GT201600208A - Dispersión sólida amorfa que comprende taxano, comprimido que comprende la misma, y método para su preparación - Google Patents

Dispersión sólida amorfa que comprende taxano, comprimido que comprende la misma, y método para su preparación

Info

Publication number
GT201600208A
GT201600208A GT201600208A GT201600208A GT201600208A GT 201600208 A GT201600208 A GT 201600208A GT 201600208 A GT201600208 A GT 201600208A GT 201600208 A GT201600208 A GT 201600208A GT 201600208 A GT201600208 A GT 201600208A
Authority
GT
Guatemala
Prior art keywords
understanding
solid dispersion
preparation
same
amorphes
Prior art date
Application number
GT201600208A
Other languages
English (en)
Inventor
Shanmugam Srinivasan
Ho Taek Im
Young Su Yoon
Yong Ii Kim
Jae Hyun Park
Jong Soo Woo
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=GT201600208(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 GT201600208A publication Critical patent/GT201600208A/es

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
    • A61K31/335—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
    • A61K9/141—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
    • A61K9/1617—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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic 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 ACEPATBLE DEL MISMO, UN POLÍMERO FARMACÉUTICAMENTE ACEPATBLE Y UN SURFACTANTE FARMACÉUTICAMENTE ACEPATBLE, 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.
GT201600208A 2014-03-31 2016-09-30 Dispersión sólida amorfa que comprende taxano, comprimido que comprende la misma, y método para su preparación GT201600208A (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
GT201600208A true GT201600208A (es) 2018-11-27

Family

ID=54240734

Family Applications (1)

Application Number Title Priority Date Filing Date
GT201600208A GT201600208A (es) 2014-03-31 2016-09-30 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) MX2016012596A (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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MA44987A (fr) * 2016-05-09 2019-03-20 Dispersol Technologies Llc Formulations de médicaments améliorées
CN110742895A (zh) * 2017-03-30 2020-02-04 复旦大学附属中山医院 Fxr激动剂在制备治疗脂肪肉瘤药物中的用途
SG11202003003TA (en) * 2017-10-06 2020-04-29 Athenex Hk Innovative Ltd High-strength oral taxane compositions and methods
CA3081358A1 (en) * 2017-11-10 2019-05-16 Dispersol Technologies, Llc Improved drug formulations
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
CN110105368B (zh) * 2019-05-09 2022-01-07 上海大学 去氧紫杉烷类似物及其制备方法
WO2021177930A1 (en) * 2020-03-06 2021-09-10 Vyshnevskyy Ihor Anatoliyovych Pharmaceutical composition with increased solubility of gesperidine and method of its preparation
JP2023544615A (ja) 2020-10-07 2023-10-24 アセネックス インコーポレイテッド アセトアミド－フェニルテトラゾール誘導体およびその使用方法
IL309447A (en) * 2021-06-23 2024-02-01 Blueprint Medicines Corp Pharmaceutical preparations of epidermal growth factor receptor inhibitor
WO2023154171A1 (en) * 2022-02-14 2023-08-17 Purdue Research Foundation Polymer salts for improved drug delivery from amorphous solid dispersions
AU2022368370A1 (en) * 2022-03-08 2023-09-28 Cnpharm Co., Ltd. Pharmaceutical composition containing docetaxel or pharmaceutically acceptable salt thereof and preparation method therefor
CN115429766B (zh) * 2022-09-08 2023-10-27 江苏集萃新型药物制剂技术研究所有限公司 淫羊藿苷固体分散体、复方药物双层片剂及其制备方法与应用

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Also Published As

Publication number Publication date
DK3125872T3 (da) 2019-10-14
CA2944438C (en) 2021-10-26
EP3125872A4 (en) 2017-10-11
SA516371952B1 (ar) 2020-12-07
AU2015242738B2 (en) 2019-09-26
UY36055A (es) 2016-09-30
HUE046616T2 (hu) 2020-03-30
SG11201607456RA (en) 2016-10-28
WO2015152544A1 (en) 2015-10-08
LT3125872T (lt) 2019-10-10
BR112016022528B1 (pt) 2023-04-11
RU2016136636A3 (es) 2018-09-25
IL247977A0 (en) 2016-11-30
SI3125872T1 (sl) 2019-11-29
NZ723991A (en) 2021-01-29
PH12016501825A1 (en) 2016-11-07
JP6539675B2 (ja) 2019-07-03
KR101851571B1 (ko) 2018-04-26
DOP2016000262A (es) 2017-01-15
CN106255496B (zh) 2019-10-18
WO2015152433A1 (en) 2015-10-08
ES2748686T3 (es) 2020-03-17
TW201620506A (zh) 2016-06-16
US20170112799A1 (en) 2017-04-27
MY175387A (en) 2020-06-23
MA39361B1 (fr) 2018-06-29
PL3125872T3 (pl) 2020-03-31
TWI706793B (zh) 2020-10-11
PH12016501825B1 (en) 2016-11-07
US9867801B2 (en) 2018-01-16
MA39361A1 (fr) 2017-06-30
CN106255496A (zh) 2016-12-21
EP3125872B1 (en) 2019-08-14
KR20160124904A (ko) 2016-10-28
MX2016012596A (es) 2017-01-09
IL247977B (en) 2019-09-26
PE20161477A1 (es) 2017-01-29
BR112016022528A2 (pt) 2017-08-15
JP2017509653A (ja) 2017-04-06
RU2016136636A (ru) 2018-05-03
CL2016002441A1 (es) 2017-02-17
AR099886A1 (es) 2016-08-24
UA117610C2 (uk) 2018-08-27
CU24486B1 (es) 2020-11-30
CA2944438A1 (en) 2015-10-08
RU2684632C2 (ru) 2019-04-11
EP3125872A1 (en) 2017-02-08
AU2015242738A1 (en) 2016-09-22
PT3125872T (pt) 2019-10-24

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