Nanoemulsion-based injectable dosage forms: design, development, and scale-up strategies

Nanoemulsion injectable dosage forms represent a novel approach in drug delivery systems, offering numerous advantages such as enhanced bioavailability, prolonged and controlled drug release and stability of drug molecules. The chapter provides an indepth exploration of the design and development aspects of nanoemulsion injectable formulations, along with the overall methodology required for scaling up these injectable nanoemulsions. It begins with an overview of nanoemulsions, discussing their application in parenteral drug delivery. It explores the formulation components, including surfactants, cosurfactants, aqueous phase, oil phase, and others, in detail. Additionally, it explains the design, formulation, and characterization techniques used to assess the quality and stability of nanoemulsions. A crucial aspect in the transition from laboratory scale to commercial production, analyzing key aspects of this pathway and discussing regulatory factors, with a focus on guidance provided by leading health authorities is covered. The chapter highlights the role of Process Analytical Technology in facilitating real-time monitoring to enhance quality control. As part of its comprehensive approach, the chapter shares multiple case studies of successful scale-up strategies, offering valuable insights for researchers and industry professionals. Finally, it concludes with future directions of nanoemulsion technology, including emerging trends and applications beyond injectable formulations. Hence, this chapter serves as a practical guide for professionals involved in the formulation, product development, and commercialization of nanoemulsion-based drug delivery systems, emphasizing recent developments and applications.