HRP20110801T1 - Tekući oblik fsh - Google Patents

Tekući oblik fsh Download PDF

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Publication number
HRP20110801T1
HRP20110801T1 HR20110801T HRP20110801T HRP20110801T1 HR P20110801 T1 HRP20110801 T1 HR P20110801T1 HR 20110801 T HR20110801 T HR 20110801T HR P20110801 T HRP20110801 T HR P20110801T HR P20110801 T1 HRP20110801 T1 HR P20110801T1
Authority
HR
Croatia
Prior art keywords
liquid pharmaceutical
pharmaceutical form
form according
fsh
benzalkonium chloride
Prior art date
Application number
HR20110801T
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English (en)
Inventor
Stolzenberger Sascha
Kohler Erich
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.)
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Publication date
Application filed by Biogenerix Ag filed Critical Biogenerix Ag
Publication of HRP20110801T1 publication Critical patent/HRP20110801T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs 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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (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)

Abstract

Tekući farmaceutski oblik koji sadrži folikulostimulirajući hormon (FSH) ili njegovu varijantu, te benzalkonijev klorid i benzil alkohol kao konzervanse. Patent sadrži još 14 patentnih zahtjeva.

Claims (15)

1. Tekući farmaceutski oblik koji sadrži folikulostimulirajući hormon (FSH) ili njegovu varijantu, te benzalkonijev klorid i benzil alkohol kao konzervanse.
2. Tekući farmaceutski oblik prema zahtjevu 1, gdje je benzalkonijev klorid prisutan u koncentraciji od 0.005 - 0.03 mg/ml i benzil alkohol je prisutan u koncentraciji od 5.0 do 12.0 mg/ml.
3. Tekući farmaceutski oblik prema zahtjevu 1 ili 2, gdje je FSH ili njegova varijanta prisutan u koncentraciji od 10 do 200 µg/ml.
4. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva, koji dalje sadrži metionin kao antioksidans.
5. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva, koji dalje sadrži surfaktant.
6. Tekući farmaceutski oblik prema zahtjevu 5, pri čemu je surfaktant polioksietilen sorbitan alkilester.
7. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva, koji dalje sadrži sredstvo za modificiranje toničnosti.
8. Tekući farmaceutski oblik prema zahtjevu 7, gdje je sredstvo za modificiranje toničnosti šećerni alkohol ili šećer.
9. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva koji ima pH u rasponu 6.5 do 7.5.
10. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva, koji dalje sadrži fiziološki prihvatljivi pufer.
11. Tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva, pri čemu oblik sadrži FSH ili njegovu varijantu kao djelatnu tvar, Polisorbat 20 i/ili Polisorbat 80 kao surfaktant, manitol kao sredstvo za podešavanje toničnosti, fosfat kao pufer, metionin kao stabilizator i benzil alkohol i benzalkonijev klorid kao konzervanse, i niti jednu drugu pomoćnu tvar.
12. Farmaceutski spremnik koji sadrži tekući farmaceutski oblik prema bilo kojem od prethodnih zahtjeva.
13. Postupak pripreme tekućeg farmaceutskog oblika prema bilo kojem od zahtjeva 1 do 11, gdje je FSH ili njegova varijanta kao djelatna tvar oblikovan u vodenom pripravku koji sadrži i benzalkonijev klorid i benzil alkohol kao konzervanse i druge farmaceutske pomoćne tvari.
14. Postupak proizvodnje zapakiranog farmaceutskog oblika koji obuhvaća stavljanje otopine koja sadrži FSH ili njegovu varijantu, i benzalkonijev klorid i benzil alkohol u bočicu, ampulu, karpulu ili kazetu.
15. Tekući farmaceutski oblik prema bilo kojem od zahtjeva 1 do 11 za uporabu u višedozirnoj primjeni.
HR20110801T 2008-02-08 2011-11-02 Tekući oblik fsh HRP20110801T1 (hr)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
HRP20110801T1 true HRP20110801T1 (hr) 2011-12-31

Family

ID=40568186

Family Applications (1)

Application Number Title Priority Date Filing Date
HR20110801T HRP20110801T1 (hr) 2008-02-08 2011-11-02 Tekući oblik fsh

Country Status (27)

Country Link
US (4) US20110054410A1 (hr)
EP (2) EP2412385A1 (hr)
JP (1) JP5620824B2 (hr)
KR (2) KR101573773B1 (hr)
CN (3) CN104688679A (hr)
AT (1) ATE523209T1 (hr)
AU (1) AU2009211331B2 (hr)
BR (1) BRPI0908887B8 (hr)
CA (2) CA2713386C (hr)
CY (1) CY1112082T1 (hr)
DE (1) DE202009009905U1 (hr)
DK (1) DK2249869T3 (hr)
EA (1) EA019530B1 (hr)
ES (1) ES2372470T3 (hr)
HK (1) HK1149494A1 (hr)
HR (1) HRP20110801T1 (hr)
IL (1) IL206759A (hr)
ME (1) ME01337B (hr)
MX (1) MX2010008802A (hr)
NZ (1) NZ586588A (hr)
PL (1) PL2249869T3 (hr)
PT (1) PT2249869E (hr)
RS (1) RS52106B (hr)
SI (1) SI2249869T1 (hr)
UA (1) UA99337C2 (hr)
WO (1) WO2009098318A1 (hr)
ZA (1) ZA201004457B (hr)

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EP3228320B1 (de) 2008-10-17 2019-12-18 Sanofi-Aventis Deutschland GmbH Kombination von einem insulin und einem glp-1-agonisten
AR080669A1 (es) 2009-11-13 2012-05-02 Sanofi Aventis Deutschland Composicion farmaceutica que comprende un agonista de glp-1, una insulina y metionina
UY33025A (es) * 2009-11-13 2011-06-30 Sanofi Aventis Deustschland Gmbh Composicion farmaceutica que comprende un agonista de glp-1 metionina
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
MX339614B (es) 2010-08-30 2016-06-02 Sanofi - Aventis Deutschland GmbH Uso de ave0010 para la fabricacion de un medicamento para el tratamiento de la diabetes mellitus 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
RU2650616C2 (ru) 2011-08-29 2018-04-16 Санофи-Авентис Дойчланд Гмбх Фармацевтическая комбинация для применения при гликемическом контроле у пациентов с сахарным диабетом 2 типа
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
BR112014008872A2 (pt) * 2011-11-09 2017-04-18 Adisseo France Sas dieta antes do abate que inclui metionina e seu uso em métodos para melhorar a maciez de carne
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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 一种卵泡刺激素的长效制剂
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CN105726468A (zh) * 2016-02-28 2016-07-06 中国农业科学院特产研究所 梅花鹿用超数排卵聚乙烯吡咯烷酮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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Also Published As

Publication number Publication date
HK1149494A1 (en) 2011-10-07
US20160303202A1 (en) 2016-10-20
PL2249869T3 (pl) 2012-02-29
DK2249869T3 (da) 2011-12-12
PT2249869E (pt) 2011-12-16
EA019530B1 (ru) 2014-04-30
AU2009211331A1 (en) 2009-08-13
EP2249869A1 (en) 2010-11-17
CN101970010A (zh) 2011-02-09
US20160303238A1 (en) 2016-10-20
RS52106B (en) 2012-08-31
ZA201004457B (en) 2011-05-25
ME01337B (me) 2013-12-20
JP2011514317A (ja) 2011-05-06
EP2412385A1 (en) 2012-02-01
BRPI0908887B1 (pt) 2021-01-19
KR101662631B1 (ko) 2016-10-05
US20160303201A1 (en) 2016-10-20
NZ586588A (en) 2012-10-26
BRPI0908887B8 (pt) 2021-05-25
BRPI0908887A2 (pt) 2015-09-15
AU2009211331B2 (en) 2014-07-03
IL206759A (en) 2015-02-26
SI2249869T1 (sl) 2012-01-31
KR20150138428A (ko) 2015-12-09
US20110054410A1 (en) 2011-03-03
KR101573773B1 (ko) 2015-12-02
EP2249869B1 (en) 2011-09-07
IL206759A0 (en) 2010-12-30
CN110433136A (zh) 2019-11-12
CY1112082T1 (el) 2015-11-04
CA2713386A1 (en) 2009-08-13
CA2926500A1 (en) 2009-08-13
WO2009098318A1 (en) 2009-08-13
ES2372470T3 (es) 2012-01-20
DE202009009905U1 (de) 2009-10-29
MX2010008802A (es) 2011-03-29
ATE523209T1 (de) 2011-09-15
KR20100123697A (ko) 2010-11-24
CA2713386C (en) 2016-04-19
EA201070940A1 (ru) 2010-12-30
JP5620824B2 (ja) 2014-11-05
CN104688679A (zh) 2015-06-10
UA99337C2 (ru) 2012-08-10

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