CO5680422A2 - DOSAGE FORM OF PRAMIPEXOL IN A DAILY ONLY DOSE - Google Patents
DOSAGE FORM OF PRAMIPEXOL IN A DAILY ONLY DOSEInfo
- Publication number
- CO5680422A2 CO5680422A2 CO05005921A CO05005921A CO5680422A2 CO 5680422 A2 CO5680422 A2 CO 5680422A2 CO 05005921 A CO05005921 A CO 05005921A CO 05005921 A CO05005921 A CO 05005921A CO 5680422 A2 CO5680422 A2 CO 5680422A2
- Authority
- CO
- Colombia
- Prior art keywords
- hours
- pramipexole
- average
- absorption
- reach
- Prior art date
Links
- FASDKYOPVNHBLU-ZETCQYMHSA-N pramipexole Chemical compound C1[C@@H](NCCC)CCC2=C1SC(N)=N2 FASDKYOPVNHBLU-ZETCQYMHSA-N 0.000 title abstract 7
- 239000002552 dosage form Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 7
- 238000010521 absorption reaction Methods 0.000 abstract 6
- 229960003089 pramipexole Drugs 0.000 abstract 6
- 238000007922 dissolution test Methods 0.000 abstract 2
- 238000000338 in vitro Methods 0.000 abstract 2
- 238000001727 in vivo Methods 0.000 abstract 2
- 238000004090 dissolution Methods 0.000 abstract 1
- 239000012738 dissolution medium Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 239000008363 phosphate buffer Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
1.- Una composición farmacéutica administrable oralmente que comprende una cantidad terapéuticamente eficaz de pramipexol o una de sus sales farmacéuticamente aceptables y al menos un excipiente farmacéuticamente aceptable, presentando dicha composición al menos uno entre (a) un perfil de liberación in vitro en el que de media no más de aproximadamente 20% del pramipexol se disuelve en 2 horas después de la colocación de la composición en un ensayo de disolución convencional; y (b) un perfil de absorción de pramipexol in vivo después de la administración oral de una dosis única a humanos adultos sanos en el que el tiempo para alcanzar una media de 20% de absorción es mayor que aproximadamente 2 horas y/o el tiempo para alcanzar una media de 40% de absorción es mayor que aproximadamente 4 horas.2.- La composición según la reivindicación 1 que presenta un perfil de liberación in vitro en el que de media no más de aproximadamente 20% del pramipexol se disuelve en 2 horas después de la colocación de la composición en un ensayo de disolución convencional realizado según la USP 24 utilizando el dispositivo 1 con una velocidad de rotación del eje de 100 rpm y un medio de disolución de un tampón de fosfato 0,05M, pH 6,8, a 37°C, o un ensayo esencialmente equivalente a él.3.- La composición según la reivindicación 2, en la que no más de aproximadamente 12% del pramipexol se disuelve en 1 hora en dicho ensayo.4.- La composición según cualquiera de las reivindicaciones 2 ó 3, en la que el tiempo para alcanzar la disolución de 50% es de al menos aproximadamente 4 horas, preferiblemente al menos aproximadamente 6 horas, más preferiblemente al menos aproximadamente 8 horas y más preferiblemente al menos aproximadamente 12 horas.5.- La composición según la reivindicación 1 que presenta un perfil de absorción de pramipexol in vivo después de la administración oral de una dosis única a humanos adultos sanos en el que el tiempo para alcanzar una media de absorción de 20% es mayor que aproximadamente 2 horas y/o el tiempo para alcanzar una media de absorción de 40% es mayor que aproximadamente 4 horas.1. 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 of (a) an in vitro release profile in which on average no more than about 20% of pramipexole dissolves in 2 hours after placing the composition in a conventional dissolution test; and (b) an absorption profile of pramipexole in vivo after oral administration of a single dose to healthy adult humans in which the time to reach an average of 20% absorption is greater than about 2 hours and / or the time to reach an average of 40% absorption is greater than about 4 hours. 2. The composition according to claim 1 which has an in vitro release profile in which on average no more than about 20% of the pramipexole is dissolved in 2 hours after placing the composition in a conventional dissolution test carried out according to USP 24 using the device 1 with an axis rotation speed of 100 rpm and a dissolution medium of a 0.05M phosphate buffer, pH 6, 8, at 37 ° C, or a test essentially equivalent to it. 3.- The composition according to claim 2, wherein no more than about 12% of the pramipexole dissolves in 1 hour in said test. 4.- The composition according to any of claims 2 or 3, wherein the time to reach 50% dissolution is at least about 4 hours, preferably at least about 6 hours, more preferably at least about 8 hours and more preferably at least about 12 hours .5.- The composition according to claim 1 having an absorption profile of pramipexole in vivo after oral administration of a single dose to healthy adult humans in which the time to reach an average absorption of 20% is greater than approximately 2 hours and / or the time to reach an average absorption of 40% is greater than approximately 4 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CO05005921A CO5680422A2 (en) | 2005-01-25 | 2005-01-25 | DOSAGE FORM OF PRAMIPEXOL IN A DAILY ONLY DOSE |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CO05005921A CO5680422A2 (en) | 2005-01-25 | 2005-01-25 | DOSAGE FORM OF PRAMIPEXOL IN A DAILY ONLY DOSE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO5680422A2 true CO5680422A2 (en) | 2006-09-29 |
Family
ID=42138682
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO05005921A CO5680422A2 (en) | 2005-01-25 | 2005-01-25 | DOSAGE FORM OF PRAMIPEXOL IN A DAILY ONLY DOSE |
Country Status (1)
| Country | Link |
|---|---|
| CO (1) | CO5680422A2 (en) |
-
2005
- 2005-01-25 CO CO05005921A patent/CO5680422A2/en not_active Application Discontinuation
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Application granted | ||
| FD | Application lapsed |