Particulate Science in Drug Development

Particulate Science in Drug Development bridges fundamental particle science concepts with pharmaceutical formulation, manufacturing, and bioavailability optimization across diverse dosage forms and delivery routes. This comprehensive resource examines core particle attributes-size, shape, morphology, surface area, crystal structure, and flow properties-and directly links them to solubility enhancement, absorption performance, content uniformity, and clinical efficacy. The book systematically addresses characterization methodologies including dynamic light scattering, BET surface area analysis, particle size distribution measurement, and rheological assessment. Coverage spans design approaches for tablets, capsules, injectable suspensions, inhalable powders, and nanotechnology-enabled systems. Practical sections emphasize quality by design principles, process analytical technology integration, and good manufacturing practices essential for regulatory compliance globally. Real-world applications illustrate how particle engineering improves bioavailability, reduces dose burden, and addresses solubility challenges for poorly soluble compounds. The text integrates manufacturing considerations, scale-up strategies, and emerging technologies including 3D printing and AI-driven formulation optimization. Readers develop competencies in particle characterization, formulation design, manufacturing process development, and regulatory submission strategies. This volume serves pharmaceutical scientists, formulation technologists, and industry professionals worldwide.