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The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients suspended in a suitable vehicle. After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically explain the development of pharmaceutical suspensions, from the pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to the pharmaceutical field is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists who are skilled in their specific areas. Contributing authors represent a cross-sections of scholars from academic, industrial and governmental affiliations. Pharmaceutical Suspensions, From Formulation Development to Manufacturing is organized in a total of ten chapters: Chapter 1 introduces various pharmaceutical disperse systems in-depth. Chapter 2 presents the general principles of suspension dosage form and Chapter 3 discusses commonly used excipients in pharmaceuticalvi Preface suspensions. Chapter 4 systematically highlights steps involved in pharmaceutical development of suspension dosage forms. Chapter 5 focuses on preclinical development of suspension formulations. Analytical tools needed to characterize pharmaceutical suspensions dosage forms are discussed in Chapter 6. The clinical development aspects of suspension drug products are discussed in Chapter 7. Chapter 8 highlights scale up and technology transfer of the development of pharmaceutical suspensions. Chapter 9 reviews the science and regulatory perspectives of pharmaceutical suspensions. Finally, Chapter 10 deals with the pharmaceutical applications of nano-suspensions as nanomedicine, an emerging technology area. Pharmaceutical Suspensions, From Formulation Development to Manufacturing should serve as a good resource for pharmaceutical scientists, process scientists and chemical engineers involved in the areas of research and development of pharmaceutical suspension dosage forms, and for new and sustaining scientists of the pharmaceutical and chemical fields. The fundamental aspects together with the practical case studies should also make this a useful source for undergraduate and
graduate education.Forth Worth, TX Alok K. Kulshreshtha, Ph.D.
Onkar N. Singh. Ph.D., M.B.A.
G. Michael Wall, Ph.D.
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