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ME01337B - Tečni preparat fsh - Google Patents

Tečni preparat fsh

Info

Publication number
ME01337B
ME01337B MEP-2011-182A MEP18211A ME01337B ME 01337 B ME01337 B ME 01337B ME P18211 A MEP18211 A ME P18211A ME 01337 B ME01337 B ME 01337B
Authority
ME
Montenegro
Prior art keywords
pharmaceutical preparation
liquid pharmaceutical
preparation according
fsh
benzalkonium chloride
Prior art date
Application number
MEP-2011-182A
Other languages
English (en)
French (fr)
Inventor
Sascha Stolzenberger
Erich Kohler
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 ME01337B publication Critical patent/ME01337B/me

Links

Classifications

    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Reproductive Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (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)

Claims (15)

1.Tečni farmaceutski preparat koji obuhvata folikul-stimulirajući hormon (FSH) ili njegovu varijantu, kao i benzalkonijum hlorid i benzil alkohol kao sredstva za čuvanje.
2.Tečni farmaceutski preparat prema zahtevu 1, pri čemu je benzalkonijum hlorid 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.Tečni farmaceutski preparat prema zahtevu 1 ili 2, pri čemu je FSH ili njegova varijanta prisutan u koncentraciji od 10 do 200 μg/ml.
4.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, koji dalje obuhvata metionin kao antioksidant.
5.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, koji dalje obuhvata površinski aktivno sredstvo.
6.Tečni farmaceutski preparat prema zahtevu 5, pri čemu je površinski aktivno sredstvo polioksietilen sorbitan alikilestar.
7.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, koji dalje obuhvata agens modifikovanja toničnosti.
8.Tečni farmaceutski preparat prema zahtevu 7, pri čemu je agens modifikovanja toničnosti šećerni alkohol ili šećer.
9.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, koji ima pH u rasponu od 6.5 do 7.5.
10.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, koji dalje obuhvata fiziološki prihvatljiv agens puferisanja.
11.Tečni farmaceutski preparat prema bilo kom od prethodnih zahteva, pri čemu preparat sadrži FSH ili njegovu varijantu kao aktivni agens, Polisorbat 20 i/ili Polisorbat 80 kao površinski aktivno sredstvo, manitol kao agens modifikovanja toničnosti, fosfat kao pufer, metionin kao stabilizujući agens i benzil alkohol i benzalkonijum hlorid kao sredstva za čuvanje, i ne sadrži dodatne nosače.
12.Farmaceutski kontejner koji sadrži tečni farmaceutski preparat prema bilo kom od predhodnih zahteva.
13.Postupak za pripremanje tečnog farmaceutskog preparata prema bilo kom od zahteva 1 do 11, gde je FSH ili njegova varijanta kao aktivni sastojak formulisan u vodenom preparatu koji obuhvata i benzalkonijum hlorid i benzil alkohol kao sredstva za čuvanje i dodatne farmaceutske nosače.
14.Postupak proizvodnje pakovanog farmaceutskog preparata koji obuhvata stavljanje rastvora koji obuhvata FSH ili njegovu varijantu i benzalkonijum hlorid i benzil alkohol u vijal, ampulu, karpulu ili kasetu.
15.Tečni farmaceutski preparat prema bilo kom od zahteva 1 do 11 za upotrebu u više-doznom davanju.
MEP-2011-182A 2008-02-08 2009-02-09 Tečni preparat fsh ME01337B (me)

Applications Claiming Priority (3)

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
EP09708298A EP2249869B1 (en) 2008-02-08 2009-02-09 Liquid formulation of fsh

Publications (1)

Publication Number Publication Date
ME01337B true ME01337B (me) 2013-12-20

Family

ID=40568186

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2011-182A ME01337B (me) 2008-02-08 2009-02-09 Tečni preparat fsh

Country Status (26)

Country Link
US (4) US20110054410A1 (me)
EP (2) EP2412385A1 (me)
JP (1) JP5620824B2 (me)
KR (2) KR101662631B1 (me)
CN (3) CN101970010A (me)
AT (1) ATE523209T1 (me)
AU (1) AU2009211331B2 (me)
BR (1) BRPI0908887B8 (me)
CA (2) CA2713386C (me)
CY (1) CY1112082T1 (me)
DE (1) DE202009009905U1 (me)
DK (1) DK2249869T3 (me)
EA (1) EA019530B1 (me)
ES (1) ES2372470T3 (me)
HR (1) HRP20110801T1 (me)
IL (1) IL206759A (me)
ME (1) ME01337B (me)
MX (1) MX2010008802A (me)
NZ (1) NZ586588A (me)
PL (1) PL2249869T3 (me)
PT (1) PT2249869E (me)
RS (1) RS52106B (me)
SI (1) SI2249869T1 (me)
UA (1) UA99337C2 (me)
WO (1) WO2009098318A1 (me)
ZA (1) ZA201004457B (me)

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PL2349324T3 (pl) 2008-10-17 2018-02-28 Sanofi-Aventis Deutschland Gmbh Kombinacja insuliny i agonisty GLP-1
SG10201500871TA (en) 2009-11-13 2015-04-29 Sanofi Aventis Deutschland Pharmaceutical composition comprising a glp-1 agonist and methionine
PL2498802T3 (pl) 2009-11-13 2015-06-30 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę
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
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
PL2611458T3 (pl) 2010-08-30 2017-02-28 Sanofi-Aventis Deutschland Gmbh Zastosowanie AVE0010 do produkcji leku do leczenia cukrzycy typu 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
CA2846413C (en) 2011-08-29 2021-11-02 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for use in glycemic control in diabetes type 2 patients
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
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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
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Also Published As

Publication number Publication date
CA2713386C (en) 2016-04-19
EA201070940A1 (ru) 2010-12-30
PT2249869E (pt) 2011-12-16
CA2713386A1 (en) 2009-08-13
CY1112082T1 (el) 2015-11-04
KR20100123697A (ko) 2010-11-24
US20110054410A1 (en) 2011-03-03
EP2249869B1 (en) 2011-09-07
HRP20110801T1 (hr) 2011-12-31
PL2249869T3 (pl) 2012-02-29
KR101662631B1 (ko) 2016-10-05
IL206759A (en) 2015-02-26
EA019530B1 (ru) 2014-04-30
RS52106B (en) 2012-08-31
KR20150138428A (ko) 2015-12-09
BRPI0908887A2 (pt) 2015-09-15
CN104688679A (zh) 2015-06-10
CN101970010A (zh) 2011-02-09
WO2009098318A1 (en) 2009-08-13
CA2926500A1 (en) 2009-08-13
JP5620824B2 (ja) 2014-11-05
NZ586588A (en) 2012-10-26
DK2249869T3 (da) 2011-12-12
EP2249869A1 (en) 2010-11-17
JP2011514317A (ja) 2011-05-06
DE202009009905U1 (de) 2009-10-29
US20160303201A1 (en) 2016-10-20
BRPI0908887B1 (pt) 2021-01-19
AU2009211331B2 (en) 2014-07-03
KR101573773B1 (ko) 2015-12-02
ATE523209T1 (de) 2011-09-15
IL206759A0 (en) 2010-12-30
MX2010008802A (es) 2011-03-29
US20160303202A1 (en) 2016-10-20
ZA201004457B (en) 2011-05-25
BRPI0908887B8 (pt) 2021-05-25
CN110433136A (zh) 2019-11-12
US20160303238A1 (en) 2016-10-20
EP2412385A1 (en) 2012-02-01
AU2009211331A1 (en) 2009-08-13
ES2372470T3 (es) 2012-01-20
SI2249869T1 (sl) 2012-01-31
HK1149494A1 (en) 2011-10-07
UA99337C2 (ru) 2012-08-10

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