UY38137A - A SOLID PHARMACEUTICAL SOLID ORAL DOSAGE FORM - Google Patents

A SOLID PHARMACEUTICAL SOLID ORAL DOSAGE FORM

Info

Publication number
UY38137A
UY38137A UY0001038137A UY38137A UY38137A UY 38137 A UY38137 A UY 38137A UY 0001038137 A UY0001038137 A UY 0001038137A UY 38137 A UY38137 A UY 38137A UY 38137 A UY38137 A UY 38137A
Authority
UY
Uruguay
Prior art keywords
dosage form
solifenacin
oral dosage
solid oral
solid
Prior art date
Application number
UY0001038137A
Other languages
Spanish (es)
Inventor
Villarreal Ana Purón
Munárriz Ainara Lecumberri
Original Assignee
Intas Third Party Sales 2005 S L
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 Intas Third Party Sales 2005 S L filed Critical Intas Third Party Sales 2005 S L
Publication of UY38137A publication Critical patent/UY38137A/en

Links

Classifications

    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Physiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a una forma de dosificación oral sólida farmacéutica de solifenacina o una sal farmacéuticamente aceptable de la misma, una resina de intercambio iónico, y uno o más excipientes o vehículos farmacéuticamente aceptables, en la que la solifenacina y la resina de intercambio iónico forman una matriz y la forma de dosificación presenta un perfil de disolución de acuerdo con el que: (i) después de 5 minutos a pH de 6,5 a 7,5, menos de un 10 % p/p del contenido de solifenacina se disuelve, y (ii) después de 30 minutos a pH de 1,0 a 1,6, más de un 80 % p/p del contenido de solifenacina se disuelve. También se refiere a un procedimiento para su preparación, y el uso de la forma de dosificación oral sólida farmacéutica en el tratamiento de síntomas del tracto urinario inferior asociados con el síndrome de vejiga hiperactiva.The present invention relates to a pharmaceutical solid oral dosage form of solifenacin or a pharmaceutically acceptable salt thereof, an ion exchange resin, and one or more pharmaceutically acceptable excipients or carriers, in which solifenacin and the exchange resin Ionic form a matrix and the dosage form has a dissolution profile according to which: (i) after 5 minutes at pH 6.5 to 7.5, less than 10% w / w solifenacin content dissolves, and (ii) after 30 minutes at a pH of 1.0 to 1.6, more than 80% w / w of the solifenacin content dissolves. It also refers to a procedure for its preparation, and the use of pharmaceutical solid oral dosage form in the treatment of lower urinary tract symptoms associated with overactive bladder syndrome.

UY0001038137A 2018-03-08 2019-03-06 A SOLID PHARMACEUTICAL SOLID ORAL DOSAGE FORM UY38137A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18382149 2018-03-08
EP18382472 2018-06-26

Publications (1)

Publication Number Publication Date
UY38137A true UY38137A (en) 2019-07-31

Family

ID=65598664

Family Applications (1)

Application Number Title Priority Date Filing Date
UY0001038137A UY38137A (en) 2018-03-08 2019-03-06 A SOLID PHARMACEUTICAL SOLID ORAL DOSAGE FORM

Country Status (5)

Country Link
JP (1) JP2021526504A (en)
MX (1) MX2020009204A (en)
TW (1) TW201938163A (en)
UY (1) UY38137A (en)
WO (1) WO2019170795A1 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2561167C (en) 2004-03-25 2012-09-11 Astellas Pharma Inc. Composition of solifenacin or salt thereof for use in solid formulation
JP4277904B2 (en) 2004-04-30 2009-06-10 アステラス製薬株式会社 Timed release particulate pharmaceutical composition for oral administration and intraoral quick disintegrating tablet containing the composition
EP2146693A2 (en) * 2007-04-11 2010-01-27 Dr. Reddy's Laboratories Ltd. Solifenacin compositions
LT2572717T (en) * 2010-05-19 2016-09-26 Astellas Pharma Inc. Pharmaceutical composition containing solifenacin

Also Published As

Publication number Publication date
WO2019170795A1 (en) 2019-09-12
MX2020009204A (en) 2021-01-15
TW201938163A (en) 2019-10-01
JP2021526504A (en) 2021-10-07

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