2. Slow speed of dissolution in waterSlow speed of dissolution in water
Low absorption in GI tractLow absorption in GI tract
High degradation in acidic media (pH: 1): 50%High degradation in acidic media (pH: 1): 50%
in 30 minutesin 30 minutes
Difficulties in case of micronizing:Difficulties in case of micronizing:
Specialized equipmentSpecialized equipment
High CostHigh Cost
Handling difficultiesHandling difficulties
( contamination)( contamination)
Drospirenone Vaginal RingsDrospirenone Vaginal Rings
Formulation ConsiderationsFormulation Considerations
PolyMicrocaps®
PolyNanocaps®
5. PREPARACION DEL ESTANDAR
•Disolver las cantidades pesadas ( 2 mg drospirenona / 1 mg estradiol –hemihidrato) en acetonitrilo y llevar a volumen de 25 ml
concentraciones finales : 0,08 mg DSP/ ml y 0,04 mg EE / ml .
•Filtrar por membrana de 0,45 micras PTFE a vial de HPLC
•Setear el equipo con las siguientes condiciones:
Flujo : 1 ml / minuto Temperatura columna: sin control
Fase móvil : acetonitrilo: agua 50:50
Volumen de inyección: 20 microlitros Inyeccion estandar
Columna : C18 5 micras
Detector UV : 250 nm Stop time : 40 min
Presion: 400 bar Post time : 30 min
Drospirenone Vaginal RingsDrospirenone Vaginal Rings
Analytical MethodologyAnalytical Methodology
PolyMicrocaps® PolyNanocaps®