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Overcoming Poor Solubility in Formulation Development

Summary: Poor solubility remains an ongoing challenge in formulation development. Dr. Julien Meissonnier, Director R &D shares insights on lipid-based drug-delivery systems to solve solubility challenges. A Self-Micro Emulsifying Drug Delivery System (SMEDDS) is a lipid-based “preconcentrate” of solubilized drug composed of lipid excipients; surfactants and co-surfactants (hydrophilic or lipophilic), and co-solvents. These formulations can be readily made into softgels or capsules, which have numerous patient experience benefits, as well as formulation benefits of ensuring dose uniformity and offering an established scale-up route. When such formulations are diluted with gastrointestinal fluids, a thermodynamically stable microemulsion is formed, which maintains the drug in solution and prevents its precipitation irrespective of variations in biological conditions (i.e. enzymes,pH, bile salts).The company’s softgel technology has to date enabled more than 50 poorly soluble drugs (NDAs) to be commercialized, leveraging LBDDS and making it one of the most successful advanced drug delivery technologies applied to BCS Class II drugs.

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