Pharmaceutical Blending And Mixing

Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

This edited volume brings together the expertise of numerous specialists on the topic of particles – their physical, chemical, pharmacological and toxicological characteristics – when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.

This volume is a valuable reference work for the student and the practising engineer in the chemical, pharmaceutical, minerals, food, plastics, paper and metallurgical industries. The second edition of this successful text has been thoroughly rewritten and updated. Based on the long running post-experience course produced by the University of Bradford, in association with the Institution of Chemical Engineers, it covers all aspects of mixing, from fundamentals through to design procedures in single and multi-phase systems. Experts from both industry and academia have contributed to this work giving both a theoretical practical approach. It covers dry and wet powders, single and two-phase liquids, solid/liquid and gas/liquid systems. The range of mixers available for such diverse duties is dealt with, including tumbler mixers for powders, mechanically agitated vessels, in-line continuous mixers and jet mixers. Coverage is given of the range of mixing objectives, varying from achieving product uniformity to obtaining optimum conditions for mass transfer and chemical reactions. This volume is a valuable reference work for the student and the practising engineer in the chemical, pharmaceutical, minerals, food, plastics, paper and metallurgical industries. The second edition of this successful text has been thoroughly rewritten and updated. Based on the long running post-experience course produced by the University of Bradford, in association with the Institution of Chemical Engineers, it covers all aspects of mixing, from fundamentals through to design procedures in single and multi-phase systems. Experts from both industry and academia have contributed to this work giving both a theoretical practical approach. It covers dry and wet powders, single and two-phase liquids, solid/liquid and gas/liquid systems. The range of mixers available for such diverse duties is dealt with, including tumbler mixers for powders, mechanically agitated vessels, in-line continuous mixers and jet mixers. Coverage is given of the range of mixing objectives, varying from achieving product uniformity to obtaining optimum conditions for mass transfer and chemical reactions.

Handbook of Industrial Mixing will explain the difference and uses of a variety of mixers including gear mixers, top entry mixers, side entry mixers, bottom entry mixers, on-line mixers, and submerged mixers The Handbook discusses the trade-offs among various mixers, concentrating on which might be considered for a particular process. Handbook of Industrial Mixing explains industrial mixers in a clear concise manner, and also: * Contains a CD-ROM with video clips showing different type of mixers in action and a overview of their uses. * Gives practical insights by the top professional in the field. * Details applications in key industries. * Provides the professional with information he did receive in school

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

The transition from traditional batch blending to continuous blending is an opportunity for the pharmaceutical industry to reduce costs and improve quality control. This operational shift necessitates a deeper understanding of the mixing process informed by particle dynamics and variable interdependencies. The thesis aims to establish a framework for characterizing and improving continuous pharmaceutical blending using a tiered experimental methodology and multivariate analysis. This parameter space exploration attempts to reconcile previous research within the context of cohesive pharmaceutical powders and develop general design principles for maximizing blender performance. A design of experiments was conducted to determine mixing performance with respect to three factors - physical design, operating parameters, and material properties. Multivariate analysis using projections to latent structures was employed to quantify the effect of raw and intermediate variables on the variance reduction ratio. Significant parameters identified included the choice of API, fill fraction, the number of blade passes, the mean residence time, the Bodenstein number, and the period of input feed fluctuations. The results highlight the importance of shear and radial mixing for cohesive powders, which suggest that one-dimensional axial models common in blending literature may not be a sufficient theoretical framework for pharmaceutical applications. The research yielded several insights into design principles for optimizing blending performance. Increasing mean residence time and radial mixing create more robust processing by reducing the impact of material properties and fluctuations in feed consistency. The variance reduction ratio can be improved in a cost-effective manner by determining the fill fraction which maximizes intermediate metrics such as space time, mean residence time, and the number of blade passes. Multivariate analysis was demonstrated to be a practical tool for parameter space optimization and a promising technique for characterizing the effect of material properties on processing.

The operation of a powder mixer requires a knowledge not only of the mixing mechanisms but of the physical properties of the powders being mixed. Powder Mixing is unique in that it explores the relevant physics of the powder systems including characterization procedures and rheology, and contains an extensive review of different methods that have been employed to study the structure of mixtures. The techniques for achieving structured mixtures such as microencapsulation, and recent developments in deterministic chaos theory and fractal geometry as applied to the study of powder mixing systems, are reviewed. In particular, new techniques for studying the mixing powders based on avalanching theory and critically self-organized systems are studied. These are followed by a review of the wide range of different mixers commercially available and an extensive bibliography. Powder Mixing is an essential reference for all those interested in the basic science of powder mixing and the availability of industrial systems to achieve a mixture of different kinds. The main emphasis of the text is on working principles and operative systems, and is suitable for industrial workers, chemical engineers and students alike.

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.

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Advances in Industrial Mixing is a companion volume and update to the Handbook of Industrial Mixing. The second volume fills in gaps for a number of industries that were not covered in the first edition. Significant changes in five of the fundamental areas are covered in entirely updated or new chapters. The original text is provided as a searchable pdf file on the accompanying USB. This book explains industrial mixers and mixing problems clearly and concisely. Gives practical insights by the top professionals in the field, combining industrial design standards with fundamental insight. Details applications in 14 key industries. Six of these are new since the first edition. Provides the professional with information he/she did not receive in school. Five completely rewritten chapters on mixing fundamentals where significant advances have happened since the first edition and seven concise update chapters which summarize critical technical information.