Lipid‐Based Oral Formulations

Lipid-based formulations have been used for oral dosage forms for many years, as there have always been drugs to be formulated which are oil-soluble, e.g. the fat-soluble vitamins and their derivatives. Lipid-based dosage forms may contain a pure oil as the vehicle, a combination of lipids and surfactants, and in some cases consist primarily of surfactants with some co-solvents added. Drug release tests are an important part of preclinical development, belong to the routine quality control of dosage forms and can also be useful in predicting the in vivo performance of the drug product. E. Jantratid et al. compared biorelevant dissolution test methods with standard compendial methods, using both the USP apparatus 2 (paddle method) and the USP apparatus 3 (BioDis method), in terms of their ability to predict the plasma profiles observed.