TNSN05019A1 - DOSAGE FORM OF PRAMIPEXOLE ADMINISTRATION ONCE A DAY - Google Patents
DOSAGE FORM OF PRAMIPEXOLE ADMINISTRATION ONCE A DAYInfo
- Publication number
- TNSN05019A1 TNSN05019A1 TNP2005000019A TNSN05019A TNSN05019A1 TN SN05019 A1 TNSN05019 A1 TN SN05019A1 TN P2005000019 A TNP2005000019 A TN P2005000019A TN SN05019 A TNSN05019 A TN SN05019A TN SN05019 A1 TNSN05019 A1 TN SN05019A1
- Authority
- TN
- Tunisia
- Prior art keywords
- pramipexole
- composition
- hours
- average
- day
- Prior art date
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
L'invention concerne une composition pharmaceutique pouvant être administrée par voie orale comprend une quantité thérapeutiquement efficace de pramipexole ou d'un de ses sels pharmaceutiquement acceptable, et au moins un excipient pharmaceutiquement acceptable, ladite composition présentant au moins un ou des profils consistant en (a) un profil de libération in vitro dans lequel, en moyenne, une proposition non supérieure à environ 20 % du pramipexole est dissoute dans les 2 heures suivant la mise en place de la composition dans un essai de dissolution classique ; (b) un profil d'absorption de pramipexole in vivo après administration d'une dose unique à des êtres humains adultes sains, dans lequel le temps pour atteindre une moyenne de 20 % d'absorption est supérieur à environ 2 heures et/ou le temps pour atteindre une moyenne d'environ 40 % d'absorption est supérieur à 4 heures. La composition est utile pour l'administration orale, pas plus d'une fois par jour, à un sujet présentant une affection ou un trouble pour lequel un agoniste du récepteur de dopamine est indiqué.The present invention relates to an orally administrable pharmaceutical composition comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient, said composition having at least one or more profiles consisting of a) an in vitro release profile in which, on average, a proposal no greater than about 20% of the pramipexole is dissolved within 2 hours of placement of the composition in a conventional dissolution test; (b) a pramipexole uptake profile in vivo after single dose administration to healthy adult humans, wherein the time to reach an average of 20% absorption is greater than about 2 hours and / or the time to reach an average of about 40% absorption is greater than 4 hours. The composition is useful for oral administration, no more than once a day, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US39842702P | 2002-07-25 | 2002-07-25 | |
PCT/US2003/023522 WO2004010999A1 (en) | 2002-07-25 | 2003-07-25 | Pramipexole once-daily dosage form |
Publications (1)
Publication Number | Publication Date |
---|---|
TNSN05019A1 true TNSN05019A1 (en) | 2007-05-14 |
Family
ID=38181237
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TNP2005000020A TNSN05020A1 (en) | 2002-07-25 | 2005-01-25 | PRAMIPEXOLE COMPOSITION NOT CONSISTING OF PROLONGED RELEASE PRAMIPEXOLE COMPOSITION |
TNP2005000019A TNSN05019A1 (en) | 2002-07-25 | 2005-01-25 | DOSAGE FORM OF PRAMIPEXOLE ADMINISTRATION ONCE A DAY |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TNP2005000020A TNSN05020A1 (en) | 2002-07-25 | 2005-01-25 | PRAMIPEXOLE COMPOSITION NOT CONSISTING OF PROLONGED RELEASE PRAMIPEXOLE COMPOSITION |
Country Status (2)
Country | Link |
---|---|
CR (1) | CR7660A (en) |
TN (2) | TNSN05020A1 (en) |
-
2005
- 2005-01-24 CR CR7660A patent/CR7660A/en not_active Application Discontinuation
- 2005-01-25 TN TNP2005000020A patent/TNSN05020A1/en unknown
- 2005-01-25 TN TNP2005000019A patent/TNSN05019A1/en unknown
Also Published As
Publication number | Publication date |
---|---|
CR7660A (en) | 2005-06-08 |
TNSN05020A1 (en) | 2007-05-14 |
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