Particles and Nanoparticles in Pharmaceutical Products

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 dosageand delivery systems.

Covers everything from manufacturing to characterization and from pharma regulations to toxicity issues Includes contributions by both academics and researchers in industrial R&D Offers the particle technology perspective on pharmaceutical products

Autorentext
About the Editors:
Dr. Henk G. Merkus has been working at Delft University of Technology for about 35 years, the last 20 years of it in Particle Characterization in the Particle Technology Group. Since over 15 years he has been a member of ISO/TC24 on Sieving and Other Methods for Particle Size Measurement. Although retired, he continues to be active in giving courses on this subject, in the Netherlands as well as in Sweden and the United Kingdom.
Merkus is the Editor of three other Springer books: "Particle Size Measurements" (2009), "Particulate Products" (2014) and "Production, Handling and Characterization of Particulate Materials" (2016), the latter two in collaboration with co-editor Gabriel M.H. Meesters.
Gabriel M. H. Meesters has a BSc and MSc in Chemical Engineering with a major in BioProcessTechnology from the Delft University of Technology. He has a PhD in Particle Technology also from the Delft University of Technology. He worked at biotechnology companies like Gist-Brocades in The Netherlands , as well as for Genencor International and currently at DSM in research and development in The Netherlands. In all these functions he was working on formulation and product development. Since 1996 he holds a part time position at the Delft University of Technology, as assistant professor at the faculty of Applied Sciences, first in the Particle Technology group, later the Nano Structured Materials Group and currently in the Product and Process Engineering group. He supervised over 15 PhD students and more than 50 MSc students. He published over 70 refereed papers, holds around 15 patents and patent applications and is co-author and co-editor of the books 'Particulate Products - Tailoring Properties for Optimal Performance' (2014; Springer) and 'Production, Handling and Characterization of Particulate Materials' (2016, Springer). He (co-) organized several international conferences in the field of particle technology and was president of the World Congress on Particle Technology in 2010.

Wim Oostra obtained his PhD in chemical engineering from Delft University of Technology. He works in Pharma since 1998. Originally he started his career in formulation development, later moving to process development and upscaling. He currently works for Abbott's Established Products Division where he is a Sr. Technical Manager in the Manufacturing Science and Technology department. While working previously for Organon, Schering Plough and MSD, Wim was a member of the corresponding quality by design (QbD) and process analytical technology (PAT) teams, and was actively involved in two QbD filings of new products, including the online control of Blend uniformity by near infräred spectroscopy (NIR). Wim was a member of the International Society for Pharmaceutical Engineering (ISPE) Product Quality Lifecycle Implementation® (PQLI) initiative and is cöchair of the European federation for pharmaceutical sciences (EuFEPS) PAT and QbD network.

Inhalt
Preface.- Author Information.- ****Introduction.- Guide to Pharmaceutical Product Quality.- Bio-Nano: Theranostic at Cellular Level.- Moving Liposome Technology from the Bench to the Oncological Patient: Towards Performance by Design.- Fundamentals of Dry Powder Inhaler Technology.- Blending and Characterization of Pharmaceutical Powders.- Guidance on Drug Substance Particle Size Controls.- Effects of Particle Size, Surface Nature and Crystal Type on Dissolution Rate.- Amorphous APIs: Improved Release, Preparation, Characterization.- Particle Properties: Impact on the Processing and Performance of Oral Extended-Release Hydrophilic Matrix Tablets.- The Role of Particulates in Film Coating of Pharmaceutical Tablets.- Particulates in Semi-solid Pharmaceutical Products.- The Side Effects of Drugs: Nanopathological Hazards and Risks.- Subject Index.