Particles and Nanoparticles in Pharmaceutical Products: Design, Manufacturing, Behavior and Performance (AAPS Advances in the Pharmaceutical Sciences Series (29))

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. Front Matter ....Pages i-xii Introduction (Henk G. Merkus)....Pages 1-52 Guide to Pharmaceutical Product Quality (Henk G. Merkus)....Pages 53-83 Bio-nano: Theranostic at Cellular Level (Martin Kluenker, Sven Kurch, Muhammad Nawaz Tahir, Wolfgang Tremel)....Pages 85-170 Moving Liposome Technology from the Bench to the Oncological Patient: Towards Performance-by-Design (Ana Filipa Cruz, Nuno A. Fonseca, Ana C. Gregório, Vera Moura, Sérgio Simões, João Nuno Moreira)....Pages 171-211 Fundamentals of Dry Powder Inhaler Technology (Anthony J. Hickey)....Pages 213-232 Blending and Characterization of Pharmaceutical Powders (Carl A. Anderson, Natasha L. Velez)....Pages 233-275 Guidance on Drug Substance Particle Size Controls for Solid Oral Dose Forms (Jon Hilden, Christopher L. Burcham, Stephen D. Stamatis, Jim Miesle, Carrie A. Coutant)....Pages 277-302 Effects of Particle Size, Surface Nature and Crystal Type on Dissolution Rate (Giuseppina Sandri, Maria Cristina Bonferoni, Silvia Rossi, Carla M. Caramella, Franca Ferrari)....Pages 303-328 Amorphous APIs: Improved Release, Preparation, Characterization (Sheila Khodadadi, Gabriel M. H. Meesters)....Pages 329-346 Particle Properties: Impact on the Processing and Performance of Oral Extended-Release Hydrophilic Matrix Tablets (Peter Timmins, Carl Allenspach)....Pages 347-372 The Role of Particulates in Film Coating of Pharmaceutical Tablets (Anneke M. Dijkhuis-Bouwman)....Pages 373-398 Particulates in Semi-Solid Pharmaceutical Products (David Harris)....Pages 399-428 The Side Effects of Drugs: Nanopathological Hazards and Risks (Antonietta M. Gatti, Stefano Montanari)....Pages 429-443 Back Matter ....Pages 445-446