Physical Characterization Of Pharmaceutical Solids

This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.

The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection

Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis Illustrates the various phases or forms that solids can assume and discussesvarious issues related to the relative stability of solid forms and tendencies to undergo transformation Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time

Edited by one of the leading experts in the field, this handbook emphasizes why solid-state issues are important, which approaches should be taken to avoid problems and exploit the opportunities offered by solid state properties in the pharmaceutical and agricultural industries. With its practical approach, this is at once a guideline for development chemists just entering the field as well as a high-quality source of reference material for specialists in the pharmaceutical and chemical industry, structural chemists, physicochemists, crystallographers, inorganic chemists, and patent departments.

Meeting the need for a hands-on guide elucidating the role of molecular spectroscopy in the physical characterization of pharmaceutical solids, two experts from the industry gather theoretical discussions of infrared, Raman, and nuclear magnetic resonance spectroscopy. They provide recommendations on spectral data acquisition techniques and include 600 spectra for 300 of the most commonly used excipients. Complete with references, equations, tables, and a CAS registry number index, the book covers the drug development process, including chemical identification of substances, investigative studies, competitor analysis, problem solving activities, reproduction of spectral data, and more.

Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.

Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. * Presents comprehensive reviews covering all aspects of drug development and formulation of drugs * Now encompassing critical review chapters * Meets the information needs of the drug development community

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. Contributions from leading authorities Informs and updates on all the latest developments in the field

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 44, presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. The series encompasses review articles, with this release focusing on Cefpodoxime proxetil, Levetiracetam, Paclitaxel, Sorafenib, Sucrose octaacetate, Thiouracil, Topiramate, Spectrophotometric analysis, and Cocrystal Systems of Pharmaceutical Interest: 2012-2014. Contains contributions from leading authorities Informs and updates on all the latest developments in the field of drug substances, excipients and methodologies