AR094936A1 - Suspensión para administración oral que comprende tolvaptán amorfo, y a un método para producirla - Google Patents

Suspensión para administración oral que comprende tolvaptán amorfo, y a un método para producirla

Info

Publication number
AR094936A1
AR094936A1 ARP140100649A ARP140100649A AR094936A1 AR 094936 A1 AR094936 A1 AR 094936A1 AR P140100649 A ARP140100649 A AR P140100649A AR P140100649 A ARP140100649 A AR P140100649A AR 094936 A1 AR094936 A1 AR 094936A1
Authority
AR
Argentina
Prior art keywords
suspension
oral administration
tolvaptan
amorfo
produce
Prior art date
Application number
ARP140100649A
Other languages
English (en)
Inventor
Akagi Akitsuna
Suzuki Kai
Nakamura Atsuya
Nishibayashi Toru
Original Assignee
Otsuka Pharma 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 Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of AR094936A1 publication Critical patent/AR094936A1/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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/10—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
    • A61K9/16—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Una suspensión para administración oral que comprende partículas que contienen tolvaptán amorfo que pueden inhibir o retardar la cristalización del tolvaptán amorfo con el tiempo en la suspensión, y mantener en forma estable una alta solubilidad del tolvaptán y una excelente absorbabilidad del tolvaptán en el tracto gastrointestinal, y una formulación sólida para administración oral que se puede suspender para preparar la suspensión para administración oral al momento de uso. Se refiere a una suspensión para administración oral, en particular, un jarabe, que comprende (a) partículas que contienen tolvaptán amorfo, (b) hidroxipropilmetilcelulosa (HPMC), y (c) un solvente, donde la cantidad de HPMC (b) oscila entre el 0,1 y el 25% en peso en base al peso total de la suspensión para administración oral. Reivindicación 9: La suspensión para administración oral de acuerdo con cualquiera de las reivindicaciones 1 a 8, que también comprende (d) un agente de suspensión y/o (e) un edulcorante. Reivindicación 10: La suspensión para administración oral de acuerdo con la reivindicación 9, caracterizada porque el agente de suspensión (d) es al menos un miembro seleccionado entre el grupo compuesto por goma xántica, goma gellan, carragenano, polímeros de carboxivinilo y carboximetilcelulosa de sodio.
ARP140100649A 2013-03-01 2014-02-28 Suspensión para administración oral que comprende tolvaptán amorfo, y a un método para producirla AR094936A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2013041105 2013-03-01

Publications (1)

Publication Number Publication Date
AR094936A1 true AR094936A1 (es) 2015-09-09

Family

ID=50382524

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP140100649A AR094936A1 (es) 2013-03-01 2014-02-28 Suspensión para administración oral que comprende tolvaptán amorfo, y a un método para producirla

Country Status (13)

Country Link
US (2) US11759470B2 (es)
EP (1) EP2961383B1 (es)
JP (1) JP6339089B2 (es)
KR (1) KR102241643B1 (es)
CN (1) CN105007897B (es)
AR (1) AR094936A1 (es)
AU (1) AU2014221630B2 (es)
CA (1) CA2902413A1 (es)
ES (1) ES2724245T3 (es)
HK (1) HK1216620A1 (es)
PH (1) PH12015501877B1 (es)
TW (1) TWI660748B (es)
WO (1) WO2014133196A1 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170348419A1 (en) * 2016-06-06 2017-12-07 NuBioPharma, LLC Oral liquid suspensions
SG10201609137PA (en) * 2016-11-01 2018-06-28 Xylonix Ip Holdings Pte Ltd Gamma-polyglutamic acid and zinc compositions
SG10201609131YA (en) 2016-11-01 2018-06-28 Xylonix Ip Holdings Pte Ltd Zinc-pga compositions and methods for treating cancer
US10487212B2 (en) * 2017-02-06 2019-11-26 Hong Kong Baptist University Thermally stable color pigments with nanofiber coating
KR102540472B1 (ko) 2017-08-11 2023-06-08 (주)아모레퍼시픽 (r)-n-[1-(3,5-다이플루오로-4-메테인설폰일아미노-페닐)-에틸]-3-(2-프로필-6-트라이플루오로메틸-피리딘-3-일)-아크릴아마이드를 함유하는 약학 조성물
KR20200074046A (ko) * 2018-12-14 2020-06-24 명인제약주식회사 톨밥탄을 포함하는 고체분산체 제조를 위한 약제학적 조성물 및 이의 제조방법
CN109528636B (zh) * 2018-12-20 2022-05-03 常州市阳光药业有限公司 托伐普坦口服溶液及其制备方法
CN111888335A (zh) * 2020-08-21 2020-11-06 福安药业集团重庆礼邦药物开发有限公司 一种托伐普坦的药物固体制剂及制备方法
WO2023054668A1 (en) * 2021-10-01 2023-04-06 Otsuka Pharmaceutical Co., Ltd. Amorphous Tolvaptan-Containing Composition
KR20230133029A (ko) 2022-03-10 2023-09-19 건양대학교산학협력단 톨밥탄을 포함하는 자가 유화 약물 전달 시스템 조성물 및 이의 제조방법

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0450097B1 (en) 1989-10-20 1996-04-24 Otsuka Pharmaceutical Co., Ltd. Benzoheterocyclic compounds
JP4210355B2 (ja) * 1997-07-03 2009-01-14 大塚製薬株式会社 固形製剤組成物
US20080260837A1 (en) * 2007-04-20 2008-10-23 Qpharma, L.L.C. Physically stable aqueous suspensions of active pharmaceuticals
TWI405574B (zh) 2007-06-21 2013-08-21 Otsuka Pharma Co Ltd 藥學固體製劑及其製造方法
TWI459947B (zh) * 2007-06-26 2014-11-11 Otsuka Pharma Co Ltd 苯并氮呯化合物及藥學製劑
CA2702904A1 (en) * 2007-10-19 2009-04-23 Otsuka Pharmaceutical Co., Ltd. Matrix-type pharmaceutical solid preparation
US8263652B2 (en) * 2007-10-31 2012-09-11 Sk Biopharmaceuticals Co., Ltd. Stabilized pediatric suspension of carisbamate
TW201010743A (en) 2008-09-05 2010-03-16 Otsuka Pharma Co Ltd Pharmaceutical solid preparation
CN102293734A (zh) * 2010-06-25 2011-12-28 江苏恒瑞医药股份有限公司 托伐普坦固体分散体及其制备方法
EP2468258A1 (en) * 2010-12-22 2012-06-27 LEK Pharmaceuticals d.d. Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient
CN102366412B (zh) * 2011-10-21 2013-05-15 四川百利药业有限责任公司 一种托伐普坦片剂的制备方法
WO2014104412A1 (en) * 2012-12-28 2014-07-03 Otsuka Pharmaceutical Co., Ltd. Injectable depot formulation comprising optically active tolvaptan and process of producing the same

Also Published As

Publication number Publication date
US11759470B2 (en) 2023-09-19
JP2016509990A (ja) 2016-04-04
CN105007897A (zh) 2015-10-28
WO2014133196A1 (en) 2014-09-04
PH12015501877A1 (en) 2015-12-07
KR20150122728A (ko) 2015-11-02
TWI660748B (zh) 2019-06-01
EP2961383A1 (en) 2016-01-06
AU2014221630A1 (en) 2015-09-03
US20160000801A1 (en) 2016-01-07
HK1216620A1 (zh) 2016-11-25
CN105007897B (zh) 2019-05-10
AU2014221630B2 (en) 2018-02-22
CA2902413A1 (en) 2014-09-04
ES2724245T3 (es) 2019-09-09
US20230381194A1 (en) 2023-11-30
JP6339089B2 (ja) 2018-06-06
PH12015501877B1 (en) 2015-12-07
TW201501730A (zh) 2015-01-16
EP2961383B1 (en) 2019-02-27
KR102241643B1 (ko) 2021-04-20

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