Ajit S. Narang - Böcker

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation.

Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm, Second Edition offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. This completely revised and updated edition features five new chapters covering new AI tools applied to scaling up granulation processes, model drive design, machine learning models for granule property prediction, design and scale up of fluid bed granulation, and process analytical methods. This book is the prefect reference for pharmaceutical manufacturing professionals. Academic researchers will benefit from the practical advice provided by the editors and chapter authors.

Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulationExamines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms.Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Organ Specific Drug Delivery and Targeting to the Lungs provides up to date information on the multidisciplinary field of particle engineering and drug delivery to the lungs, including advancements of nanotechnology. The text presents a unique, pragmatic focus with case studies, that help translate scientific understanding to practical implementation. In addition to highlighting the successful case studies, it also offers practical advice on watchouts, limitations, and ‘bookend’ boundaries involved in the stages of testing and development.Additional Features Include: Provides an account of particle engineering, discovery, biology, development, and delivery in relation with the advancements of nanotechnology, unlike any previous book. Brings together the leading experts and researchers in the field to critically assess and discuss various topics influencing drug delivery. Highlights the interplay of different scientific disciplines and the balance of requirements that are critical to molecule and product design.With the strategic focus on what matters during new product development, this book provides a guide to understanding and navigating new drug discovery and development for lung targets.

Organ Specific Drug Delivery and Targeting to the Lungs provides up to date information on the multidisciplinary field of particle engineering and drug delivery to the lungs, including advancements of nanotechnology. The text presents a unique, pragmatic focus with case studies, that help translate scientific understanding to practical implementation. In addition to highlighting the successful case studies, it also offers practical advice on watchouts, limitations, and ‘bookend’ boundaries involved in the stages of testing and development.Additional Features Include: Provides an account of particle engineering, discovery, biology, development, and delivery in relation with the advancements of nanotechnology, unlike any previous book. Brings together the leading experts and researchers in the field to critically assess and discuss various topics influencing drug delivery. Highlights the interplay of different scientific disciplines and the balance of requirements that are critical to molecule and product design.With the strategic focus on what matters during new product development, this book provides a guide to understanding and navigating new drug discovery and development for lung targets.

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever.Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation.Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

Completely revised and updated, this fourth edition elucidates the principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery.With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Consequently, this edition of the book emphasizes the heightened focus that the recent remarkable progress in gene editing, immunotherapy, and nanotechnology has brought to the design of new drugs and diagnostic approaches along with novel dosage forms.Apart from new chapters, this edition highlights the emerging emphasis on the role of artificial intelligence (AI) in drug discovery, mRNA and antibody-based therapies, genome editing, immunotherapy, chemical kinetics, and the stability of drug products.Features: · Includes new chapters on antibody therapeutics, gene editing, and immunotherapy.· Explains newer approaches and future methods and the significance of artificial intelligence (AI) in drug discovery. · Updated sections on pharmacy mathematics, chemical kinetics, and the stability of medicinal products. · Important updates on parenteral drug products, protein and peptide treatments, and biotechnology-based pharmaceuticals to provide a contemporary perspective on drug development, delivery, and pharmaceutical sciences.· Expansion of review questions and answers to clarify concepts for students and add to their grasp of key concepts covered in this book.Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors, and professionals, saving their time and money.•

Site-specific drug delivery and targeting attracts much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Focusing on the delivery technologies that utilize both systemic and local routes of administration, Targeted Delivery of Small and Macromolecular Drugs brings together field experts who summarize current progress and discuss novel ideas currently being explored to overcome these challenges. The contributors discuss the most promising strategies for drug targeting and also examine targeted drug delivery platforms and technologies at various stages of clinical and preclinical development, including: Active targeting Nucleic acid delivery and targeting Intracellular/organelle-specific strategies Prodrug strategies Organ or tissue-specific drug delivery Drug-polymer conjugates and micelles Stimuli-responsive systems The book demonstrates why targeted delivery is one of the most exciting contributions pharmaceutical sciences can make to drug therapy.

Site-specific drug delivery and targeting attracts much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Focusing on the delivery technologies that utilize both systemic and local routes of administration, Targeted Delivery of Small and Macromolecular Drugs brings together field experts who summarize current progress and discuss novel ideas currently being explored to overcome these challenges. The contributors discuss the most promising strategies for drug targeting and also examine targeted drug delivery platforms and technologies at various stages of clinical and preclinical development, including: Active targeting Nucleic acid delivery and targeting Intracellular/organelle-specific strategies Prodrug strategies Organ or tissue-specific drug delivery Drug-polymer conjugates and micelles Stimuli-responsive systems The book demonstrates why targeted delivery is one of the most exciting contributions pharmaceutical sciences can make to drug therapy.

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever.Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation.Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.