BR112015015758B8 - Dispersão sólida, formulação sólida de dose unitária, preparação farmacêutica e uso de uma dispersão sólida - Google Patents

Dispersão sólida, formulação sólida de dose unitária, preparação farmacêutica e uso de uma dispersão sólida

Info

Publication number
BR112015015758B8
BR112015015758B8 BR112015015758A BR112015015758A BR112015015758B8 BR 112015015758 B8 BR112015015758 B8 BR 112015015758B8 BR 112015015758 A BR112015015758 A BR 112015015758A BR 112015015758 A BR112015015758 A BR 112015015758A BR 112015015758 B8 BR112015015758 B8 BR 112015015758B8
Authority
BR
Brazil
Prior art keywords
solid
solid dispersion
pharmaceutical preparation
unit dose
dispersion
Prior art date
Application number
BR112015015758A
Other languages
English (en)
Other versions
BR112015015758B1 (pt
BR112015015758A2 (pt
Inventor
K Sandhu Harpreet
Hua Ma
Allen Matchett Michael
Hargovindas Shah Navnit
Steve Lomuscio
yu-e Zhang
Original Assignee
Hoffmann La Roche
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=50023547&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112015015758(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR112015015758A2 publication Critical patent/BR112015015758A2/pt
Publication of BR112015015758B8 publication Critical patent/BR112015015758B8/pt
Publication of BR112015015758B1 publication Critical patent/BR112015015758B1/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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/28—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
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • A61K9/2813—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

dispersão sólida, formulação sólida, método de preparo de uma dispersão sólida, preparação farmacêutica e uso de uma dispersão sólida. a invenção refere-se a dispersões sólidas de compostos pouco solúveis em água, em particular composto a, conforme divulgado no presente pedido, formadas por coprecipitação de solvente ou por secagem por aspersão, resultando em biodisponibilidade, segurança e tolerância aprimoradas dos ditos compostos.
BR112015015758-0A 2013-01-22 2014-01-20 Dispersão sólida, formulação sólida de dose unitária, preparação farmacêutica e uso de uma dispersão sólida BR112015015758B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361755074P 2013-01-22 2013-01-22
US61/755,074 2013-01-22
PCT/EP2014/050974 WO2014114575A1 (en) 2013-01-22 2014-01-20 Pharmaceutical composition with improved bioavailability

Publications (3)

Publication Number Publication Date
BR112015015758A2 BR112015015758A2 (pt) 2018-06-19
BR112015015758B8 true BR112015015758B8 (pt) 2021-10-13
BR112015015758B1 BR112015015758B1 (pt) 2022-01-04

Family

ID=50023547

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015015758-0A BR112015015758B1 (pt) 2013-01-22 2014-01-20 Dispersão sólida, formulação sólida de dose unitária, preparação farmacêutica e uso de uma dispersão sólida

Country Status (24)

Country Link
US (2) US9427427B2 (pt)
EP (1) EP2948141A1 (pt)
JP (1) JP6192244B2 (pt)
KR (1) KR101737250B1 (pt)
CN (3) CN112353762A (pt)
AR (1) AR094548A1 (pt)
AU (1) AU2014210103B2 (pt)
BR (1) BR112015015758B1 (pt)
CA (1) CA2892025C (pt)
CL (1) CL2015001649A1 (pt)
CR (1) CR20150287A (pt)
EA (1) EA028009B1 (pt)
HK (1) HK1211217A1 (pt)
IL (1) IL239657B (pt)
MA (1) MA38289A1 (pt)
MX (1) MX2015008911A (pt)
MY (1) MY192032A (pt)
NZ (1) NZ708272A (pt)
PE (1) PE20151335A1 (pt)
PH (1) PH12015501620B1 (pt)
SG (1) SG11201504499VA (pt)
UA (1) UA116004C2 (pt)
WO (1) WO2014114575A1 (pt)
ZA (1) ZA201504187B (pt)

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EP3459933B1 (en) * 2014-04-15 2022-08-24 F. Hoffmann-La Roche AG Solid forms of a pharmaceutically active compound
PT107846B (pt) * 2014-08-01 2019-03-22 Hovione Farm S A Produção de nano- partículas de dispersões sólidas amorfas por co-precipitação controlada
LT3226842T (lt) * 2014-12-05 2021-03-25 Aragon Pharmaceuticals, Inc. Priešvėžinės kompozicijos
HUE054935T2 (hu) 2014-12-05 2021-10-28 Aragon Pharmaceuticals Inc Rákellenes készítmények
EP3307246A1 (en) * 2015-06-09 2018-04-18 Capsugel Belgium NV Formulations to achieve rapid dissolution of drug from spray-dried dispersions in capsules
GB201609222D0 (en) 2016-05-25 2016-07-06 F2G Ltd Pharmaceutical formulation
KR20180118519A (ko) * 2017-04-21 2018-10-31 (주)바이오시네틱스 지질을 밀링 공정의 윤활제로 이용하는 활성물질 나노입자의 제조 방법
US11304945B2 (en) * 2017-07-04 2022-04-19 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition and method for preparing same
ES2967689T3 (es) 2018-04-06 2024-05-03 Capsugel Belgium Nv Proceso de secado por aspersión para partículas de baja relación de aspecto que comprenden poli[(metacrilato de metilo)-co-(ácido metacrílico)]
WO2019213106A1 (en) 2018-04-30 2019-11-07 Teva Pharmaceuticals International Gmbh Solid state forms of idasanutlin
TW202043225A (zh) * 2019-01-25 2020-12-01 英屬開曼群島商百濟神州有限公司 B-raf激酶二聚體抑制劑之穩定固體分散體、製備方法及其用途
US11819503B2 (en) 2019-04-23 2023-11-21 F2G Ltd Method of treating coccidioides infection
CN113825511A (zh) * 2019-05-31 2021-12-21 江苏恒瑞医药股份有限公司 一种固体分散体及其制备方法
JP2022548787A (ja) * 2019-09-23 2022-11-21 バイオノミクス リミテッド 治療用製剤およびその使用
US20230000775A1 (en) * 2019-12-02 2023-01-05 Astrazeneca Ab Solid pharmaceutical formulations of 6-(2-chloro-6-methylpyridin-4-yl)-5-(4-fluorophenyl)-1,2,4-triazin-3-amine
JP2023506920A (ja) * 2019-12-20 2023-02-20 インターベット インターナショナル ベー． フェー． ポリマーマトリックス中に分散されたピラゾール化合物の医薬組成物
TW202211911A (zh) * 2020-06-05 2022-04-01 美商應用材料股份有限公司 經塗佈的藥物組成物及製備彼之方法
CN112022812B (zh) * 2020-11-03 2021-01-29 上海亚盛医药科技有限公司 一种包含杂环类化合物的组合物、其制备方法和应用
EP4119128A1 (en) * 2021-07-13 2023-01-18 Dr. Falk Pharma Gmbh Pharmaceutical composition for the oral administration of poorly soluble drugs comprising an amorphous solid dispersion
WO2024025609A1 (en) * 2022-07-26 2024-02-01 Wellstat Therapeutics Corporation Uridine triacetate amorphous formulation and uses thereof

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Also Published As

Publication number Publication date
IL239657A0 (en) 2015-08-31
HK1211217A1 (en) 2016-05-20
US10034854B2 (en) 2018-07-31
MA38289A1 (fr) 2017-01-31
EP2948141A1 (en) 2015-12-02
EA201591276A1 (ru) 2016-01-29
AU2014210103B2 (en) 2018-09-06
MX2015008911A (es) 2015-10-22
US9427427B2 (en) 2016-08-30
AU2014210103A1 (en) 2015-06-11
PH12015501620A1 (en) 2015-09-28
CN104936589A (zh) 2015-09-23
MY192032A (en) 2022-07-24
US20170000764A1 (en) 2017-01-05
CR20150287A (es) 2015-09-01
AR094548A1 (es) 2015-08-12
PH12015501620B1 (en) 2015-09-28
EA028009B1 (ru) 2017-09-29
BR112015015758B1 (pt) 2022-01-04
US20140206742A1 (en) 2014-07-24
KR20150097792A (ko) 2015-08-26
NZ708272A (en) 2020-07-31
CN112370427A (zh) 2021-02-19
JP2016505029A (ja) 2016-02-18
KR101737250B1 (ko) 2017-05-17
CA2892025C (en) 2022-02-15
UA116004C2 (uk) 2018-01-25
PE20151335A1 (es) 2015-09-18
ZA201504187B (en) 2018-11-28
CN112353762A (zh) 2021-02-12
IL239657B (en) 2019-05-30
BR112015015758A2 (pt) 2018-06-19
JP6192244B2 (ja) 2017-09-06
WO2014114575A1 (en) 2014-07-31
CA2892025A1 (en) 2014-07-31
SG11201504499VA (en) 2015-08-28
CL2015001649A1 (es) 2015-10-23

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