HRP20120660T1 - Tekuće formulacije lh - Google Patents

Tekuće formulacije lh Download PDF

Info

Publication number
HRP20120660T1
HRP20120660T1 HRP20120660AT HRP20120660T HRP20120660T1 HR P20120660 T1 HRP20120660 T1 HR P20120660T1 HR P20120660A T HRP20120660A T HR P20120660AT HR P20120660 T HRP20120660 T HR P20120660T HR P20120660 T1 HRP20120660 T1 HR P20120660T1
Authority
HR
Croatia
Prior art keywords
formulation according
luteinizing hormone
concentration
formulation
hlh
Prior art date
Application number
HRP20120660AT
Other languages
English (en)
Inventor
Agostinetto Rita
Samaritani Fabrizio
Del Rio Alessandra
Richard Joel
Original Assignee
Merck Serono Sa
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 Merck Serono Sa filed Critical Merck Serono Sa
Publication of HRP20120660T1 publication Critical patent/HRP20120660T1/hr

Links

Classifications

    • 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
    • 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
    • A61K47/06Organic 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Reproductive Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Tekuća formulacija koja sadr·i luteinizirajući hormon (LH) ili njegovu varijantu naznačena time da navedena formulacija sadr·i fosfatni pufer i stabilizirajuću količinu arginina ili njegovih soli u koncentraciji od 10 do 50 mg/ml i/ili lizina ili njegovih soli u koncentraciji od 10 do 50 mg/ml. Patent sadr·i jo® 26 patentnih zahtjeva.

Claims (27)

1. Tekuća formulacija koja sadrži luteinizirajući hormon (LH) ili njegovu varijantu naznačena time da navedena formulacija sadrži fosfatni pufer i stabilizirajuću količinu arginina ili njegovih soli u koncentraciji od 10 do 50 mg/ml i/ili lizina ili njegovih soli u koncentraciji od 10 do 50 mg/ml.
2. Formulacija prema zahtjevu 1, naznačena time da luteinizirajući hormon (LH) je humani luteinizirajući hormon (hLH).
3. Formulacija prema zahtjevu 1 ili 2, naznačena time da luteinizirajući hormon (LH) je rekombinantni humani luteinizirajući hormon (r-hLH).
4. Formulacija prema zahtjevu 1 ili 2, naznačena time da luteinizirajući hormon (LH) je urinarni humani luteinizirajući hormon (u-hLH).
5. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da je luteinizirajući hormon (LH) prisutan u koncentraciji od oko 1 do od oko 50 μg/ml.
6. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da fosfatni pufer je prisutan u koncentraciji od 1 do100 mM.
7. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da je fosfatni pufer poželjno natrijev fosfatni pufer.
8. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da nadalje sadrži surfaktant.
9. Formulacija prema zahtjevu 8, naznačena time da surfaktant je Polisorbat 20.
10. Formulacija prema zahtjevu 9, naznačena time da je Polisorbat 20 prisutan u koncentraciji od 0,01 do 10 mg/ml.
11. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da nadalje sadrži metionin.
12. Formulacija prema zahtjevu 11, naznačena time da je metionin prisutan u koncentraciji od 0,01 do 5,0 mg/ml.
13. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da nadalje sadrži bakteriostatsko sredstvo.
14. Formulacija prema zahtjevu 13 naznačena time da je bakteriostatsko sredstvo odabrano od bilo kojeg od benzil alkohola, fenola i kombinacije benzil alkohola i benzalkonijevog klorida.
15. Formulacija prema zahtjevu 13 ili 14, naznačena time da je bakteriostatsko sredstvo prisutno u koncentraciji od 0,005 do 15 mg/ml.
16. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da nadalje sadrži vodu za injekcije.
17. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da ima pH u rasponu od 7,5 do 8,5.
18. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da sadrži najmanje 25 μg/ml r-hLH, 1.65 mg/ml Na2HPO4 2H2O, 0.104 mg/ml NaH2PO4 H2O, 31.5 mg/ml L-arginin monohidroklorida, 0,05 mg/ml Tween 20, 0,5 mg/ml metionina i 5 mg/ml fenola.
19. Formulacija prema bilo kojem od zahtjeva 1 do 17 naznačena time da sadrži najmanje 25 μg/ml r-hLH, 1,65 mg/ml Na2HPO4 2H2O, 0,104 mg/ml NaH2PO4 H2O, 28,5 mg/ml lizin monohidroklorida. 0,05 mg/ml Tween 20, 0,5 mg/ml metionina i 12 mg/ml benzil alkohola.
20. Formulacija prema bilo kojem od zahtjeva 1 do 17 naznačena time da sadrži najmanje 25 μg/ml r-hLH. 1,65 mg/ml Na2HPO4 2H2O, 0,104 mg/ml NaH2PO4 H2O, 28,5 mg/ml lizin monohidroklorida, 0,05 mg/ml Tween 20, 0,5 mg/ml metionina, 3 mg/ml benzil alkohola i 0,01 mg/ml i benzalkonijevog klorida.
21. Farmaceutski pripravak naznačen time da sadrži formulaciju prema bilo kojem od zahtjeva 1 do 20.
22. Prezentacijski oblik formulacije prema bilo kojem od zahtjeva 1 do 20 naznačen time da je hermetički zatvoren pod sterilnim uvjetima u spremniku koji je pogodan za pohranjivanje prije uporabe.
23. Postupak za dobivanje formulacije prema bilo kojem od zahtjeva 1 do 20 naznačen time da sadrži razrjeđivanje luteinizirajućeg hormona (LH) sa otopinom koja sadrži pomoćne tvari.
24. Uporaba formulacije prema bilo kojem od zahtjeva 1 do 20 naznačena time da je za dobivanje lijeka.
25. Uporaba formulacije prema bilo kojem od zahtjeva 1 do 20 naznačena time da je za dobivanje lijeka za liječenje neplodnosti žena i/ili muškaraca.
26. Uporaba formulacije prema bilo kojem od zahtjeva 1 do 20 naznačena time da je u kombinaciji sa tekućom formulacijom koja sadrži folikulo-stimulirajući hormon (FSH) ili njegovu varijantu.
27. Formulacija prema bilo kojem od zahtjeva 1 do 20 naznačena time da je za liječenje neplodnosti žena i/ili muškaraca.
HRP20120660AT 2007-11-01 2012-08-15 Tekuće formulacije lh HRP20120660T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07119832 2007-11-01
US448107P 2007-11-28 2007-11-28
PCT/EP2008/064679 WO2009056569A1 (en) 2007-11-01 2008-10-29 Lh liquid formulations

Publications (1)

Publication Number Publication Date
HRP20120660T1 true HRP20120660T1 (hr) 2012-09-30

Family

ID=39167502

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20120660AT HRP20120660T1 (hr) 2007-11-01 2012-08-15 Tekuće formulacije lh

Country Status (26)

Country Link
US (1) US8664369B2 (hr)
EP (1) EP2219607B1 (hr)
JP (1) JP5551601B2 (hr)
KR (1) KR101513181B1 (hr)
CN (1) CN101842083B (hr)
AU (1) AU2008320844B2 (hr)
BR (1) BRPI0818324B8 (hr)
CA (1) CA2700662C (hr)
CY (1) CY1113121T1 (hr)
DK (1) DK2219607T3 (hr)
EA (1) EA019432B1 (hr)
EC (1) ECSP10010224A (hr)
ES (1) ES2393233T3 (hr)
HK (1) HK1145443A1 (hr)
HR (1) HRP20120660T1 (hr)
IL (1) IL205105A (hr)
MX (1) MX2010004639A (hr)
MY (1) MY153976A (hr)
NZ (1) NZ583991A (hr)
PL (1) PL2219607T3 (hr)
PT (1) PT2219607E (hr)
RS (1) RS52566B (hr)
SI (1) SI2219607T1 (hr)
UA (1) UA101484C2 (hr)
WO (1) WO2009056569A1 (hr)
ZA (1) ZA201001907B (hr)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2229407B1 (de) 2008-01-09 2016-11-16 Sanofi-Aventis Deutschland GmbH Neue insulinderivate mit extrem verzögertem zeit- / wirkungsprofil
HUE037449T2 (hu) 2008-10-17 2018-08-28 Sanofi Aventis Deutschland Egy inzulin és egy GLP-1 agonista kombinációja
JP2011001273A (ja) * 2009-06-16 2011-01-06 Eci Inc eMIPを有効成分とする水溶性製剤
JP5735960B2 (ja) * 2009-07-06 2015-06-17 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング メチオニンを含むインスリン製剤
AR080669A1 (es) 2009-11-13 2012-05-02 Sanofi Aventis Deutschland Composicion farmaceutica que comprende un agonista de glp-1, una insulina y metionina
WO2011058082A1 (de) * 2009-11-13 2011-05-19 Sanofi-Aventis Deutschland Gmbh Pharmazeutische zusammensetzung umfassend einen glp-1-agonisten und methionin
WO2011099036A2 (en) * 2010-02-12 2011-08-18 Intas Biopharmaceuticals Limited Liquid formulation of follicle stimulating hormone
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
CN102293756A (zh) * 2011-08-24 2011-12-28 蚌埠丰原涂山制药有限公司 一种尿促性素冻干粉针剂及其制备方法
BR112014004726A2 (pt) 2011-08-29 2017-04-04 Sanofi Aventis Deutschland combinação farmacêutica para uso no controle glicêmico em pacientes de diabetes tipo 2
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
WO2014102623A1 (en) * 2012-12-26 2014-07-03 Wockhardt Limited Pharmaceutical composition
TWI780236B (zh) 2013-02-04 2022-10-11 法商賽諾菲公司 胰島素類似物及/或胰島素衍生物之穩定化醫藥調配物
US20160024181A1 (en) 2013-03-13 2016-01-28 Moderna Therapeutics, Inc. Long-lived polynucleotide molecules
CN105899190B (zh) 2014-01-09 2022-06-14 赛诺菲 门冬胰岛素的稳定化药物制剂
AU2015205624A1 (en) 2014-01-09 2016-07-14 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
SG11201604708VA (en) 2014-01-09 2016-07-28 Sanofi Sa Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives
PL3229828T3 (pl) 2014-12-12 2023-07-31 Sanofi-Aventis Deutschland Gmbh Formulacja o ustalonym stosunku insuliny glargine/liksysenatydu
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
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE64738B1 (en) 1990-03-20 1995-09-06 Akzo Nv Stabilized gonadotropin containing preparations
IT1250075B (it) * 1991-12-18 1995-03-30 Serono Cesare Ist Ricerca Composizioni farmaceutiche contenenti gonadotropine.
US5681302A (en) * 1994-06-14 1997-10-28 Minnesota Mining And Manufacturing Company Elastic sheet-like composite
AU707796B2 (en) * 1995-03-21 1999-07-22 Merck Serono Sa HCG liquid formulations
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
EP2174663A1 (en) * 2003-01-08 2010-04-14 Novartis Vaccines and Diagnostics, Inc. Stabilized aqueous compositions comprising tissue factor pathway inhibitor (TFPI) or tissue factor pathway inhibitor variant
US7387998B2 (en) 2003-03-28 2008-06-17 New York University STQ peptides
CA2518903C (en) * 2003-04-02 2013-02-05 Ares Trading S.A. Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant

Also Published As

Publication number Publication date
ES2393233T3 (es) 2012-12-19
UA101484C2 (en) 2013-04-10
JP5551601B2 (ja) 2014-07-16
WO2009056569A9 (en) 2010-01-21
SI2219607T1 (sl) 2012-09-28
CN101842083A (zh) 2010-09-22
US20100261649A1 (en) 2010-10-14
PL2219607T3 (pl) 2012-12-31
CN101842083B (zh) 2012-11-14
US8664369B2 (en) 2014-03-04
EA201070549A1 (ru) 2010-10-29
MY153976A (en) 2015-04-30
AU2008320844B2 (en) 2013-08-29
AU2008320844A1 (en) 2009-05-07
WO2009056569A1 (en) 2009-05-07
EA019432B1 (ru) 2014-03-31
JP2011502968A (ja) 2011-01-27
KR101513181B1 (ko) 2015-04-21
CA2700662A1 (en) 2009-05-07
ZA201001907B (en) 2011-05-25
BRPI0818324B8 (pt) 2021-05-25
CY1113121T1 (el) 2016-04-13
BRPI0818324A2 (pt) 2017-05-16
RS52566B (en) 2013-04-30
IL205105A (en) 2015-04-30
NZ583991A (en) 2012-02-24
EP2219607B1 (en) 2012-08-15
BRPI0818324B1 (pt) 2019-12-24
HK1145443A1 (en) 2011-04-21
IL205105A0 (en) 2010-11-30
KR20100088147A (ko) 2010-08-06
ECSP10010224A (es) 2010-07-30
CA2700662C (en) 2015-10-13
PT2219607E (pt) 2012-08-31
MX2010004639A (es) 2010-08-04
DK2219607T3 (da) 2013-06-17
EP2219607A1 (en) 2010-08-25

Similar Documents

Publication Publication Date Title
HRP20120660T1 (hr) Tekuće formulacije lh
JP2011502968A5 (hr)
AR082024A1 (es) Formulacion de anticuerpo contra ox40l humano
HRP20210298T1 (hr) Dostava terapijskih agensa u središnji živčani sustav
HRP20200434T1 (hr) Stabilne vodene formulacije adalimumaba
HRP20171256T1 (hr) Farmaceutski pripravci karbetocina
RU2407514C2 (ru) Водные композиции чфсг
HRP20191843T1 (hr) Mikobakterijski antigenski pripravak
US11162500B2 (en) Stable liquid formulation of AMG 416 (etelcalcetide)
TW201630622A (zh) 速效胰島素組合物
AR107014A1 (es) Formulación farmacéutica acuosa
HRP20110444T1 (hr) Formulacije paratiroidnih hormona i njihove uporabe
EA201492021A1 (ru) Антительный состав
AR067011A1 (es) Formulaciones de anticuerpos
JP2015527402A5 (hr)
ES2893121T3 (es) Formulaciones y métodos para controlar el ciclo reproductivo y la ovulación
CN102821782B (zh) 促卵泡激素的液体配制品
RU2015115127A (ru) Жидкие лекарственные композиции апиксабана
HRP20230929T1 (hr) Stabilni pripravci semaglutida i njihova upotreba
US20170189528A1 (en) Stable aqueous adalimumab formulation
HRP20140676T1 (hr) Formulacije deoksikolne kiseline i njezinih soli
RU2018129077A (ru) Стабильная фармацевтическая композиция
HRP20200196T1 (hr) Fiziološki balansirane injektabilne formulacije fosnetupitanta
HRP20201161T1 (hr) Formulacije sa smanjenom oksidacijom
BG106512A (bg) Циклесонид-съдържащ фармацевтичен състав за прилагане върху мукоза