PL2654723T3 - Stałe postacie leku zawierające tadalafil i sposoby ich otrzymywania - Google Patents

Stałe postacie leku zawierające tadalafil i sposoby ich otrzymywania

Info

Publication number
PL2654723T3
PL2654723T3 PL11813321T PL11813321T PL2654723T3 PL 2654723 T3 PL2654723 T3 PL 2654723T3 PL 11813321 T PL11813321 T PL 11813321T PL 11813321 T PL11813321 T PL 11813321T PL 2654723 T3 PL2654723 T3 PL 2654723T3
Authority
PL
Poland
Prior art keywords
tadalafil
preparation
methods
dosage forms
pharmaceutical dosage
Prior art date
Application number
PL11813321T
Other languages
English (en)
Inventor
Daniel Żakowiecki
Jarosław Mazgalski
Aleksandra Tukalska
Original Assignee
Zakl Farmaceutyczne Polpharma 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 Zakl Farmaceutyczne Polpharma Sa filed Critical Zakl Farmaceutyczne Polpharma Sa
Priority claimed from PCT/EP2011/006544 external-priority patent/WO2012095151A1/en
Publication of PL2654723T3 publication Critical patent/PL2654723T3/pl

Links

Classifications

    • 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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/14—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PL11813321T 2010-12-23 2011-12-23 Stałe postacie leku zawierające tadalafil i sposoby ich otrzymywania PL2654723T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP2010460052 2010-12-23
PCT/EP2011/006544 WO2012095151A1 (en) 2010-12-23 2011-12-23 Solid pharmaceutical dosage forms comprising tadalafil and methods of preparation thereof
EP11813321.4A EP2654723B1 (en) 2010-12-23 2011-12-23 Solid pharmaceutical dosage forms comprising tadalafil and methods of preparation thereof

Publications (1)

Publication Number Publication Date
PL2654723T3 true PL2654723T3 (pl) 2015-05-29

Family

ID=45653340

Family Applications (1)

Application Number Title Priority Date Filing Date
PL11813321T PL2654723T3 (pl) 2010-12-23 2011-12-23 Stałe postacie leku zawierające tadalafil i sposoby ich otrzymywania

Country Status (4)

Country Link
EP (1) EP2654723B1 (pl)
HR (1) HRP20150158T1 (pl)
PL (1) PL2654723T3 (pl)
SI (1) SI2654723T1 (pl)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014167579A2 (en) * 2013-03-28 2014-10-16 Astron Research Limited Stable pharmaceutical compositions of tadalafil
CN113577079B (zh) * 2021-07-28 2022-08-23 山东裕欣药业有限公司 一种磷酸二酯酶抑制剂的制备方法及组合物
CN113855639B (zh) * 2021-11-04 2023-03-24 昆明源瑞制药有限公司 一种他达拉非片剂及其制备方法

Also Published As

Publication number Publication date
SI2654723T1 (sl) 2015-04-30
EP2654723A1 (en) 2013-10-30
EP2654723B1 (en) 2014-12-31
HRP20150158T1 (hr) 2015-04-24

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