-20 2022-11-29 Biocon Limited Formulações de histidina-trealose do anticorpo t1h
MX2012008171A (es) * 2010-01-15 2012-12-17 Lithera Inc Formulaciones aglomeradas liofilizadas.
CN107496917B (zh) 2010-02-26 2021-06-11 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
EP2575761B1 (en) 2010-05-28 2024-08-14 Novo Nordisk A/S Stable multi-dose compositions comprising an antibody and a preservative
EP4289445A3 (en) * 2010-09-17 2024-02-21 Takeda Pharmaceutical Company Limited Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
AU2011336869B2 (en) 2010-11-24 2016-09-15 Neothetics, Inc. Selective, lipophilic, and long-acting beta agonist monotherapeutic formulations and methods for the cosmetic treatment of adiposity and contour bulging
SI2691112T1 (en) * 2011-03-31 2018-07-31 Merck Sharp & Dohme Corp. STABILITY FORMULATION PROTITELES FOR HUMAN PROGRAMMED DEPRESSOR RECEPTOR PD-1 AND RELATED HEALTH
EP4527855A3 (en) * 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent formulations
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
EP2970465B1 (en) 2013-03-15 2019-09-25 Takeda GmbH Formulation of an antibody and use thereof
EP3738613A1 (en) 2013-07-23 2020-11-18 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
CN118873480A (zh) * 2016-10-07 2024-11-01 瑞泽恩制药公司 室温稳定的冻干蛋白质
ES2991182T3 (es) 2016-10-21 2024-12-02 Biocon Ltd Un anticuerpo monoclonal y un método de uso para el tratamiento del lupus
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
MX2019013072A (es) 2017-05-02 2019-12-16 Merck Sharp & Dohme Formulaciones de anticuerpos anti-lag3 y coformulaciones de anticuerpos anti-lag3 y anticuerpos anti-pd-1.
BR112020020741A2 (pt) * 2018-04-10 2021-01-19 Dr. Reddy's Laboratories Limited Formulação farmacêutica estável de um anticorpo, e, formulação de anticorpo alfa4beta7 estável.
WO2019198100A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Antibody formulation
JP2021521171A (ja) * 2018-04-10 2021-08-26 ドクター レディズ ラボラトリーズ リミテッド 治療用抗体の安定な製剤
AU2019377456A1 (en) 2018-11-07 2021-05-27 Merck Sharp & Dohme Llc Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
SG11202104166QA (en) * 2018-11-21 2021-05-28 Regeneron Pharma High concentration protein formulation
PH12021551916A1 (en) 2019-02-18 2022-05-23 Lilly Co Eli Therapeutic antibody formulation.
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
AU2024282654A1 (en) 2023-05-30 2025-12-04 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions 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
WO2003009817A2 (en) * 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
EP1592440A4 (en) * 2003-02-10 2007-07-11 Elan Pharm Inc IMMUNOGLOBULIN PREPARATION AND METHOD OF PRODUCING THE SAME
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
KR20100038100A (ko) 2010-04-12
ECSP099837A (es) 2010-01-29
AU2008265930A1 (en) 2008-12-24
WO2008157409A8 (en) 2010-03-11
JP2010530003A (ja) 2010-09-02
MX2009013558A (es) 2010-03-08
US20090208492A1 (en) 2009-08-20
EP2167126A4 (en) 2012-03-07
EA201000018A1 (ru) 2010-06-30
MA31519B1 (fr) 2010-07-01
EP2167126A1 (en) 2010-03-31
CA2691855A1 (en) 2008-12-24
CN101827608A (zh) 2010-09-08
IL202660A0 (en) 2011-08-01
WO2008157409A1 (en) 2008-12-24
CO6251275A2 (es) 2011-02-21

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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]