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)
Portuguese (pt)
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

    • 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
    • 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
    • A61K47/06—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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • 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
    • 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)
  • 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)
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 (25)

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

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ586590A (en) 2008-01-09 2012-06-29 Sanofi Aventis Deutschland Insulin analogues or derivatives having an extremely delayed time-action profile
LT2349324T (lt) 2008-10-17 2017-12-27 Sanofi-Aventis Deutschland Gmbh Insulino ir glp-1 agonisto derinys
JP2011001273A (ja) * 2009-06-16 2011-01-06 Eci Inc ｅＭＩＰを有効成分とする水溶性製剤
KR101853606B1 (ko) * 2009-07-06 2018-05-03 사노피-아벤티스 도이칠란트 게엠베하 메티오닌을 함유하는 수성 인슐린 제제
JP5832439B2 (ja) 2009-11-13 2015-12-16 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 Ｇｌｐ−１アゴニスト、インスリン及びメチオニンを含む薬学的組成物
CN102711804B (zh) * 2009-11-13 2015-09-16 赛诺菲-安万特德国有限公司 包含glp-1激动剂和甲硫氨酸的药物组合物
CN102821782B (zh) * 2010-02-12 2015-07-15 印塔斯生物制药有限公司 促卵泡激素的液体配制品
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
WO2013030160A1 (en) 2011-08-29 2013-03-07 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
JP2016505601A (ja) * 2012-12-26 2016-02-25 ウォックハート リミテッド 医薬組成物
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
JP6735674B2 (ja) 2014-01-09 2020-08-05 サノフイＳａｎｏｆｉ インスリンアスパルトの安定化された医薬製剤
EP3091995B1 (en) 2014-01-09 2024-03-20 Sanofi Stabilized pharmaceutical formulations of insulin aspart
US9895424B2 (en) 2014-01-09 2018-02-20 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
MA41138B1 (fr) 2014-12-12 2023-07-31 Sanofi Aventis Deutschland Formulation à rapport fixe d'insuline glargine/lixisenatide
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
JP2006515882A (ja) * 2003-01-08 2006-06-08 カイロン コーポレイション 組織因子経路インヒビター（ｔｆｐｉ）または組織因子経路インヒビター改変体を含有する安定化水性組成物
US7387998B2 (en) 2003-03-28 2008-06-17 New York University STQ peptides
US7741268B2 (en) * 2003-04-02 2010-06-22 Ares Trading S.A. Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant

Also Published As

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

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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