Received 9 January 2015; received in revised form 9 May 2015; accepted 26 May 2015 | Sandeep Kalepu, Vijaykumar Nekkanti
This review article discusses recent advances and business prospects in the field of insoluble drug delivery strategies. The authors highlight the challenges associated with poorly water-soluble drugs, which often lead to low bioavailability and suboptimal drug delivery. They emphasize that about 40% of approved drugs and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. To address these issues, various insoluble drug delivery technologies have been developed, including pH modification, salt formation, co-solvency, surfactant solubilization, amorphous forms, solid dispersions, cocrystals, polymeric micelles, inclusion complexation, size reduction, nanonization, solid lipid nanoparticles, liposomes, proliposomes, microemulsions, and self-emulsifying drug delivery systems (SMEDDS). These technologies have been successfully applied to improve the solubility, bioavailability, and therapeutic efficacy of poorly soluble drugs, leading to improved patient compliance and commercial success. The article also provides a detailed overview of the clinical benefits and business potentials of these technologies, emphasizing their potential to enhance the market exclusivity and patent protection for pharmaceutical companies.This review article discusses recent advances and business prospects in the field of insoluble drug delivery strategies. The authors highlight the challenges associated with poorly water-soluble drugs, which often lead to low bioavailability and suboptimal drug delivery. They emphasize that about 40% of approved drugs and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. To address these issues, various insoluble drug delivery technologies have been developed, including pH modification, salt formation, co-solvency, surfactant solubilization, amorphous forms, solid dispersions, cocrystals, polymeric micelles, inclusion complexation, size reduction, nanonization, solid lipid nanoparticles, liposomes, proliposomes, microemulsions, and self-emulsifying drug delivery systems (SMEDDS). These technologies have been successfully applied to improve the solubility, bioavailability, and therapeutic efficacy of poorly soluble drugs, leading to improved patient compliance and commercial success. The article also provides a detailed overview of the clinical benefits and business potentials of these technologies, emphasizing their potential to enhance the market exclusivity and patent protection for pharmaceutical companies.