Book description
An examination of all aspects of the science and art of dosage form development
Integrating physical pharmacy, drug design, and drug regulation, this
book examines all the key elements needed to produce effective dosage
forms for drug delivery. It begins by setting a solid foundation of
physical pharmacy principles such as drug stability estimation,
rheology, and interfacial properties. Next, the authors explain how to
incorporate these principles into product design. Lastly, the book
integrates harmonized pharmaceutical development regulatory guidelines
and requirements with the science and technology of pharmaceutical
product design in the United States, European Union, and Japan.
Integrated Pharmaceutics offers a comprehensive portrait of
pharmaceutical product design, fully describing the science and art of
dosage form development. Readers will find clear and thorough coverage of:
- Fundamental physical pharmacy principles and their role in drug
product design
- Regulatory science section covering drug regulation, pharmacy
compounding practices, manufacturing validation, and quality
systems and controls
- Recent regulatory guidelines for quality by design, design space
analysis, process analytical technology, polymorphism
characterization, blend sample uniformity, stability protocols,
and biopharmaceutical classification systems
Each chapter includes a glossary defining key terms and a list of
references leading to the primary literature in the field. Many of the
chapters also feature case studies, reference appendices, and
practical problems, enabling readers to apply the principles set forth
in the book to solve common problems in drug product design.
With its comprehensive, multidisciplinary approach, Integrated
Pharmaceutics is recommended for graduate-level courses in
pharmacy, the pharmaceutical sciences, pharmaceutics, physical
pharmacy, drug formulation and design, and biomedicine. The book will
also enable professionals in the pharmaceutical industry to apply an
effective integrated approach to drug product design.
ANTOINE AL-ACHI, PhD, CT (ASCP), is Associate Professor of
Pharmaceutics in the College of Pharmacy & Health Sciences at
Campbell University. He is also the former head of the Formulation
Development Division of Campbell's Pharmaceutical Sciences Institute (CUPSI).
MALI RAM GUPTA, PhD, is Associate Professor of Pharmaceutical
Sciences and Director of Pharmaceutical Education & Research
Center (PERC) in the College of Pharmacy & Health Sciences. Prior
to joining the faculty at Campbell University, he spent twenty-five
years in various positions at Revlon, including director of quality
control and assurance.
WILLIAM CRAIG STAGNER, PhD, RPh, is Professor of Pharmaceutical
Sciences and Director of Campbell University's Center for Analysis of
Pharmaceutical Biomaterials. Prior to joining the faculty at Campbell,
he established the Pharmaceutics Department at Glaxo Research
Institute.
