BRPI0818324B8 - formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica - Google Patents

formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica

Info

Publication number
BRPI0818324B8
BRPI0818324B8 BRPI0818324A BRPI0818324A BRPI0818324B8 BR PI0818324 B8 BRPI0818324 B8 BR PI0818324B8 BR PI0818324 A BRPI0818324 A BR PI0818324A BR PI0818324 A BRPI0818324 A BR PI0818324A BR PI0818324 B8 BRPI0818324 B8 BR PI0818324B8
Authority
BR
Brazil
Prior art keywords
presentation
variant
preparation
pharmaceutical composition
formulation containing
Prior art date
Application number
BRPI0818324A
Other languages
English (en)
Inventor
Del Rio Alessandra
Samaritani Fabrizio
Richard Joel
Agostinetto Rita
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 BRPI0818324A2 publication Critical patent/BRPI0818324A2/pt
Publication of BRPI0818324B1 publication Critical patent/BRPI0818324B1/pt
Publication of BRPI0818324B8 publication Critical patent/BRPI0818324B8/pt

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

formulação líquida contendo hormônio luteinizante(lh) ou uma variante do mesmo, composição farmacêutica, forma de apresentação da formulação, processo para a preparação e uso da dita formulação. a invenção refere-se ás formulações farmacêuticas líquidas de hormônio (lh) para administração única ou de multidoses.
BRPI0818324A 2007-11-01 2008-10-29 formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica BRPI0818324B8 (pt)

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 (3)

Publication Number Publication Date
BRPI0818324A2 BRPI0818324A2 (pt) 2017-05-16
BRPI0818324B1 BRPI0818324B1 (pt) 2019-12-24
BRPI0818324B8 true BRPI0818324B8 (pt) 2021-05-25

Family

ID=39167502

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0818324A BRPI0818324B8 (pt) 2007-11-01 2008-10-29 formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica

Country Status (26)

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

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102007143B (zh) 2008-01-09 2015-08-26 塞诺菲-安万特德国有限公司 具有超延迟时效特征的新型胰岛素衍生物
MX344293B (es) 2008-10-17 2016-12-13 Sanofi Aventis Deutschland Combinacion de una insulina y un agonista de glp-1.
JP2011001273A (ja) * 2009-06-16 2011-01-06 Eci Inc eMIPを有効成分とする水溶性製剤
PT2451437T (pt) * 2009-07-06 2017-01-17 Sanofi Aventis Deutschland Preparações aquosas de insulina contendo metionina
KR101772372B1 (ko) * 2009-11-13 2017-08-29 사노피-아벤티스 도이칠란트 게엠베하 Glp-1 효능제 및 메티오닌을 포함하는 약제학적 조성물
AU2010317995B2 (en) 2009-11-13 2014-04-17 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a GLP-1 agonist, an insulin, and methionine
RU2553375C2 (ru) * 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Жидкий состав фолликулостимулирующего гормона
CN103179978A (zh) 2010-08-30 2013-06-26 赛诺菲-安万特德国有限公司 Ave0010用于制造供治疗2型糖尿病用的药物的用途
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
AU2012300978B2 (en) 2011-08-29 2017-04-27 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
CA2889162A1 (en) * 2012-12-26 2014-07-03 Wockhardt Limited Pharmaceutical composition
TWI641381B (zh) 2013-02-04 2018-11-21 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
EP2968391A1 (en) 2013-03-13 2016-01-20 Moderna Therapeutics, Inc. Long-lived polynucleotide molecules
AU2015205624A1 (en) 2014-01-09 2016-07-14 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
CA2932875A1 (en) 2014-01-09 2015-07-16 Sanofi Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives
MX2016008977A (es) 2014-01-09 2016-10-04 Sanofi Sa Formulaciones farmaceuticas de insulina aspart estabilizadas.
TN2017000235A1 (en) 2014-12-12 2018-10-19 Sanofi Aventis Deutschland Insulin glargine/lixisenatide fixed ratio formulation
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
JP4165718B2 (ja) * 1995-03-21 2008-10-15 ラボラトワール セローノ ソシエテ アノニム hCG液体製剤
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
JP4719357B2 (ja) * 1998-07-23 2011-07-06 アレス トレイディング ソシエテ アノニム Fsh及びfsh変異体の製剤、製品及び方法
DE602004019761D1 (de) * 2003-01-08 2009-04-16 Novartis Vaccines & Diagnostic Stabilisierte wässrige zusammensetzungen mit gewebefaktorinhibitor (tfpi) oder gewebefaktorinhibitor-variante
US7387998B2 (en) 2003-03-28 2008-06-17 New York University STQ peptides
RS57872B1 (sr) * 2003-04-02 2018-12-31 Ares Trading Sa Tečne farmaceutske formulacije fsh i lh zajedno sa nejonskim surfaktantom

Also Published As

Publication number Publication date
UA101484C2 (en) 2013-04-10
CN101842083B (zh) 2012-11-14
HK1145443A1 (en) 2011-04-21
RS52566B (en) 2013-04-30
HRP20120660T1 (hr) 2012-09-30
US20100261649A1 (en) 2010-10-14
ECSP10010224A (es) 2010-07-30
PL2219607T3 (pl) 2012-12-31
BRPI0818324B1 (pt) 2019-12-24
US8664369B2 (en) 2014-03-04
NZ583991A (en) 2012-02-24
EA019432B1 (ru) 2014-03-31
IL205105A (en) 2015-04-30
KR20100088147A (ko) 2010-08-06
CY1113121T1 (el) 2016-04-13
AU2008320844B2 (en) 2013-08-29
EP2219607A1 (en) 2010-08-25
AU2008320844A1 (en) 2009-05-07
CA2700662C (en) 2015-10-13
PT2219607E (pt) 2012-08-31
MY153976A (en) 2015-04-30
BRPI0818324A2 (pt) 2017-05-16
CN101842083A (zh) 2010-09-22
MX2010004639A (es) 2010-08-04
SI2219607T1 (sl) 2012-09-28
IL205105A0 (en) 2010-11-30
KR101513181B1 (ko) 2015-04-21
EP2219607B1 (en) 2012-08-15
ZA201001907B (en) 2011-05-25
ES2393233T3 (es) 2012-12-19
DK2219607T3 (da) 2013-06-17
JP2011502968A (ja) 2011-01-27
WO2009056569A1 (en) 2009-05-07
CA2700662A1 (en) 2009-05-07
WO2009056569A9 (en) 2010-01-21
JP5551601B2 (ja) 2014-07-16
EA201070549A1 (ru) 2010-10-29

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Legal Events

Date Code Title Description
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]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 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 24/12/2019, 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 29/10/2008 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF