CA3235733A1 - Tadalafil oral suspension - Google Patents

Tadalafil oral suspension Download PDF

Info

Publication number
CA3235733A1
CA3235733A1 CA3235733A CA3235733A CA3235733A1 CA 3235733 A1 CA3235733 A1 CA 3235733A1 CA 3235733 A CA3235733 A CA 3235733A CA 3235733 A CA3235733 A CA 3235733A CA 3235733 A1 CA3235733 A1 CA 3235733A1
Authority
CA
Canada
Prior art keywords
comprised
preferably comprised
still
tadalafil
sodium
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
CA3235733A
Other languages
English (en)
French (fr)
Inventor
Nuria Sanz Menendez
Angel Munoz Ruiz
Luis Narciso Sante Serna
Antonio Portoles Perez
Emilio VARGAS CASTRILLON
Guillermo RUBIO MENCO
Raquel HORCAJADA CORDOBA
Ester DUART GONZALEZ
Jose Carlos Iglesias Sanchez
Antonia Gomez Calvo
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 CA3235733A1 publication Critical patent/CA3235733A1/en
Pending legal-status Critical Current

Links

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)
CA3235733A 2021-10-25 2022-10-24 Tadalafil oral suspension Pending CA3235733A1 (en)

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
CA3235733A1 true CA3235733A1 (en) 2023-05-04

Family

ID=78528864

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3235733A Pending CA3235733A1 (en) 2021-10-25 2022-10-24 Tadalafil oral suspension

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
JP2024541013A (ja) 2024-11-06
AU2022374786A1 (en) 2024-06-13
WO2023072872A1 (en) 2023-05-04

Similar Documents

Publication Publication Date Title
CA2567075C (en) Pharmaceutical suspension composition
BRPI0212922B1 (pt) Composição farmacêutica na forma de um comprimido dispersável compreendendo uma dispersão sólida de 40-o-(2-hidroxietil)-rapamicina, seu processo de preparação e uso da dita composição
TW200803831A (en) Solid pharmaceutical compositions containing pregabalin
CA2992404C (en) Pharmaceutical composition containing celecoxib and tramadol
CN104736142A (zh) 阿哌沙班液体制剂
US20020147232A1 (en) Pharmaceutical compositions comprising desglymidodrine as an active drug substance
JP2021185139A (ja) ミラベグロンまたはその塩を含む放出調節用薬剤学的組成物
CA2393737A1 (en) Compositions containing itraconazole with improved bioavailability and narrow intra- and inter-individual variation of its absorption
US20080064713A1 (en) Dry Syrup Containing Loratadine
US20040052847A1 (en) Oral dosage forms of water insoluble drugs and methods of making the same
EP4422599B1 (en) Tadalafil oral suspension
EP3968955B1 (en) Pharmaceutical oral liquid solution of ivacaftor
JP4995099B2 (ja) 非可塑性薬の矯味システム
CA3164495C (en) LIQUID COMPOSITION CONTAINING IBUPROFEN AND PHENYLEPHRINE
EP2138173A1 (en) Pharmaceutical compositions comprising aminoadamantane derivatives
CA2802142C (en) Ciprofloxacin dry syrup composition
Namdev Formulation and Evaluation of Mouth Dissolving Tablets of Metoprolol Tartrate
HK40077494B (en) Liquid composition comprising ibuprofen and phenylephrine
HK40077494A (en) Liquid composition comprising ibuprofen and phenylephrine
CN119546305A (zh) 泛raf激酶抑制剂的口服液体悬浮液
Patel Formulation, Development and Evaluation of Expectorant Extended Release Tablet
Rakkanka 1. A novel self-sealing chewable sustained release tablet of acetaminophen, 2. Development and evaluation of novel itraconazole oral formulations, 3. A novel zero order release matrix tablet
HK1198466A1 (en) Prasugrel-containing immediate release stable oral pharmaceutical compositions
HK1198466B (en) Prasugrel-containing immediate release stable oral pharmaceutical compositions
HK1172252A (en) Pharmaceutical suspension composition

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 2ND ANNIV.) - STANDARD

Year of fee payment: 2

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241018

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241018

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241018

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251017

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251017