BR112014001921A2 - formulação aquosa, método para aumentar a estabilidade de uma formulação aquosa, uso de uma formulação e embalagem principal - Google Patents

formulação aquosa, método para aumentar a estabilidade de uma formulação aquosa, uso de uma formulação e embalagem principal

Info

Publication number
BR112014001921A2
BR112014001921A2 BR112014001921A BR112014001921A BR112014001921A2 BR 112014001921 A2 BR112014001921 A2 BR 112014001921A2 BR 112014001921 A BR112014001921 A BR 112014001921A BR 112014001921 A BR112014001921 A BR 112014001921A BR 112014001921 A2 BR112014001921 A2 BR 112014001921A2
Authority
BR
Brazil
Prior art keywords
formulation
aqueous formulation
stability
increasing
aqueous
Prior art date
Application number
BR112014001921A
Other languages
English (en)
Other versions
BR112014001921B1 (pt
Inventor
Pragl Bernt
Fuertinger Sabine
Original Assignee
Sandoz Ag
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 Sandoz Ag filed Critical Sandoz Ag
Publication of BR112014001921A2 publication Critical patent/BR112014001921A2/pt
Publication of BR112014001921B1 publication Critical patent/BR112014001921B1/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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112014001921-5A 2011-07-25 2012-07-25 Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal BR112014001921B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161511168P 2011-07-25 2011-07-25
US61/511,168 2011-07-25
PCT/EP2012/064613 WO2013014196A1 (en) 2011-07-25 2012-07-25 Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein

Publications (2)

Publication Number Publication Date
BR112014001921A2 true BR112014001921A2 (pt) 2019-04-02
BR112014001921B1 BR112014001921B1 (pt) 2022-05-10

Family

ID=46634124

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014001921-5A BR112014001921B1 (pt) 2011-07-25 2012-07-25 Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal

Country Status (5)

Country Link
US (2) US20140194356A1 (pt)
EP (1) EP2736490A1 (pt)
JP (1) JP6363949B2 (pt)
BR (1) BR112014001921B1 (pt)
WO (1) WO2013014196A1 (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210024082A (ko) 2018-06-25 2021-03-04 제이씨알 파마 가부시키가이샤 단백질 함유 수성 액제
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 (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994003198A1 (en) * 1992-07-31 1994-02-17 Genentech, Inc. Human growth hormone aqueous formulation
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
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
JP3723857B2 (ja) * 1998-02-04 2005-12-07 日本ケミカルリサーチ株式会社 ヒト成長ホルモン含有水性医薬組成物
CZ200260A3 (cs) 1999-07-12 2002-04-17 Grandis Biotech Gmbh Formulace růstového hormonu
CA2491478A1 (en) * 2002-07-09 2004-01-15 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
US20060252682A1 (en) * 2003-03-18 2006-11-09 Ares Trading S.A. Liquid growth hormone formulation and process of preparation thereof
CA2551510C (en) * 2003-12-23 2013-07-30 Pharmacia Corporation Stable growth hormone liquid formulation
DK1740213T3 (da) * 2004-04-07 2012-04-10 Ares Trading Sa Væskeformulering til væksthormoner
WO2008076819A2 (en) * 2006-12-18 2008-06-26 Altus Pharmaceuticals Inc. Human growth hormone formulations
CA2780554C (en) * 2009-11-17 2017-08-15 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination

Also Published As

Publication number Publication date
US20140194356A1 (en) 2014-07-10
EP2736490A1 (en) 2014-06-04
US11446381B2 (en) 2022-09-20
JP6363949B2 (ja) 2018-07-25
WO2013014196A1 (en) 2013-01-31
JP2014528919A (ja) 2014-10-30
US20180256722A1 (en) 2018-09-13
BR112014001921B1 (pt) 2022-05-10

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/07/2012, OBSERVADAS AS CONDICOES LEGAIS