Bridging the gaps between academic research and industrial product developments of lipid-based formulations

摘要

Lipid-based formulations, including self-emulsifying drug delivery systems (SEDDS), are an interesting formulation technology that enables the clinical use of compounds for which a low aqueous solubility may be a limitation. From an academic perspective, the technology is interesting on several levels: what drives solubility, what determines bioperformance, what is the potential for solidification etc. From an industrial perspective, >35 lipid-based formulations are available and there is an unknown number of projects in the pipeline. Hence, while there is scientific interest from both academic and industrial perspectives, the agendas/needs in the two settings are different. From an industrial perspective, risks are associated with uncertainty; hence the more that is known about a technology the better - knowledge that in principle can be generated in both the academia and industry. This focuses on the development of lipid-based formulations and the knowledge gaps that could be investigated with the hope that all stakeholders in the field of lipid-based formulations, including academia, industry, CRO's, lipid excipient manufacturers etc., would share their insight, so that this technology can be even further developed. Some of the gaps discussed include the selection of compounds suited for lipid-based formulations, which potential modifications that could be investigated, e.g., lipophilic salts, what is a relevant definition of accelerated stability studies, how best to construct an industrial development program of a lipid-based formulation, etc. (C) 2019 Elsevier B.V. All rights reserved.