BR112017023161A2 - composições de ácido obeticólico e métodos de uso - Google Patents

composições de ácido obeticólico e métodos de uso

Info

Publication number
BR112017023161A2
BR112017023161A2 BR112017023161-1A BR112017023161A BR112017023161A2 BR 112017023161 A2 BR112017023161 A2 BR 112017023161A2 BR 112017023161 A BR112017023161 A BR 112017023161A BR 112017023161 A2 BR112017023161 A2 BR 112017023161A2
Authority
BR
Brazil
Prior art keywords
methods
acid compositions
obeticolic acid
obeticolic
dissolution
Prior art date
Application number
BR112017023161-1A
Other languages
English (en)
Inventor
G. Lancaster Richard
K. Olmstead Kay
Kagihiro Masashi
Taoka Ikuko
Matono Mitsuhiro
Pruzanski Mark
Shapiro David
Hooshmand-Rad Roya
Pencek Richard
Sciacca Cathi
Eliot Lise
Edwards Jeffrey
A. Macconell Leigh
K. Marmon Tonya
Original Assignee
Intercept Pharmaceuticals, Inc.
Sumitomo Dainippon Pharma Co., Ltd.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57198868&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112017023161(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Intercept Pharmaceuticals, Inc., Sumitomo Dainippon Pharma Co., Ltd. filed Critical Intercept Pharmaceuticals, Inc.
Publication of BR112017023161A2 publication Critical patent/BR112017023161A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07JSTEROIDS
    • C07J9/00Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane
    • C07J9/005Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane containing a carboxylic function directly attached or attached by a chain containing only carbon atoms to the cyclopenta[a]hydrophenanthrene skeleton

Abstract

a presente invenção refere-se a formulações de ácido obeticólico com estabilidade, dissolução e/ou solubilidade melhoradas, métodos de preparação das mesmas para uso e métodos de tratamento de várias doenças e afeções.
BR112017023161-1A 2015-04-27 2016-04-26 composições de ácido obeticólico e métodos de uso BR112017023161A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562153040P 2015-04-27 2015-04-27
US62/153,040 2015-04-27
US201662317933P 2016-04-04 2016-04-04
US62/317,933 2016-04-04
PCT/US2016/029369 WO2016176208A1 (en) 2015-04-27 2016-04-26 Compositions of obeticholic acid and methods of use

Publications (1)

Publication Number Publication Date
BR112017023161A2 true BR112017023161A2 (pt) 2018-07-24

Family

ID=57198868

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017023161-1A BR112017023161A2 (pt) 2015-04-27 2016-04-26 composições de ácido obeticólico e métodos de uso

Country Status (25)

Country Link
US (8) US10052337B2 (pt)
EP (2) EP3971199A1 (pt)
JP (2) JP6941057B2 (pt)
KR (1) KR20170140325A (pt)
CN (1) CN107531742A (pt)
AU (2) AU2016255045B2 (pt)
BR (1) BR112017023161A2 (pt)
CA (1) CA2983609A1 (pt)
CL (1) CL2017002727A1 (pt)
CO (1) CO2017011535A2 (pt)
CR (1) CR20170492A (pt)
EA (1) EA201792354A1 (pt)
EC (1) ECSP17078433A (pt)
IL (2) IL255269B (pt)
MA (1) MA41999A (pt)
MX (1) MX2017013805A (pt)
NI (1) NI201700128A (pt)
PE (1) PE20180690A1 (pt)
PH (1) PH12017501956A1 (pt)
SG (2) SG11201708606VA (pt)
SV (1) SV2017005555A (pt)
TN (1) TN2017000452A1 (pt)
TW (1) TWI723017B (pt)
WO (1) WO2016176208A1 (pt)
ZA (1) ZA201707981B (pt)

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Also Published As

Publication number Publication date
AU2016255045B2 (en) 2020-04-16
CL2017002727A1 (es) 2018-04-27
US20200046736A1 (en) 2020-02-13
EP3288958A4 (en) 2018-09-26
TWI723017B (zh) 2021-04-01
US10758549B2 (en) 2020-09-01
ECSP17078433A (es) 2018-02-28
IL255269A (en) 2018-02-28
CR20170492A (es) 2018-05-15
ZA201707981B (en) 2019-03-27
SG11201708606VA (en) 2017-11-29
EP3971199A1 (en) 2022-03-23
US10751349B2 (en) 2020-08-25
SV2017005555A (es) 2019-01-18
JP2021183651A (ja) 2021-12-02
US20200054650A1 (en) 2020-02-20
CO2017011535A2 (es) 2018-01-31
US20200046735A1 (en) 2020-02-13
US10646499B2 (en) 2020-05-12
IL255269B (en) 2022-08-01
MX2017013805A (es) 2018-09-06
IL294575A (en) 2022-09-01
TN2017000452A1 (en) 2019-04-12
US20170035784A1 (en) 2017-02-09
JP6941057B2 (ja) 2021-09-29
CA2983609A1 (en) 2016-11-03
PH12017501956A1 (en) 2018-03-26
AU2016255045A1 (en) 2017-11-09
NI201700128A (es) 2018-04-11
CN107531742A (zh) 2018-01-02
KR20170140325A (ko) 2017-12-20
PE20180690A1 (es) 2018-04-23
AU2020205315A1 (en) 2020-08-06
WO2016176208A1 (en) 2016-11-03
EP3288958A1 (en) 2018-03-07
MA41999A (fr) 2018-03-07
US20190255071A1 (en) 2019-08-22
TW201703773A (zh) 2017-02-01
US20200171053A1 (en) 2020-06-04
US10052337B2 (en) 2018-08-21
SG10202003110PA (en) 2020-05-28
JP2018514534A (ja) 2018-06-07
US20220133745A1 (en) 2022-05-05
US20190076446A1 (en) 2019-03-14
EA201792354A1 (ru) 2018-03-30

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B15K Others concerning applications: alteration of classification

Free format text: AS CLASSIFICACOES ANTERIORES ERAM: C07J 9/00 , A61K 31/575 , A61K 9/14 , A61K 9/20

Ipc: A61K 31/575 (2006.01), C07J 9/00 (2006.01), A61K 9

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B25G Requested change of headquarter approved

Owner name: SUMITOMO DAINIPPON PHARMA CO., LTD. (JP) ; INTERCEPT PHARMACEUTICALS, INC. (US)

B25A Requested transfer of rights approved

Owner name: INTERCEPT PHARMACEUTICALS, INC. (US)

B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B07C Technical examination (opinion): republication [chapter 7.3 patent gazette]

Free format text: REFERENTE AO DESPACHO 7.1 PUBLICADO NA RPI NO 2716, DE 24/01/2023

B09B Patent application refused [chapter 9.2 patent gazette]