EMERGING PARADIGMS IN DRUG DESIGN: A REVIEW OF FORMULATION STRATEGIES

The rapid evolution of pharmaceutical sciences has led to a paradigm shift from molecule-centric drug discovery to formulation-centric drug design, in which the delivery system plays a decisive role in determining therapeutic success. Although advances in medicinal chemistry have produced highly potent drug candidates, many fail to reach clinical utility due to poor solubility, instability, low bioavailability, rapid metabolism, and off-target toxicity. This review provides a comprehensive overview of emerging paradigms in drug design with a particular focus on advanced formulation strategies that address these challenges. Fundamental principles of drug formulation, including the role of excipients, the Biopharmaceutics Classification System, and pharmacokinetic–pharmacodynamic relationships, are discussed to establish the scientific basis for rational formulation design. The limitations of conventional dosage forms are critically examined, followed by an in-depth analysis of modern delivery platforms such as nanotechnology-based systems, lipid carriers, amorphous solid dispersions, targeted drug delivery, and controlled-release technologies. The growing role of artificial intelligence and machine learning in formulation optimization, excipient selection, and digital twin modeling is highlighted as a key driver of next-generation pharmaceutical development. Regulatory, manufacturing, and clinical translation aspects are also explored to provide a holistic perspective on the development and commercialization of advanced drug products. Finally, current challenges and future directions, including personalized medicine, 3D-printed dosage forms, and smart drug delivery systems, are discussed. Collectively, this review underscores the pivotal role of formulation strategies in enhancing drug performance, improving patient outcomes, and shaping the future of pharmaceutical innovation.