TEXT BOOK OF MODERN PHARMACEUTICS

About Book

The Textbook of Modern Pharmaceutics is a comprehensive guide that addresses both theoretical foundations and practical aspects of pharmaceutical sciences. It begins with preformulation concepts, emphasizing drug–excipient interactions, kinetics of stability, and stability testing methods, which are crucial for developing safe and effective dosage forms. It also discusses theories of dispersions with a focus on emulsions, suspensions, and advanced delivery systems like self-microemulsifying drug delivery systems (SMEDDS). Special attention is given to stability considerations in parenteral preparations, covering both large- and small-volume injections with physiological and formulation perspectives. The section concludes with insights into manufacturing processes and their evaluation. The second part of the book focuses on optimization techniques in pharmaceutical formulation. It introduces the concept of optimization, outlines key parameters, and explains its role in enhancing formulation efficiency. Various statistical and experimental design approaches are discussed, including response surface methods, contour designs, and factorial designs, showing their applications in formulation and processing. These tools equip researchers with the means to systematically improve pharmaceutical products. Next, the book delves into validation, starting with its introduction and scope. It highlights the merits of validation in ensuring product quality and compliance with regulations. The section elaborates on validation and calibration master plans, drawing from ICH and WHO guidelines for equipment and process validation. Specific dosage form validation is addressed, alongside different types of validation such as prospective, concurrent, and retrospective. Government regulations, manufacturing process models, and qualification stages (URS, DQ, IQ, OQ, PQ) are also explained thoroughly. The fourth section explores current good manufacturing practices (cGMP), describing their objectives and policies. It covers the layout of pharmaceutical buildings, service systems, and equipment maintenance, ensuring that facilities meet strict quality and safety standards. This part establishes the foundation for compliant and efficient manufacturing environments. Following this, the book discusses industrial management, highlighting its importance in pharmaceutical industries. It addresses production management and organization, material handling, and transportation systems. Inventory management and control strategies are explored in detail, along with production planning, scheduling, and control techniques. The section also discusses sales forecasting, budgeting, and cost control methods, tying them to industrial and personnel relationships that maintain harmony in the workplace. The seventh chapter provides an in-depth understanding of compression and compaction in tablet formulation. It explains the physics of tablet compression, the processes of consolidation, and the influence of friction on powder behavior. Key topics such as force distribution, compaction profiles, and solubility aspects are also covered, linking material properties to performance.