BR112015010271A8 - produto de comicronização, processo para o preparo de um produto de comicronização, composição farmacêutica e seus usos - Google Patents

produto de comicronização, processo para o preparo de um produto de comicronização, composição farmacêutica e seus usos

Info

Publication number
BR112015010271A8
BR112015010271A8 BR112015010271A BR112015010271A BR112015010271A8 BR 112015010271 A8 BR112015010271 A8 BR 112015010271A8 BR 112015010271 A BR112015010271 A BR 112015010271A BR 112015010271 A BR112015010271 A BR 112015010271A BR 112015010271 A8 BR112015010271 A8 BR 112015010271A8
Authority
BR
Brazil
Prior art keywords
product
comicronization
pharmaceutical composition
comicronization product
preparation
Prior art date
Application number
BR112015010271A
Other languages
English (en)
Other versions
BR112015010271A2 (pt
BR112015010271B1 (pt
Inventor
Colin Aude
Battung Florian
Hecq Jérôme
Juvin Pierre-Yves
Original Assignee
Hra Pharma Lab
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 Hra Pharma Lab filed Critical Hra Pharma Lab
Publication of BR112015010271A2 publication Critical patent/BR112015010271A2/pt
Publication of BR112015010271A8 publication Critical patent/BR112015010271A8/pt
Publication of BR112015010271B1 publication Critical patent/BR112015010271B1/pt

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

Abstract

produto de comicronização, composição farmacêutica e seus usos a invenção refere-se a um produto de comicronização que compreende: um princípio ativo selecionado a partir do grupo constituído por acetato de ulipristal, um metabólito de acetato de ulipristal e suas misturas, e um surfactante sólido farmaceuticamente aceitável. a invenção também se refere a uma composição farmacêutica compreendendo o referido produto de comicronização e seus usos terapêuticos.
BR112015010271A 2012-11-08 2013-11-07 produto de comicronização, processo para o preparo de um produto de comicronização, composição farmacêutica e seus usos BR112015010271B1 (pt)

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
BR112015010271A2 BR112015010271A2 (pt) 2017-07-11
BR112015010271A8 true BR112015010271A8 (pt) 2019-10-01
BR112015010271B1 BR112015010271B1 (pt) 2020-04-22

Family

ID=47878175

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015010271A BR112015010271B1 (pt) 2012-11-08 2013-11-07 produto de comicronização, processo para o preparo de um produto de comicronização, composição farmacêutica e seus usos

Country Status (30)

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

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

Family Cites Families (18)

* 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
US4954490A (en) * 1988-06-23 1990-09-04 Research Triangle Institute 11 β-substituted progesterone analogs
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
IL127129A (en) * 1998-11-18 2004-06-01 Ferring Bv Method for preparation of progesterone tablets for vaginal delivery and tablets so prepared
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
ES2212912B1 (es) * 2003-01-22 2005-10-01 Crystal Pharma, S.A. Procedimiento para la obtencion de 17alfa-acetoxi-11beta-(4-n,n-dimetilaminofenil)-19-norpregna-4,9-dien-3,20-diona.
BRPI0513141A (pt) 2004-07-09 2008-04-29 Population Council Inc composição para anel vaginal, e, processo de contracepção a longo prazo
EP2077822B1 (en) 2006-09-27 2018-04-25 Medley S.A. Indústria Farmacêutica Oxcarbazepine-containing oral formulation and a process to obtain the same
ES2531929T3 (es) 2006-12-20 2015-03-20 Teva Women's Health, Inc. Formas de dosificación solidas que se disgregan en la boca que comprenden progestina y métodos para hacer y usar las mismas
MX2009006912A (es) * 2006-12-28 2009-08-12 Repros Therapeutics Inc Metodos y formulaciones para biodisponibilidad mejorada de antiprogestinas.
US20090142395A1 (en) * 2007-11-19 2009-06-04 Uri Zadok Deferasirox pharmaceutical compositions
US8299050B2 (en) * 2008-01-29 2012-10-30 Laboratoire Hra-Pharma Method for treating uterine fibroids
US8512745B2 (en) * 2008-12-08 2013-08-20 Laboratoire Hra Pharma Ulipristal acetate tablets
CA2757496A1 (en) 2009-04-14 2010-10-21 Andre Ulmann Method for on-demand contraception
EP2471537A1 (en) * 2010-12-30 2012-07-04 PregLem S.A. Treatment of pain associated with dislocation of basal endometrium
FR2997627B1 (fr) * 2012-11-08 2015-01-16 Hra Pharma Lab Produit de co-micronisation comprenant de l'ulipristal acetate

Also Published As

Publication number Publication date
BR112015010271A2 (pt) 2017-07-11
EP2916871B1 (fr) 2016-09-14
HRP20161624T1 (hr) 2017-01-27
CA2890272A1 (fr) 2014-05-15
EP2916871A1 (fr) 2015-09-16
MX2015005762A (es) 2016-02-11
HUE031911T2 (en) 2017-08-28
DK2916871T3 (da) 2017-01-02
SMT201600445B (it) 2017-01-10
AU2013343320B2 (en) 2018-03-08
SI2916871T1 (sl) 2017-03-31
TW201427718A (zh) 2014-07-16
WO2014072646A1 (fr) 2014-05-15
FR2997627B1 (fr) 2015-01-16
CN104902928B (zh) 2018-10-23
AU2013343320A1 (en) 2015-06-04
GEP201706637B (en) 2017-03-10
AR093402A1 (es) 2015-06-03
US9610293B2 (en) 2017-04-04
ES2606307T3 (es) 2017-03-23
BR112015010271B1 (pt) 2020-04-22
CR20150297A (es) 2015-08-14
KR20150093170A (ko) 2015-08-17
PL2916871T3 (pl) 2017-02-28
US20170157146A1 (en) 2017-06-08
RS55429B1 (sr) 2017-04-28
JP2015536968A (ja) 2015-12-24
US20150290218A1 (en) 2015-10-15
FR2997627A1 (fr) 2014-05-09
ECSP15022442A (es) 2016-01-29
MD4563B1 (ro) 2018-05-31
CY1119542T1 (el) 2018-03-07
MD20150053A2 (ro) 2015-10-31
MD4563C1 (ro) 2018-12-31
CN104902928A (zh) 2015-09-09
MX363699B (es) 2019-03-28
TWI617325B (zh) 2018-03-11
LT2916871T (lt) 2016-12-27
UA117465C2 (uk) 2018-08-10
EA201500513A1 (ru) 2015-08-31
PT2916871T (pt) 2016-12-15
EA027641B1 (ru) 2017-08-31

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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]
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]
B06A Patent application procedure suspended [chapter 6.1 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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/11/2013, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 8A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2643 DE 31-08-2021 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.