This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Controlled Release in Oral Drug Delivery provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.

Controlled release dosage form is a dosage form that release one or more drugs continuously in predetermined pattern for a fixed period of time, either systemically or locally to specified target organ. Greater attention is paid on development of oral controlled release drug delivery systems due to flexibility in designing of dosage form. The main challenges to oral drug delivery systems are to deliver a drug at therapeutically effective rate to desirable site, modulation of GI transit time and minimization of first pass elimination. Control release dosage form provides better maintenance of optimal and effective drug level for prolonged duration with less dosing frequency and side effects.

The goal of every drug delivery system is to deliver the precise amount of a drug at a pre-programmed rate to the desired location in order to achieve the drug level necessary for the treatment. An essential guide for biomedical engineers and pharmaceutical designers, this resource combines physicochemical principles with physiological processes to facilitate the design of systems that will deliver medication at the time and place it is most needed.

ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (GIT) and detailing the conditions and absorption processes occurring in the GIT that determine a formulation’s oral bioavailability. The second section explores the design of modified release formulations, covering early drug substance testing, the biopharmaceutics classification system, an array of formulation technologies that can be used for MR dosage forms, and more. The final section focuses on in vitro, in silico, and in vivo evaluation and regulatory considerations for MR formulations. Topics include biorelevant dissolution testing, preclinical evaluation, and physiologically-based pharmacokinetic modelling (PBPK) of in vivo behaviour. Featuring contributions from leading researchers with expertise in the different aspects of MR formulations, this volume: Provides authoritative coverage of physiology, physicochemical determinants, and in-vitro in-vivo correlation (IVIVC) Explains the different types of MR formulations and defines the key terms used in the field Discusses the present status of MR technologies and identifies current gaps in research Includes a summary of regulatory guidelines from both the US and the EU Shares industrial experiences and perspectives on the evaluation of MR dosage formulations Oral Drug Delivery for Modified Release Formulations is an invaluable reference and guide for researchers, industrial scientists, and graduate students in general areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.