BR112019002007A2 - composições farmacêuticas, processo para a fabricação de grânulos, processo para a fabricação de uma composição farmacêutica, processo para a preparação de monocloridrato de ipatasertib amorfo, método para o tratamento de distúrbios hiperproliferativos, utilização de uma composição farmacêutica e presente invenção - Google Patents

composições farmacêuticas, processo para a fabricação de grânulos, processo para a fabricação de uma composição farmacêutica, processo para a preparação de monocloridrato de ipatasertib amorfo, método para o tratamento de distúrbios hiperproliferativos, utilização de uma composição farmacêutica e presente invenção

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Publication number
BR112019002007A2
BR112019002007A2 BR112019002007-1A BR112019002007A BR112019002007A2 BR 112019002007 A2 BR112019002007 A2 BR 112019002007A2 BR 112019002007 A BR112019002007 A BR 112019002007A BR 112019002007 A2 BR112019002007 A2 BR 112019002007A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
manufacturing
present
hyperproliferative disorders
pharmaceutical compositions
Prior art date
Application number
BR112019002007-1A
Other languages
English (en)
Other versions
BR112019002007B1 (pt
Inventor
Reents Reinhard
Hidber Pirmin
Hell André
Steidle Peter
Wunderlich Martin
Pepelnjak Marie
Gosselin Francis
Yost Edward
Original Assignee
F. Hoffmann-La Roche Ag
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 F. Hoffmann-La Roche Ag filed Critical F. Hoffmann-La Roche Ag
Publication of BR112019002007A2 publication Critical patent/BR112019002007A2/pt
Publication of BR112019002007B1 publication Critical patent/BR112019002007B1/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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005—Coating of tablets or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
    • C07D239/70—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings condensed with carbocyclic rings or ring systems

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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

a presente invenção se refere às composições farmacêuticas que compreendem os inibidores da proteína quinase akt com atividade terapêutica contra as doenças, tais como o câncer, bem como aos processos para a sua preparação e sua utilização como medicamento.
BR112019002007-1A 2016-08-10 2017-08-09 Composição farmacêutica e uso de uma composição farmacêutica BR112019002007B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662373252P 2016-08-10 2016-08-10
US62/373,252 2016-08-10
PCT/EP2017/070128 WO2018029226A1 (en) 2016-08-10 2017-08-09 Pharmaceutical compositions comprising akt protein kinase inhibitors

Publications (2)

Publication Number Publication Date
BR112019002007A2 true BR112019002007A2 (pt) 2019-05-07
BR112019002007B1 BR112019002007B1 (pt) 2024-01-16

Family

ID=59569321

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019002007-1A BR112019002007B1 (pt) 2016-08-10 2017-08-09 Composição farmacêutica e uso de uma composição farmacêutica

Country Status (12)

Country Link
US (2) US11337977B2 (pt)
EP (1) EP3496722A1 (pt)
JP (3) JP6875501B2 (pt)
KR (3) KR102281695B1 (pt)
CN (3) CN116172869A (pt)
AU (3) AU2017310454B2 (pt)
BR (1) BR112019002007B1 (pt)
CA (1) CA3032233C (pt)
IL (3) IL293480B2 (pt)
MX (2) MX2019001579A (pt)
TW (3) TWI777658B (pt)
WO (1) WO2018029226A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL293480B2 (en) 2016-08-10 2024-02-01 Hoffmann La Roche Medical preparations containing AKT protein kinase inhibitors
AU2019309435A1 (en) * 2018-07-27 2021-01-21 Sandoz Ag Process for preparing rapidly or very rapidly dissolving tablets comprising freely soluble API
BR112022001627A2 (pt) * 2019-07-31 2022-04-19 Hoffmann La Roche Composições farmacêuticas, minicomprimido, embalagem do tipo stickpack, kit, processo para produzir a composição farmacêutica, métodos para o tratamento de doenças e para tratar tipos específicos de câncer, método de tratamento de câncer em um paciente em necessidade do mesmo e invenção
JP6953054B1 (ja) 2021-03-31 2021-10-27 Ｄｅｌｔａ−Ｆｌｙ Ｐｈａｒｍａ株式会社 湿度に敏感な医薬用途物質を安定化する方法及び安定製剤
WO2022258684A1 (en) * 2021-06-09 2022-12-15 Bend Research, Inc. Mixed solvents for spray drying for preparation of amorphous solid dispersions
WO2023069733A1 (en) * 2021-10-22 2023-04-27 Aquestive Therapeutics, Inc. Pharmaceutical compositions with enhanced stability profiles

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JP2005525405A (ja) * 2002-04-29 2005-08-25 アルザ・コーポレーシヨン オキシコドンを制御して補給する方法および剤型
CA2393720C (en) * 2002-07-12 2010-09-14 Eli Lilly And Company Crystalline 2,5-dione-3-(1-methyl-1h-indol-3-yl)-4-[1-(pyridin-2-ylmethyl)piperidin-4-yl]-1h-indol-3-yl]-1h-pyrrole mono-hydrochloride
EP1675576A1 (en) * 2003-10-03 2006-07-05 LifeCycle Pharma A/S A method for preparing modified release pharmaceutical compositions
JP2007509979A (ja) 2003-10-29 2007-04-19 アルザ・コーポレーシヨン １日１回の、経口用、制御放出、オキシコドン投与形態物
US20070232624A1 (en) 2006-04-03 2007-10-04 Palumbo Joseph M Use of paliperidone for the treatment of sleep disturbances and/or excessive daytime sleepiness in psychiatric patients
UA95641C2 (en) 2006-07-06 2011-08-25 Эррей Биофарма Инк. Hydroxylated cyclopenta [d] pyrimidines as akt protein kinase inhibitors
US8063050B2 (en) * 2006-07-06 2011-11-22 Array Biopharma Inc. Hydroxylated and methoxylated pyrimidyl cyclopentanes as AKT protein kinase inhibitors
AU2009233829A1 (en) * 2008-04-07 2009-10-15 Chelsea Therapeutics, Inc. Crystalline salt forms of antifolate compounds and methods of manufacturing thereof
WO2010084066A1 (en) 2009-01-23 2010-07-29 F. Hoffmann-La Roche Ag Pharmaceutical composition comprising aleglitazar
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TWI505828B (zh) 2010-12-20 2015-11-01 葛蘭素史克智慧財產（第二）有限公司 新穎醫藥組成物
MY169029A (en) 2012-05-17 2019-02-04 Genentech Inc Process of making hydroxylated cyclopentapyrimidine compounds and salts thereof
KR20220143143A (ko) * 2012-05-17 2022-10-24 제넨테크, 인크. 무정형 형태의 akt 저해성 피리미디닐 - 사이클로펜탄 화합물, 조성물 및 이들의 방법
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RU2015127037A (ru) * 2012-12-07 2017-01-11 Дзе Дженерал Хоспитал Корпорейшн Комбинации ингибитора pi3k/akt с ингибитором her3/egfr и способы их применения
MY191759A (en) 2013-11-15 2022-07-14 Hoffmann La Roche Processes for the preparation of pyrimidinylcyclopentane compounds
WO2016012963A1 (en) 2014-07-25 2016-01-28 Novartis Ag Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide
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IL293480B2 (en) 2016-08-10 2024-02-01 Hoffmann La Roche Medical preparations containing AKT protein kinase inhibitors

Also Published As

Publication number Publication date
AU2017310454A1 (en) 2019-02-14
TW201808337A (zh) 2018-03-16
JP2019524804A (ja) 2019-09-05
US20220241279A1 (en) 2022-08-04
CN109789141A (zh) 2019-05-21
KR102281695B1 (ko) 2021-07-28
CA3032233C (en) 2021-09-14
US20180055845A1 (en) 2018-03-01
TWI736660B (zh) 2021-08-21
TW202214299A (zh) 2022-04-16
IL264593B (en) 2022-07-01
JP6875501B2 (ja) 2021-05-26
AU2021282472B2 (en) 2024-02-22
CA3032233A1 (en) 2018-02-15
IL293480A (en) 2022-08-01
JP2023100657A (ja) 2023-07-19
KR20230124110A (ko) 2023-08-24
US11337977B2 (en) 2022-05-24
AU2020204167B2 (en) 2021-10-21
MX2019001579A (es) 2019-06-20
CN109789141B (zh) 2022-08-26
JP2021120376A (ja) 2021-08-19
TWI777658B (zh) 2022-09-11
MX2021010041A (es) 2022-06-14
AU2020204167A1 (en) 2020-07-09
AU2017310454B2 (en) 2020-06-04
IL293480B1 (en) 2023-10-01
KR20190038619A (ko) 2019-04-08
US11969426B2 (en) 2024-04-30
EP3496722A1 (en) 2019-06-19
AU2021282472A1 (en) 2022-01-06
CN116172869A (zh) 2023-05-30
TW202329972A (zh) 2023-08-01
BR112019002007B1 (pt) 2024-01-16
KR20210094667A (ko) 2021-07-29
IL305639A (en) 2023-11-01
CN115350192A (zh) 2022-11-18
IL293480B2 (en) 2024-02-01
WO2018029226A1 (en) 2018-02-15
IL264593A (en) 2019-02-28
KR102569636B1 (ko) 2023-08-23

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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.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 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 09/08/2017, OBSERVADAS AS CONDICOES LEGAIS