The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. - Explains the commonly used modeling and simulation tools - Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing - Practical examples of the application of modeling tools through case studies - Discussion of modeling techniques used for a risk-based approach to regulatory filings - Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Provides comprehensive coverage of theoretical and equipment aspects in unit operations relevant to pharmaceutical industry. All intricate aspects are explained in simple language with specific explanations and substantiated with neat and elaborate diagrammatic sketches.

This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.

It Is Well Known That The Applications Of Unit Operations Like Heat Transfer, Evaporation, Extraction, Mixing, Filtration And A Host Of Others Are Quite Common In The Pharmaceutical Industry, Be It In The Production Of Synthetic Drugs, Biological And Microbiological Products Or In The Manufacture Of Pharmaceutical Formulations. As Such Anyone Who Is To Look After These Manufacturing Operations Must Be Quite Knowledgeable With The Theoretical And Equipment Aspects Involved In The Relevant Unit Operations.Since A Major Involvement Of The Pharmacy Graduates Lies In The Numerous Manufacturing Operations Mentioned Above, It Is Very Much Necessary That The Subject Is Taught With A Pharmacy Orientation. There Is No Book So Far Which Has Achieved This. The Existing Books On Unit Operations Give Extensive Theory And Also Deal With A Lot Of Equipment Not Employed In The Pharmaceutical Industry. Due To A Lack Of A Pharmacy-Oriented Book In This Area, The Students And The Teachers Are Facing Difficulties In Many Ways.The Present Book Is The First One Of Its Kind On Pharmaceutical Engineering. The Special Features Of This Book Are As Follows: It Includes Theoretical And Equipment Aspects Relevant To Thepharmaceutical Industry And That Too To The Extent Needed For Pharmacy Graduates And Examples From Pharmaceutical Industry Are Quoted Extensively; Solutions To A Number Of Simpler Numerical Problems Are Given. At The End Of Each Chapter, A Large Number Of Questions, Both Theoretical And Numerical, Are Given. There Is Therefore No Doubt That The Book Will Be Of Great Use Not Only To The Students But Also To The Teachers In The Subject In India And Abroad As Well.

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. - Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues