MA39361A1 - Dispersion solide amorphe comprenant un taxane, comprimé contenant la dispersion, et méthode de préparation associée - Google Patents

Dispersion solide amorphe comprenant un taxane, comprimé contenant la dispersion, et méthode de préparation associée

Info

Publication number
MA39361A1
MA39361A1 MA39361A MA39361A MA39361A1 MA 39361 A1 MA39361 A1 MA 39361A1 MA 39361 A MA39361 A MA 39361A MA 39361 A MA39361 A MA 39361A MA 39361 A1 MA39361 A1 MA 39361A1
Authority
MA
Morocco
Prior art keywords
dispersion
amorphous solid
taxane
solid dispersion
preparation
Prior art date
Application number
MA39361A
Other languages
English (en)
Other versions
MA39361B1 (fr
Inventor
Yong Il Kim
Jae Hyun Park
Jong Soo Woo
Shanmugam Srinivasan
Ho Taek Im
Young Su Yoon
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=MA39361(A1) "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 MA39361A1 publication Critical patent/MA39361A1/fr
Publication of MA39361B1 publication Critical patent/MA39361B1/fr

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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (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)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une dispersion solide amorphe comprenant un taxane ou un sel pharmaceutiquement acceptable de celui-ci, un polymère acceptable sur le plan pharmaceutique, et un tensioactif acceptable sur le plan pharmaceutique, ladite dispersion présentant une plus grande solubilité. L'invention concerne également une méthode de préparation de la dispersion solide. La présente invention concerne également un comprimé ayant une bonne solubilité, une bonne biodisponibilité et une bonne stabilité, qui comprend la dispersion solide amorphe, un excipient intragranulaire et un excipient extragranulaire.
MA39361A 2014-03-31 2015-03-20 Dispersion solide amorphe comprenant un taxane, comprimé contenant la dispersion, et méthode de préparation associée MA39361B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/KR2014/002734 WO2015152433A1 (fr) 2014-03-31 2014-03-31 Dispersion solide amorphe comprenant du paclitaxel, comprimé la comprenant, et son procédé de préparation
PCT/KR2015/002756 WO2015152544A1 (fr) 2014-03-31 2015-03-20 Dispersion solide amorphe comprenant un taxane, comprimé contenant la dispersion, et méthode de préparation associée

Publications (2)

Publication Number Publication Date
MA39361A1 true MA39361A1 (fr) 2017-06-30
MA39361B1 MA39361B1 (fr) 2018-06-29

Family

ID=54240734

Family Applications (1)

Application Number Title Priority Date Filing Date
MA39361A MA39361B1 (fr) 2014-03-31 2015-03-20 Dispersion solide amorphe comprenant un taxane, comprimé contenant la dispersion, et méthode de préparation associée

Country Status (33)

Country Link
US (1) US9867801B2 (fr)
EP (1) EP3125872B1 (fr)
JP (1) JP6539675B2 (fr)
KR (1) KR101851571B1 (fr)
CN (1) CN106255496B (fr)
AR (1) AR099886A1 (fr)
AU (1) AU2015242738B2 (fr)
BR (1) BR112016022528B1 (fr)
CA (1) CA2944438C (fr)
CL (1) CL2016002441A1 (fr)
CU (1) CU24486B1 (fr)
DK (1) DK3125872T3 (fr)
DO (1) DOP2016000262A (fr)
ES (1) ES2748686T3 (fr)
GT (1) GT201600208A (fr)
HU (1) HUE046616T2 (fr)
IL (1) IL247977B (fr)
LT (1) LT3125872T (fr)
MA (1) MA39361B1 (fr)
MX (1) MX2016012596A (fr)
MY (1) MY175387A (fr)
PE (1) PE20161477A1 (fr)
PH (1) PH12016501825A1 (fr)
PL (1) PL3125872T3 (fr)
PT (1) PT3125872T (fr)
RU (1) RU2684632C2 (fr)
SA (1) SA516371952B1 (fr)
SG (1) SG11201607456RA (fr)
SI (1) SI3125872T1 (fr)
TW (1) TWI706793B (fr)
UA (1) UA117610C2 (fr)
UY (1) UY36055A (fr)
WO (2) WO2015152433A1 (fr)

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CN106955288B (zh) * 2017-03-30 2020-01-10 复旦大学附属中山医院 Fxr激动剂在制备治疗脂肪肉瘤相关疾病药物中的用途
TWI833710B (zh) * 2017-10-06 2024-03-01 香港商慧源香港創新有限公司 高單位含量口服型紫杉烷組合物及方法
CN111511365A (zh) * 2017-11-10 2020-08-07 分散技术有限责任公司 改进的药物制剂
KR20210120039A (ko) * 2019-01-25 2021-10-06 베이진 엘티디 B-raf 키나제 이합체 억제제의 안정적인 고체 분산액, 이의 제조 방법 및 용도
CN109851593B (zh) * 2019-02-01 2021-04-16 沈阳药科大学 基于淋巴介导转运的甘油三酯前药及其制备方法
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 (fr) * 2020-03-06 2021-09-10 Vyshnevskyy Ihor Anatoliyovych Composition pharmaceutique à solubilité accrue de la gespéridine et son procédé de préparation
CN116964044A (zh) 2020-10-07 2023-10-27 希华医药有限公司 乙酰胺基-苯基四唑衍生物及其使用方法
EP4358942A1 (fr) * 2021-06-23 2024-05-01 Blueprint Medicines Corporation Compositions pharmaceutiques d'un inhibiteur du récepteur du facteur de croissance épidermique
WO2023154171A1 (fr) * 2022-02-14 2023-08-17 Purdue Research Foundation Sels polymères destinés à améliorer l'administration de médicament à partir de dispersions solides amorphes
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
SA516371952B1 (ar) 2020-12-07
PL3125872T3 (pl) 2020-03-31
AR099886A1 (es) 2016-08-24
IL247977A0 (en) 2016-11-30
UA117610C2 (uk) 2018-08-27
US9867801B2 (en) 2018-01-16
SI3125872T1 (sl) 2019-11-29
GT201600208A (es) 2018-11-27
BR112016022528A2 (pt) 2017-08-15
SG11201607456RA (en) 2016-10-28
CA2944438C (fr) 2021-10-26
LT3125872T (lt) 2019-10-10
PT3125872T (pt) 2019-10-24
ES2748686T3 (es) 2020-03-17
RU2016136636A3 (fr) 2018-09-25
CU24486B1 (es) 2020-11-30
MA39361B1 (fr) 2018-06-29
PH12016501825B1 (en) 2016-11-07
EP3125872A1 (fr) 2017-02-08
EP3125872A4 (fr) 2017-10-11
KR101851571B1 (ko) 2018-04-26
AU2015242738A1 (en) 2016-09-22
JP2017509653A (ja) 2017-04-06
HUE046616T2 (hu) 2020-03-30
CN106255496A (zh) 2016-12-21
CA2944438A1 (fr) 2015-10-08
JP6539675B2 (ja) 2019-07-03
IL247977B (en) 2019-09-26
EP3125872B1 (fr) 2019-08-14
RU2684632C2 (ru) 2019-04-11
WO2015152433A1 (fr) 2015-10-08
WO2015152544A1 (fr) 2015-10-08
PH12016501825A1 (en) 2016-11-07
MY175387A (en) 2020-06-23
KR20160124904A (ko) 2016-10-28
CN106255496B (zh) 2019-10-18
RU2016136636A (ru) 2018-05-03
TWI706793B (zh) 2020-10-11
TW201620506A (zh) 2016-06-16
CL2016002441A1 (es) 2017-02-17
DOP2016000262A (es) 2017-01-15
BR112016022528B1 (pt) 2023-04-11
AU2015242738B2 (en) 2019-09-26
DK3125872T3 (da) 2019-10-14
MX2016012596A (es) 2017-01-09
PE20161477A1 (es) 2017-01-29
NZ723991A (en) 2021-01-29
US20170112799A1 (en) 2017-04-27
UY36055A (es) 2016-09-30

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