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An optimal formulation is the simplest option that meets the product and patient’s needs. A technology agnostic approach based on a fundamental understanding of API properties, a well-defined yet flexible target product profile, and a mindset for scalability and commercial relevance leads to success in formulation development and drug product design.
In the modern landscape for oral dosage forms, enabled formulations for bioavailability enhancement are increasingly common. Drug candidates are no longer ruled out in discovery due to low solubility or low permeability, allowing for more explicit optimization of molecular properties that drive safety and efficacy while relying on formulation and delivery technologies to overcome the barriers associated with limited oral absorption. A developability assessment to determine the most appropriate technology should take into consideration molecular properties of the API, bio-performance modeling to predict absorption as a function of form and formulation, and a comprehensive understanding of the patient population, product design, and program strategy.
In this webinar, we’ll discuss how to use this approach to strategically guide formulation technology selection. When an enabled formulation is required, we’ll discuss how these same tools can further help to guide formulation development and product design.
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