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Formulation Development for Scalability

Summary: Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules.  For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities.  However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development.

If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted.  Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.

The webinar discusses strategies for bridging early-phase and late-phase considerations in formulation development for scalability and manufacturability

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