JP2024541013A - タダラフィル経口懸濁剤 - Google Patents

タダラフィル経口懸濁剤 Download PDF

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Publication number
JP2024541013A
JP2024541013A JP2024524693A JP2024524693A JP2024541013A JP 2024541013 A JP2024541013 A JP 2024541013A JP 2024524693 A JP2024524693 A JP 2024524693A JP 2024524693 A JP2024524693 A JP 2024524693A JP 2024541013 A JP2024541013 A JP 2024541013A
Authority
JP
Japan
Prior art keywords
tadalafil
sodium
cyclodextrin
composition
comprised
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2024524693A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024541013A5 (enExample
Inventor
ヌリア、サンス、メネンデス
アンヘル、ムニョス、ルイス
ルイス、ナルシソ、サンテ、セルナ
アントニオ、ポルトレス、ペレス
エミリオ、バルガス、カストリジョン
ギジェルモ、ルビオ、メンコ
ラケール、オルカハダ、コルドバ
エステル、ドゥアルト、ゴンサレス
ホセ、カルロス、イグレシアス、サンチェス
アントニア、ゴメス、カルボ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Farmalider SA
Original Assignee
Farmalider SA
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 Farmalider SA filed Critical Farmalider SA
Publication of JP2024541013A publication Critical patent/JP2024541013A/ja
Publication of JP2024541013A5 publication Critical patent/JP2024541013A5/ja
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/18Sulfonamides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/20Organic 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
    • 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
    • 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
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2024524693A 2021-10-25 2022-10-24 タダラフィル経口懸濁剤 Pending JP2024541013A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP21382964 2021-10-25
EP21382964.1 2021-10-25
PCT/EP2022/079659 WO2023072872A1 (en) 2021-10-25 2022-10-24 Tadalafil oral suspension

Publications (2)

Publication Number Publication Date
JP2024541013A true JP2024541013A (ja) 2024-11-06
JP2024541013A5 JP2024541013A5 (enExample) 2025-11-04

Family

ID=78528864

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024524693A Pending JP2024541013A (ja) 2021-10-25 2022-10-24 タダラフィル経口懸濁剤

Country Status (10)

Country Link
US (1) US20250241911A1 (enExample)
EP (1) EP4422599B1 (enExample)
JP (1) JP2024541013A (enExample)
CN (1) CN118284408A (enExample)
AU (1) AU2022374786A1 (enExample)
CA (1) CA3235733A1 (enExample)
DK (1) DK4422599T3 (enExample)
FI (1) FI4422599T3 (enExample)
MX (1) MX2024005048A (enExample)
WO (1) WO2023072872A1 (enExample)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7018658B2 (en) 2002-11-14 2006-03-28 Synthon Bv Pharmaceutical pellets comprising tamsulosin
US20060147531A1 (en) 2003-07-01 2006-07-06 Mojca Segula Tamsulosin core with a coating of polyvinylpyrrolidone and polyfinylacetate
SI21637A (sl) 2003-12-23 2005-06-30 LEK farmacevtska dru�ba d.d. Farmacevtska oblika z nadzorovanim sproščanjem
KR20070021806A (ko) 2005-08-19 2007-02-23 (주)아모레퍼시픽 α1-수용체 차단제의 서방형 펠렛제제 및 이의 제조 방법
KR100745515B1 (ko) 2006-04-10 2007-08-02 주식회사 대웅제약 염산 탐술로신 함유 서방성 펠렛 및 그의 제조방법
KR20160021095A (ko) 2013-06-21 2016-02-24 욱크하르트 리미티드 탐술로신 또는 이의 염의 약학 조성물
CZ2015225A3 (cs) 2015-03-30 2016-10-12 Zentiva, K.S. Nový krok ve způsobu potahování pelet obsahujících Tamsulosin.HCI
EP3498264B1 (en) * 2016-08-12 2023-11-08 Hanmi Pharm. Co., Ltd. Pharmaceutical preparation for oral administration with controlled dissolution rate, the preparation comprising tamsulosin hydrochloride-containing sustained-release pellets
EP3576741A1 (en) 2017-02-02 2019-12-11 Dukebox SP. Z O.O. A method of manufacturing a suspension of nanoparticles of tadalafil or sildenafil citrate
EP3473245A1 (en) 2017-10-20 2019-04-24 Veru Inc. Controlled release oral tamsulosin hydrochloride
WO2020039263A2 (en) 2018-08-18 2020-02-27 Ftf Pharma Private Limited Pharmaceutical suspension for oral dosage

Also Published As

Publication number Publication date
US20250241911A1 (en) 2025-07-31
MX2024005048A (es) 2024-05-10
EP4422599A1 (en) 2024-09-04
DK4422599T3 (da) 2026-03-30
FI4422599T3 (fi) 2026-03-25
CN118284408A (zh) 2024-07-02
EP4422599B1 (en) 2026-01-28
AU2022374786A1 (en) 2024-06-13
WO2023072872A1 (en) 2023-05-04
CA3235733A1 (en) 2023-05-04

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