The recognition of the potential of lipid-based formulations for improving the gastrointestinal absorption of poorly water-soluble drugs has been a major driver for the development of liquid-filled capsule technology (1-4). Lipid excipients possess a wide range of desirable characteristics, such as broad chemical compatibility, low melting points, surfactant or self-emulsifying properties, and suitability for large-scale manufacture. The increasing application of lipid-based formulations has prompted the production equipment and capsule manufacturers to develop new materials, processing systems, and product formats. Lipid-based capsule formulations are encountered not only in ethical pharmaceutical products but in consumer and "high-end" nutriceutical products as well. The market is therefore diverse and presents numerous technical challenges for the formulation and manufacture of these dosage forms.
This chapter will describe the material-selection and process issues for oral lipid-based formulations with an emphasis on their use in hard-capsule format. It reflects specialist development and manufacturing experience acquired over 15 years and in over 1500 batches of lipid-based capsule products ranging from simple nutriceutical oil formulations to cytotoxics. In order to provide a basis for the successful manufacture of a novel lipid-based oral dosage form, options in formulation excipients and capsule shell selection will be discussed along with the main processing routes employed.
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