Formulation and Analytical Development for Low-Dose Oral Drug Products

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students. excipient background, manufacturing platform technology, using fluidized bed granulation, drug particle size distribution, solid oral drug products, drug substance particle size, granulation vehicle, dry granulation processing, pharmaceutical development report, cleaning verification assays, content uniformity criteria, volume dissolution vessels, product content uniformity, ideal mixing model, fluidized bed granulation process, small volume vessels, dissolution method development, cut potency, charged aerosol detection, granulation particle size distribution, poor content uniformity, tooling strength, final blending process, percentage drug dissolved, tablet content uniformity