ABSTRACT

INTRODUCTION Modified-release (MR) dosage forms have represented a broad segment of research and development in the pharmaceutical industry for many years. Incorporating an existing drug into a new drug delivery system can significantly improve its performance in terms of efficacy, safety, and patient compliance. Oral ingestion is by far the most popular route of drug administration, providing a convenient method to release drugs in a controlled and predetermined fashion and/or target to selective sites in the gastrointestinal (GI) tract. However, neither in the scientific literature nor in current pharmacopoeias can a harmonized definition of modified release for oral delivery be found.