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MD4563B1 - Produs de comicronizare cu conţinut de acetat de ulipristal - Google Patents

Produs de comicronizare cu conţinut de acetat de ulipristal

Info

Publication number
MD4563B1
MD4563B1 MDA20150053A MD20150053A MD4563B1 MD 4563 B1 MD4563 B1 MD 4563B1 MD A20150053 A MDA20150053 A MD A20150053A MD 20150053 A MD20150053 A MD 20150053A MD 4563 B1 MD4563 B1 MD 4563B1
Authority
MD
Moldova
Prior art keywords
ulipristal acetate
micronisation
product
micronisation product
relates
Prior art date
Application number
MDA20150053A
Other languages
English (en)
Russian (ru)
Other versions
MD20150053A2 (ro
MD4563C1 (ro
Inventor
Флориан Баттюн
Пьер-Ив Жувен
Жером Эк
Оде Колен
Original Assignee
Laboratoire Hra-Pharma
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 Laboratoire Hra-Pharma filed Critical Laboratoire Hra-Pharma
Publication of MD20150053A2 publication Critical patent/MD20150053A2/ro
Publication of MD4563B1 publication Critical patent/MD4563B1/ro
Publication of MD4563C1 publication Critical patent/MD4563C1/ro

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61P15/18—Feminine contraceptives
    • 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
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Circuit Arrangements For Discharge Lamps (AREA)
  • Emergency Protection Circuit Devices (AREA)
  • Thyristors (AREA)

Abstract

Invenţia se referă la un produs de comicronizare ce conţine un ingredient activ selectat din grupul ce constă din acetat de ulipristal, un metabolit al acetatului de ulipristal şi amestecul acestora, şi un surfactant solid farmaceutic acceptabil selectat din săruri alchilsulfat C8-C20 şi amestecurile acestora.Invenţia de asemenea se referă la un procedeu de obţinere a produsului de comicronizare, la o compoziţie farmaceutică ce conţine produsul de comicronizare menţionat şi la utilizarea acesteia în calitate de contraceptiv şi în tratamentul sau prevenirea tulburărilor ginecologice.
MDA20150053A 2012-11-08 2013-11-07 Produs de comicronizare cu conţinut de acetat de ulipristal MD4563C1 (ro)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1260603A FR2997627B1 (fr) 2012-11-08 2012-11-08 Produit de co-micronisation comprenant de l'ulipristal acetate
PCT/FR2013/052670 WO2014072646A1 (fr) 2012-11-08 2013-11-07 Produit de co-micronisation comprenant de l'ulipristal acetate

Publications (3)

Publication Number Publication Date
MD20150053A2 MD20150053A2 (ro) 2015-10-31
MD4563B1 true MD4563B1 (ro) 2018-05-31
MD4563C1 MD4563C1 (ro) 2018-12-31

Family

ID=47878175

Family Applications (1)

Application Number Title Priority Date Filing Date
MDA20150053A MD4563C1 (ro) 2012-11-08 2013-11-07 Produs de comicronizare cu conţinut de acetat de ulipristal

Country Status (30)

Country Link
US (2) US9610293B2 (ro)
EP (1) EP2916871B1 (ro)
JP (1) JP2015536968A (ro)
KR (1) KR20150093170A (ro)
CN (1) CN104902928B (ro)
AR (1) AR093402A1 (ro)
AU (1) AU2013343320B2 (ro)
BR (1) BR112015010271B1 (ro)
CA (1) CA2890272A1 (ro)
CR (1) CR20150297A (ro)
CY (1) CY1119542T1 (ro)
DK (1) DK2916871T3 (ro)
EA (1) EA027641B1 (ro)
EC (1) ECSP15022442A (ro)
ES (1) ES2606307T3 (ro)
FR (1) FR2997627B1 (ro)
GE (1) GEP201706637B (ro)
HR (1) HRP20161624T1 (ro)
HU (1) HUE031911T2 (ro)
LT (1) LT2916871T (ro)
MD (1) MD4563C1 (ro)
MX (1) MX363699B (ro)
PL (1) PL2916871T3 (ro)
PT (1) PT2916871T (ro)
RS (1) RS55429B1 (ro)
SI (1) SI2916871T1 (ro)
SM (1) SMT201600445B (ro)
TW (1) TWI617325B (ro)
UA (1) UA117465C2 (ro)
WO (1) WO2014072646A1 (ro)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2997627B1 (fr) * 2012-11-08 2015-01-16 Hra Pharma Lab Produit de co-micronisation comprenant de l'ulipristal acetate
CN103923154B (zh) * 2013-01-16 2017-09-26 杭州容立医药科技有限公司 醋酸乌利司他的共晶及制备方法
CN105663140A (zh) * 2014-11-21 2016-06-15 四川海思科制药有限公司 一种含醋酸乌利司他的药物组合物及其制备方法
CN104865215A (zh) * 2015-05-16 2015-08-26 南京海纳医药科技有限公司 一种醋酸乌利司他片剂及其溶出度测定方法
CN105919150A (zh) * 2016-05-12 2016-09-07 高洁珺 一种代替压片工艺中化工添加剂的方法
CN106265533A (zh) * 2016-10-10 2017-01-04 朱隆娅 一种阿德呋啉颗粒剂及其制备方法
FR3060389B1 (fr) 2016-12-20 2019-05-31 Laboratoire Hra-Pharma Comprime enrobe comprenant de l'ulipristal acetate ou un de ses metabolites

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0422100A1 (en) * 1988-06-23 1991-04-17 Res Triangle Inst 11-BETA SUBSTITUTED PROGESTERONE ANALOGS.
WO2000028970A1 (en) * 1998-11-18 2000-05-25 Ferring Bv Vaginally administrable progesterone-containing tablets and method for preparing same
EP1602662A1 (en) * 2003-01-22 2005-12-07 Crystal Pharma, S.A. Method of obtaining 17alpha-acetoxy-11beta-(4-n,n-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione
US20090192130A1 (en) * 2008-01-29 2009-07-30 Hra Pharma Method for Treating Uterine Fibroids
WO2010066749A2 (en) * 2008-12-08 2010-06-17 Laboratoire Hra Pharma Ulipristal acetate tablets
EP2471537A1 (en) * 2010-12-30 2012-07-04 PregLem S.A. Treatment of pain associated with dislocation of basal endometrium

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2627696B1 (fr) * 1988-02-26 1991-09-13 Fournier Innovation Synergie Nouvelle forme galenique du fenofibrate
GB9608719D0 (en) 1996-04-26 1996-07-03 Scherer Ltd R P Pharmaceutical compositions
FR2757397B1 (fr) * 1996-12-23 1999-03-05 Mazal Pharma Composition pharmaceutique a base de rheine ou de diacerheine a biodisponibilite amelioree
FR2821555B1 (fr) * 2001-03-01 2003-05-16 Besins Int Lab Progestatif co-micronise avec un tensioactif, composition pharmaceutique le comprenant, leurs procedes de fabrication et leurs utilisations
FR2841138B1 (fr) * 2002-06-25 2005-02-25 Cll Pharma Composition pharmaceutique solide contenant un principe actif lipophile, son procede de preparation
DE602005026290D1 (de) 2004-07-09 2011-03-24 Population Council Inc Zusammensetzungen mit verzögerter freisetzung mit progesteron-rezeptormodulatoren
EP2077822B1 (en) 2006-09-27 2018-04-25 Medley S.A. Indústria Farmacêutica Oxcarbazepine-containing oral formulation and a process to obtain the same
WO2008079245A2 (en) 2006-12-20 2008-07-03 Duramed Pharmaceuticals, Inc. Orally disintegrating solid dosage forms comprising progestin and methods of making and use thereof
WO2008083192A2 (en) * 2006-12-28 2008-07-10 Repros Therapeutics Inc. Methods and formulations for improved bioavailability of antiprogestins
US20090142395A1 (en) * 2007-11-19 2009-06-04 Uri Zadok Deferasirox pharmaceutical compositions
WO2010119029A1 (en) 2009-04-14 2010-10-21 Laboratoire Hra-Pharma Method for on-demand contraception
FR2997627B1 (fr) * 2012-11-08 2015-01-16 Hra Pharma Lab Produit de co-micronisation comprenant de l'ulipristal acetate

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0422100A1 (en) * 1988-06-23 1991-04-17 Res Triangle Inst 11-BETA SUBSTITUTED PROGESTERONE ANALOGS.
WO2000028970A1 (en) * 1998-11-18 2000-05-25 Ferring Bv Vaginally administrable progesterone-containing tablets and method for preparing same
EP1602662A1 (en) * 2003-01-22 2005-12-07 Crystal Pharma, S.A. Method of obtaining 17alpha-acetoxy-11beta-(4-n,n-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione
US20090192130A1 (en) * 2008-01-29 2009-07-30 Hra Pharma Method for Treating Uterine Fibroids
WO2010066749A2 (en) * 2008-12-08 2010-06-17 Laboratoire Hra Pharma Ulipristal acetate tablets
EP2471537A1 (en) * 2010-12-30 2012-07-04 PregLem S.A. Treatment of pain associated with dislocation of basal endometrium

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Donnez ş. a., N Engl J Med. 2012, 366(5):421-32 *
Fine ş. a., Obstet Gynecol. 2010, 115:257-63 *
Glasier ş. a., Lancet. 2010, 375(9714):555-62 *

Also Published As

Publication number Publication date
CN104902928A (zh) 2015-09-09
US20170157146A1 (en) 2017-06-08
PT2916871T (pt) 2016-12-15
JP2015536968A (ja) 2015-12-24
CY1119542T1 (el) 2018-03-07
LT2916871T (lt) 2016-12-27
ES2606307T3 (es) 2017-03-23
CN104902928B (zh) 2018-10-23
RS55429B1 (sr) 2017-04-28
WO2014072646A1 (fr) 2014-05-15
TW201427718A (zh) 2014-07-16
BR112015010271B1 (pt) 2020-04-22
EA027641B1 (ru) 2017-08-31
MX2015005762A (es) 2016-02-11
GEP201706637B (en) 2017-03-10
MX363699B (es) 2019-03-28
TWI617325B (zh) 2018-03-11
HRP20161624T1 (hr) 2017-01-27
FR2997627A1 (fr) 2014-05-09
CA2890272A1 (fr) 2014-05-15
AR093402A1 (es) 2015-06-03
UA117465C2 (uk) 2018-08-10
BR112015010271A2 (pt) 2017-07-11
US9610293B2 (en) 2017-04-04
AU2013343320A1 (en) 2015-06-04
EA201500513A1 (ru) 2015-08-31
FR2997627B1 (fr) 2015-01-16
DK2916871T3 (da) 2017-01-02
PL2916871T3 (pl) 2017-02-28
US20150290218A1 (en) 2015-10-15
EP2916871A1 (fr) 2015-09-16
ECSP15022442A (es) 2016-01-29
SMT201600445B (it) 2017-01-10
AU2013343320B2 (en) 2018-03-08
HUE031911T2 (en) 2017-08-28
KR20150093170A (ko) 2015-08-17
BR112015010271A8 (pt) 2019-10-01
SI2916871T1 (sl) 2017-03-31
MD20150053A2 (ro) 2015-10-31
MD4563C1 (ro) 2018-12-31
EP2916871B1 (fr) 2016-09-14
CR20150297A (es) 2015-08-14

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Legal Events

Date Code Title Description
FG4A Patent for invention issued
KA4A Patent for invention lapsed due to non-payment of fees (with right of restoration)
MM4A Patent for invention definitely lapsed due to non-payment of fees