Early Development of Poorly Water-Soluble NCEs - American ...

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Solid Dispersion by Melt ExtrusionTechnologyMelt extrusion is a single-step process ideally suitableto manufacture solid dispersionHomogeneous mixture of active, polymerplasticizer, surfactantRef: Adapted from J. Kowalski (Novartis) presentation18
Challenges with Melt ExtrusionFeed portHeated barrel withtemperature zonesMotor19Conveying zoneMixingzoneDie• Relatively short dwell time in the heated barrel• Temperature must be higher than the melting temperature (~15-20°C) for complete conversion to amorphous form and easeof processing (reduced viscosity)• Risk associated with chemical stability – thermo-labilecompounds• High Tg of commonly used polymers (150-160 °C) – needsuitable plasticizers; temperature must be > Tg• Lack of miscibility between drug and polymer
Page 1: Early Development of Poorly Water-S
Page 4 and 5: Development Strategies vsOutsourcin
Page 6 and 7: How Does Salt Formation IncreaseDis
Page 8 and 9: 8Nanotechnology
Page 10 and 11: 10High-energy Solid
Page 12 and 13: Heat content(enthalpy, H)Advantage
Page 14 and 15: Preparation of Solid Dispersion -So
Page 16 and 17: Preparation of Solid Dispersion -Me
Page 20 and 21: Nanoemulsion/Solid NanoemulsionPrec
Page 22 and 23: Limitation of Lipid-based DrugDeliv
Page 24: Outsourcing of Early Development of

Early Development of Poorly Water-Soluble NCEs - American ...

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