Insoluble drug delivery strategies: review of recent advances and business prospects Sandeep Kalepu, Vijaykumar Nekkanti Abstract: The development of drug candidates with greater lipophilicity, high molecular weight, and poor water solubility has led to many drug failures due to poor solubility. About 40% of approved drugs and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. Various insoluble drug delivery technologies have been developed to address this issue. Many drugs with poor solubility and low bioavailability have been formulated into successful drug products. Several marketed drugs have been reformulated to improve efficacy, safety, and patient compliance. Pharmaceutical companies have adopted insoluble drug delivery technologies to gain marketing exclusivity and patent protection. This review covers recent advances in insoluble drug delivery and business prospects. Insoluble drug delivery technologies include pH modification and salt forms, co-solvency and surfactant solubilization, amorphous forms, solid dispersions, cocrystals, polymeric micelles, inclusion complexation, solid lipid nanoparticles, liposomes and proliposomes, microemulsions and self-emulsifying drug delivery systems. These technologies have been used to improve solubility, bioavailability, and stability of drugs. Examples include the use of cyclodextrins, salt forms, and polymeric micelles to enhance solubility and bioavailability of drugs. These technologies have also been used to develop new formulations with improved clinical and commercial benefits. The review highlights the potential of these technologies in improving drug delivery and their business prospects.Insoluble drug delivery strategies: review of recent advances and business prospects Sandeep Kalepu, Vijaykumar Nekkanti Abstract: The development of drug candidates with greater lipophilicity, high molecular weight, and poor water solubility has led to many drug failures due to poor solubility. About 40% of approved drugs and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. Various insoluble drug delivery technologies have been developed to address this issue. Many drugs with poor solubility and low bioavailability have been formulated into successful drug products. Several marketed drugs have been reformulated to improve efficacy, safety, and patient compliance. Pharmaceutical companies have adopted insoluble drug delivery technologies to gain marketing exclusivity and patent protection. This review covers recent advances in insoluble drug delivery and business prospects. Insoluble drug delivery technologies include pH modification and salt forms, co-solvency and surfactant solubilization, amorphous forms, solid dispersions, cocrystals, polymeric micelles, inclusion complexation, solid lipid nanoparticles, liposomes and proliposomes, microemulsions and self-emulsifying drug delivery systems. These technologies have been used to improve solubility, bioavailability, and stability of drugs. Examples include the use of cyclodextrins, salt forms, and polymeric micelles to enhance solubility and bioavailability of drugs. These technologies have also been used to develop new formulations with improved clinical and commercial benefits. The review highlights the potential of these technologies in improving drug delivery and their business prospects.