Fundamental Aspects of Lipid-Based Excipients in Lipid-Based Product Development

Poor aqueous solubility of drugs is still a foremost challenge in pharmaceutical product development. The use of lipids in designing formulations provides an opportunity to enhance the aqueous solubility and consequently bioavailability of drugs. Pre-dissolution of drugs in lipids, surfactants, or mixtures of lipid excipients and surfactants eliminate the dissolution/dissolving step, which is likely to be the rate-limiting factor for oral absorption of poorly water-soluble drugs. In this review, we exhaustively summarize the lipids excipients in relation to their classification, absorption mechanisms, and lipid-based product development. Methodologies utilized for the preparation of solid and semi-solid lipid formulations, applications, phase behaviour, and regulatory perspective of lipid excipients are discussed.

Automated summary

Poor aqueous solubility of drugs remains a major challenge in pharmaceutical product development. Utilizing lipids in formulation design offers an opportunity to enhance the solubility and bioavailability of drugs. This review comprehensively summarizes the classification, absorption mechanisms, and lipid-based product development of lipid excipients, as well as discusses the preparation methodologies, applications, phase behavior, and regulatory perspective of solid and semi-solid lipid formulations.