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MX2016012596A - Dispersion solida amorfa que comprende taxano, comprimido que comprende la misma, y metodo para su preparacion. - Google Patents

Dispersion solida amorfa que comprende taxano, comprimido que comprende la misma, y metodo para su preparacion.

Info

Publication number
MX2016012596A
MX2016012596A MX2016012596A MX2016012596A MX2016012596A MX 2016012596 A MX2016012596 A MX 2016012596A MX 2016012596 A MX2016012596 A MX 2016012596A MX 2016012596 A MX2016012596 A MX 2016012596A MX 2016012596 A MX2016012596 A MX 2016012596A
Authority
MX
Mexico
Prior art keywords
understands
solid dispersion
preparation
taxano
amorfa
Prior art date
Application number
MX2016012596A
Other languages
English (en)
Other versions
MX373189B (es
Inventor
Il Kim Yong
Hyun Park Jae
Soo Woo Jong
Taek Im Ho
Srinivasan Shanmugam
Su Yoon Young
Original Assignee
Hanmi Pharm Ind 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=54240734&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016012596(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of MX2016012596A publication Critical patent/MX2016012596A/es
Publication of MX373189B publication Critical patent/MX373189B/es

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • A61K47/06—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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/145—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 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2022—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

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

Abstract

La presente invención provee una dispersión sólida amorfa que comprende un taxano o una sal farmacéuticamente aceptable del mismo, un polímero farmacéuticamente aceptable, y un surfactante farmacéuticamente aceptable, que tiene una solubilidad mejorada. También se suministra un método para la preparación de la dispersión sólida. La presente invención también suministra un comprimido que tiene buena solubilidad, biodisponibilidad y estabilidad, el cual comprende la dispersión sólida amorfa, un excipiente intragranular, y un excipiente extragranular.
MX2016012596A 2014-03-31 2015-03-20 Dispersión sólida amorfa que comprende taxano, comprimido que comprende la misma, y método para su preparación. MX373189B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/KR2014/002734 WO2015152433A1 (en) 2014-03-31 2014-03-31 Amorphous solid dispersion comprising paclitaxel, tablet comprising the same, and method for preparing the same
PCT/KR2015/002756 WO2015152544A1 (en) 2014-03-31 2015-03-20 Amorphous solid dispersion comprising taxane, tablet comprising the same, and method for preparing the same

Publications (2)

Publication Number Publication Date
MX2016012596A true MX2016012596A (es) 2017-01-09
MX373189B MX373189B (es) 2020-04-21

Family

ID=54240734

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016012596A MX373189B (es) 2014-03-31 2015-03-20 Dispersión sólida amorfa que comprende taxano, comprimido que comprende la misma, y método para su preparación.

Country Status (33)

Country Link
US (1) US9867801B2 (es)
EP (1) EP3125872B1 (es)
JP (1) JP6539675B2 (es)
KR (1) KR101851571B1 (es)
CN (1) CN106255496B (es)
AR (1) AR099886A1 (es)
AU (1) AU2015242738B2 (es)
BR (1) BR112016022528B1 (es)
CA (1) CA2944438C (es)
CL (1) CL2016002441A1 (es)
CU (1) CU24486B1 (es)
DK (1) DK3125872T3 (es)
DO (1) DOP2016000262A (es)
ES (1) ES2748686T3 (es)
GT (1) GT201600208A (es)
HU (1) HUE046616T2 (es)
IL (1) IL247977B (es)
LT (1) LT3125872T (es)
MA (1) MA39361B1 (es)
MX (1) MX373189B (es)
MY (1) MY175387A (es)
PE (1) PE20161477A1 (es)
PH (1) PH12016501825B1 (es)
PL (1) PL3125872T3 (es)
PT (1) PT3125872T (es)
RU (1) RU2684632C2 (es)
SA (1) SA516371952B1 (es)
SG (1) SG11201607456RA (es)
SI (1) SI3125872T1 (es)
TW (1) TWI706793B (es)
UA (1) UA117610C2 (es)
UY (1) UY36055A (es)
WO (2) WO2015152433A1 (es)

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ES2977281T3 (es) 2019-12-02 2024-08-21 Astrazeneca Ab Formulaciones farmacéuticas sólidas de 6-(2-cloro-6-metilpiridin-4-il)-5-(4-fluorofenil)-1,2,4-triazin-3-amina
WO2021177930A1 (en) * 2020-03-06 2021-09-10 Vyshnevskyy Ihor Anatoliyovych Pharmaceutical composition with increased solubility of gesperidine and method of its preparation
CA3194694A1 (en) 2020-10-07 2022-04-14 Sameer Urgaonkar Acetamido-phenyltetrazole derivatives and methods of using the same
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Also Published As

Publication number Publication date
TW201620506A (zh) 2016-06-16
AR099886A1 (es) 2016-08-24
PT3125872T (pt) 2019-10-24
PH12016501825A1 (en) 2016-11-07
CL2016002441A1 (es) 2017-02-17
GT201600208A (es) 2018-11-27
KR101851571B1 (ko) 2018-04-26
MY175387A (en) 2020-06-23
SI3125872T1 (sl) 2019-11-29
BR112016022528B1 (pt) 2023-04-11
ES2748686T3 (es) 2020-03-17
CN106255496B (zh) 2019-10-18
JP2017509653A (ja) 2017-04-06
MA39361B1 (fr) 2018-06-29
AU2015242738A1 (en) 2016-09-22
WO2015152544A1 (en) 2015-10-08
MA39361A1 (fr) 2017-06-30
DK3125872T3 (da) 2019-10-14
DOP2016000262A (es) 2017-01-15
WO2015152433A1 (en) 2015-10-08
EP3125872B1 (en) 2019-08-14
CA2944438C (en) 2021-10-26
TWI706793B (zh) 2020-10-11
AU2015242738B2 (en) 2019-09-26
KR20160124904A (ko) 2016-10-28
RU2016136636A (ru) 2018-05-03
LT3125872T (lt) 2019-10-10
NZ723991A (en) 2021-01-29
IL247977A0 (en) 2016-11-30
JP6539675B2 (ja) 2019-07-03
CU24486B1 (es) 2020-11-30
MX373189B (es) 2020-04-21
EP3125872A4 (en) 2017-10-11
PE20161477A1 (es) 2017-01-29
PH12016501825B1 (en) 2021-06-23
EP3125872A1 (en) 2017-02-08
SA516371952B1 (ar) 2020-12-07
BR112016022528A2 (pt) 2017-08-15
SG11201607456RA (en) 2016-10-28
RU2684632C2 (ru) 2019-04-11
IL247977B (en) 2019-09-26
PL3125872T3 (pl) 2020-03-31
HUE046616T2 (hu) 2020-03-30
US9867801B2 (en) 2018-01-16
CA2944438A1 (en) 2015-10-08
RU2016136636A3 (es) 2018-09-25
UY36055A (es) 2016-09-30
CN106255496A (zh) 2016-12-21
US20170112799A1 (en) 2017-04-27
UA117610C2 (uk) 2018-08-27

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