BRPI0908887A2 - composição farmacêutica líquida, recipiente farmacêutico, métodos para preparar e para fabricar uma composição farmacêutica, e, uso de uma composição farmacêutica - Google Patents

composição farmacêutica líquida, recipiente farmacêutico, métodos para preparar e para fabricar uma composição farmacêutica, e, uso de uma composição farmacêutica

Info

Publication number
BRPI0908887A2
BRPI0908887A2 BRPI0908887A BRPI0908887A BRPI0908887A2 BR PI0908887 A2 BRPI0908887 A2 BR PI0908887A2 BR PI0908887 A BRPI0908887 A BR PI0908887A BR PI0908887 A BRPI0908887 A BR PI0908887A BR PI0908887 A2 BRPI0908887 A2 BR PI0908887A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
composition
pharmaceutical
preparing
manufacturing
Prior art date
Application number
BRPI0908887A
Other languages
English (en)
Inventor
Erich Kohler
Sascha Stolzenberger
Original Assignee
Biogenerix 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 Biogenerix Ag filed Critical Biogenerix Ag
Publication of BRPI0908887A2 publication Critical patent/BRPI0908887A2/pt
Publication of BRPI0908887B1 publication Critical patent/BRPI0908887B1/pt
Publication of BRPI0908887B8 publication Critical patent/BRPI0908887B8/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
    • A61K47/16—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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Reproductive Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
BRPI0908887A 2008-02-08 2009-02-09 composição farmacêutica líquida, recipiente farmacêutico, e, métodos para preparar e para fabricar uma composição farmacêutica BRPI0908887B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08151231.1 2008-02-08
EP08151231 2008-02-08
PCT/EP2009/051451 WO2009098318A1 (en) 2008-02-08 2009-02-09 Liquid formulation of fsh

Publications (3)

Publication Number Publication Date
BRPI0908887A2 true BRPI0908887A2 (pt) 2015-09-15
BRPI0908887B1 BRPI0908887B1 (pt) 2021-01-19
BRPI0908887B8 BRPI0908887B8 (pt) 2021-05-25

Family

ID=40568186

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0908887A BRPI0908887B8 (pt) 2008-02-08 2009-02-09 composição farmacêutica líquida, recipiente farmacêutico, e, métodos para preparar e para fabricar uma composição farmacêutica

Country Status (27)

Country Link
US (4) US20110054410A1 (pt)
EP (2) EP2249869B1 (pt)
JP (1) JP5620824B2 (pt)
KR (2) KR101662631B1 (pt)
CN (3) CN101970010A (pt)
AT (1) ATE523209T1 (pt)
AU (1) AU2009211331B2 (pt)
BR (1) BRPI0908887B8 (pt)
CA (2) CA2926500A1 (pt)
CY (1) CY1112082T1 (pt)
DE (1) DE202009009905U1 (pt)
DK (1) DK2249869T3 (pt)
EA (1) EA019530B1 (pt)
ES (1) ES2372470T3 (pt)
HK (1) HK1149494A1 (pt)
HR (1) HRP20110801T1 (pt)
IL (1) IL206759A (pt)
ME (1) ME01337B (pt)
MX (1) MX2010008802A (pt)
NZ (1) NZ586588A (pt)
PL (1) PL2249869T3 (pt)
PT (1) PT2249869E (pt)
RS (1) RS52106B (pt)
SI (1) SI2249869T1 (pt)
UA (1) UA99337C2 (pt)
WO (1) WO2009098318A1 (pt)
ZA (1) ZA201004457B (pt)

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KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
KR101820024B1 (ko) 2008-10-17 2018-01-18 사노피-아벤티스 도이칠란트 게엠베하 인슐린과 ｇｌｐ－1 효능제의 병용물
TR201809460T4 (tr) 2009-11-13 2018-07-23 Sanofi Aventis Deutschland Bir GLP- 1-agonisti, bir insülin ve metiyonin içeren farmasötik bileşim.
EP3345593B1 (de) * 2009-11-13 2023-09-06 Sanofi-Aventis Deutschland GmbH Pharmazeutische zusammensetzung umfassend despro36exendin-4(1-39)-lys6-nh2 und methionin
JP5800527B2 (ja) * 2010-03-30 2015-10-28 日東電工株式会社 安定化医薬組成物、安定化医薬組成物溶液製剤、フィルム状製剤及びフィルム状製剤の製造方法
AR081755A1 (es) * 2010-04-02 2012-10-17 Hanmi Holdings Co Ltd Formulacion de accion prolongada de la hormona estimuladora de los foliculos donde se usa un fragmento de inmunoglobulina, metodo de preparacion y metodo para tratar a un sujeto que sufre un trastorno reproductivo
ES2606554T3 (es) 2010-08-30 2017-03-24 Sanofi-Aventis Deutschland Gmbh Uso de AVE0010 para la fabricación de un medicamento para el tratamiento de la diabetes mellitus de tipo 2
US9821032B2 (en) 2011-05-13 2017-11-21 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
TWI608847B (zh) 2011-08-29 2017-12-21 賽諾菲阿凡提斯德意志有限公司 用於控制糖尿病二型病患血糖的醫藥組合物
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
RU2014122342A (ru) * 2011-11-09 2015-12-20 Адиссео Франс С.А.С. Предубойная диета, включающая метионин
WO2014159813A1 (en) 2013-03-13 2014-10-02 Moderna Therapeutics, Inc. Long-lived polynucleotide molecules
PE20171622A1 (es) 2014-12-12 2017-11-02 Sanofi Aventis Deutschland Formulacion de relacion fija de insulina glargina/lixisenatida
TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患之治療
CN105727260A (zh) * 2016-02-03 2016-07-06 华侨大学 一种***的长效制剂
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
CN105726468A (zh) * 2016-02-28 2016-07-06 中国农业科学院特产研究所 梅花鹿用超数***聚乙烯吡咯烷酮fsh复合缓释注射剂
US10085971B2 (en) 2016-08-22 2018-10-02 Navinta Iii Inc Pharmaceutical solution of asenapine for sublingual or buccal use
CN108728465A (zh) * 2017-04-14 2018-11-02 深圳新诺微环生物科技有限公司 一种表达靶细胞-效应细胞桥接器的微环dna载体及其制备方法和应用
US20230364172A1 (en) * 2022-05-14 2023-11-16 Syncotrance, LLC Modulation of solubility, palatability, absorption, and bioavailability of mitragyna speciosa-derived compounds for oral and buccal delivery

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US4840896A (en) 1983-11-02 1989-06-20 Integrated Genetics, Inc. Heteropolymeric protein
US4923805A (en) 1983-11-02 1990-05-08 Integrated Genetics, Inc. Fsh
IT1206302B (it) 1987-06-26 1989-04-14 Serono Cesare Ist Ricerca Ormone follicolo-stimolante urinario
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
CA2018676C (en) 1989-06-20 2003-05-06 Christie A. Kelton Novel heteropolymeric protein production methods
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
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TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
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US20030166525A1 (en) * 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
JP4574865B2 (ja) 1999-04-16 2010-11-04 インスチチュート マッソーネ エス．エイ． 高度に精製されたゴナドトロピン組成物およびそれらの製造方法
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JP4763616B2 (ja) 2003-12-22 2011-08-31 アレス トレーディング ソシエテ アノニム Ｆｓｈを精製するための方法
PL1809663T3 (pl) 2004-11-09 2009-01-30 Ares Trading Sa Sposób oczyszczania FSH
KR101105871B1 (ko) 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
US8318457B2 (en) 2007-06-28 2012-11-27 Biogenerix Ag FSH producing cell clone

Also Published As

Publication number Publication date
EP2249869A1 (en) 2010-11-17
IL206759A (en) 2015-02-26
CA2713386A1 (en) 2009-08-13
US20110054410A1 (en) 2011-03-03
MX2010008802A (es) 2011-03-29
BRPI0908887B1 (pt) 2021-01-19
DK2249869T3 (da) 2011-12-12
RS52106B (en) 2012-08-31
NZ586588A (en) 2012-10-26
BRPI0908887B8 (pt) 2021-05-25
EP2249869B1 (en) 2011-09-07
US20160303201A1 (en) 2016-10-20
PL2249869T3 (pl) 2012-02-29
US20160303238A1 (en) 2016-10-20
KR101573773B1 (ko) 2015-12-02
EA019530B1 (ru) 2014-04-30
KR20150138428A (ko) 2015-12-09
HRP20110801T1 (hr) 2011-12-31
AU2009211331A1 (en) 2009-08-13
ATE523209T1 (de) 2011-09-15
AU2009211331B2 (en) 2014-07-03
HK1149494A1 (en) 2011-10-07
KR101662631B1 (ko) 2016-10-05
CA2926500A1 (en) 2009-08-13
CA2713386C (en) 2016-04-19
EA201070940A1 (ru) 2010-12-30
CN110433136A (zh) 2019-11-12
JP2011514317A (ja) 2011-05-06
DE202009009905U1 (de) 2009-10-29
PT2249869E (pt) 2011-12-16
ES2372470T3 (es) 2012-01-20
KR20100123697A (ko) 2010-11-24
UA99337C2 (ru) 2012-08-10
US20160303202A1 (en) 2016-10-20
CY1112082T1 (el) 2015-11-04
CN104688679A (zh) 2015-06-10
SI2249869T1 (sl) 2012-01-31
ME01337B (me) 2013-12-20
JP5620824B2 (ja) 2014-11-05
CN101970010A (zh) 2011-02-09
WO2009098318A1 (en) 2009-08-13
IL206759A0 (en) 2010-12-30
ZA201004457B (en) 2011-05-25
EP2412385A1 (en) 2012-02-01

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 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 19/01/2021, 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 09/02/2009 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B25D Requested change of name of applicant approved

Owner name: BIOGENERIX GMBH (DE)

B25A Requested transfer of rights approved

Owner name: RATIOPHARM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: THERAMEX HQ UK LIMITED (GB)

B25G Requested change of headquarter approved

Owner name: THERAMEX HQ UK LIMITED (GB)