Vandana B. Patravale - Böcker

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

This book provides a comprehensive overview of synthetic polymers and their applications in designing delivery systems for the management of inflammatory diseases. It presents introductory insights into inflammatory conditions, delves into the role of synthetic polymers, and examines diverse delivery approaches. Synthetic Polymeric Materials-Based Drug Delivery Systems for Inflammatory Diseases explores the potential of synthetic polymers in designing drug delivery systems for managing inflammatory diseases, including inflammatory lung diseases, inflammatory bowel diseases, and inflammatory skin diseases, as well as other conditions like cancer, neurodegenerative disorders, rheumatoid arthritis, and eye-related inflammatory conditions. It also discusses the role of synthetic polymers in modulating immune system responses in different disease conditions. Furthermore, it analyzes the 3D printing technologies employed for the preparation of drug delivery systems based on synthetic polymers. Toward the end, the book highlights the challenges and prospects of synthetic polymers in designing delivery systems for the effective management of inflammatory diseases and their clinical usage. This book is intended for researchers and professionals in the fields of pharmaceutical sciences, nanotechnology, and drug delivery systems.Key FeaturesHighlights the role of a synthetic polymer-based drug delivery system against inflammatory responsesExplores the cutting-edge technology of 3D printing and its application in preparing drug delivery systems based on synthetic polymersProvides valuable insights into how synthetic polymers can be used to modulate immune system responsesPresents regulatory compliance using synthetic polymers in drug delivery systems for inflammatory diseasesExamines challenges associated with synthetic polymers in drug delivery systems for inflammatory diseases

The commercial production of nanomedicines involves challenges related to scalability, reproducibility, safety, and regulatory approvals. It is essential to have access to a preparation method that can produce large quantities of nanomedicines in a scalable way while maintaining a consistently high level of quality and batch-to-batch reproducibility. This book provides comprehensive guidance on the commercial-scale production of nanotechnology-based products, facilities requirements, and quality assurance.Authored by industrial and academic expertsOffers regulatory guidance on the chemistry, manufacturing, and controls (CMC) of nanoparticles and commercial translation of nanomedicines from the lab to marketFeatures case studies of successfully marketed nanotechnologiesThis book serves as a valuable resource for students and researchers in pharmaceutics, pharmaceutical technology, drug delivery, drug targeting, and biomedical engineering.It also supports industrial personnel working in nanomedicine manufacturing with the latest updates and those seeking to switch or extend their current product range to nanomedicines or start a new venture in nanomedicine production.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Parenteral delivery of hydrophobic drugs is a challenging task. Research on exploiting newer approachesto make the delivery of pharmaceuticals by nondigestive tracts effective yet safe and cost effective showsthat microemulsion is one such approach for parenteral delivery. This new book provides systematicinformation regarding the preformulation of drugs, formulation using quality by design (QbD) principles,and characterization of parenteral microemulsions for drug delivery. The book explores specific aspectsof microemulsions such as the role of surfactants and cosurfactants in formulation, clinical aspects ofparenteral microemulsion, regulatory perspectives and patents, as well as future challenges in this fieldof research.

The COVID-19 pandemic has altered the world and reiterated the perpetual need for the development of effective strategies for the prevention and treatment of infectious diseases. While globally prevalent infectious diseases receive extensive attention in terms of drug development and delivery, the neglected and/or emerging infectious diseases that affect developing countries are often overlooked. Additionally, the therapeutic efficacy of existing anti-infective agents is often limited due to sub-optimal biopharmaceutical properties, sub-therapeutic levels of the drugs at the infection site due to various physiological barriers, the expulsion of the drug by efflux transporters, and the emergence of drug-resistant strains.From the commercialization of AmBisome® to the emergency authorization of mRNA-based vaccines, nanotechnology has played a vital role in the prevention and treatment of infectious diseases. More importantly, nanotechnology has enabled the effective utilization ofexisting armamentarium against infectious diseases leading to improved therapeutic outcomes with a concomitant reduction in the side effects associated with anti-infective agents. In particular, nanotechnology can bring about a paradigm shift in the management of neglected and emerging infectious diseases and may compensate for the lack of drug discovery efforts. While there are several books dedicated to pharmaceutical and/or biomedical applications of nanotechnology or nanotechnology for cancer therapy a comprehensive book focusing on the prevention and/or treatment of viral, bacterial, fungal, and parasitic infections is not available. This book addresses an unmet need in pharmaceutical and medical education.This book provides a comprehensive and up-to-date overview of the latest advancements in nanomedicine, which show great potential for preventing and treating infectious diseases. Covering a wide range of topics, it explores various formulation strategies for combating microbial, fungal, parasitic, and viral infections. The book emphasizes the advantages of nano-scale vaccines over traditional ones and discusses their production. It also examines feasible treatment approaches for diseases like malaria, trypanosomiasis, candidiasis, Hepatitis B, HIV, and the ongoing COVID-19 pandemic. Additionally, it highlights the role of nano-adjuvants in vaccine development, as well as the use of peptide antibiotics and pulmonary delivery of drugs, which open up new possibilities in fighting infectious diseases. Furthermore, the book explores the critical role of nanomedicine in addressing veterinary parasitic infections. The emergence of nanotechnology has led to novel strategies for diagnosing, treating, and preventing parasitic infections in animals.In summary, this book offers a comprehensive description of clinically viable and investigational nanotechnology-enabled medicines (nanomedicines) for the prevention and treatment of globally prevalent, neglected, and emerging infectious diseases.

The COVID-19 pandemic has altered the world and reiterated the perpetual need for the development of effective strategies for the prevention and treatment of infectious diseases.