CO5770093A1 - SOLID PHARMACEUTICAL COMPOSITIONS THAT INCLUDE A COMBINATION OF DROSPIRENONE, ETHYLINESTRADIOL AND AN APPROPRIATE SOUTHFACTING AGENT THAT PRESENTS A HOMOGENEITY OF CONTENT AND SPEED OF DISSOLVED INSURANCE FOR NON-MICRONIZED DRUG, RPOCEDI - Google Patents
SOLID PHARMACEUTICAL COMPOSITIONS THAT INCLUDE A COMBINATION OF DROSPIRENONE, ETHYLINESTRADIOL AND AN APPROPRIATE SOUTHFACTING AGENT THAT PRESENTS A HOMOGENEITY OF CONTENT AND SPEED OF DISSOLVED INSURANCE FOR NON-MICRONIZED DRUG, RPOCEDIInfo
- Publication number
- CO5770093A1 CO5770093A1 CO05130115A CO05130115A CO5770093A1 CO 5770093 A1 CO5770093 A1 CO 5770093A1 CO 05130115 A CO05130115 A CO 05130115A CO 05130115 A CO05130115 A CO 05130115A CO 5770093 A1 CO5770093 A1 CO 5770093A1
- Authority
- CO
- Colombia
- Prior art keywords
- drospirenone
- pharmaceutical composition
- clause
- approximately
- combination
- Prior art date
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
COMPOSICIÓN FARMACÉUTICA caracterizada porque comprende una combinación de dos principios activos, a saber drospirenona y etinilestradiol, un agente surfactante y excipientes farmacéuticamente aceptables con la condición de que la drospirenona presente la siguiente distribución: aproximadamente el 95% de ellos presenten un tamaño de partícula inferior a 100 µm, aproximadamente el 26 % presente un tamaño de partícula inferior a 20 µm, y aproximadamente el 15 % presente un tamaño de partícula inferior a 10.00 µm. COMPOSICIÓN FARMACÉUTICA caracterizada porque comprende una combinación de dos principios activos, a saber drospirenona y etinilestradiol, un agente surfactante y excipientes farmacéuticamente aceptables con la condición de que la drospirenona presente una área superficial menor a 10.000 cm2/g. COMPOSICION FARMACÉUTICA de acuerdo con la cláusula 1 o 2 caracterizada porque la cantidad de drospirenona se encuentra en el rango de 500 a 5000 µg y la cantidad de etinilestradiol se encuentra en el rango de 20 µmg a 50 µg. COMPOSICIÓN FARMACÉUTICA de acuerdo con la cláusula 1 o 2 caracterizada porque comprende el agente surfactante es no iónico. COMPOSICIÓN FARMACÉUTICA de acuerdo con la cláusula 1 o 2 caracterizada porque la drospirenona no se encuentra micronizada. COMPOSICIÓN FARMACÉUTICA de acuerdo con la cláusula 1, 2 o 5 caracterizada porque aproximadamente el 80% de la drospirenona se disuelve dentro de un periodo de 10 minutos y aproximadamente el 95% se disuelve en un periodo de 20 minutos, donde la disolución esta determinada por un método de paletas USP II usando laurilsulfato de sodio al 0.5% como medio de disolución y una velocidad de agitación de 75 rpm. COMPOSICIÓN FARMACÉUTICA de acuerdo con la cláusula 1, 2 o 3 caracterizada porque es para administración oral.PHARMACEUTICAL COMPOSITION characterized in that it comprises a combination of two active ingredients, namely drospirenone and ethinyl estradiol, a pharmaceutically acceptable surfactant and excipients with the proviso that drospirenone has the following distribution: approximately 95% of them have a particle size less than 100 µm, approximately 26% have a particle size of less than 20 µm, and approximately 15% have a particle size of less than 10.00 µm. PHARMACEUTICAL COMPOSITION characterized in that it comprises a combination of two active ingredients, namely drospirenone and ethinyl estradiol, a pharmaceutically acceptable surfactant and excipients with the proviso that drospirenone has a surface area of less than 10,000 cm2 / g. PHARMACEUTICAL COMPOSITION according to clause 1 or 2 characterized in that the amount of drospirenone is in the range of 500 to 5000 µg and the amount of ethinyl estradiol is in the range of 20 µmg to 50 µg. PHARMACEUTICAL COMPOSITION according to clause 1 or 2 characterized in that it comprises the surfactant is non-ionic. PHARMACEUTICAL COMPOSITION according to clause 1 or 2 characterized in that drospirenone is not micronized. PHARMACEUTICAL COMPOSITION according to clause 1, 2 or 5 characterized in that approximately 80% of drospirenone dissolves within a period of 10 minutes and approximately 95% dissolves in a period of 20 minutes, where the dissolution is determined by a USP II vane method using 0.5% sodium lauryl sulfate as a dissolution medium and a stirring speed of 75 rpm. PHARMACEUTICAL COMPOSITION according to clause 1, 2 or 3 characterized in that it is for oral administration.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP040104928 AR047782A1 (en) | 2004-12-28 | 2004-12-28 | SOLID PHARMACEUTICAL COMPOSITIONS THAT INCLUDE A COMBINATION OF DROSPIRENONE, ETHYLYNESTRADIOL AND AN APPROPRIATE SURFACTING AGENT THAT PRESENTS A HOMOGENEITY OF CONTENT AND SPEED OF DISSOLVED INSURANCE FOR NON-MICRONIZED DRUG, PROCEDURE FOR PREPARATION OF USE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO5770093A1 true CO5770093A1 (en) | 2007-06-29 |
Family
ID=36607162
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO05130115A CO5770093A1 (en) | 2004-12-28 | 2005-12-27 | SOLID PHARMACEUTICAL COMPOSITIONS THAT INCLUDE A COMBINATION OF DROSPIRENONE, ETHYLINESTRADIOL AND AN APPROPRIATE SOUTHFACTING AGENT THAT PRESENTS A HOMOGENEITY OF CONTENT AND SPEED OF DISSOLVED INSURANCE FOR NON-MICRONIZED DRUG, RPOCEDI |
Country Status (4)
| Country | Link |
|---|---|
| AR (1) | AR047782A1 (en) |
| CO (1) | CO5770093A1 (en) |
| PE (1) | PE20061112A1 (en) |
| UY (1) | UY29227A1 (en) |
-
2004
- 2004-12-28 AR ARP040104928 patent/AR047782A1/en unknown
-
2005
- 2005-11-24 UY UY29227A patent/UY29227A1/en not_active Application Discontinuation
- 2005-12-27 CO CO05130115A patent/CO5770093A1/en not_active Application Discontinuation
-
2006
- 2006-01-03 PE PE2006000018A patent/PE20061112A1/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| AR047782A1 (en) | 2006-02-22 |
| PE20061112A1 (en) | 2006-11-27 |
| UY29227A1 (en) | 2005-12-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Application refused |