BRPI0514411B8 - formulação, e, método de produzir uma formulação - Google Patents

formulação, e, método de produzir uma formulação

Info

Publication number
BRPI0514411B8
BRPI0514411B8 BRPI0514411A BRPI0514411A BRPI0514411B8 BR PI0514411 B8 BRPI0514411 B8 BR PI0514411B8 BR PI0514411 A BRPI0514411 A BR PI0514411A BR PI0514411 A BRPI0514411 A BR PI0514411A BR PI0514411 B8 BRPI0514411 B8 BR PI0514411B8
Authority
BR
Brazil
Prior art keywords
formulation
producing
seq
antagonist
lyophilized formulation
Prior art date
Application number
BRPI0514411A
Other languages
English (en)
Inventor
Dix Daniel
Chimanlall Goolcharran
Bowers Katherine
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of BRPI0514411A publication Critical patent/BRPI0514411A/pt
Publication of BRPI0514411B1 publication Critical patent/BRPI0514411B1/pt
Publication of BRPI0514411B8 publication Critical patent/BRPI0514411B8/pt

Links

Classifications

    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2006—IL-1
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/54—Interleukins [IL]
    • C07K14/545—IL-1
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers

Abstract

formulação, e, método de produzir uma formulação. proporciona-se formulações de um antagonista de interleucina-1 (il-1) incluindo uma formulação pré-liofilizada, um formulação liofilizada reconstituída, e uma formulação líquida estável. de preferência, o antagonista de il-1 é uma captação de il-1 constituída de um dímero de duas proteínas de fusão apresentado uma seqüência de aminoácidos selecionada do grupo que consiste de seq id no: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, e 26. da forma mais preferível, a proteína de fusão tem a seqüência da seq id no: 10.
BRPI0514411A 2004-08-17 2005-08-17 formulação, e, método de produzir uma formulação BRPI0514411B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60213704P 2004-08-17 2004-08-17
US60/602,137 2004-08-17
PCT/US2005/029428 WO2006023665A2 (en) 2004-08-17 2005-08-17 Il-1 antagonist formulations

Publications (3)

Publication Number Publication Date
BRPI0514411A BRPI0514411A (pt) 2008-06-10
BRPI0514411B1 BRPI0514411B1 (pt) 2020-09-15
BRPI0514411B8 true BRPI0514411B8 (pt) 2021-05-25

Family

ID=35968186

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0514411A BRPI0514411B8 (pt) 2004-08-17 2005-08-17 formulação, e, método de produzir uma formulação

Country Status (15)

Country Link
US (1) US7365165B2 (pt)
EP (2) EP1778723B1 (pt)
JP (2) JP4948410B2 (pt)
CN (1) CN101014617B (pt)
AU (1) AU2005277357B2 (pt)
BR (1) BRPI0514411B8 (pt)
CA (1) CA2576519C (pt)
DK (1) DK1778723T3 (pt)
ES (1) ES2395035T3 (pt)
HK (1) HK1105421A1 (pt)
PL (1) PL1778723T3 (pt)
PT (1) PT1778723E (pt)
SI (1) SI1778723T1 (pt)
WO (1) WO2006023665A2 (pt)
ZA (1) ZA200701529B (pt)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2264065B1 (en) 2003-08-05 2017-03-08 Novo Nordisk A/S Novel insulin derivatives
ES2371361T3 (es) 2005-12-28 2011-12-30 Novo Nordisk A/S Composiciones que comprenden una insulina acilada y zinc y método de producción de dichas composiciones.
US7879805B2 (en) * 2007-06-01 2011-02-01 Acologix, Inc. High temperature stable peptide formulation
ES2744384T3 (es) 2007-06-13 2020-02-24 Novo Nordisk As Formulación farmacéutica que comprende un derivado de insulina
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
US9492375B2 (en) 2008-07-23 2016-11-15 Warsaw Orthopedic, Inc. Foam carrier for bone grafting
RU2540922C2 (ru) 2008-10-30 2015-02-10 Ново Нордиск А/С Лечение сахарного диабета с использованием инъекций инсулина с частотой менее одного раза в день
NZ605928A (en) 2010-07-29 2015-02-27 Eleven Biotherapeutics Inc Chimeric il-1 receptor type i agonists and antagonists
BR112013010345A2 (pt) 2010-10-27 2017-07-25 Novo Nordisk As tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção
EP2790681B9 (en) 2011-11-18 2023-07-26 Regeneron Pharmaceuticals, Inc. Method of manufacturing an extended release pharmaceutical formulation comprising polymer coated protein microparticles using spray-drying
ES2828656T3 (es) 2012-04-04 2021-05-27 Polaris Group Composición que comprende arginina desiminasa pegilada
WO2014035361A1 (en) * 2012-08-26 2014-03-06 R-PHARM, CJSC (Closed Joint Stock Company) IL-1β INHIBITOR COMPOSITION AND USE THEREOF
JP6450364B2 (ja) 2013-03-13 2019-01-09 セセン バイオ， インコーポレイテッド 眼送達のためのキメラサイトカイン製剤
US10137172B2 (en) 2013-04-30 2018-11-27 Novo Nordisk A/S Administration regime
US20190216925A1 (en) 2016-09-16 2019-07-18 Leukocare Ag A Novel Method for Stabilization of a Biopharmaceutical Drug Product During Processing
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993000807A1 (en) * 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
JP3822383B2 (ja) * 1993-12-17 2006-09-20 持田製薬株式会社 可溶性トロンボモジュリン含有組成物
JP2000510813A (ja) * 1995-02-06 2000-08-22 ジェネテイックス・インスティテュート・インコーポレイテッド Ｉｌ−１２用処方
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
JP4172842B2 (ja) * 1997-05-02 2008-10-29 生化学工業株式会社 コンドロイチナーゼ組成物
US6436897B2 (en) 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
US6927044B2 (en) 1998-09-25 2005-08-09 Regeneron Pharmaceuticals, Inc. IL-1 receptor based cytokine traps
US6472179B2 (en) * 1998-09-25 2002-10-29 Regeneron Pharmaceuticals, Inc. Receptor based antagonists and methods of making and using
MXPA04000747A (es) * 2001-07-25 2004-07-08 Protein Desing Labs Inc Formulacion farmaceutica liofilizada estable de anticuerpos igg.
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
WO2004062646A1 (en) * 2003-01-08 2004-07-29 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants

Also Published As

Publication number Publication date
CA2576519C (en) 2013-05-21
US20060040852A1 (en) 2006-02-23
JP4948410B2 (ja) 2012-06-06
JP2012121894A (ja) 2012-06-28
WO2006023665A3 (en) 2006-08-03
BRPI0514411B1 (pt) 2020-09-15
AU2005277357A1 (en) 2006-03-02
SI1778723T1 (sl) 2013-02-28
CA2576519A1 (en) 2006-03-02
PL1778723T3 (pl) 2013-03-29
US7365165B2 (en) 2008-04-29
BRPI0514411A (pt) 2008-06-10
EP1778723B1 (en) 2012-11-14
EP1778723A2 (en) 2007-05-02
DK1778723T3 (da) 2012-12-03
CN101014617A (zh) 2007-08-08
EP2311871A3 (en) 2012-08-08
PT1778723E (pt) 2013-01-25
CN101014617B (zh) 2011-03-30
HK1105421A1 (en) 2008-02-15
AU2005277357B2 (en) 2011-08-04
ES2395035T3 (es) 2013-02-07
JP2008510716A (ja) 2008-04-10
EP2311871A2 (en) 2011-04-20
WO2006023665A2 (en) 2006-03-02
ZA200701529B (en) 2008-09-25

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 15/09/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/08/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 18A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2736 DE 13-06-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.