Spectroscopic and chemometric methods have become routinely applied tools in pharmaceutical industries because they reduce the analysis time and minimize the use of chemicals. The contents of this digital primer are to help newcomers in the field by providing basic content information about various spectroscopic and chemometric tools used in pharmaceutical analysis.
This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.
This book takes a systematic approach to address the gaps relating to nanomedicine and bring together fragmented knowledge on the advances on nanomaterials and their biomedical applicability. In particular, it demonstrates an exclusive compilation of state of the art research with a focus on fundamental concepts, current trends, limitations, and future directions of nanomedicine.
The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. - Provides an overview of practical information for clinical trials - Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) - Examines recent developments and suggests future directions for drug production methods and techniques
Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
Amorphous solid dispersion (ASD) is a powerful formulation technology to improve oral absorption of poorly soluble drugs. Despite their being in existence for more than half a century, controlling ASD performance is still regarded as difficult because of ASD’s natural non-equilibrium. However, recent significant advances in ASD knowledge and technology may enable a much broader use of ASD technology. This Special Issue, which includes 3 reviews and 6 original articles, focuses on recent progresses in ASD technology in hopes of helping to accelerate developmental studies in the pharmaceutical industry. In striving for a deep understanding of ASD non-equilibrium behavior, the Special issue also delves into and makes progress in the theory of soft-matter dynamics.
In the process industry, understanding the unit operation of particulate drying is imperative to yield products with desired properties and characteristics and to ensure process safety, optimal energy efficiency and drying performance, as well as low environmental impact. There are many techniques and tools available, which can cause confusion. Particulate Drying: Techniques and Industry Applications provides an overview of various particulate drying techniques, their advantages and limitations, industrial applications, and simple design methods. This book: • Covers advances in particulate drying and their importance in the process industry • Highlights recent developments in conventional drying techniques and new drying technologies • Helps readers gain insight into selecting the appropriate drying techniques for a particular product • Summarizes various applications from a wide range of industries, including chemical, food, pharmaceutical, biotech, polymer, mineral, and agro-industries • Projects future research trends and demands in particulate drying This book serves as a reference for process and plant engineers as well as researchers in the fields of particulate processing, mineral processing, food processing, chemical engineering, and mechanical engineering, especially those involved in the selection of drying equipment for particulate solids and R&D of drying of particulate materials.
This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.
This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development.Shows how to overcome pharmaceutical, technological, and economic constraint
Providing optimal care to patients is a primary concern in the healthcare field. By utilizing the latest resources and research in biomedical applications, the needs and expectations of patients can be successfully exceeded. Novel Approaches for Drug Delivery is an authoritative reference source for the latest scholarly research on emerging developments within the pharmaceutical industry, examining the current state and future directions of drug delivery systems. Highlighting therapeutic applications, predictive toxicology, and risk assessment perspectives, this book is ideally designed for medical practitioners, pharmacists, graduate-level students, scientists, and researchers.
