BRPI0418115A - formulação lìquida estável de hormÈnio de crescimento - Google Patents

formulação lìquida estável de hormÈnio de crescimento

Info

Publication number
BRPI0418115A
BRPI0418115A BRPI0418115-8A BRPI0418115A BRPI0418115A BR PI0418115 A BRPI0418115 A BR PI0418115A BR PI0418115 A BRPI0418115 A BR PI0418115A BR PI0418115 A BRPI0418115 A BR PI0418115A
Authority
BR
Brazil
Prior art keywords
growth hormone
present
stable liquid
formulations
liquid growth
Prior art date
Application number
BRPI0418115-8A
Other languages
English (en)
Inventor
Advait Badkar
Sandeep Nema
Manpreet Wadhwa
Original Assignee
Pharmacia Corp
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 Pharmacia Corp filed Critical Pharmacia Corp
Publication of BRPI0418115A publication Critical patent/BRPI0418115A/pt

Links

Classifications

    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biochemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

"FORMULAçãO LìQUIDA ESTáVEL DE HORMÈNIO DE CRESCIMENTO". A presente invenção refere-se a formulações estáveis líquidas de hormónio do crescimento humano, as quais permanecem estáveis após agitação física e após exposição a um ou mais eventos de congelamento/ descongelamento. As formulações da presente invenção podem ser armazenadas durante longos prazos sob variadas temperaturas, até mesmo congeladas. Na presente invenção, uma mistura de tampão e agentes de estabilização, incluindo um tensoativo não-iónico (por exemplo, Polissorbato 20), um estabilizador de polímero (por exemplo, polietilenoglicol) e outros opcionais estabilizadores, se combinam para proporcionar inesperada estabilidade para as formulações aquosas de um hormónio de crescimento (por exemplo, o hormónio do crescimento humano).
BRPI0418115-8A 2003-12-23 2004-12-13 formulação lìquida estável de hormÈnio de crescimento BRPI0418115A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US53184303P 2003-12-23 2003-12-23
PCT/IB2004/004159 WO2005063298A1 (en) 2003-12-23 2004-12-13 Stable growth hormone liquid formulation

Publications (1)

Publication Number Publication Date
BRPI0418115A true BRPI0418115A (pt) 2007-04-17

Family

ID=34738712

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0418115-8A BRPI0418115A (pt) 2003-12-23 2004-12-13 formulação lìquida estável de hormÈnio de crescimento

Country Status (8)

Country Link
US (1) US8338374B2 (pt)
EP (1) EP1706150B1 (pt)
JP (1) JP4845741B2 (pt)
AT (1) ATE554792T1 (pt)
BR (1) BRPI0418115A (pt)
CA (1) CA2551510C (pt)
ES (1) ES2383691T3 (pt)
WO (1) WO2005063298A1 (pt)

Families Citing this family (19)

* 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
CN101389650B (zh) 2005-12-28 2012-10-10 诺沃-诺迪斯克有限公司 包含酰化胰岛素和锌的组合物以及制备所述组合物的方法
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
CN101505789A (zh) * 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂
JP5552046B2 (ja) 2007-06-13 2014-07-16 ノボ・ノルデイスク・エー／エス インスリン誘導体を含有する薬学的製剤
EP2170268A2 (en) 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
US9603904B2 (en) 2008-10-30 2017-03-28 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
EP2538974B1 (en) 2010-02-24 2018-04-18 Arecor Limited Protein formulations
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
RU2013123515A (ru) 2010-10-27 2014-12-10 Ново Нордиск А/С Лечение сахарного диабета с помощью инъекций инсулина, вводимых с различными интервалами
BR112014001921B1 (pt) 2011-07-25 2022-05-10 Sandoz Ag Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
JP5487276B2 (ja) * 2012-11-12 2014-05-07 デウン カンパニー，リミテッド ヒト成長ホルモンを含有する安定した液状製剤
RU2015143521A (ru) * 2013-03-13 2017-04-19 Илэвэн Байотерапьютикс, Инк. Лекарственные формы химерных цитокинов для глазной доставки
EP2991672A1 (en) 2013-04-30 2016-03-09 Novo Nordisk A/S Novel administration regime
TW201605468A (zh) 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
WO2016011281A1 (en) * 2014-07-17 2016-01-21 Teva Pharmaceutical Industries Ltd. FORMULATIONS OF AN ALBUMIN-hGH FUSION PROTEIN
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
CN112494638B (zh) * 2020-12-22 2023-12-19 深圳科兴药业有限公司 一种人生长激素注射剂组合物及其制备方法

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763394A (en) 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5272135A (en) 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
US5206219A (en) 1991-11-25 1993-04-27 Applied Analytical Industries, Inc. Oral compositions of proteinaceous medicaments
SE9201073D0 (sv) 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
AU686567C (en) * 1992-07-31 2002-08-08 Genentech Inc. Human growth hormone aqueous formulation
US5358708A (en) * 1993-01-29 1994-10-25 Schering Corporation Stabilization of protein formulations
SE9503679D0 (sv) * 1995-10-20 1995-10-20 Pharmacia Ab Antioxidants
AUPN801296A0 (en) 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
US20030162711A1 (en) 1996-04-24 2003-08-28 Soren Bjorn Pharmaceutical formulation
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
DK1017413T4 (da) 1997-09-23 2008-03-25 Rentschler Biotech Gmbh Flydende formulering af interferon-beta
MXPA02000404A (es) 1999-07-12 2004-05-21 Grandis Biotech Gmbh Formulaciones de hormona de crecimiento.
PT1491208E (pt) * 1999-10-04 2010-05-12 Novartis Vaccines & Diagnostic Composições farmacêuticas contendo polipéptido líquidas estabilizadas
KR100416242B1 (ko) 1999-12-22 2004-01-31 주식회사 삼양사 약물전달체용 생분해성 블록 공중합체의 액체 조성물 및이의 제조방법
EP1329224A4 (en) 2000-09-01 2004-04-14 Chugai Pharmaceutical Co Ltd PREPARATIONS OF STABILIZED SOLUTIONS OVER A LONG PERIOD OF TIME

Also Published As

Publication number Publication date
JP4845741B2 (ja) 2011-12-28
ATE554792T1 (de) 2012-05-15
EP1706150A1 (en) 2006-10-04
CA2551510A1 (en) 2005-07-14
CA2551510C (en) 2013-07-30
JP2007516274A (ja) 2007-06-21
US20080125356A1 (en) 2008-05-29
WO2005063298A1 (en) 2005-07-14
ES2383691T3 (es) 2012-06-25
US8338374B2 (en) 2012-12-25
EP1706150B1 (en) 2012-04-25

Similar Documents

Publication Publication Date Title
BRPI0418115A (pt) formulação lìquida estável de hormÈnio de crescimento
CO4940385A1 (es) Composiciones limpiadoras liquidas suaves antimicrobianas que se quitan enjuagando surfactantes acidos
PE20010627A1 (es) Composiciones que tienen estabilidad mejorada
ME00180B (me) Kiseli preparati insulina sa poboljšanom stabilnošću
DK1133316T3 (da) Adenovirus-formulering til genterapi
BR0008405A (pt) Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa
DE60019902D1 (de) Echinocandin pharmazeutische zusammensetzungen
PE20070437A1 (es) FORMULACION ACUOSA hFSH
ES2139021T3 (es) Composiciones germicidas de detergente-yodo que tienen un contenido reducido de detergente.
TR199801558T2 (xx) Stabile edilmi� b�y�me hormonu form�lasyonu ve haz�rlama y�ntemi.
AR040529A1 (es) Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol
AR025243A1 (es) Composicion liquida de pesticida.
DE602004015725D1 (de) Stabilisierte lyophilisierte zubereitungen mit gewebefaktor-inhibitor (tfpi) oder varianten des gewebefaktor-inhibitors
ATE421312T1 (de) Nachschäumendes reinigungsmittel
EA200401298A1 (ru) Жидкие фармацевтические композиции, содержащие низкую дозу энтекавира, и их применение
TR200200034T2 (tr) Büyüme hormonu formülasyonları.
HN1999000135A (es) Formulacion liquida.
AR017925A1 (es) Una formulacion acuosa para verter, topicamente aceptable, adaptada para su aplicacion externa localizada en un animal, su uso y un metodo para formularla
ATE430571T1 (de) Wässrige pharmazeutische formulierungen von wasserlöslichen prodrugs von propofol- verbindungen
DK1171100T3 (da) Solubiliseret farmaceutisk komposition til parenteral administration
KR930001903A (ko) 유비데카레논 경구용 수용액 제제
ATE247970T1 (de) Tierärztliche zusammensetzungen zur behandlung von parasiterkrankungen
CL2022001989A1 (es) Formulación de anticuerpos estable
AR044449A1 (es) Composiciones acuosas desinfectantes y/o bactericidas
MX9207344A (es) Formulaciones mejoradas que tienen mejoradores hidrofobicos de penetracion transdermica y metodo para proveerla.

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 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: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2158 DE 15/05/2012.