Pharmaceutical Powder Compaction Technology


Book Description

Compaction of powder constituents-both active ingredient and excipients-is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists,




Chemical Engineering in the Pharmaceutical Industry


Book Description

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.




Pharmaceutical Dosage Forms - Tablets


Book Description

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an




Chemical Engineering in the Pharmaceutical Industry


Book Description

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.




Handbook of Pharmaceutical Granulation Technology


Book Description

Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies




Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems


Book Description

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.




Adhesion of Dust and Powder


Book Description

ties on adhesion (Chapter V); and the detachment of particles by an air stream (Chapter X). The other chapters have undergone substantial revision: New material has been introduced, and topics such as autohesion, wetting, film ad hesion, and surface washing have been eliminated. The expansion of research on adhesive interaction has led to many joint endeavors with students and followers; the author gives special thanks to G. A. Serebryakov, K. A. Lazarev, E. I. Andrianov, E. I. Dergunov, and E. A. Ronginskii. Many years of creative cooperation bind the author to the staff of the Omsk Branch of the Frunze Polytechnic Institute, headed by Zh. T. Tekenov, Candidate of Physico mathematical Sciences. The author thanks Professor G.1. Fuks, Doctor of Chemical Sciences, for his help in the preparation of the first and second editions of this monograph; his constructive criticism and gracious assistance have raised the level of quality of the material set forth here. In the preparation of this book, as in all the previous books, inestimable help has been given by my wife, Antonina Alekseevna Zimon, without whose participation it would have been unthinkable to carry out such a volume of work.




Pharmaceutical Dosage Forms


Book Description




Powder Flow


Book Description

Powder flow has attracted increased attention in recent years as novel formulated and functional products are being developed in powder forms, particularly in pharmaceutical and high value additive manufacturing industries. This book meets a need for a truly integrated modern treatment of dry powder flow, covering theory, robust characterisation techniques, modelling tools and applications. Written by leaders in the field, the book opens by introducing the wide range of powder processing problems faced by industry, the complexities of powders and the myriad of ways their flow behaviour can be characterised. The authors then move on, with contributions from experts, to describe fundamental properties that can be measured, defining the states of stress and shear rate and the considerations that need to be taken account. By providing a comprehensive treatment of all available characterisation techniques, as well as various modelling tools, the reader obtains a clear, practical overview. Case studies and applications connect theory to practical examples across a broad range of industries. This book stands out by not only providing the reader with guidance on what to measure but also how to interpret results, ensuring this is an invaluable text for anyone working on powder flow in the chemical, pharmaceutical and manufacturing industries, as well as students and researchers across chemical and process engineering disciplines.




Pharmaceutical Excipients


Book Description

This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients