Application of the solubility parameter concept to assist with oral delivery of poorly water‐soluble drugs – a PEARRL review
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Objectives: Solubility parameters have been used for decades in various scientific fields includ-ing pharmaceutics. It is, however, still a field of active research both on a conceptual and experi-mental level. This work addresses the need to review solubility parameter applications in pharma-ceutics of poorly water-soluble drugs. Summary: An overview of the different experimental and calculation methods to determine sol-ubility parameters is provided, which covers from classical to modern approaches. In the pharma-ceutical field, solubility parameters are primarily used to guide organic solvent selection, co-crystals and salt screening, lipid-based delivery, solid dispersions, and nano- or microparticulate drug delivery systems. Solubility parameters have been applied for a quantitative assessment of mixtures or they are simply used to rank excipients for a given drug. Conclusions: Especially partial solubility parameters hold great promise for aiding the develop-ment of poorly soluble drug delivery systems. This is particularly true in early stage development, where compound availability and resources are limited. The experimental determination of solu-bility parameters has its merits despite being rather labour-intensive because further data can be used to continuously improve in silico predictions. Such improvements will ensure that solubility parameters will also in the future guide scientists in finding suitable drug formulations.