Drospirenone estradiol vaginal rings
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Vaginal rings offer the possibility of achieving patient adherence whilst attaining a differential pharmacokinetics
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Drospirenone estradiol vaginal rings
- 1. Pharm. Claudio Cerati November 2017 Drospirenone /EstradiolDrospirenone /Estradiol Vaginal Rings FormulationVaginal Rings Formulation PolyMicrocaps® PolyNanocaps®
- 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®
- 3. PolyMicrocaps® PolyNanocaps® Drospirenone Vaginal RingsDrospirenone Vaginal Rings Microscopy : Drospirenone API 40XMicroscopy : Drospirenone API 40X
- 4. 1 micra PolyMicrocaps® PolyNanocaps® Drospirenone Vaginal RingsDrospirenone Vaginal Rings Microscopy : Drospirenone Polymersomes 100XMicroscopy : Drospirenone Polymersomes 100X
- 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®
- 6. PolyMicrocaps® PolyNanocaps® Drospirenone Vaginal RingsDrospirenone Vaginal Rings Formulation DevelopmentFormulation Development
- 7. Drospirenone Vaginal RingsDrospirenone Vaginal Rings Estradiol Degradation by UV LightEstradiol Degradation by UV Light PolyMicrocaps® PolyNanocaps®
- 8. Drospirenone Vaginal RingsDrospirenone Vaginal Rings Drospirenone Stability under Visible LightDrospirenone Stability under Visible Light PolyMicrocaps® PolyNanocaps®
- 9. PolyMicrocaps® PolyNanocaps® Drospirenone Vaginal RingsDrospirenone Vaginal Rings Drospirenone releaseDrospirenone release