ECSP20057951A - Composición granular, método de producción para composición granular y método de mejora de la propiedad de disolución para composición granular - Google Patents

Composición granular, método de producción para composición granular y método de mejora de la propiedad de disolución para composición granular

Info

Publication number
ECSP20057951A
ECSP20057951A ECSENADI202057951A ECDI202057951A ECSP20057951A EC SP20057951 A ECSP20057951 A EC SP20057951A EC SENADI202057951 A ECSENADI202057951 A EC SENADI202057951A EC DI202057951 A ECDI202057951 A EC DI202057951A EC SP20057951 A ECSP20057951 A EC SP20057951A
Authority
EC
Ecuador
Prior art keywords
granular composition
production method
dissolution property
property improvement
granular
Prior art date
Application number
ECSENADI202057951A
Other languages
English (en)
Inventor
Rie Yamada
Toshinori Tanaka
Original Assignee
Nippon Shinyaku 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
Application filed by Nippon Shinyaku Co Ltd filed Critical Nippon Shinyaku Co Ltd
Publication of ECSP20057951A publication Critical patent/ECSP20057951A/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/4965Non-condensed pyrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate

Landscapes

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

Abstract

Se proporciona un método de producción para una composición granular en el que se mejora la propiedad de disolución de 2–{4–[N–(5,6–difenilpiradin–2–il)–N–isopropilamino]butiloxi}–N–(metilsulfonil)acetamida. El método de producción para una composición granular incluye una etapa de moldeo por compresión de una mezcla obtenida por mezcla de 2–{4–[N–(5,6–difenilpiradin–2–il)–N–isopropilamino]butiloxi}–N–(metilsulfonil)acetamida y al menos uno o más excipientes seleccionados del grupo que consiste en un alcohol de azúcar, un almidón y un sacárido, obteniendo así un material moldeado por compresión.
ECSENADI202057951A 2018-02-21 2020-09-17 Composición granular, método de producción para composición granular y método de mejora de la propiedad de disolución para composición granular ECSP20057951A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2018029093 2018-02-21

Publications (1)

Publication Number Publication Date
ECSP20057951A true ECSP20057951A (es) 2020-10-30

Family

ID=67687749

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI202057951A ECSP20057951A (es) 2018-02-21 2020-09-17 Composición granular, método de producción para composición granular y método de mejora de la propiedad de disolución para composición granular

Country Status (21)

Country Link
US (1) US20200397700A1 (es)
EP (1) EP3756670A4 (es)
JP (2) JP7430629B2 (es)
KR (1) KR20200123447A (es)
CN (1) CN112055591A (es)
AR (1) AR114399A1 (es)
AU (1) AU2019225516A1 (es)
BR (1) BR112020016230A2 (es)
CA (1) CA3091584A1 (es)
CL (1) CL2020002129A1 (es)
CO (1) CO2020011034A2 (es)
EC (1) ECSP20057951A (es)
IL (1) IL276732A (es)
MA (1) MA51913A (es)
MX (1) MX2020008695A (es)
PE (1) PE20210448A1 (es)
PH (1) PH12020551285A1 (es)
RU (1) RU2020130411A (es)
SG (1) SG11202007967YA (es)
TW (1) TW201936175A (es)
WO (1) WO2019163822A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220401441A1 (en) * 2019-10-23 2022-12-22 Actelion Pharmaceuticals Ltd Pharmaceutical composition comprising selexipag
JP6989064B1 (ja) * 2020-04-10 2022-01-05 日本新薬株式会社 固形製剤及びその製造方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2654197B2 (ja) * 1989-09-25 1997-09-17 三菱電機株式会社 スターリングエンジンの圧縮機駆動装置
WO2002024168A1 (fr) * 2000-09-25 2002-03-28 Nippon Shinyaku Co., Ltd. Procede de production d'une dispersion solide medicinale
TWI316055B (es) 2001-04-26 2009-10-21 Nippon Shinyaku Co Ltd
ES2312741T3 (es) * 2003-05-06 2009-03-01 Gumlink A/S Procedimiento para producir granulos de goma de mascar y granulos de goma comprimidos, y un equipo para granular goma de mascar.
GB0423103D0 (en) * 2004-10-19 2004-11-17 Boots Healthcare Int Ltd Therapeutic agents
KR20240090717A (ko) * 2009-06-26 2024-06-21 니뽄 신야쿠 가부시키가이샤 결정
JP6825574B2 (ja) 2015-12-02 2021-02-03 日本新薬株式会社 2−{4−[n−(5,6−ジフェニルピラジン−2−イル)−n−イソプロピルアミノ]ブチルオキシ}−n−(メチルスルホニル)アセトアミドを含有する医薬組成物
WO2017121806A1 (en) * 2016-01-15 2017-07-20 Sandoz Ag Pharmaceutical composition of selexipag

Also Published As

Publication number Publication date
EP3756670A1 (en) 2020-12-30
RU2020130411A3 (es) 2022-03-21
JP2023182650A (ja) 2023-12-26
MX2020008695A (es) 2020-09-25
CO2020011034A2 (es) 2020-12-10
AR114399A1 (es) 2020-09-02
CN112055591A (zh) 2020-12-08
JPWO2019163822A1 (ja) 2021-02-04
SG11202007967YA (en) 2020-09-29
PE20210448A1 (es) 2021-03-08
TW201936175A (zh) 2019-09-16
CA3091584A1 (en) 2019-08-29
EP3756670A4 (en) 2021-11-03
PH12020551285A1 (en) 2021-05-31
US20200397700A1 (en) 2020-12-24
JP7430629B2 (ja) 2024-02-13
CL2020002129A1 (es) 2021-02-05
KR20200123447A (ko) 2020-10-29
AU2019225516A1 (en) 2020-10-08
RU2020130411A (ru) 2022-03-21
MA51913A (fr) 2020-12-30
WO2019163822A1 (ja) 2019-08-29
IL276732A (en) 2020-09-30
BR112020016230A2 (pt) 2020-12-08

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