MX395463B - Forma de dosificacion solida que tiene excelente estabilidad - Google Patents

Forma de dosificacion solida que tiene excelente estabilidad

Info

Publication number
MX395463B
MX395463B MX2020011130A MX2020011130A MX395463B MX 395463 B MX395463 B MX 395463B MX 2020011130 A MX2020011130 A MX 2020011130A MX 2020011130 A MX2020011130 A MX 2020011130A MX 395463 B MX395463 B MX 395463B
Authority
MX
Mexico
Prior art keywords
excellent stability
solid formulation
dosage form
solid dosage
water
Prior art date
Application number
MX2020011130A
Other languages
English (en)
Other versions
MX2020011130A (es
Inventor
Go Kimura
Maki Okabe
Masaaki Ito
Masayuki Morimoto
Naoya Mizutani
Original Assignee
Shionogi & Co
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 Shionogi & Co filed Critical Shionogi & Co
Priority claimed from PCT/JP2019/017146 external-priority patent/WO2019208540A1/ja
Publication of MX2020011130A publication Critical patent/MX2020011130A/es
Publication of MX395463B publication Critical patent/MX395463B/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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/36—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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses

Landscapes

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

Abstract

La presente invención puede proporcionar una forma de dosificación sólida que tenga buena estabilidad, capacidad de suspensión en agua y fluidez mediante la preparación de una forma de dosificación sólida que contiene un compuesto representado por la fórmula (I) o una sal farmacéuticamente aceptable del mismo, un estabilizador, un alcohol de azúcar y/o un azúcar, un polímero soluble en agua y una sustancia inorgánica.
MX2020011130A 2018-04-24 2019-04-23 Forma de dosificacion solida que tiene excelente estabilidad MX395463B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018083006 2018-04-24
PCT/JP2019/017146 WO2019208540A1 (ja) 2018-04-24 2019-04-23 安定性に優れた固形製剤

Publications (2)

Publication Number Publication Date
MX2020011130A MX2020011130A (es) 2022-09-09
MX395463B true MX395463B (es) 2025-03-25

Family

ID=68235009

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020011130A MX395463B (es) 2018-04-24 2019-04-23 Forma de dosificacion solida que tiene excelente estabilidad

Country Status (7)

Country Link
US (1) US12427156B2 (es)
EP (1) EP3785716A4 (es)
JP (1) JP6590436B1 (es)
AU (1) AU2023201826B2 (es)
BR (1) BR122022006356B1 (es)
IL (1) IL278161B2 (es)
MX (1) MX395463B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3106055B1 (fr) 2020-01-13 2022-01-28 Centre Nat Rech Scient Combinaison de diltiazem et autres agents antiviraux
US12570627B2 (en) 2020-05-15 2026-03-10 Shionogi & Co., Ltd. Pharmaceutical composition in which production of impurities is suppressed
WO2022054096A1 (en) * 2020-09-14 2022-03-17 Cipla Limited Solid forms of substituted polycyclic pyridone compounds and prodrugs therof and process of preparation thereof

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09249563A (ja) * 1996-03-11 1997-09-22 Nippon Iyakuhin Kogyo Kk チザニジン含有組成物
FR2759293B1 (fr) * 1997-02-11 1999-04-30 Ethypharm Lab Prod Ethiques Microgranules contenant du cisplatine, procede de fabrication, preparation pharmaceutique et utilisation en polychimiotherapie ou en association avec une radiotherapie
BR9910494B1 (pt) * 1998-05-15 2011-11-01 composições sólidas contendo derivados de ácido gama-aminobutìrico e processo para o seu preparo.
DE19831869A1 (de) * 1998-07-16 2000-01-20 Merck Patent Gmbh Farbgebung mit Perlglanzpigmenten im Lebensmittel- und Pharmabereich
JP5202856B2 (ja) * 2006-03-06 2013-06-05 富山化学工業株式会社 トシル酸トスフロキサシンを含有する粒状固形製剤
TW200808375A (en) * 2006-05-12 2008-02-16 Otsuka Pharma Co Ltd Hydrogel suspension and manufacturing process thereof
JP2008007420A (ja) 2006-06-27 2008-01-17 Mitsubishi Tanabe Pharma Corp 造粒物
KR20100075599A (ko) 2007-10-03 2010-07-02 아사히비루 가부시키가이샤 과립, 정제 및 이들의 제조 방법
JP2010120912A (ja) 2008-11-21 2010-06-03 Lead Chemical Co Ltd ５−メチル−１−フェニル−２−（１ｈ）−ピリドン含有貼付剤
EP3335711A1 (en) * 2010-03-31 2018-06-20 Supernus Pharmaceuticals, Inc. Formulations of mazindol
IN2014CN02850A (es) 2011-10-31 2015-07-03 Glaxosmithkline Intellectual Property Ltd
JP5223140B1 (ja) * 2012-06-01 2013-06-26 哲夫 村山 簡易レインコート
JP2016079102A (ja) 2014-10-10 2016-05-16 テバ製薬株式会社 ソリフェナシン含有製剤
HRP20241039T1 (hr) * 2015-04-28 2024-11-08 Shionogi & Co., Ltd Supstituirani derivat policikličkog piridona i njegov predlijek
SG10201911957QA (en) * 2015-12-15 2020-02-27 Shionogi & Co Medicine for treating influenza characterized by comprising combination of cap-dependent endonuclease inhibitor with anti-influenza drug
AU2017282305B2 (en) 2016-06-20 2021-06-10 Shionogi & Co., Ltd. Method for producing substituted polycyclic pyridone derivative and crystal of same
UA125218C2 (uk) 2016-08-10 2022-02-02 Сіоногі Енд Ко., Лтд. Фармацевтичні композиції, що містять заміщені поліциклічні піридонові похідні та їх проліки
WO2019070059A1 (ja) 2017-10-06 2019-04-11 塩野義製薬株式会社 置換された多環性ピリドン誘導体の立体選択的な製造方法
TWI795462B (zh) * 2017-11-17 2023-03-11 日商鹽野義製藥股份有限公司 光安定性及溶出性優異的醫藥製劑
CN108440564B (zh) 2018-04-11 2019-08-06 安帝康（无锡）生物科技有限公司 被取代的多环氨基甲酰基吡啶酮衍生物及其前药

Also Published As

Publication number Publication date
EP3785716A4 (en) 2022-03-02
IL278161B2 (en) 2024-12-01
IL278161A (en) 2020-12-31
AU2023201826A1 (en) 2023-04-27
JP6590436B1 (ja) 2019-10-16
IL278161B1 (en) 2024-08-01
US12427156B2 (en) 2025-09-30
AU2023201826B2 (en) 2023-11-09
JPWO2019208540A1 (ja) 2020-04-30
BR122022006356B1 (pt) 2022-10-04
US20240252505A1 (en) 2024-08-01
MX2020011130A (es) 2022-09-09
EP3785716A1 (en) 2021-03-03

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