Formulation and Analytical Development for Low-Dose Oral Drug Products

Tested-and-proven strategies for developing and manufacturing low-dose oral drug products

Developing and commercializing a low-dose oral drug product presents a number of hurdles that can quickly offset the drug's benefits. Written by a team of leading scientists in drug development, this book collects and synthesizes the knowledge, techniques, and strategies needed for developing low-dose drugs successfully. With this book's practical support, readers can overcome the hurdles at all stages in drug development, from formulation to manufacturing and control to regulatory compliance.

Following an overview of the drug discovery and development process, the book is divided into four parts:

• Part One examines formulation and process development of low-dose drugs, including theoretical considerations concerning the particle size of the drug substance and content uniformity, micronization of the drug substance, and manufacturing platform technologies.

• Part Two focuses on challenges in analytical method development, including analytical control strategy, physical characterization of the micronized powder and the solid state of the active pharmaceutical ingredient in dosage forms, and cleaning verification of manufacturing equipment.

• Part Three investigates containment technologies used in analytical laboratories and manufacturing plants.

• Part Four deals with important regulatory considerations.

Readers learn how a variety of analytical methodologies are used in low-dose drug development, including dissolution testing, NMR, HPLC, and X-ray diffraction. Moreover, the book explains several possible manufacturing techniques, such as wet granulation, roller compaction, and direct compression alongside containment technologies for highly potent drugs. Case studies throughout the book demonstrate how particular strategies and techniques are applied in practice.

Pharmaceutical scientists as well as students will find overcoming the obstacles in developing low-dose drug products much easier when they have this book on hand to consult at all stages in the drug development and manufacturing process.

Doody Review Services

Reviewer:Joseph Boullata, PharmD(University of Pennsylvania College of Nursing)
Description:This welcome addition to books on dosage formulations has as its focus the challenging issue of developing and bringing to market oral drug products containing a low dose (< 1 mg) of active ingredient. These include widely used products such as oral contraceptives and thyroid hormone replacement.
Purpose:The objective is to provide a concise review of the development of low-dose drug products from pharmaceutical, analytical, and regulatory perspectives.
Audience:This book is written primarily for formulation scientists, analytical scientists, and regulatory specialists who will deal with low-dose oral drug products in industry or academia, as well as graduate students and postdoctoral fellows preparing for the field.
Features:Following an excellent overview chapter by the editor, the book is divided into four sections. The first section on formulation development provides detailed information on strategies dealing with particle size and process methods issues. The second section discusses analytical methods for low dose products given the challenges of such low quantities of active ingredient. The third section has two chapters on technology for containment related to the potency of the active ingredient. The last section includes a final chapter on regulatory considerations. Among the book's outstanding features are 97 tables, 74 figures, some color plates, and dozens of equations. Numerous formulation case studies are provided. The referencing format is not consistent across the chapters, but the 7-page index appears to be adequate. The contributors come predominantly from industry, and it is unfortunate not to have more from academia and regulatory bodies.
Assessment:This book is unique in its depth of coverage of the topic.

Jack Zheng, PhD, is Research Advisor and Team Leader in the Pharmaceutical Sciences R&D Division of Eli Lilly and Company and Adjunct Professor at Beijing University. Dr. Zheng is the author of more than thirty articles and several book chapters. He has been invited to present his work at numerous national and international scientific meetings. He was involved in more than ten new drug product development and regulatory filing with the Food and Drug Administration.