One of the major hurdles in developing a lipid-based solid dispersion formulation involves the selection of a suitable excipient. An ideal excipient should
■ be safe, inert, and available at a purity level suitable for human use,
■ not degrade during manufacturing or storage,
■ be capable of solubilizing the drug dose in a volume not exceeding that of an oral capsule,
■ (preferably) possess surface active properties to enable self-emulsification or complete dissolution of the drug dose,
■ reliably and reproducibly enhance the oral bioavailability of the drug relative to a conventional formulation,
■ be physically and chemically stable, and compatible with a wide range of drugs and other excipients,
■ be nonhygroscopic and inert to the capsule shell or other packaging components,
■ allow simple and efficient dosage form manufacture and permit ready scale-up from bench top to production-sized batches.
Some important aspects and challenges that need to be addressed during selection of a suitable excipient will now be discussed in greater detail.
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