CN118284408A - 他达拉非经口混悬剂 - Google Patents

他达拉非经口混悬剂 Download PDF

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Publication number
CN118284408A
CN118284408A CN202280077312.5A CN202280077312A CN118284408A CN 118284408 A CN118284408 A CN 118284408A CN 202280077312 A CN202280077312 A CN 202280077312A CN 118284408 A CN118284408 A CN 118284408A
Authority
CN
China
Prior art keywords
still
tadalafil
cyclodextrin
sodium
amount
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
CN202280077312.5A
Other languages
English (en)
Chinese (zh)
Inventor
努里亚·桑斯梅嫩德斯
安格尔·穆奥斯鲁伊斯
路易斯·纳西索·桑特塞尔纳
安东尼奥·波托莱斯佩雷斯
埃米利奥·巴尔加斯卡斯特里隆
吉列尔莫·鲁维奥门科
拉克尔·奥卡哈达科尔多巴
埃斯特尔·杜阿尔特冈萨雷斯
乔斯·卡洛斯·伊格莱西亚斯桑切斯
安东尼娅·戈麦斯卡尔沃
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 CN118284408A publication Critical patent/CN118284408A/zh
Pending legal-status Critical Current

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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
    • A61K31/495—Heterocyclic 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
    • A61K31/4985—Pyrazines or piperazines 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/30—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
    • 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
    • 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
    • A61K47/40—Cyclodextrins; 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
    • A61K9/10—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
    • 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
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs 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)
CN202280077312.5A 2021-10-25 2022-10-24 他达拉非经口混悬剂 Pending CN118284408A (zh)

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 (1)

Publication Number Publication Date
CN118284408A true CN118284408A (zh) 2024-07-02

Family

ID=78528864

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280077312.5A Pending CN118284408A (zh) 2021-10-25 2022-10-24 他达拉非经口混悬剂

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
EP4422599B1 (en) 2026-01-28
JP2024541013A (ja) 2024-11-06
AU2022374786A1 (en) 2024-06-13
WO2023072872A1 (en) 2023-05-04
CA3235733A1 (en) 2023-05-04

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