HPLC/UHPLC

Abstract

Includes index. The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research. Preface; Contents; Contributors; Editor's Biography; Part I: Spectroscopic and Spectrometric Techniques; Chapter 1: UV/Vis Spectrophotometry and UV Imaging; 1 Introduction; 2 Principles of Measurement; 2.1 Lambert-Beerś Law; 2.2 Deviations from Lambert-Beerś Law and Sources of Error; 3 Instrumentation; 3.1 Single Beam Spectrophotometers; 3.2 Double Beam Spectrophotometers; 3.3 Photodiode Array and Charge-Coupled Device Spectrophotometers; 3.3.1 Micro-volume Spectrophotometers; 3.3.2 UV Fiber Optic Probes; 3.4 UV Imaging; 4 Applications of UV/Visible Spectrophotometry. 4.1 Qualitative Analysis4.2 Quantitative Analysis; 4.3 Physicochemical Properties; 4.3.1 pKa Values; 4.3.2 Equilibrium Constants and Complexation; 4.3.3 Kinetics and Reaction Monitoring; 4.3.4 Dissolution Testing; 5 Applications of UV Imaging; 5.1 Drug Dissolution; 5.2 Drug Diffusion and Release; 6 Conclusions and Perspectives; References; Chapter 2: Fluorescence Spectroscopy: Basic Foundations and Methods; 1 A Brief Historical Overview; 2 Foundations of the Fluorescence Phenomenon and Typical Fluorescent Parameters; 2.1 Absorption and the Beer-Lambert Law. 2.2 Fluorescence Lifetimes and Fluorescence Quantum Yields2.3 Fluorescence Emission Spectra; 2.4 Fluorescence Excitation Spectra; 2.5 Fluorescence Polarization; 2.6 Other Useful Fluorescence Related Methods; 2.6.1 Quenching of Fluorescence; 2.6.2 Förster Resonance Energy Transfer (FRET); 2.6.3 Fluorescence Fluctuations-Based Approaches; 3 Fluorescence Markers and Reporters; 4 Some Instrumental Considerations; 4.1 Steady State Fluorescence Excitation and Emission Spectra; 4.2 Fluorescence Lifetimes; 5 Pharmaceutical Applications. 5.1 Human Serum Albumin: Drug Interactions Studied by Fluorescence Methods5.2 Do Liposomes Penetrate Skin?; 6 Concluding Remarks; References; Chapter 3: Mid and Near Infrared Spectroscopy; 1 Theoretical Background, Instrumentation and Data Analysis; 1.1 The Origin of Mid and Near Infrared Spectra; 1.2 MIR Instrumentation and Sampling; 1.3 NIR Instrumentation and Sampling; 1.4 Spectral Data Analysis; 2 Practical Challenges of Multivariate NIR Method Implementation; 2.1 Qualitative Analysis; 2.2 Quantitative Analysis. 3 Application in Solid-State Characterization of Drug Molecules and Excipients3.1 Determination of Water Content and Hydration State; 3.2 Identification and Quantification of Polymorphic Forms; 3.3 Cocrystal Characterization; 3.4 Assessment of Crystallinity and Amorphous State; 4 Use as Real-Time PAT Tools in Drug Substance Manufacture; 4.1 Reaction Monitoring; 4.2 Crystallization; 4.3 Drying; 5 Application on Solid Oral Dosage Forms; 5.1 Molecular Characterization of Solid Dispersions; 5.2 Challenges of Particle Size Determination; 5.3 Nondestructive Tablet Hardness Testing.