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Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field. Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications fo...
Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in
The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to come--maintaining currency through its supplements [Volume 18/Supplement 1: Published November, 1998] The Encyclopedia contains interdisciplinary contributions in a wide array of subjects, including Drugs decomposition metabolism pharmaceutical incompatibilities pharmacokinetics physicochemical properties preformulation stability Drug Delivery Systems and Devices-Development and Manufacture analysis and controls bioavailability use of computerization formulation and processing alternatives national and international registration packaging patents process validation scale-up safety and efficacy stability standards Post-Production and Practical Considerations governmental/industrial/professional organizations legal aspects national and international agencies patent life of drugs patient compliance ...and much, much more!
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
This volume presents the most up-to-date and detailed information available on protein-based biopolymer films and coatings. It provides a comprehensive overview of the design, technology, properties, functionality, and applications of biopolymer films and coatings (edible and inedible) from plant and animal proteins. Both widely commercialized and
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes
The Comprehensive, Single-Source Reference on Multiple Emulsions In theory, multiple emulsions have significant potential for breakthrough applications in food, agricultural, pharmaceutical, nutraceutical, and cosmetic industries in which they can facilitate the sustained release and transport of active material. However, in practice, multiple emulsions are thermodynamically unstable. This book presents recent findings that can help formulators understand how to enhance their stability. With chapters contributed by leading experts from around the world, it covers the definition and properties of multiple emulsions, their formation and stability, and potential applications, with an emphasis o...
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the moder...
This book approaches the subject from a mechanistic perspective that pitches the language at a level that is understandable to those entering the field and who are not familiar with its common phrases or complex terms. It provides a simple encapsulation of concepts and expands on them. In each chapter the basic concept is explained as simply and clearly as possible without a great deal of detail, then in subsequent sections additional material, exceptions to the general rule, examples, etc., is introduced and built up. Such material was generously supplemented with diagrams; conceptually elegant line diagrams in two or three colors. The artwork was well thought out and able to condense the scientific principles into a novel and visually exciting form. The diagrams encourage browsing or draw the reader to salient points. In addition, the technique of highlighting key concepts in a separate box is used throughout each chapter.