Recent major advances in particle size analysis, particularly with regard to its application in the pharmaceutical and related industries, provides justification for this title. It is a book for technicians and senior technicians, project and development managers, and formulation More...development scientists in a wide range of industries, pharmace
At Particle Analytical, we have been working with determination of particle sizes for the pharmaceutical industry since 2000. Our customers have in general showed a large interest for an introduction to this area from a down-to-earth and practical perspective. The intended readers of this booklet are pharmacists and technicians working with determination of particles sizes. This booklet is not meant as a thorough introduction into theory behind determination of particle sizes, and only a limited number of references will be given: The booklet is primarily based on our own experiences and is a practical introduction to the area with a brief introduction to "why" and "how" in determination of particle sizes.
Learn about the analytical tools used to characterize particulate drug delivery systems with this comprehensive overview Edited by a leading expert in the field, Characterization of Pharmaceutical Nano- and Microsystems provides a complete description of the analytical techniques used to characterize particulate drug systems on the micro- and nanoscale. The book offers readers a full understanding of the basic physicochemical characteristics, material properties and differences between micro- and nanosystems. It explains how and why greater experience and more reliable measurement techniques are required as particle size shrinks, and the measured phenomena grow weaker. Characterization of Pharmaceutical Nano- and Microsystems deals with a wide variety of topics relevant to chemical and solid-state analysis of drug delivery systems, including drug release, permeation, cell interaction, and safety. It is a complete resource for those interested in the development and manufacture of new medicines, the drug development process, and the translation of those drugs into life-enriching and lifesaving medicines. Characterization of Pharmaceutical Nano- and Microsystems covers all of the following topics: An introduction to the analytical tools applied to determine particle size, morphology, and shape Common chemical approaches to drug system characterization A description of solid-state characterization of drug systems Drug release and permeation studies Toxicity and safety issues The interaction of drug particles with cells Perfect for pharmaceutical chemists and engineers, as well as all other industry professionals and researchers who deal with drug delivery systems on a regular basis, Characterization of Pharmaceutical Nano- and Microsystems also belongs on bookshelves of interested students and faculty who interact with this topic.
This book focuses on the practical aspects of particle size measurement: a major difference with existing books, which have a more theoretical approach. Of course, the emphasis still lies on the measurement techniques. For optimum application, their theoretical background is accompanied by quantitative quality aspects, limitations and problem identification. In addition the book covers the phenomena of sampling and dispersion of powders, either of which may be dominant in the overall analysis error. Moreover, there are chapters on the general aspects of quality for particle size analysis, quality management, reference materials and written standards, in- and on-line measurement, definitions and multilingual terminology, and on the statistics required for adequate interpretation of results. Importantly, a relation is made to product performance, both during processing as well as in final application. In view of its set-up, this book is well suited to support particle size measurement courses.
Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.
This is the fifth edition of the highly successful work first published in 1968, comprising two definitive volumes on particle characterisation. The first volume is devoted to sampling and particle size measurement, while surface area and pore size determination are reviewed in volume 2. Particle size and characterisation are central to understanding powder properties and behaviour. This book describes numerous potential measuring devices, how they operate and their advantages and disadvantages. It comprise a fully comprehensive treatise on the wide range of available equipment with an extensive literature survey, and a list of manufacturers and suppliers. The author's blend of academic and industrial experience results in a readable technical book with information on how to analyse, present, and extract useful information from data. This is an essential reference book for both industrial and academic research workers in a variety of areas including: pharmaceuticals, food science, pollution analysis and control, electronic materials, agricultural products, polymers, pigments and chemicals.
Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.
This book focuses on practical, proven applications to automate the microbial identification process economically and with greater levels of safety and quality for patients. A diverse group of recognized experts survey the topic and present the latest techniques and technologies for microbial detection. They cover bacteria and yeasts, the technology of automation, equipment, methods, and the validation issues involved in "going automated." They also explore the challenges of detection and quantititation of contaminants in the increasing number of biologic injectable drugs and identify current trends in the industry. Features
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
